[Congressional Record Volume 158, Number 79 (Wednesday, May 30, 2012)]
[House]
[Pages H3192-H3230]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012
Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill
(H.R. 5651) to amend the Federal Food, Drug, and Cosmetic Act to revise
and extend the user-fee programs for prescription drugs and for medical
devices, to establish user-fee programs for generic drugs and
biosimilars, and for other purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 5651
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Administration
Reform Act of 2012''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References in Act.
TITLE I--FEES RELATING TO DRUGS
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.
TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2012
Sec. 201. Short title; findings.
[[Page H3193]]
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Savings clause.
Sec. 206. Effective date.
Sec. 207. Sunset clause.
Sec. 208. Streamlined hiring authority to support activities related to
the process for the review of device applications.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. Amendment with respect to misbranding.
Sec. 307. Streamlined hiring authority to support activities related to
human generic drugs.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding.
Sec. 402. Fees relating to biosimilar biological products.
Sec. 403. Reauthorization; reporting requirements.
Sec. 404. Sunset dates.
Sec. 405. Effective date.
Sec. 406. Savings clause.
Sec. 407. Conforming amendment.
TITLE V--REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT AND
PEDIATRIC RESEARCH EQUITY ACT
Sec. 501. Permanent extension of Best Pharmaceuticals for Children Act
and Pediatric Research Equity Act.
Sec. 502. Food and Drug Administration Report.
Sec. 503. Internal Committee for Review of Pediatric Plans,
Assessments, Deferrals, Deferral Extensions, and Waivers.
Sec. 504. Staff of Office of Pediatric Therapeutics.
Sec. 505. Continuation of operation of Pediatric Advisory Committee.
Sec. 506. Pediatric Subcommittee of the Oncologic Drugs Advisory
Committee.
TITLE VI--FOOD AND DRUG ADMINISTRATION ADMINISTRATIVE REFORMS
Sec. 601. Public participation in issuance of FDA guidance documents.
Sec. 602. Conflicts of interest.
Sec. 603. Electronic submission of applications.
Sec. 604. Notification of FDA intent to regulate laboratory-developed
tests.
TITLE VII--MEDICAL DEVICE REGULATORY IMPROVEMENTS
Subtitle A--Premarket Predictability
Sec. 701. Investigational device exemptions.
Sec. 702. Clarification of least burdensome standard.
Sec. 703. Agency documentation and review of significant decisions.
Sec. 704. Transparency in clearance process.
Sec. 705. Device Modifications Requiring Premarket Notification Prior
to Marketing.
Subtitle B--Patients Come First
Sec. 711. Establishment of schedule and promulgation of regulation.
Sec. 712. Program to improve the device recall system.
Subtitle C--Novel Device Regulatory Relief
Sec. 721. Modification of de novo application process.
Subtitle D--Keeping America Competitive Through Harmonization
Sec. 731. Harmonization of device premarket review, inspection, and
labeling symbols; report.
Sec. 732. Participation in international fora.
Subtitle E--FDA Renewing Efficiency From Outside Reviewer Management
Sec. 741. Reauthorization of Third Party Review.
Sec. 742. Reauthorization of third party inspection.
Subtitle F--Humanitarian Device Reform
Sec. 751. Expanded access to humanitarian use devices.
Subtitle G--Records and Reports on Devices
Sec. 761. Unique device identification system regulations.
Sec. 762. Effective device sentinel program.
Subtitle H--Miscellaneous
Sec. 771. Custom devices.
Sec. 772. Pediatric device reauthorization.
Sec. 773. Report on regulation of health information technology.
TITLE VIII--DRUG REGULATORY IMPROVEMENTS
Subtitle A--Drug Supply Chain
Sec. 801. Registration of producers of drugs.
Sec. 802. Inspection of drugs.
Sec. 803. Drug supply quality and safety.
Sec. 804. Prohibition against delaying, denying, limiting, or refusing
inspection.
Sec. 805. Destruction of adulterated, misbranded, or counterfeit drugs
offered for import.
Sec. 806. Administrative detention.
Sec. 807. Enhanced criminal penalty for counterfeit drugs.
Sec. 808. Unique facility identification number.
Sec. 809. Documentation for admissibility of imports.
Sec. 810. Registration of commercial importers.
Sec. 811. Notification.
Sec. 812. Exchange of information.
Sec. 813. Extraterritorial jurisdiction.
Sec. 814. Protection against intentional adulteration.
Sec. 815. Records for inspection.
Subtitle B--Medical Gas Safety
Sec. 821. Regulation of medical gases.
Sec. 822. Changes to regulations.
Sec. 823. Rules of construction.
Subtitle C--Generating Antibiotic Incentives Now
Sec. 831. Extension of exclusivity period for drugs.
Sec. 832. Study on incentives for qualified infectious disease
biological products.
Sec. 833. Clinical trials.
Sec. 834. Reassessment of qualified infectious disease product
incentives in 5 years.
Sec. 835. Guidance on pathogen-focused antibacterial drug development.
Subtitle D--Accelerated Approval
Sec. 841. Expedited approval of drugs for serious or life-threatening
diseases or conditions.
Sec. 842. Guidance; amended regulations.
Sec. 843. Independent review.
Subtitle E--Critical Path Reauthorization
Sec. 851. Reauthorization of the critical path public-private
partnerships.
Subtitle F--Miscellaneous
Sec. 861. Reauthorization of provision relating to exclusivity of
certain drugs containing single enantiomers.
Sec. 862. Extension of period for first applicant To obtain tentative
approval without forfeiting 180-day exclusivity period.
Sec. 863. Final agency action relating to petitions and civil actions.
Sec. 864. Deadline for determination on certain petitions.
Sec. 865. Rare pediatric disease priority review voucher incentive
program.
Sec. 866. Combating prescription drug abuse.
Sec. 867. Assessment and modification of REMS.
Sec. 868. Consultation with external experts on rare diseases, targeted
therapies, and genetic targeting of treatments.
Sec. 869. Breakthrough therapies.
Sec. 870. Grants and Contracts for the Development of Orphan Drugs.
TITLE IX--DRUG SHORTAGES
Sec. 901. Discontinuance and interruptions of manufacturing of certain
drugs.
Sec. 902. Drug shortage list.
Sec. 903. Quotas applicable to drugs in shortage.
Sec. 904. Expedited review of major manufacturing changes for potential
and verified shortages of drugs that are life-supporting,
life-sustaining, or intended for use in the prevention of
a debilitating disease or condition.
Sec. 905. Study on drug shortages.
Sec. 906. Annual report on drug shortages.
Sec. 907. Attorney General report on drug shortages.
Sec. 908. Hospital repackaging of drugs in shortage.
SEC. 3. REFERENCES IN ACT.
Except as otherwise specified, amendments made by this Act
to a section or other provision of law are amendments to such
section or other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
TITLE I--FEES RELATING TO DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the
``Prescription Drug User Fee Amendments of 2012''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made in this title will be dedicated toward
expediting the drug development process and the process for
the review of human drug applications, including postmarket
drug safety activities, as set forth in the goals identified
for purposes of part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, in the letters from the
Secretary of Health and Human Services to the Chairman of the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Chairman of the Committee on Energy and
Commerce of the House of Representatives, as set forth in the
Congressional Record.
SEC. 102. DEFINITIONS.
Section 735(7) (21 U.S.C. 379g) is amended by striking
``expenses incurred in connection with'' and inserting
``expenses in connection with''.
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
Section 736 (21 U.S.C. 379h) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking
``fiscal year 2008'' and inserting ``fiscal year 2013'';
(B) in paragraph (1)(A)--
(i) in clause (i), by striking ``(c)(5)'' and inserting
``(c)(4)''; and
(ii) in clause (ii), by striking ``(c)(5)'' and inserting
``(c)(4)'';
[[Page H3194]]
(C) in the matter following clause (ii) in paragraph
(2)(A)--
(i) by striking ``(c)(5)'' and inserting ``(c)(4)''; and
(ii) by striking ``payable on or before October 1 of each
year'' and inserting ``due on the later of the first business
day on or after October 1 of such fiscal year or the first
business day after the enactment of an appropriations Act
providing for the collection and obligation of fees for such
fiscal year under this section'';
(D) in paragraph (3)--
(i) in subparagraph (A)--
(I) by striking ``subsection (c)(5)'' and inserting
``subsection (c)(4)''; and
(II) by striking ``payable on or before October 1 of each
year.'' and inserting ``due on the later of the first
business day on or after October 1 of each such fiscal year
or the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of fees for each such fiscal year under this
section.''; and
(ii) by amending subparagraph (B) to read as follows:
``(B) Exception.--A prescription drug product shall not be
assessed a fee under subparagraph (A) if such product is--
``(i) identified on the list compiled under section
505(j)(7)(A) with a potency described in terms of per 100 mL;
``(ii) the same product as another product that--
``(I) was approved under an application filed under section
505(b) or 505(j); and
``(II) is not in the list of discontinued products compiled
under section 505(j)(7)(A);
``(iii) the same product as another product that was
approved under an abbreviated application filed under section
507 (as in effect on the day before the date of enactment of
the Food and Drug Administration Modernization Act of 1997);
or
``(iv) the same product as another product that was
approved under an abbreviated new drug application pursuant
to regulations in effect prior to the implementation of the
Drug Price Competition and Patent Term Restoration Act of
1984.'';
(2) in subsection (b)--
(A) in paragraph (1)--
(i) in the language preceding subparagraph (A), by striking
``fiscal years 2008 through 2012'' and inserting ``fiscal
years 2013 through 2017''; and
(ii) in subparagraph (A), by striking ``$392,783,000; and''
and inserting ``$693,099,000;''; and
(iii) by striking subparagraph (B) and inserting the
following:
``(B) the dollar amount equal to the inflation adjustment
for fiscal year 2013 (as determined under paragraph (3)(A));
and
``(C) the dollar amount equal to the workload adjustment
for fiscal year 2013 (as determined under paragraph
(3)(B)).''; and
(B) by striking paragraphs (3) and (4) and inserting the
following:
``(3) Fiscal year 2013 inflation and workload
adjustments.--For purposes of paragraph (1), the dollar
amount of the inflation and workload adjustments for fiscal
year 2013 shall be determined as follows:
``(A) Inflation adjustment.--The inflation adjustment for
fiscal year 2013 shall be the sum of--
``(i) $652,709,000 multiplied by the result of an inflation
adjustment calculation determined using the methodology
described in subsection (c)(1)(B); and
``(ii) $652,709,000 multiplied by the result of an
inflation adjustment calculation determined using the
methodology described in subsection (c)(1)(C).
``(B) Workload adjustment.--Subject to subparagraph (C),
the workload adjustment for fiscal 2013 shall be--
``(i) $652,709,000 plus the amount of the inflation
adjustment calculated under subparagraph (A); multiplied by
``(ii) the amount (if any) by which a percentage workload
adjustment for fiscal year 2013, as determined using the
methodology described in subsection (c)(2)(A), would exceed
the percentage workload adjustment (as so determined) for
fiscal year 2012, if both such adjustment percentages were
calculated using the 5-year base period consisting of fiscal
years 2003 through 2007.
``(C) Limitation.--Under no circumstances shall the
adjustment under subparagraph (B) result in fee revenues for
fiscal year 2013 that are less than the sum of the amount
under paragraph (1)(A) and the amount under paragraph
(1)(B).'';
(3) by striking subsection (c) and inserting the following:
``(c) Adjustments.--
``(1) Inflation adjustment.--For fiscal year 2014 and
subsequent fiscal years, the revenues established in
subsection (b) shall be adjusted by the Secretary by notice,
published in the Federal Register, for a fiscal year by the
amount equal to the sum of--
``(A) one;
``(B) the average annual percent change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 years of
the preceding 4 fiscal years, multiplied by the proportion of
personnel compensation and benefits costs to total costs of
the process for the review of human drug applications (as
defined in section 735(6)) for the first 3 years of the
preceding 4 fiscal years, and
``(C) the average annual percent change that occurred in
the Consumer Price Index for urban consumers (Washington-
Baltimore, DC MD VA WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the preceding 4 years
of available data multiplied by the proportion of all costs
other than personnel compensation and benefits costs to total
costs of the process for the review of human drug
applications (as defined in section 735(6)) for the first 3
years of the preceding 4 fiscal years.
The adjustment made each fiscal year under this paragraph
shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2013
under this paragraph.
``(2) Workload adjustment.--For fiscal year 2014 and
subsequent fiscal years, after the fee revenues established
in subsection (b) are adjusted for a fiscal year for
inflation in accordance with paragraph (1), the fee revenues
shall be adjusted further for such fiscal year to reflect
changes in the workload of the Secretary for the process for
the review of human drug applications. With respect to such
adjustment:
``(A) The adjustment shall be determined by the Secretary
based on a weighted average of the change in the total number
of human drug applications (adjusted for changes in review
activities, as described in the notice that the Secretary is
required to publish in the Federal Register under this
subparagraph), efficacy supplements, and manufacturing
supplements submitted to the Secretary, and the change in the
total number of active commercial investigational new drug
applications (adjusted for changes in review activities, as
so described) during the most recent 12-month period for
which data on such submissions is available. The Secretary
shall publish in the Federal Register the fee revenues and
fees resulting from the adjustment and the supporting
methodologies.
``(B) Under no circumstances shall the adjustment result in
fee revenues for a fiscal year that are less than the sum of
the amount under subsection (b)(1)(A) and the amount under
subsection (b)(1)(B), as adjusted for inflation under
paragraph (1).
``(C) The Secretary shall contract with an independent
accounting or consulting firm to periodically review the
adequacy of the adjustment and publish the results of those
reviews. The first review shall be conducted and published by
the end of fiscal year 2013 (to examine the performance of
the adjustment since fiscal year 2009), and the second review
shall be conducted and published by the end of fiscal year
2015 (to examine the continued performance of the
adjustment). The reports shall evaluate whether the
adjustment reasonably represents actual changes in workload
volume and complexity and present options to discontinue,
retain, or modify any elements of the adjustment. The reports
shall be published for public comment. After review of the
reports and receipt of public comments, the Secretary shall,
if warranted, adopt appropriate changes to the methodology.
If the Secretary adopts changes to the methodology based on
the first report, the changes shall be effective for the
first fiscal year for which fees are set after the Secretary
adopts such changes and each subsequent fiscal year.
``(3) Final year adjustment.--For fiscal year 2017, the
Secretary may, in addition to adjustments under this
paragraph and paragraphs (1) and (2), further increase the
fee revenues and fees established in subsection (b) if such
an adjustment is necessary to provide for not more than 3
months of operating reserves of carryover user fees for the
process for the review of human drug applications for the
first 3 months of fiscal year 2018. If such an adjustment is
necessary, the rationale for the amount of the increase shall
be contained in the annual notice establishing fee revenues
and fees for fiscal year 2017. If the Secretary has carryover
balances for such process in excess of 3 months of such
operating reserves, the adjustment under this subparagraph
shall not be made.
``(4) Annual fee setting.--The Secretary shall, not later
than 60 days before the start of each fiscal year that begins
after September 30, 2012, establish, for the next fiscal
year, application, product, and establishment fees under
subsection (a), based on the revenue amounts established
under subsection (b) and the adjustments provided under this
subsection.
``(5) Limit.--The total amount of fees charged, as adjusted
under this subsection, for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for the process for the review of human drug applications.'';
and
(4) in subsection (g)--
(A) in paragraph (1), by striking ``Fees authorized'' and
inserting ``Subject to paragraph (2)(C), fees authorized'';
(B) in paragraph (2)--
(i) in subparagraph (A)(i), by striking ``shall be
retained'' and inserting ``shall be collected and
available'';
(ii) in subparagraph (A)(ii), by striking ``shall only be
collected and available'' and inserting ``shall be
available''; and
(iii) by adding at the end the following new subparagraph:
``(C) Provision for early payments.--Payment of fees
authorized under this section for a fiscal year, prior to the
due date for such fees, may be accepted by the Secretary in
accordance with authority provided in advance in a prior year
appropriations Act.'';
(C) in paragraph (3), by striking ``fiscal years 2008
through 2012'' and inserting ``fiscal years 2013 through
2017''; and
(D) in paragraph (4)--
[[Page H3195]]
(i) by striking ``fiscal years 2008 through 2010'' and
inserting ``fiscal years 2013 through 2015'';
(ii) by striking ``fiscal year 2011'' and inserting
``fiscal year 2016'';
(iii) by striking ``fiscal years 2008 through 2011'' and
inserting ``fiscal years 2013 through 2016''; and
(iv) by striking ``fiscal year 2012'' and inserting
``fiscal year 2017''.
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 736B (21 U.S.C. 379h 2) is amended--
(1) by amending subsection (a) to read as follows:
``(a) Performance Report.--
``(1) In general.--Beginning with fiscal year 2013, not
later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
concerning--
``(A) the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in
section 101(b) of the Prescription Drug User Fee Amendments
of 2012 during such fiscal year and the future plans of the
Food and Drug Administration for meeting the goals, including
the status of the independent assessment described in such
letters; and
``(B) the progress of the Center for Drug Evaluation and
Research and the Center for Biologics Evaluation and Research
in achieving the goals, and future plans for meeting the
goals, including, for each review division--
``(i) the number of original standard new drug applications
and biologics license applications filed per fiscal year for
each review division;
``(ii) the number of original priority new drug
applications and biologics license applications filed per
fiscal year for each review division;
``(iii) the number of standard efficacy supplements filed
per fiscal year for each review division;
``(iv) the number of priority efficacy supplements filed
per fiscal year for each review division;
``(v) the number of applications filed for review under
accelerated approval per fiscal year for each review
division;
``(vi) the number of applications filed for review as fast
track products per fiscal year for each review division; and
``(vii) the number of applications filed for orphan-
designated products per fiscal year for each review division.
``(2) Inclusion.--The report under this subsection for a
fiscal year shall include information on all previous cohorts
for which the Secretary has not given a complete response on
all human drug applications and supplements in the cohort.''.
(2) in subsection (b), by striking ``2008'' and inserting
``2013''; and
(3) in subsection (d), by striking ``2012'' each place it
appears and inserting ``2017''.
SEC. 105. SUNSET DATES.
(a) Authorization.--Sections 735 and 736 (21 U.S.C. 379g;
379h) are repealed October 1, 2017.
(b) Reporting Requirements.--Section 736B (21 U.S.C. 379h
2) is repealed January 31, 2018.
(c) Previous Sunset Provision.--
(1) In general.--Section 106 of the Prescription Drug User
Fee Amendments of 2007 (Title I of Public Law 110 85) is
repealed.
(2) Conforming amendment.--The Food and Drug Administration
Amendments Act of 2007 (Public Law 110-85) is amended in the
table of contents in section 2, by striking the item relating
to section 106.
(d) Technical Clarifications.--
(1) Effective September 30, 2007--
(A) section 509 of the Prescription Drug User Fee
Amendments Act of 2002 (Title V of Public Law 107 188) is
repealed; and
(B) the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (Public Law 107-188) is
amended in the table of contents in section 1(b), by striking
the item relating to section 509.
(2) Effective September 30, 2002--
(A) section 107 of the Food and Drug Administration
Modernization Act of 1997 (Public Law 105 115) is repealed;
and
(B) the table of contents in section 1(c) of such Act is
amended by striking the item related to section 107.
(3) Effective September 30, 1997, section 105 of the
Prescription Drug User Fee Act of 1992 (Public Law 102 571)
is repealed.
SEC. 106. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2012, or the date of the enactment of this Act,
whichever is later, except that fees under part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act shall be assessed for all human drug
applications received on or after October 1, 2012, regardless
of the date of the enactment of this Act.
SEC. 107. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 2
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as in effect on the day before the date of the
enactment of this title, shall continue to be in effect with
respect to human drug applications and supplements (as
defined in such part as of such day) that on or after October
1, 2007, but before October 1, 2012, were accepted by the
Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2012.
TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2012
SEC. 201. SHORT TITLE; FINDINGS.
(a) Short Title.--This Act may be cited as the ``Medical
Device User Fee Amendments of 2012''.
(b) Findings.--The Congress finds that the fees authorized
under the amendments made by this title will be dedicated
toward expediting the process for the review of device
applications and for assuring the safety and effectiveness of
devices, as set forth in the goals identified for purposes of
part 3 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act in the letters from the Secretary of
Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the Congressional Record.
SEC. 202. DEFINITIONS.
Section 737 (21 U.S.C. 379i) is amended--
(1) in paragraph (9), by striking ``incurred'' after
``expenses'';
(2) in paragraph (10), by striking ``October 2001'' and
inserting ``October 2011''; and
(3) in paragraph (13), by striking ``is required to
register'' and all that follows through the end of paragraph
(13) and inserting the following: ``is registered (or is
required to register) with the Secretary under section 510
because such establishment is engaged in the manufacture,
preparation, propagation, compounding, or processing of a
device.''.
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--Section 738(a) (21 U.S.C. 379j(a)) is
amended--
(1) in paragraph (1), by striking ``fiscal year 2008'' and
inserting ``fiscal year 2013'';
(2) in paragraph (2)(A)--
(A) in the matter preceding clause (i)--
(i) by striking ``subsections (d) and (e)'' and inserting
``subsections (d), (e), and (f)'';
(ii) by striking ``October 1, 2002'' and inserting
``October 1, 2012''; and
(iii) by striking ``subsection (c)(1)'' and inserting
``subsection (c)''; and
(B) in clause (viii), by striking ``1.84'' and inserting
``2''; and
(3) in paragraph (3)--
(A) in subparagraph (A), by inserting ``and subsection
(f)'' after ``subparagraph (B)''; and
(B) in subparagraph (C), by striking ``initial
registration'' and all that follows through ``section 510.''
and inserting ``later of--
``(i) the initial or annual registration (as applicable) of
the establishment under section 510; or
``(ii) the first business day after the date of enactment
of an appropriations Act providing for the collection and
obligation of fees for such year under this section.''.
(b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is
amended to read as follows:
``(b) Fee Amounts.--
``(1) In general.--Subject to subsections (c), (d), (e),
(f), and (i), for each of fiscal years 2013 through 2017,
fees under subsection (a) shall be derived from the base fee
amounts specified in paragraph (2), to generate the total
revenue amounts specified in paragraph (3).
``(2) Base fee amounts specified.--For purposes of
paragraph (1), the base fee amounts specified in this
paragraph are as follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year
``Fee Type 2013 2014 2015 2016 2017
----------------------------------------------------------------------------------------------------------------
Premarket Application.......................... $248,000 $252,960 $258,019 $263,180 $268,443
Establishment Registration..................... $2,575 $3,200 $3,750 $3,872 $3,872
----------------------------------------------------------------------------------------------------------------
``(3) Total revenue amounts.--For purposes of paragraph
(1), the total revenue amounts specified in this paragraph
are as follows:
``(A) $97,722,301 for fiscal year 2013.
``(B) $112,580,497 for fiscal year 2014.
``(C) $125,767,107 for fiscal year 2015.
``(D) $129,339,949 for fiscal year 2016.
``(E) $130,184,348 for fiscal year 2017.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) (21
U.S.C. 379j(c)) is amended--
(1) in the subsection heading, by inserting ``;
Adjustments'' after ``Setting'';
(2) by striking paragraphs (1) and (2);
[[Page H3196]]
(3) by redesignating paragraphs (3) and (4) as paragraphs
(4) and (5), respectively; and
(4) by inserting before paragraph (4), as so redesignated,
the following:
``(1) In general.--The Secretary shall, 60 days before the
start of each fiscal year after September 30, 2012, establish
fees under subsection (a), based on amounts specified under
subsection (b) and the adjustments provided under this
subsection, and publish such fees, and the rationale for any
adjustments to such fees, in the Federal Register.
``(2) Inflation adjustments.--
``(A) Adjustment to total revenue amounts.--For fiscal year
2014 and each subsequent fiscal year, the Secretary shall
adjust the total revenue amount specified in subsection
(b)(3) for such fiscal year by multiplying such amount by the
applicable inflation adjustment under subparagraph (B) for
such year.
``(B) Applicable inflation adjustment to total revenue
amounts.--The applicable inflation adjustment for a fiscal
year is--
``(i) for fiscal year 2014, the base inflation adjustment
under subparagraph (C) for such fiscal year; and
``(ii) for fiscal year 2015 and each subsequent fiscal
year, the product of--
``(I) the base inflation adjustment under subparagraph (C)
for such fiscal year; and
``(II) the product of the base inflation adjustment under
subparagraph (C) for each of the fiscal years preceding such
fiscal year, beginning with fiscal year 2014.
``(C) Base inflation adjustment to total revenue amounts.--
``(i) In general.--Subject to further adjustment under
clause (ii), the base inflation adjustment for a fiscal year
is the sum of one plus--
``(I) the average annual percent change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 years of
the preceding 4 fiscal years, multiplied by 0.60; and
``(II) the average annual percent change that occurred in
the Consumer Price Index for urban consumers (Washington-
Baltimore, DC MD VA WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the preceding 4 years
of available data multiplied by 0.40.
``(ii) Limitations.--For purposes of subparagraph (B), if
the base inflation adjustment for a fiscal year under clause
(i)--
``(I) is less than 1, such adjustment shall be considered
to be equal to 1; or
``(II) is greater than 1.04, such adjustment shall be
considered to be equal to 1.04.
``(D) Adjustment to base fee amounts.--For each of fiscal
years 2014 through 2017, the base fee amounts specified in
subsection (b)(2) shall be adjusted as needed, on a uniform
proportionate basis, to generate the total revenue amounts
under subsection (b)(3), as adjusted for inflation under
subparagraph (A).
``(3) Volume-based adjustments to establishment
registration base fees.--For each of fiscal years 2014
through 2017, after the base fee amounts specified in
subsection (b)(2) are adjusted under paragraph (2)(D), the
base establishment registration fee amounts specified in such
subsection shall be further adjusted, as the Secretary
estimates is necessary in order for total fee collections for
such fiscal year to generate the total revenue amounts, as
adjusted under paragraph (2).''.
(d) Fee Waiver or Reduction.--Section 738 (21 U.S.C. 379j)
is amended by--
(1) redesignating subsections (f) through (k) as
subsections (g) through (l), respectively; and
(2) by inserting after subsection (e) the following new
subsection (f):
``(f) Fee Waiver or Reduction.--
``(1) In general.--The Secretary may, at the Secretary's
sole discretion, grant a waiver or reduction of fees under
subsection (a)(2) or (a)(3) if the Secretary finds that such
waiver or reduction is in the interest of public health.
``(2) Limitation.--The sum of all fee waivers or reductions
granted by the Secretary in any fiscal year under paragraph
(1) shall not exceed 2 percent of the total fee revenue
amounts established for such year under subsection (c).
``(3) Duration.--The authority provided by this subsection
terminates October 1, 2017.''.
(e) Conditions.--Section 738(h)(1)(A) (21 U.S.C.
379j(h)(1)(A)), as redesignated by subsection (d)(1), is
amended by striking ``$205,720,000'' and inserting
``$280,587,000''.
(f) Crediting and Availability of Fees.--Section 738(i) (21
U.S.C. 379j(i)), as redesignated by subsection (d)(1), is
amended--
(1) in paragraph (1), by striking ``Fees authorized'' and
inserting ``Subject to paragraph (2)(C), fees authorized'';
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in clause (i), by striking ``shall be retained'' and
inserting ``subject to subparagraph (C), shall be collected
and available''; and
(ii) in clause (ii)--
(I) by striking ``collected and'' after ``shall only be'';
and
(II) by striking ``fiscal year 2002'' and inserting
``fiscal year 2009''; and
(B) by adding at the end, the following:
``(C) Provision for early year payments.--Payment of fees
authorized under this section for a fiscal year, prior to the
due date for such fees, may be accepted by the Secretary in
accordance with authority provided in advance in a prior year
appropriations Act.'';
(3) in paragraph (3), by amending to read as follows:
``(3) Authorizations of appropriations.--For each of the
fiscal years 2013 through 2017, there is authorized to be
appropriated for fees under this section an amount equal to
the total revenue amount specified under subsection (b)(3)
for the fiscal year, as adjusted under subsection (c) and,
for fiscal year 2017 only, as further adjusted under
paragraph (4).''; and
(4) in paragraph (4)--
(A) by striking ``fiscal years 2008, 2009, and 2010'' and
inserting ``fiscal years 2013, 2014, and 2015'';
(B) by striking ``fiscal year 2011'' and inserting ``fiscal
year 2016'';
(C) by striking ``June 30, 2011'' and inserting ``June 30,
2016'';
(D) by striking ``the amount of fees specified in aggregate
in'' and inserting ``the cumulative amount appropriated
pursuant to'';
(E) by striking ``aggregate amount in'' before ``excess
shall be credited''; and
(F) by striking ``fiscal year 2012'' and inserting ``fiscal
year 2017''.
(g) Conforming Amendment.--Section 515(c)(4)(A) (21 U.S.C.
360e(c)(4)(A)) is amended by striking ``738(g)'' and
inserting ``738(h)''.
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Reauthorization.--Section 738A(b) (21 U.S.C. 379j 1(b))
is amended--
(1) in paragraph (1), by striking ``2012'' and inserting
``2017''; and
(2) in paragraph (5), by striking ``2012'' and inserting
``2017''.
(b) Performance Reports.--Section 738A(a) (21 U.S.C. 379j
1(a)) is amended--
(1) by striking paragraph (1) and inserting the following:
``(1) Performance report.--
``(A) In general.--Beginning with fiscal year 2013, for
each fiscal year for which fees are collected under this
part, the Secretary shall prepare and submit to the Committee
on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of
Representatives annual reports concerning the progress of the
Food and Drug Administration in achieving the goals
identified in the letters described in section 201(b) of the
Medical Device User Fee Amendments of 2012 during such fiscal
year and the future plans of the Food and Drug Administration
for meeting the goals.
``(B) Publication.--With regard to information to be
reported by the Food and Drug Administration to industry on a
quarterly and annual basis pursuant to the letters described
in section 201(b) of the Medical Device User Fee Amendments
Act of 2012, the Secretary shall make such information
publicly available on the Internet Website of the Food and
Drug Administration not later than 60 days after the end of
each quarter or 120 days after the end of each fiscal year,
respectively, to which such information applies. This
information shall include the status of the independent
assessment identified in the letters described in such
section 201(b).
``(C) Updates.--The Secretary shall include in each report
under subparagraph (A) information on all previous cohorts
for which the Secretary has not given a complete response on
all device premarket applications and reports, supplements,
and premarket notifications in the cohort.''; and
(2) in paragraph (2), by striking ``2008 through 2012'' and
inserting ``2013 through 2017''.
SEC. 205. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 3
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the
day before the date of the enactment of this title, shall
continue to be in effect with respect to the submissions
listed in section 738(a)(2)(A) of such Act (as defined in
such part as of such day) that on or after October 1, 2007,
but before October 1, 2012, were accepted by the Food and
Drug Administration for filing with respect to assessing and
collecting any fee required by such part for a fiscal year
prior to fiscal year 2013.
SEC. 206. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2012, or the date of the enactment of this Act,
whichever is later, except that fees under part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act shall be assessed for all submissions listed in
section 738(a)(2)(A) of such Act received on or after October
1, 2012, regardless of the date of the enactment of this Act.
SEC. 207. SUNSET CLAUSE.
(a) In General.--Sections 737 and 738 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to
be effective October 1, 2017. Section 738A (21 U.S.C. 739j 1)
of the Federal Food, Drug, and Cosmetic Act (regarding
reauthorization and reporting requirements) is repealed
January 31, 2018.
(b) Previous Sunset Provision.--
(1) In general.--Section 217 of the Medical Device User Fee
Amendments of 2007 (Title II of Public Law 110 85) is
repealed.
(2) Conforming amendment.--The Food and Drug Administration
Amendments Act of 2007 (Public Law 110-85) is amended in the
table of contents in section 2, by striking the item relating
to section 217.
(c) Technical Clarification.--Effective September 30,
2007--
[[Page H3197]]
(1) section 107 of the Medical Device User Fee and
Modernization Act of 2002 (Public Law 107 250) is repealed;
and
(2) the table of contents in section 1(b) of such Act is
amended by striking the item related to section 107.
SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES
RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE
APPLICATIONS.
Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is
amended by inserting after section 713 the following new
section:
``SEC. 714. STREAMLINED HIRING AUTHORITY.
``(a) In General.--In addition to any other personnel
authorities under other provisions of law, the Secretary may,
without regard to the provisions of title 5, United States
Code, governing appointments in the competitive service,
appoint employees to positions in the Food and Drug
Administration to perform, administer, or support activities
described in subsection (b), if the Secretary determines that
such appointments are needed to achieve the objectives
specified in subsection (c).
``(b) Activities Described.--The activities described in
this subsection are activities under this Act related to the
process for the review of device applications (as defined in
section 737(8)).
``(c) Objectives Specified.--The objectives specified in
this subsection are with respect to the activities under
subsection (b)(1), the goals referred to in section
738A(a)(1).
``(d) Internal Controls.--The Secretary shall institute
appropriate internal controls for appointments under this
section.
``(e) Sunset.--The authority to appoint employees under
this section shall terminate on the date that is three years
after the date of enactment of this section.''.
TITLE III--FEES RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE.
(a) Short Title.--This title may be cited as the ``Generic
Drug User Fee Amendments of 2012''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made in this title will be dedicated to
human generic drug activities, as set forth in the goals
identified for purposes of part 7 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act, in the
letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate and the Chairman of the Committee
on Energy and Commerce of the House of Representatives, as
set forth in the Congressional Record.
SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG
FEES.
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is
amended by adding at the end the following:
``PART 7--FEES RELATING TO GENERIC DRUGS
``SEC. 744A. DEFINITIONS.
``For purposes of this part:
``(1) The term `abbreviated new drug application'--
``(A) means an application submitted under section 505(j),
an abbreviated application submitted under section 507 (as in
effect on the day before the date of enactment of the Food
and Drug Administration Modernization Act of 1997), or an
abbreviated new drug application submitted pursuant to
regulations in effect prior to the implementation of the Drug
Price Competition and Patent Term Restoration Act of 1984;
and
``(B) does not include an application for a positron
emission tomography drug.
``(2) The term `active pharmaceutical ingredient' means--
``(A) a substance, or a mixture when the substance is
unstable or cannot be transported on its own, intended--
``(i) to be used as a component of a drug; and
``(ii) to furnish pharmacological activity or other direct
effect in the diagnosis, cure, mitigation, treatment, or
prevention of disease, or to affect the structure or any
function of the human body; or
``(B) a substance intended for final crystallization,
purification, or salt formation, or any combination of those
activities, to become a substance or mixture described in
subparagraph (A).
``(3) The term `adjustment factor' means a factor
applicable to a fiscal year that is the Consumer Price Index
for all urban consumers (all items; United States city
average) for October of the preceding fiscal year divided by
such Index for October 2011.
``(4) The term `affiliate' means a business entity that has
a relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power to
control, the other business entity; or
``(B) a third party controls, or has power to control, both
of the business entities.
``(5)(A) The term `facility'--
``(i) means a business or other entity--
``(I) under one management, either direct or indirect; and
``(II) at one geographic location or address engaged in
manufacturing or processing an active pharmaceutical
ingredient or a finished dosage form; and
``(ii) does not include a business or other entity whose
only manufacturing or processing activities are one or more
of the following: repackaging, relabeling, or testing.
``(B) For purposes of subparagraph (A), separate buildings
within close proximity are considered to be at one geographic
location or address if the activities in them are--
``(i) closely related to the same business enterprise;
``(ii) under the supervision of the same local management;
and
``(iii) capable of being inspected by the Food and Drug
Administration during a single inspection.
``(C) If a business or other entity would meet the
definition of a facility under this paragraph but for being
under multiple management, the business or other entity is
deemed to constitute multiple facilities, one per management
entity, for purposes of this paragraph.
``(6) The term `finished dosage form' means--
``(A) a drug product in the form in which it will be
administered to a patient, such as a tablet, capsule,
solution, or topical application;
``(B) a drug product in a form in which reconstitution is
necessary prior to administration to a patient, such as oral
suspensions or lyophilized powders; or
``(C) any combination of an active pharmaceutical
ingredient with another component of a drug product for
purposes of production of a drug product described in
subparagraph (A) or (B).
``(7) The term `generic drug submission' means an
abbreviated new drug application, an amendment to an
abbreviated new drug application, or a prior approval
supplement to an abbreviated new drug application.
``(8) The term `human generic drug activities' means the
following activities of the Secretary associated with generic
drugs and inspection of facilities associated with generic
drugs:
``(A) The activities necessary for the review of generic
drug submissions, including review of drug master files
referenced in such submissions.
``(B) The issuance of--
``(i) approval letters which approve abbreviated new drug
applications or supplements to such applications; or
``(ii) complete response letters which set forth in detail
the specific deficiencies in such applications and, where
appropriate, the actions necessary to place such applications
in condition for approval.
``(C) The issuance of letters related to Type II active
pharmaceutical drug master files which--
``(i) set forth in detail the specific deficiencies in such
submissions, and where appropriate, the actions necessary to
resolve those deficiencies; or
``(ii) document that no deficiencies need to be addressed.
``(D) Inspections related to generic drugs.
``(E) Monitoring of research conducted in connection with
the review of generic drug submissions and drug master files.
``(F) Postmarket safety activities with respect to drugs
approved under abbreviated new drug applications or
supplements, including the following activities:
``(i) Collecting, developing, and reviewing safety
information on approved drugs, including adverse event
reports.
``(ii) Developing and using improved adverse-event data-
collection systems, including information technology systems.
``(iii) Developing and using improved analytical tools to
assess potential safety problems, including access to
external data bases.
``(iv) Implementing and enforcing section 505(o) (relating
to postapproval studies and clinical trials and labeling
changes) and section 505(p) (relating to risk evaluation and
mitigation strategies) insofar as those activities relate to
abbreviated new drug applications.
``(v) Carrying out section 505(k)(5) (relating to adverse-
event reports and postmarket safety activities).
``(G) Regulatory science activities related to generic
drugs.
``(9) The term `positron emission tomography drug' has the
meaning given to the term `compounded positron emission
tomography drug' in section 201(ii), except that paragraph
(1)(B) of such section shall not apply.
``(10) The term `prior approval supplement' means a request
to the Secretary to approve a change in the drug substance,
drug product, production process, quality controls,
equipment, or facilities covered by an approved abbreviated
new drug application when that change has a substantial
potential to have an adverse effect on the identity,
strength, quality, purity, or potency of the drug product as
these factors may relate to the safety or effectiveness of
the drug product.
``(11) The term `resources allocated for human generic drug
activities' means the expenses for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to
such officers and employees and to contracts with such
contractors;
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under subsection (a) and accounting
for resources allocated for the review of abbreviated new
drug applications and supplements and inspection related to
generic drugs.
[[Page H3198]]
``(12) The term `Type II active pharmaceutical ingredient
drug master file' means a submission of information to the
Secretary by a person that intends to authorize the Food and
Drug Administration to reference the information to support
approval of a generic drug submission without the submitter
having to disclose the information to the generic drug
submission applicant.
``SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG
FEES.
``(a) Types of Fees.--Beginning in fiscal year 2013, the
Secretary shall assess and collect fees in accordance with
this section as follows:
``(1) One-time backlog fee for abbreviated new drug
applications pending on october 1, 2012.--
``(A) In general.--Each person that owns an abbreviated new
drug application that is pending on October 1, 2012, and that
has not received a tentative approval prior to that date,
shall be subject to a fee for each such application, as
calculated under subparagraph (B).
``(B) Method of fee amount calculation.--The amount of each
one-time backlog fee shall be calculated by dividing
$50,000,000 by the total number of abbreviated new drug
applications pending on October 1, 2012, that have not
received a tentative approval as of that date.
``(C) Notice.--Not later than October 31, 2012, the
Secretary shall cause to be published in the Federal Register
a notice announcing the amount of the fee required by
subparagraph (A).
``(D) Fee due date.--The fee required by subparagraph (A)
shall be due no later than 30 calendar days after the date of
the publication of the notice specified in subparagraph (C).
``(2) Drug master file fee.--
``(A) In general.--Each person that owns a Type II active
pharmaceutical ingredient drug master file that is referenced
on or after October 1, 2012, in a generic drug submission by
any initial letter of authorization shall be subject to a
drug master file fee.
``(B) One-time payment.--If a person has paid a drug master
file fee for a Type II active pharmaceutical ingredient drug
master file, the person shall not be required to pay a
subsequent drug master file fee when that Type II active
pharmaceutical ingredient drug master file is subsequently
referenced in generic drug submissions.
``(C) Notice.--
``(i) Fiscal year 2013.--Not later than October 31, 2012,
the Secretary shall cause to be published in the Federal
Register a notice announcing the amount of the drug master
file fee for fiscal year 2013.
``(ii) Fiscal year 2014 through 2017.--Not later than 60
days before the start of each of fiscal years 2014 through
2017, the Secretary shall cause to be published in the
Federal Register the amount of the drug master file fee
established by this paragraph for such fiscal year.
``(D) Availability for reference.--
``(i) In general.--Subject to subsection (g)(2)(C), for a
generic drug submission to reference a Type II active
pharmaceutical ingredient drug master file, the drug master
file must be deemed available for reference by the Secretary.
``(ii) Conditions.--A drug master file shall be deemed
available for reference by the Secretary if--
``(I) the person that owns a Type II active pharmaceutical
ingredient drug master file has paid the fee required under
subparagraph (A) within 20 calendar days after the applicable
due date under subparagraph (E); and
``(II) the drug master file has not failed an initial
completeness assessment by the Secretary, in accordance with
criteria to be published by the Secretary.
``(iii) List.--The Secretary shall make publicly available
on the Internet Web site of the Food and Drug Administration
a list of the drug master file numbers that correspond to
drug master files that have successfully undergone an initial
completeness assessment, in accordance with criteria to be
published by the Secretary, and are available for reference.
``(E) Fee due date.--
``(i) In general.--Subject to clause (ii), a drug master
file fee shall be due no later than the date on which the
first generic drug submission is submitted that references
the associated Type II active pharmaceutical ingredient drug
master file.
``(ii) Limitation.--No fee shall be due under subparagraph
(A) for a fiscal year until the later of--
``(I) 30 calendar days after publication of the notice
provided for in clause (i) or (ii) of subparagraph (C), as
applicable; or
``(II) 30 calendar days after the date of enactment of an
appropriations Act providing for the collection and
obligation of fees under this section.
``(3) Abbreviated new drug application and prior approval
supplement filing fee.--
``(A) In general.--Each applicant that submits, on or after
October 1, 2012, an abbreviated new drug application or a
prior approval supplement to an abbreviated new drug
application shall be subject to a fee for each such
submission in the amount established under subsection (d).
``(B) Notice.--
``(i) Fiscal year 2013.--Not later than October 31, 2012,
the Secretary shall cause to be published in the Federal
Register a notice announcing the amount of the fees under
subparagraph (A) for fiscal year 2013.
``(ii) Fiscal years 2014 through 2017.--Not later than 60
days before the start of each of fiscal years 2014 through
2017, the Secretary shall cause to be published in the
Federal Register the amount of the fees under subparagraph
(A) for such fiscal year.
``(C) Fee due date.--
``(i) In general.--Except as provided in clause (ii), the
fees required by subparagraphs (A) and (F) shall be due no
later than the date of submission of the abbreviated new drug
application or prior approval supplement for which such fee
applies.
``(ii) Special rule for 2013.--For fiscal year 2013, such
fees shall be due on the later of--
``(I) the date on which the fee is due under clause (i);
``(II) 30 calendar days after publication of the notice
referred to in subparagraph (B)(i); or
``(III) if an appropriations Act is not enacted providing
for the collection and obligation of fees under this section
by the date of submission of the application or prior
approval supplement for which the fees under subparagraphs
(A) and (F) apply, 30 calendar days after the date that such
an appropriations Act is enacted.
``(D) Refund of fee if abbreviated new drug application is
not considered to have been received.--The Secretary shall
refund 75 percent of the fee paid under subparagraph (A) for
any abbreviated new drug application or prior approval
supplement to an abbreviated new drug application that the
Secretary considers not to have been received within the
meaning of section 505(j)(5)(A) for a cause other than
failure to pay fees.
``(E) Fee for an application the secretary considers not to
have been received, or that has been withdrawn.--An
abbreviated new drug application or prior approval supplement
that was submitted on or after October 1, 2012, and that the
Secretary considers not to have been received, or that has
been withdrawn, shall, upon resubmission of the application
or a subsequent new submission following the applicant's
withdrawal of the application, be subject to a full fee under
subparagraph (A).
``(F) Additional fee for active pharmaceutical ingredient
information not included by reference to type ii active
pharmaceutical ingredient drug master file.--An applicant
that submits a generic drug submission on or after October 1,
2012, shall pay a fee, in the amount determined under
subsection (d)(3), in addition to the fee required under
subparagraph (A), if--
``(i) such submission contains information concerning the
manufacture of an active pharmaceutical ingredient at a
facility by means other than reference by a letter of
authorization to a Type II active pharmaceutical drug master
file; and
``(ii) a fee in the amount equal to the drug master file
fee established in paragraph (2) has not been previously paid
with respect to such information.
``(4) Generic drug facility fee and active pharmaceutical
ingredient facility fee.--
``(A) In general.--Facilities identified, or intended to be
identified, in at least one generic drug submission that is
pending or approved to produce a finished dosage form of a
human generic drug or an active pharmaceutical ingredient
contained in a human generic drug shall be subject to fees as
follows:
``(i) Generic drug facility.--Each person that owns a
facility which is identified or intended to be identified in
at least one generic drug submission that is pending or
approved to produce one or more finished dosage forms of a
human generic drug shall be assessed an annual fee for each
such facility.
``(ii) Active pharmaceutical ingredient facility.--Each
person that owns a facility which produces, or which is
pending review to produce, one or more active pharmaceutical
ingredients identified, or intended to be identified, in at
least one generic drug submission that is pending or approved
or in a Type II active pharmaceutical ingredient drug master
file referenced in such a generic drug submission, shall be
assessed an annual fee for each such facility.
``(iii) Facilities producing both active pharmaceutical
ingredients and finished dosage forms.--Each person that owns
a facility identified, or intended to be identified, in at
least one generic drug submission that is pending or approved
to produce both one or more finished dosage forms subject to
clause (i) and one or more active pharmaceutical ingredients
subject to clause (ii) shall be subject to fees under both
such clauses for that facility.
``(B) Amount.--The amount of fees established under
subparagraph (A) shall be established under subsection (d).
``(C) Notice.--
``(i) Fiscal year 2013.--For fiscal year 2013, the
Secretary shall cause to be published in the Federal Register
a notice announcing the amount of the fees provided for in
subparagraph (A) within the timeframe specified in subsection
(d)(1)(B).
``(ii) Fiscal years 2014 through 2017.--Within the
timeframe specified in subsection (d)(2), the Secretary shall
cause to be published in the Federal Register the amount of
the fees under subparagraph (A) for such fiscal year.
``(D) Fee due date.--
``(i) Fiscal year 2013.--For fiscal year 2013, the fees
under subparagraph (A) shall be due on the later of--
``(I) not later than 45 days after the publication of the
notice under subparagraph (B); or
[[Page H3199]]
``(II) if an appropriations Act is not enacted providing
for the collection and obligation of fees under this section
by the date of the publication of such notice, 30 days after
the date that such an appropriations Act is enacted.
``(ii) Fiscal years 2014 through 2017.--For each of fiscal
years 2014 through 2017, the fees under subparagraph (A) for
such fiscal year shall be due on the later of--
``(I) the first business day on or after October 1 of each
such year; or
``(II) the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of fees under this section for such year.
``(5) Date of submission.--For purposes of this part, a
generic drug submission or Type II pharmaceutical master file
is deemed to be `submitted' to the Food and Drug
Administration--
``(A) if it is submitted via a Food and Drug Administration
electronic gateway, on the day when transmission to that
electronic gateway is completed, except that a submission or
master file that arrives on a weekend, Federal holiday, or
day when the Food and Drug Administration office that will
review that submission is not otherwise open for business
shall be deemed to be submitted on the next day when that
office is open for business; and
``(B) if it is submitted in physical media form, on the day
it arrives at the appropriate designated document room of the
Food and Drug Administration.
``(b) Fee Revenue Amounts.--
``(1) In general.--
``(A) Fiscal year 2013.--For fiscal year 2013, fees under
subsection (a) shall be established to generate a total
estimated revenue amount under such subsection of
$299,000,000. Of that amount--
``(i) $50,000,000 shall be generated by the one-time
backlog fee for generic drug applications pending on October
1, 2012, established in subsection (a)(1); and
``(ii) $249,000,000 shall be generated by the fees under
paragraphs (2) through (4) of subsection (a).
``(B) Fiscal years 2014 through 2017.--For each of the
fiscal years 2014 through 2017, fees under paragraphs (2)
through (4) of subsection (a) shall be established to
generate a total estimated revenue amount under such
subsection that is equal to $299,000,000, as adjusted
pursuant to subsection (c).
``(2) Types of fees.--In establishing fees under paragraph
(1) to generate the revenue amounts specified in paragraph
(1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each
of fiscal years 2014 through 2017, such fees shall be derived
from the fees under paragraphs (2) through (4) of subsection
(a) as follows:
``(A) 6 percent shall be derived from fees under subsection
(a)(2) (relating to drug master files).
``(B) 24 percent shall be derived from fees under
subsection (a)(3) (relating to abbreviated new drug
applications and supplements). The amount of a fee for a
prior approval supplement shall be half the amount of the fee
for an abbreviated new drug application.
``(C) 56 percent shall be derived from fees under
subsection (a)(4)(A)(i) (relating to generic drug
facilities). The amount of the fee for a facility located
outside the United States and its territories and possessions
shall be not less than $15,000 and not more than $30,000
higher than the amount of the fee for a facility located in
the United States and its territories and possessions, as
determined by the Secretary on the basis of data concerning
the difference in cost between inspections of facilities
located in the United States, including its territories and
possessions, and those located outside of the United States
and its territories and possessions.
``(D) 14 percent shall be derived from fees under
subsection (a)(4)(A)(ii) (relating to active pharmaceutical
ingredient facilities). The amount of the fee for a facility
located outside the United States and its territories and
possessions shall be not less than $15,000 and not more than
$30,000 higher than the amount of the fee for a facility
located in the United States, including its territories and
possessions, as determined by the Secretary on the basis of
data concerning the difference in cost between inspections of
facilities located in the United States and its territories
and possessions and those located outside of the United
States and its territories and possessions.
``(c) Adjustments.--
``(1) Inflation adjustment.--For fiscal year 2014 and
subsequent fiscal years, the revenues established in
subsection (b) shall be adjusted by the Secretary by notice,
published in the Federal Register, for a fiscal year, by an
amount equal to the sum of--
``(A) one;
``(B) the average annual percent change in the cost, per
full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits
paid with respect to such positions for the first 3 years of
the preceding 4 fiscal years multiplied by the proportion of
personnel compensation and benefits costs to total costs of
human generic drug activities for the first 3 years of the
preceding 4 fiscal years; and
``(C) the average annual percent change that occurred in
the Consumer Price Index for urban consumers (Washington-
Baltimore, DC MD VA WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the preceding 4 years
of available data multiplied by the proportion of all costs
other than personnel compensation and benefits costs to total
costs of human generic drug activities for the first 3 years
of the preceding 4 fiscal years.
The adjustment made each fiscal year under this subsection
shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2013
under this subsection.
``(2) Final year adjustment.--For fiscal year 2017, the
Secretary may, in addition to adjustments under paragraph
(1), further increase the fee revenues and fees established
in subsection (b) if such an adjustment is necessary to
provide for not more than 3 months of operating reserves of
carryover user fees for human generic drug activities for the
first 3 months of fiscal year 2018. Such fees may only be
used in fiscal year 2018. If such an adjustment is necessary,
the rationale for the amount of the increase shall be
contained in the annual notice establishing fee revenues and
fees for fiscal year 2017. If the Secretary has carryover
balances for such activities in excess of 3 months of such
operating reserves, the adjustment under this subparagraph
shall not be made.
``(d) Annual Fee Setting.--
``(1) Fiscal year 2013.--For fiscal year 2013--
``(A) the Secretary shall establish, by October 31, 2012,
the one-time generic drug backlog fee for generic drug
applications pending on October 1, 2012, the drug master file
fee, the abbreviated new drug application fee, and the prior
approval supplement fee under subsection (a), based on the
revenue amounts established under subsection (b); and
``(B) the Secretary shall establish, not later than 45 days
after the date to comply with the requirement for
identification of facilities in subsection (f)(2), the
generic drug facility fee and active pharmaceutical
ingredient facility fee under subsection (a) based on the
revenue amounts established under subsection (b).
``(2) Fiscal years 2014 through 2017.--Not more than 60
days before the first day of each of fiscal years 2014
through 2017, the Secretary shall establish the drug master
file fee, the abbreviated new drug application fee, the prior
approval supplement fee, the generic drug facility fee, and
the active pharmaceutical ingredient facility fee under
subsection (a) for such fiscal year, based on the revenue
amounts established under subsection (b) and the adjustments
provided under subsection (c).
``(3) Fee for active pharmaceutical ingredient information
not included by reference to type ii active pharmaceutical
ingredient drug master file.--In establishing the fees under
paragraphs (1) and (2), the amount of the fee under
subsection (a)(3)(F) shall be determined by multiplying--
``(A) the sum of--
``(i) the total number of such active pharmaceutical
ingredients in such submission; and
``(ii) for each such ingredient that is manufactured at
more than one such facility, the total number of such
additional facilities; and
``(B) the amount equal to the drug master file fee
established in subsection (a)(2) for such submission.
``(e) Limit.--The total amount of fees charged, as adjusted
under subsection (c), for a fiscal year may not exceed the
total costs for such fiscal year for the resources allocated
for human generic drug activities.
``(f) Identification of Facilities.--
``(1) Publication of notice; deadline for compliance.--Not
later than October 1, 2012, the Secretary shall cause to be
published in the Federal Register a notice requiring each
person that owns a facility described in subsection
(a)(4)(A), or a site or organization required to be
identified by paragraph (4), to submit to the Secretary
information on the identity of each such facility, site, or
organization. The notice required by this paragraph shall
specify the type of information to be submitted and the means
and format for submission of such information.
``(2) Required submission of facility identification.--Each
person that owns a facility described in subsection (a)(4)(A)
or a site or organization required to be identified by
paragraph (4) shall submit to the Secretary the information
required under this subsection each year. Such information
shall--
``(A) for fiscal year 2013, be submitted not later than 60
days after the publication of the notice under paragraph (1);
and
``(B) for each subsequent fiscal year, be submitted,
updated, or reconfirmed on or before June 1 of the previous
year.
``(3) Contents of notice.--At a minimum, the submission
required by paragraph (2) shall include for each such
facility--
``(A) identification of a facility identified or intended
to be identified in an approved or pending generic drug
submission;
``(B) whether the facility manufactures active
pharmaceutical ingredients or finished dosage forms, or both;
``(C) whether or not the facility is located within the
United States and its territories and possessions;
``(D) whether the facility manufactures positron emission
tomography drugs solely, or in addition to other drugs; and
``(E) whether the facility manufactures drugs that are not
generic drugs.
``(4) Certain sites and organizations.--
``(A) In general.--Any person that owns or operates a site
or organization described in
[[Page H3200]]
subparagraph (B) shall submit to the Secretary information
concerning the ownership, name, and address of the site or
organization.
``(B) Sites and organizations.--A site or organization is
described in this subparagraph if it is identified in a
generic drug submission and is--
``(i) a site in which a bioanalytical study is conducted;
``(ii) a clinical research organization;
``(iii) a contract analytical testing site; or
``(iv) a contract repackager site.
``(C) Notice.--The Secretary may, by notice published in
the Federal Register, specify the means and format for
submission of the information under subparagraph (A) and may
specify, as necessary for purposes of this section, any
additional information to be submitted.
``(D) Inspection authority.--The Secretary's inspection
authority under section 704(a)(1) shall extend to all such
sites and organizations.
``(g) Effect of Failure To Pay Fees.--
``(1) Generic drug backlog fee.--Failure to pay the fee
under subsection (a)(1) shall result in the Secretary placing
the person that owns the abbreviated new drug application
subject to that fee on an arrears list, such that no new
abbreviated new drug applications or supplement submitted on
or after October 1, 2012, from that person, or any affiliate
of that person, will be received within the meaning of
section 505(j)(5)(A) until such outstanding fee is paid.
``(2) Drug master file fee.--
``(A) Failure to pay the fee under subsection (a)(2) within
20 calendar days after the applicable due date under
subparagraph (E) of such subsection (as described in
subsection (a)(2)(D)(ii)(I)) shall result in the Type II
active pharmaceutical ingredient drug master file not being
deemed available for reference.
``(B)(i) Any generic drug submission submitted on or after
October 1, 2012, that references, by a letter of
authorization, a Type II active pharmaceutical ingredient
drug master file that has not been deemed available for
reference shall not be received within the meaning of section
505(j)(5)(A) unless the condition specified in clause (ii) is
met.
``(ii) The condition specified in this clause is that the
fee established under subsection (a)(2) has been paid within
20 calendar days of the Secretary providing the notification
to the sponsor of the abbreviated new drug application or
supplement of the failure of the owner of the Type II active
pharmaceutical ingredient drug master file to pay the drug
master file fee as specified in subparagraph (C).
``(C)(i) If an abbreviated new drug application or
supplement to an abbreviated new drug application references
a Type II active pharmaceutical ingredient drug master file
for which a fee under subsection (a)(2)(A) has not been paid
by the applicable date under subsection (a)(2)(E), the
Secretary shall notify the sponsor of the abbreviated new
drug application or supplement of the failure of the owner of
the Type II active pharmaceutical ingredient drug master file
to pay the applicable fee.
``(ii) If such fee is not paid within 20 calendar days of
the Secretary providing the notification, the abbreviated new
drug application or supplement to an abbreviated new drug
application shall not be received within the meaning of
505(j)(5)(A).
``(3) Abbreviated new drug application fee and prior
approval supplement fee.--Failure to pay a fee under
subparagraph (A) or (F) of subsection (a)(3) within 20
calendar days of the applicable due date under subparagraph
(C) of such subsection shall result in the abbreviated new
drug application or the prior approval supplement to an
abbreviated new drug application not being received within
the meaning of section 505(j)(5)(A) until such outstanding
fee is paid.
``(4) Generic drug facility fee and active pharmaceutical
ingredient facility fee.--
``(A) In general.--Failure to pay the fee under subsection
(a)(4) within 20 calendar days of the due date as specified
in subparagraph (D) of such subsection shall result in the
following:
``(i) The Secretary shall place the facility on a publicly
available arrears list, such that no new abbreviated new drug
application or supplement submitted on or after October 1,
2012, from the person that is responsible for paying such
fee, or any affiliate of that person, will be received within
the meaning of section 505(j)(5)(A).
``(ii) Any new generic drug submission submitted on or
after October 1, 2012, that references such a facility shall
not be received, within the meaning of section 505(j)(5)(A)
if the outstanding facility fee is not paid within 20
calendar days of the Secretary providing the notification to
the sponsor of the failure of the owner of the facility to
pay the facility fee under subsection (a)(4)(C).
``(iii) All drugs or active pharmaceutical ingredients
manufactured in such a facility or containing an ingredient
manufactured in such a facility shall be deemed misbranded
under section 502(aa).
``(B) Application of penalties.--The penalties under this
paragraph shall apply until the fee established by subsection
(a)(4) is paid or the facility is removed from all generic
drug submissions that refer to the facility.
``(C) Nonreceival for nonpayment.--
``(i) Notice.--If an abbreviated new drug application or
supplement to an abbreviated new drug application submitted
on or after October 1, 2012, references a facility for which
a facility fee has not been paid by the applicable date under
subsection (a)(4)(C), the Secretary shall notify the sponsor
of the generic drug submission of the failure of the owner of
the facility to pay the facility fee.
``(ii) Nonreceival.--If the facility fee is not paid within
20 calendar days of the Secretary providing the notification
under clause (i), the abbreviated new drug application or
supplement to an abbreviated new drug application shall not
be received within the meaning of section 505(j)(5)(A).
``(h) Limitations.--
``(1) In general.--Fees under subsection (a) shall be
refunded for a fiscal year beginning after fiscal year 2012,
unless appropriations for salaries and expenses of the Food
and Drug Administration for such fiscal year (excluding the
amount of fees appropriated for such fiscal year) are equal
to or greater than the amount of appropriations for the
salaries and expenses of the Food and Drug Administration for
the fiscal year 2009 (excluding the amount of fees
appropriated for such fiscal year) multiplied by the
adjustment factor (as defined in section 744A) applicable to
the fiscal year involved.
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year and
if at a later date in such fiscal year the Secretary may
assess such fees, the Secretary may assess and collect such
fees, without any modification in the rate, for Type II
active pharmaceutical ingredient drug master files,
abbreviated new drug applications and prior approval
supplements, and generic drug facilities and active
pharmaceutical ingredient facilities at any time in such
fiscal year notwithstanding the provisions of subsection (a)
relating to the date fees are to be paid.
``(i) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a)
shall be collected and available for obligation only to the
extent and in the amount provided in advance in
appropriations Acts, subject to paragraph (2). Such fees are
authorized to remain available until expended. Such sums as
may be necessary may be transferred from the Food and Drug
Administration salaries and expenses appropriation account
without fiscal year limitation to such appropriation account
for salaries and expenses with such fiscal year limitation.
The sums transferred shall be available solely for human
generic drug activities.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this section--
``(i) subject to subparagraphs (C) and (D), shall be
collected and available in each fiscal year in an amount not
to exceed the amount specified in appropriation Acts, or
otherwise made available for obligation for such fiscal year;
and
``(ii) shall be available for a fiscal year beginning after
fiscal year 2012 to defray the costs of human generic drug
activities (including such costs for an additional number of
full-time equivalent positions in the Department of Health
and Human Services to be engaged in such activities), only if
the Secretary allocates for such purpose an amount for such
fiscal year (excluding amounts from fees collected under this
section) no less than $97,000,000 multiplied by the
adjustment factor defined in section 744A(3) applicable to
the fiscal year involved.
``(B) Compliance.--The Secretary shall be considered to
have met the requirements of subparagraph (A)(ii) in any
fiscal year if the costs funded by appropriations and
allocated for human generic activities are not more than 10
percent below the level specified in such subparagraph.
``(C) Fee collection during first program year.--Until the
date of enactment of an Act making appropriations through
September 30, 2013 for the salaries and expenses account of
the Food and Drug Administration, fees authorized by this
section for fiscal year 2013, may be collected and shall be
credited to such account and remain available until expended.
``(D) Provision for early payments in subsequent years.--
Payment of fees authorized under this section for a fiscal
year (after fiscal year 2013), prior to the due date for such
fees, may be accepted by the Secretary in accordance with
authority provided in advance in a prior year appropriations
Act.
``(3) Authorization of appropriations.--For each of the
fiscal years 2013 through 2017, there is authorized to be
appropriated for fees under this section an amount equivalent
to the total revenue amount determined under subsection (b)
for the fiscal year, as adjusted under subsection (c), if
applicable, or as otherwise affected under paragraph (2) of
this subsection.
``(j) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 calendar days after it is due, such
fee shall be treated as a claim of the United States
Government subject to subchapter II of chapter 37 of title
31, United States Code.
``(k) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in human
generic drug activities, be reduced to offset the number of
officers, employees, and advisory committees so engaged.
[[Page H3201]]
``(l) Positron Emission Tomography Drugs.--
``(1) Exemption from fees.--Submission of an application
for a positron emission tomography drug or active
pharmaceutical ingredient for a positron emission tomography
drug shall not require the payment of any fee under this
section. Facilities that solely produce positron emission
tomography drugs shall not be required to pay a facility fee
as established in subsection (a)(4).
``(2) Identification requirement.--Facilities that produce
positron emission tomography drugs or active pharmaceutical
ingredients of such drugs are required to be identified
pursuant to subsection (f).
``(m) Disputes Concerning Fees.--To qualify for the return
of a fee claimed to have been paid in error under this
section, a person shall submit to the Secretary a written
request justifying such return within 180 calendar days after
such fee was paid.
``(n) Substantially Complete Applications.--An abbreviated
new drug application that is not considered to be received
within the meaning of section 505(j)(5)(A) because of failure
to pay an applicable fee under this provision within the time
period specified in subsection (g) shall be deemed not to
have been `substantially complete' on the date of its
submission within the meaning of section
505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug application
that is not substantially complete on the date of its
submission solely because of failure to pay an applicable fee
under the preceding sentence shall be deemed substantially
complete and received within the meaning of section
505(j)(5)(A) as of the date such applicable fee is
received.''.
SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.
Part 7 of subchapter C of chapter VII, as added by section
302 of this Act, is amended by inserting after section 744B
the following:
``SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Report.--
``(1) In general.--Beginning with fiscal year 2013, not
later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration
in achieving the goals identified in the letters described in
section 301(b) of the Generic Drug User Fee Amendments of
2012 during such fiscal year and the future plans of the Food
and Drug Administration for meeting the goals.
``(2) Regulatory science accountability metrics.--The
report required by paragraph (1) shall describe the amounts
spent, data generated, and activities undertaken, including
any FDA Advisory Committee consideration, by the Secretary
for each of the local acting bioequivalence topics (Topics 1
3) in the Regulatory Science Plan described in the letters
described in section 301(b) of the Generic Drug User Fee
Amendments of 2012.
``(b) Fiscal Report.--Beginning with fiscal year 2013, not
later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for such fiscal year.
``(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to
the public on the Internet Web site of the Food and Drug
Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals, and plans
for meeting the goals, for human generic drug activities for
the first 5 fiscal years after fiscal year 2017, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the House of
Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer advocacy
groups; and
``(F) the generic drug industry.
``(2) Prior public input.--Prior to beginning negotiations
with the generic drug industry on the reauthorization of this
part, the Secretary shall--
``(A) publish a notice in the Federal Register requesting
public input on the reauthorization;
``(B) hold a public meeting at which the public may present
its views on the reauthorization, including specific
suggestions for changes to the goals referred to in
subsection (a);
``(C) provide a period of 30 days after the public meeting
to obtain written comments from the public suggesting changes
to this part; and
``(D) publish the comments on the Food and Drug
Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every month during negotiations with the generic drug
industry, the Secretary shall hold discussions with
representatives of patient and consumer advocacy groups to
continue discussions of their views on the reauthorization
and their suggestions for changes to this part as expressed
under paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the generic drug industry, the Secretary shall--
``(A) present the recommendations developed under paragraph
(1) to the congressional committees specified in such
paragraph;
``(B) publish such recommendations in the Federal Register;
``(C) provide for a period of 30 days for the public to
provide written comments on such recommendations;
``(D) hold a meeting at which the public may present its
views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(5) Transmittal of recommendations.--Not later than
January 15, 2017, the Secretary shall transmit to the
Congress the revised recommendations under paragraph (4), a
summary of the views and comments received under such
paragraph, and any changes made to the recommendations in
response to such views and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before presenting the
recommendations developed under paragraphs (1) through (5) to
the Congress, the Secretary shall make publicly available, on
the Internet Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted under this
subsection between the Food and Drug Administration and the
generic drug industry.
``(B) Content.--The minutes described under subparagraph
(A) shall summarize any substantive proposal made by any
party to the negotiations as well as significant
controversies or differences of opinion during the
negotiations and their resolution.''.
SEC. 304. SUNSET DATES.
(a) Authorization.--Sections 744A and 744B, as added by
section 302 of this Act, are repealed October 1, 2017.
(b) Reporting Requirements.--Section 744C, as added by
section 303 of this Act, is repealed January 31, 2018.
SEC. 305. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2012, or the date of the enactment of this title,
whichever is later, except that fees under section 302 shall
be assessed for all human generic drug submissions and Type
II active pharmaceutical drug master files received on or
after October 1, 2012, regardless of the date of enactment of
this title.
SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.
Section 502 (21 U.S.C. 352) is amended by adding at the end
the following:
``(aa) If it is a drug, or an active pharmaceutical
ingredient, and it was manufactured, prepared, propagated,
compounded, or processed in a facility for which fees have
not been paid as required by section 744A(a)(4) or for which
identifying information required by section 744B(f) has not
been submitted, or it contains an active pharmaceutical
ingredient that was manufactured, prepared, propagated,
compounded, or processed in such a facility.''.
SEC. 307. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES
RELATED TO HUMAN GENERIC DRUGS.
Section 714, as added by section 208 of this Act, is
amended--
(1) by amending subsection (b) to read as follows:
``(b) Activities Described.--The activities described in
this subsection are--
``(1) activities under this Act related to the process for
the review of device applications (as defined in section
737(8)); and
``(2) activities under this Act related to human generic
drug activities (as defined in section 744A).''; and
(2) by amending subsection (c) to read as follows:
``(c) Objectives Specified.--The objectives specified in
this subsection are--
``(1) with respect to the activities under subsection
(b)(1), the goals referred to in section 738A(a)(1); and
``(2) with respect to the activities under subsection
(b)(2), the goals referred to in section 744C(a).''.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the
``Biosimilar User Fee Act of 2012''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made in this title will be dedicated to
expediting the process for the review of biosimilar
biological product applications, including postmarket safety
activities, as set forth in the goals identified for purposes
of part 8 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act, in the letters from the Secretary of
Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the Congressional Record.
SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is
amended by inserting after part 7,
[[Page H3202]]
as added by title III of this Act, the following:
``PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
``SEC. 744G. DEFINITIONS.
``For purposes of this part:
``(1) The term `adjustment factor' applicable to a fiscal
year that is the Consumer Price Index for all urban consumers
(Washington-Baltimore, DC MD VA WV; Not Seasonally Adjusted;
All items) of the preceding fiscal year divided by such Index
for September 2011.
``(2) The term `affiliate' means a business entity that has
a relationship with a second business entity if, directly or
indirectly--
``(A) one business entity controls, or has the power to
control, the other business entity; or
``(B) a third party controls, or has power to control, both
of the business entities.
``(3) The term `biosimilar biological product' means a
product for which a biosimilar biological product application
has been approved.
``(4)(A) Subject to subparagraph (B), the term `biosimilar
biological product application' means an application for
licensure of a biological product under section 351(k) of the
Public Health Service Act.
``(B) Such term does not include--
``(i) a supplement to such an application;
``(ii) an application filed under section 351(k) of the
Public Health Service Act that cites as the reference product
a bovine blood product for topical application licensed
before September 1, 1992, or a large volume parenteral drug
product approved before such date;
``(iii) an application filed under section 351(k) of the
Public Health Service Act with respect to--
``(I) whole blood or a blood component for transfusion;
``(II) an allergenic extract product;
``(III) an in vitro diagnostic biological product; or
``(IV) a biological product for further manufacturing use
only; or
``(iv) an application for licensure under section 351(k) of
the Public Health Service Act that is submitted by a State or
Federal Government entity for a product that is not
distributed commercially.
``(5) The term `biosimilar biological product development
meeting' means any meeting, other than a biosimilar initial
advisory meeting, regarding the content of a development
program, including a proposed design for, or data from, a
study intended to support a biosimilar biological product
application.
``(6) The term `biosimilar biological product development
program' means the program under this part for expediting the
process for the review of submissions in connection with
biosimilar biological product development.
``(7)(A) The term `biosimilar biological product
establishment' means a foreign or domestic place of
business--
``(i) that is at one general physical location consisting
of one or more buildings, all of which are within five miles
of each other; and
``(ii) at which one or more biosimilar biological products
are manufactured in final dosage form.
``(B) For purposes of subparagraph (A)(ii), the term
`manufactured' does not include packaging.
``(8) The term `biosimilar initial advisory meeting'--
``(A) means a meeting, if requested, that is limited to--
``(i) a general discussion regarding whether licensure
under section 351(k) of the Public Health Service Act may be
feasible for a particular product; and
``(ii) if so, general advice on the expected content of the
development program; and
``(B) does not include any meeting that involves
substantive review of summary data or full study reports.
``(9) The term `costs of resources allocated for the
process for the review of biosimilar biological product
applications' means the expenses in connection with the
process for the review of biosimilar biological product
applications for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to
such officers employees and committees and to contracts with
such contractors;
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies; and
``(D) collecting fees under section 744H and accounting for
resources allocated for the review of submissions in
connection with biosimilar biological product development,
biosimilar biological product applications, and supplements.
``(10) The term `final dosage form' means, with respect to
a biosimilar biological product, a finished dosage form which
is approved for administration to a patient without
substantial further manufacturing (such as lyophilized
products before reconstitution).
``(11) The term `financial hold'--
``(A) means an order issued by the Secretary to prohibit
the sponsor of a clinical investigation from continuing the
investigation if the Secretary determines that the
investigation is intended to support a biosimilar biological
product application and the sponsor has failed to pay any fee
for the product required under subparagraph (A), (B), or (D)
of section 744H(a)(1); and
``(B) does not mean that any of the bases for a `clinical
hold' under section 505(i)(3) have been determined by the
Secretary to exist concerning the investigation.
``(12) The term `person' includes an affiliate of such
person.
``(13) The term `process for the review of biosimilar
biological product applications' means the following
activities of the Secretary with respect to the review of
submissions in connection with biosimilar biological product
development, biosimilar biological product applications, and
supplements:
``(A) The activities necessary for the review of
submissions in connection with biosimilar biological product
development, biosimilar biological product applications, and
supplements.
``(B) Actions related to submissions in connection with
biosimilar biological product development, the issuance of
action letters which approve biosimilar biological product
applications or which set forth in detail the specific
deficiencies in such applications, and where appropriate, the
actions necessary to place such applications in condition for
approval.
``(C) The inspection of biosimilar biological product
establishments and other facilities undertaken as part of the
Secretary's review of pending biosimilar biological product
applications and supplements.
``(D) Activities necessary for the release of lots of
biosimilar biological products under section 351(k) of the
Public Health Service Act.
``(E) Monitoring of research conducted in connection with
the review of biosimilar biological product applications.
``(F) Postmarket safety activities with respect to
biologics approved under biosimilar biological product
applications or supplements, including the following
activities:
``(i) Collecting, developing, and reviewing safety
information on biosimilar biological products, including
adverse-event reports.
``(ii) Developing and using improved adverse-event data-
collection systems, including information technology systems.
``(iii) Developing and using improved analytical tools to
assess potential safety problems, including access to
external data bases.
``(iv) Implementing and enforcing section 505(o) (relating
to postapproval studies and clinical trials and labeling
changes) and section 505(p) (relating to risk evaluation and
mitigation strategies).
``(v) Carrying out section 505(k)(5) (relating to adverse-
event reports and postmarket safety activities).
``(14) The term `supplement' means a request to the
Secretary to approve a change in a biosimilar biological
product application which has been approved, including a
supplement requesting that the Secretary determine that the
biosimilar biological product meets the standards for
interchangeability described in section 351(k)(4) of the
Public Health Service Act.
``SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR
BIOLOGICAL PRODUCT FEES.
``(a) Types of Fees.--Beginning in fiscal year 2013, the
Secretary shall assess and collect fees in accordance with
this section as follows:
``(1) Biosimilar development program fees.--
``(A) Initial biosimilar biological product development
fee.--
``(i) In general.--Each person that submits to the
Secretary a meeting request described under clause (ii) or a
clinical protocol for an investigational new drug protocol
described under clause (iii) shall pay for the product named
in the meeting request or the investigational new drug
application the initial biosimilar biological product
development fee established under subsection (b)(1)(A).
``(ii) Meeting request.--The meeting request defined in
this clause is a request for a biosimilar biological product
development meeting for a product.
``(iii) Clinical protocol for ind.--A clinical protocol for
an investigational new drug protocol described in this clause
is a clinical protocol consistent with the provisions of
section 505(i), including any regulations promulgated under
section 505(i), (referred to in this section as
`investigational new drug application') describing an
investigation that the Secretary determines is intended to
support a biosimilar biological product application for a
product.
``(iv) Due date.--The initial biosimilar biological product
development fee shall be due by the earlier of the following:
``(I) Not later than 5 days after the Secretary grants a
request for a biosimilar biological product development
meeting.
``(II) The date of submission of an investigational new
drug application describing an investigation that the
Secretary determines is intended to support a biosimilar
biological product application.
``(v) Transition rule.--Each person that has submitted an
investigational new drug application prior to the date of
enactment of the Biosimilars User Fee Act of 2012 shall pay
the initial biosimilar biological product development fee by
the earlier of the following:
``(I) Not later than 60 days after the date of the
enactment of the Biosimilars User Fee Act of 2012, if the
Secretary determines that
[[Page H3203]]
the investigational new drug application describes an
investigation that is intended to support a biosimilar
biological product application.
``(II) Not later than 5 days after the Secretary grants a
request for a biosimilar biological product development
meeting.
``(B) Annual biosimilar biological product development
fee.--
``(i) In general.--A person that pays an initial biosimilar
biological product development fee for a product shall pay
for such product, beginning in the fiscal year following the
fiscal year in which the initial biosimilar biological
product development fee was paid, an annual fee established
under subsection (b)(1)(B) for biosimilar biological product
development (referred to in this section as `annual
biosimilar biological product development fee').
``(ii) Due date.--The annual biosimilar biological product
development program fee for each fiscal year will be due on
the later of--
``(I) the first business day on or after October 1 of each
such year; or
``(II) the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of fees for such year under this section.
``(iii) Exception.--The annual biosimilar development
program fee for each fiscal year will be due on the date
specified in clause (ii), unless the person has--
``(I) submitted a marketing application for the biological
product that was accepted for filing; or
``(II) discontinued participation in the biosimilar
biological product development program for the product under
subparagraph (C).
``(C) Discontinuation of fee obligation.--A person may
discontinue participation in the biosimilar biological
product development program for a product effective October 1
of a fiscal year by, not later than August 1 of the preceding
fiscal year--
``(i) if no investigational new drug application concerning
the product has been submitted, submitting to the Secretary a
written declaration that the person has no present intention
of further developing the product as a biosimilar biological
product; or
``(ii) if an investigational new drug application
concerning the product has been submitted, by withdrawing the
investigational new drug application in accordance with part
312 of title 21, Code of Federal Regulations (or any
successor regulations).
``(D) Reactivation fee.--
``(i) In general.--A person that has discontinued
participation in the biosimilar biological product
development program for a product under subparagraph (C)
shall pay a fee (referred to in this section as `reactivation
fee') by the earlier of the following:
``(I) Not later than 5 days after the Secretary grants a
request for a biosimilar biological product development
meeting for the product (after the date on which such
participation was discontinued).
``(II) Upon the date of submission (after the date on which
such participation was discontinued) of an investigational
new drug application describing an investigation that the
Secretary determines is intended to support a biosimilar
biological product application for that product.
``(ii) Application of annual fee.--A person that pays a
reactivation fee for a product shall pay for such product,
beginning in the next fiscal year, the annual biosimilar
biological product development fee under subparagraph (B).
``(E) Effect of failure to pay biosimilar development
program fees.--
``(i) No biosimilar biological product development
meetings.--If a person has failed to pay an initial or annual
biosimilar biological product development fee as required
under subparagraph (A) or (B), or a reactivation fee as
required under subparagraph (D), the Secretary shall not
provide a biosimilar biological product development meeting
relating to the product for which fees are owed.
``(ii) No receipt of investigational new drug
applications.--Except in extraordinary circumstances, the
Secretary shall not consider an investigational new drug
application to have been received under section 505(i)(2)
if--
``(I) the Secretary determines that the investigation is
intended to support a biosimilar biological product
application; and
``(II) the sponsor has failed to pay an initial or annual
biosimilar biological product development fee for the product
as required under subparagraph (A) or (B), or a reactivation
fee as required under subparagraph (D).
``(iii) Financial hold.--Notwithstanding section 505(i)(2),
except in extraordinary circumstances, the Secretary shall
prohibit the sponsor of a clinical investigation from
continuing the investigation if--
``(I) the Secretary determines that the investigation is
intended to support a biosimilar biological product
application; and
``(II) the sponsor has failed to pay an initial or annual
biosimilar biological product development fee for the product
as required under subparagraph (A) or (B), or a reactivation
fee for the product as required under subparagraph (D).
``(iv) No acceptance of biosimilar biological product
applications or supplements.--If a person has failed to pay
an initial or annual biosimilar biological product
development fee as required under subparagraph (A) or (B), or
a reactivation fee as required under subparagraph (D), any
biosimilar biological product application or supplement
submitted by that person shall be considered incomplete and
shall not be accepted for filing by the Secretary until all
such fees owed by such person have been paid.
``(F) Limits regarding biosimilar development program
fees.--
``(i) No refunds.--The Secretary shall not refund any
initial or annual biosimilar biological product development
fee paid under subparagraph (A) or (B), or any reactivation
fee paid under subparagraph (D).
``(ii) No waivers, exemptions, or reductions.--The
Secretary shall not grant a waiver, exemption, or reduction
of any initial or annual biosimilar biological product
development fee due or payable under subparagraph (A) or (B),
or any reactivation fee due or payable under subparagraph
(D).
``(2) Biosimilar biological product application and
supplement fee.--
``(A) In general.--Each person that submits, on or after
October 1, 2012, a biosimilar biological product application
or a supplement shall be subject to the following fees:
``(i) A fee for a biosimilar biological product application
that is equal to--
``(I) the amount of the fee established under subsection
(b)(1)(D) for a biosimilar biological product application for
which clinical data (other than comparative bioavailability
studies) with respect to safety or effectiveness are required
for approval; minus
``(II) the cumulative amount of fees paid, if any, under
subparagraphs (A), (B), and (D) of paragraph (1) for the
product that is the subject of the application.
``(ii) A fee for a biosimilar biological product
application for which clinical data (other than comparative
bioavailability studies) with respect to safety or
effectiveness are not required, that is equal to--
``(I) half of the amount of the fee established under
subsection (b)(1)(D) for a biosimilar biological product
application; minus
``(II) the cumulative amount of fees paid, if any, under
subparagraphs (A), (B), and (D) of paragraph (1) for that
product.
``(iii) A fee for a supplement for which clinical data
(other than comparative bioavailability studies) with respect
to safety or effectiveness are required, that is equal to
half of the amount of the fee established under subsection
(b)(1)(D) for a biosimilar biological product application.
``(B) Reduction in fees.--Notwithstanding section 404 of
the Biosimilars User Fee Act of 2012, any person who pays a
fee under subparagraph (A), (B), or (D) of paragraph (1) for
a product before October 1, 2017, but submits a biosimilar
biological product application for that product after such
date, shall be entitled to the reduction of any biosimilar
biological product application fees that may be assessed at
the time when such biosimilar biological product application
is submitted, by the cumulative amount of fees paid under
subparagraphs (A), (B), and (D) of paragraph (1) for that
product.
``(C) Payment due date.--Any fee required by subparagraph
(A) shall be due upon submission of the application or
supplement for which such fee applies.
``(D) Exception for previously filed application or
supplement.--If a biosimilar biological product application
or supplement was submitted by a person that paid the fee for
such application or supplement, was accepted for filing, and
was not approved or was withdrawn (without a waiver), the
submission of a biosimilar biological product application or
a supplement for the same product by the same person (or the
person's licensee, assignee, or successor) shall not be
subject to a fee under subparagraph (A).
``(E) Refund of application fee if application refused for
filing or withdrawn before filing.--The Secretary shall
refund 75 percent of the fee paid under this paragraph for
any application or supplement which is refused for filing or
withdrawn without a waiver before filing.
``(F) Fees for applications previously refused for filing
or withdrawn before filing.--A biosimilar biological product
application or supplement that was submitted but was refused
for filing, or was withdrawn before being accepted or refused
for filing, shall be subject to the full fee under
subparagraph (A) upon being resubmitted or filed over
protest, unless the fee is waived under subsection (c).
``(3) Biosimilar biological product establishment fee.--
``(A) In general.--Except as provided in subparagraph (E),
each person that is named as the applicant in a biosimilar
biological product application shall be assessed an annual
fee established under subsection (b)(1)(E) for each
biosimilar biological product establishment that is listed in
the approved biosimilar biological product application as an
establishment that manufactures the biosimilar biological
product named in such application.
``(B) Assessment in fiscal years.--The establishment fee
shall be assessed in each fiscal year for which the
biosimilar biological product named in the application is
assessed a fee under paragraph (4) unless the biosimilar
biological product establishment listed in the application
does not engage in the manufacture of the biosimilar
biological product during such fiscal year.
``(C) Due date.--The establishment fee for a fiscal year
shall be due on the later of--
``(i) the first business day on or after October 1 of such
fiscal year; or
``(ii) the first business day after the enactment of an
appropriations Act providing for
[[Page H3204]]
the collection and obligation of fees for such fiscal year
under this section.
``(D) Application to establishment.--
``(i) Each biosimilar biological product establishment
shall be assessed only one fee per biosimilar biological
product establishment, notwithstanding the number of
biosimilar biological products manufactured at the
establishment, subject to clause (ii).
``(ii) In the event an establishment is listed in a
biosimilar biological product application by more than one
applicant, the establishment fee for the fiscal year shall be
divided equally and assessed among the applicants whose
biosimilar biological products are manufactured by the
establishment during the fiscal year and assessed biosimilar
biological product fees under paragraph (4).
``(E) Exception for new products.--If, during the fiscal
year, an applicant initiates or causes to be initiated the
manufacture of a biosimilar biological product at an
establishment listed in its biosimilar biological product
application--
``(i) that did not manufacture the biosimilar biological
product in the previous fiscal year; and
``(ii) for which the full biosimilar biological product
establishment fee has been assessed in the fiscal year at a
time before manufacture of the biosimilar biological product
was begun,
the applicant shall not be assessed a share of the biosimilar
biological product establishment fee for the fiscal year in
which the manufacture of the product began.
``(4) Biosimilar biological product fee.--
``(A) In general.--Each person who is named as the
applicant in a biosimilar biological product application
shall pay for each such biosimilar biological product the
annual fee established under subsection (b)(1)(F).
``(B) Due date.--The biosimilar biological product fee for
a fiscal year shall be due on the later of--
``(i) the first business day on or after October 1 of each
such year; or
``(ii) the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of fees for such year under this section.
``(C) One fee per product per year.--The biosimilar
biological product fee shall be paid only once for each
product for each fiscal year.
``(b) Fee Setting and Amounts.--
``(1) In general.--Subject to paragraph (2), the Secretary
shall, 60 days before the start of each fiscal year that
begins after September 30, 2012, establish, for the next
fiscal year, the fees under subsection (a). Except as
provided in subsection (c), such fees shall be in the
following amounts:
``(A) Initial biosimilar biological product development
fee.--The initial biosimilar biological product development
fee under subsection (a)(1)(A) for a fiscal year shall be
equal to 10 percent of the amount established under section
736(c)(4) for a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.
``(B) Annual biosimilar biological product development
fee.--The annual biosimilar biological product development
fee under subsection (a)(1)(B) for a fiscal year shall be
equal to 10 percent of the amount established under section
736(c)(4) for a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.
``(C) Reactivation fee.--The reactivation fee under
subsection (a)(1)(D) for a fiscal year shall be equal to 20
percent of the amount of the fee established under section
736(c)(4) for a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.
``(D) Biosimilar biological product application fee.--The
biosimilar biological product application fee under
subsection (a)(2) for a fiscal year shall be equal to the
amount established under section 736(c)(4) for a human drug
application described in section 736(a)(1)(A)(i) for that
fiscal year.
``(E) Biosimilar biological product establishment fee.--The
biosimilar biological product establishment fee under
subsection (a)(3) for a fiscal year shall be equal to the
amount established under section 736(c)(4) for a prescription
drug establishment for that fiscal year.
``(F) Biosimilar biological product fee.--The biosimilar
biological product fee under subsection (a)(4) for a fiscal
year shall be equal to the amount established under section
736(c)(4) for a prescription drug product for that fiscal
year.
``(2) Limit.--The total amount of fees charged for a fiscal
year under this section may not exceed the total amount for
such fiscal year of the costs of resources allocated for the
process for the review of biosimilar biological product
applications.
``(c) Application Fee Waiver for Small Business.--
``(1) Waiver of application fee.--The Secretary shall grant
to a person who is named in a biosimilar biological product
application a waiver from the application fee assessed to
that person under subsection (a)(2)(A) for the first
biosimilar biological product application that a small
business or its affiliate submits to the Secretary for
review. After a small business or its affiliate is granted
such a waiver, the small business or its affiliate shall
pay--
``(A) application fees for all subsequent biosimilar
biological product applications submitted to the Secretary
for review in the same manner as an entity that is not a
small business; and
``(B) all supplement fees for all supplements to biosimilar
biological product applications submitted to the Secretary
for review in the same manner as an entity that is not a
small business.
``(2) Considerations.--In determining whether to grant a
waiver of a fee under paragraph (1), the Secretary shall
consider only the circumstances and assets of the applicant
involved and any affiliate of the applicant.
``(3) Small business defined.--In this subsection, the term
`small business' means an entity that has fewer than 500
employees, including employees of affiliates, and does not
have a drug product that has been approved under a human drug
application (as defined in section 735) or a biosimilar
biological product application (as defined in section
744G(4)) and introduced or delivered for introduction into
interstate commerce.
``(d) Effect of Failure To Pay Fees.--A biosimilar
biological product application or supplement submitted by a
person subject to fees under subsection (a) shall be
considered incomplete and shall not be accepted for filing by
the Secretary until all fees owed by such person have been
paid.
``(e) Crediting and Availability of Fees.--
``(1) In general.--Subject to paragraph (2), fees
authorized under subsection (a) shall be collected and
available for obligation only to the extent and in the amount
provided in advance in appropriations Acts. Such fees are
authorized to remain available until expended. Such sums as
may be necessary may be transferred from the Food and Drug
Administration salaries and expenses appropriation account
without fiscal year limitation to such appropriation account
for salaries and expenses with such fiscal year limitation.
The sums transferred shall be available solely for the
process for the review of biosimilar biological product
applications.
``(2) Collections and appropriation acts.--
``(A) In general.--Subject to subparagraphs (C) and (D),
the fees authorized by this section shall be collected and
available in each fiscal year in an amount not to exceed the
amount specified in appropriation Acts, or otherwise made
available for obligation for such fiscal year.
``(B) Use of fees and limitation.--The fees authorized by
this section shall be available for a fiscal year beginning
after fiscal year 2012 to defray the costs of the process for
the review of biosimilar biological product applications
(including such costs for an additional number of full-time
equivalent positions in the Department of Health and Human
Services to be engaged in such process), only if the
Secretary allocates for such purpose an amount for such
fiscal year (excluding amounts from fees collected under this
section) no less than $20,000,000, multiplied by the
adjustment factor applicable to the fiscal year involved.
``(C) Fee collection during first program year.--Until the
date of enactment of an Act making appropriations through
September 30, 2013, for the salaries and expenses account of
the Food and Drug Administration, fees authorized by this
section for fiscal year 2013 may be collected and shall be
credited to such account and remain available until expended.
``(D) Provision for early payments in subsequent years.--
Payment of fees authorized under this section for a fiscal
year (after fiscal year 2013), prior to the due date for such
fees, may be accepted by the Secretary in accordance with
authority provided in advance in a prior year appropriations
Act.
``(3) Authorization of appropriations.--For each of fiscal
years 2013 through 2017, there is authorized to be
appropriated for fees under this section an amount equivalent
to the total amount of fees assessed for such fiscal year
under this section.
``(f) Collection of Unpaid Fees.--In any case where the
Secretary does not receive payment of a fee assessed under
subsection (a) within 30 days after it is due, such fee shall
be treated as a claim of the United States Government subject
to subchapter II of chapter 37 of title 31, United States
Code.
``(g) Written Requests for Waivers and Refunds.--To qualify
for consideration for a waiver under subsection (c), or for a
refund of any fee collected in accordance with subsection
(a)(2)(A), a person shall submit to the Secretary a written
request for such waiver or refund not later than 180 days
after such fee is due.
``(h) Construction.--This section may not be construed to
require that the number of full-time equivalent positions in
the Department of Health and Human Services, for officers,
employers, and advisory committees not engaged in the process
of the review of biosimilar biological product applications,
be reduced to offset the number of officers, employees, and
advisory committees so engaged.''.
SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS.
Part 8 of subchapter C of chapter VII, as added by section
402 of this Act, is further amended by inserting after
section 744H the following:
``SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Performance Report.--Beginning with fiscal year 2013,
not later than 120 days after the end of each fiscal year for
which fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the
[[Page H3205]]
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration
in achieving the goals identified in the letters described in
section 401(b) of the Biosimilar User Fee Act of 2012 during
such fiscal year and the future plans of the Food and Drug
Administration for meeting such goals. The report for a
fiscal year shall include information on all previous cohorts
for which the Secretary has not given a complete response on
all biosimilar biological product applications and
supplements in the cohort.
``(b) Fiscal Report.--Not later than 120 days after the end
of fiscal year 2013 and each subsequent fiscal year for which
fees are collected under this part, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for such fiscal year.
``(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to
the public on the Internet Web site of the Food and Drug
Administration.
``(d) Study.--
``(1) In general.--The Secretary shall contract with an
independent accounting or consulting firm to study the
workload volume and full costs associated with the process
for the review of biosimilar biological product applications.
``(2) Interim results.--Not later than June 1, 2015, the
Secretary shall publish, for public comment, interim results
of the study described under paragraph (1).
``(3) Final results.--Not later than September 30, 2016,
the Secretary shall publish, for public comment, the final
results of the study described under paragraph (1).
``(e) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals described
in subsection (a), and plans for meeting the goals, for the
process for the review of biosimilar biological product
applications for the first 5 fiscal years after fiscal year
2017, and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with--
``(A) the Committee on Energy and Commerce of the House of
Representatives;
``(B) the Committee on Health, Education, Labor, and
Pensions of the Senate;
``(C) scientific and academic experts;
``(D) health care professionals;
``(E) representatives of patient and consumer advocacy
groups; and
``(F) the regulated industry.
``(2) Public review of recommendations.--After negotiations
with the regulated industry, the Secretary shall--
``(A) present the recommendations developed under paragraph
(1) to the congressional committees specified in such
paragraph;
``(B) publish such recommendations in the Federal Register;
``(C) provide for a period of 30 days for the public to
provide written comments on such recommendations;
``(D) hold a meeting at which the public may present its
views on such recommendations; and
``(E) after consideration of such public views and
comments, revise such recommendations as necessary.
``(3) Transmittal of recommendations.--Not later than
January 15, 2017, the Secretary shall transmit to the
Congress the revised recommendations under paragraph (2), a
summary of the views and comments received under such
paragraph, and any changes made to the recommendations in
response to such views and comments.''.
SEC. 404. SUNSET DATES.
(a) Authorization.--Sections 744G and 744H, as added by
section 402 of this Act, are repealed October 1, 2017.
(b) Reporting Requirements.--Section 744I, as added by
section 403 of this Act, is repealed January 31, 2018.
SEC. 405. EFFECTIVE DATE.
(a) In General.--Except as provided under subsection (b),
the amendments made by this title shall take effect on the
later of--
(1) October 1, 2012; or
(2) the date of the enactment of this title.
(b) Exception.--Fees under part 8 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act, as
added by this title, shall be assessed for all biosimilar
biological product applications received on or after October
1, 2012, regardless of the date of the enactment of this
title.
SEC. 406. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 2
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as in effect on the day before the date of the
enactment of this title, shall continue to be in effect with
respect to human drug applications and supplements (as
defined in such part as of such day) that were accepted by
the Food and Drug Administration for filing on or after
October 1, 2007, but before October 1, 2012, with respect to
assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2013.
SEC. 407. CONFORMING AMENDMENT.
Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by
striking ``or (k)''.
TITLE V--REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT AND
PEDIATRIC RESEARCH EQUITY ACT
SEC. 501. PERMANENT EXTENSION OF BEST PHARMACEUTICALS FOR
CHILDREN ACT AND PEDIATRIC RESEARCH EQUITY ACT.
(a) Program for Pediatric Studies of Drugs.--Section
409I(c) of the Public Health Service Act (42 U.S.C. 284m(c))
is amended--
(1) in subsection (c)(1)--
(A) in the matter preceding subparagraph (A), by inserting
``or section 351(m) of this Act,'' after ``Cosmetic Act,'';
(B) in subparagraph (A)(i), by inserting ``or section
351(k) of this Act'' after ``Cosmetic Act''; and
(C) by amending subparagraph (B) to read as follows:
``(B)(i) there remains no patent listed pursuant to section
505(b)(1) of the Federal Food, Drug, and Cosmetic Act; and
``(ii) every three-year and five-year period referred to in
subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E(iv),
(j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section
505 of the Federal Food, Drug and Cosmetic Act, or applicable
twelve-year period referred to in section 351(k)(7) of this
Act, and any seven-year period referred to in section 527 of
the Federal Food, Drug, and Cosmetic Act, has ended for at
least one form of the drug; and'';
(2) in subsection (c)(2)--
(A) in the heading of paragraph (2), by striking ``for
drugs lacking exclusivity'';
(B) by striking ``under section 505 of the Federal Food,
Drug, and Cosmetic Act''; and
(C) by striking ``505A of such Act'' and inserting ``505A
of the Federal Food, Drug, and Cosmetic Act or section 351(m)
of this Act''; and
(3) in subsection (e)(1), by striking ``to carry out this
section'' and all that follows through the end of paragraph
(1) and inserting ``$25,000,000 for each of fiscal years 2013
through 2017.''.
(b) Pediatric Studies of Drugs in FFDCA.--Section 505A (21
U.S.C. 355a) is amended--
(1) in subsection (d)(1)(A), by adding at the end the
following: ``If a request under this subparagraph does not
request studies in neonates, such request shall include a
statement describing the rationale for not requesting studies
in neonates.'';
(2) by amending subsection (h) to read as follows:
``(h) Relationship to Pediatric Research Requirements.--
Exclusivity under this section shall only be granted for the
completion of a study or studies that are the subject of a
written request and for which reports are submitted and
accepted in accordance with subsection (d)(3). Written
requests under this section may consist of a study or studies
required under section 505B.'';
(3) in subsection (k)(2), by striking ``subsection
(f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
(4) in subsection (l)--
(A) in paragraph (1)--
(i) in the paragraph heading, by striking ``year one'' and
inserting ``first 18-month period''; and
(ii) by striking ``one-year'' and inserting ``18-month'';
(B) in paragraph (2)--
(i) in the paragraph heading, by striking ``years'' and
inserting ``periods''; and
(ii) by striking ``one-year period'' and inserting ``18-
month period'';
(C) by redesignating paragraph (3) as paragraph (4); and
(D) by inserting after paragraph (2) the following:
``(3) Preservation of authority.--Nothing in this
subsection shall prohibit the Office of Pediatric
Therapeutics from providing for the review of adverse event
reports by the Pediatric Advisory Committee prior to the 18-
month period referred to in paragraph (1), if such review is
necessary to ensure safe use of a drug in a pediatric
population.'';
(5) in subsection (n)--
(A) in the subsection heading, by striking ``Completed''
and inserting ``Submitted''; and
(B) in paragraph (1)--
(i) in the text preceding subparagraph (A), by striking
``have not been completed'' and inserting ``have not been
submitted by the date specified in the written request issued
and agreed upon''; and
(ii) by revising subparagraphs (A) and (B) to read as
follows:
``(A) For a drug for which there remains any listed patent
or exclusivity protection eligible for extension under
subsection (b)(1) or (c)(1) of this section, or any
exclusivity protection eligible for extension under
subsection (m)(2) or (m)(3) of section 351 of the Public
Health Service Act, the Secretary shall make a determination
regarding whether an assessment shall be required to be
submitted under section 505B(b).
``(B) For a drug that has no remaining listed patents or
exclusivity protection eligible for extension under
subsection (b)(1) or (c)(1) of this section, or any
exclusivity protection eligible for extension under
subsection (m)(2) or (m)(3) of section 351 of the Public
Health Service Act, the Secretary shall refer the drug for
inclusion on the list established under section 409I of the
Public Health Service Act for the conduct of studies.'';
(6) in subsection (o)(2), by amending subparagraph (B) to
read as follows:
``(B) a statement of any appropriate pediatric
contraindications, warnings, precautions, or other
information that the Secretary considers necessary to assure
safe use.''; and
[[Page H3206]]
(7) by striking subsection (q) (relating to a sunset).
(c) Research Into Pediatric Uses for Drugs and Biological
Projects in FFDCA.--Section 505B (21 U.S.C. 355c) is
amended--
(1) in subsection (a)--
(A) in paragraph (1), in the matter before subparagraph
(A), by inserting ``for a drug'' after ``(or supplement to an
application)'';
(B) in paragraph (3)--
(i) by redesignating subparagraph (B) as subparagraph (D);
and
(ii) by inserting after subparagraph (A) the following:
``(B) Deferral extension.--On the initiative of the
Secretary or at the request of the applicant, the Secretary
may grant an extension of a deferral under subparagraph (A)
if--
``(i) the Secretary finds that the criteria specified in
subclause (II) or (III) of subparagraph (A)(i) continue to be
met; and
``(ii) the applicant submits the materials required under
subparagraph (A)(ii).
``(C) Consideration during deferral period.--If the
Secretary has under this paragraph deferred the date by which
an assessment must be submitted, then until the date
specified in the deferral under subparagraph (A) (including
any extension of such date under subparagraph (B))--
``(i) the assessment shall not be considered late or
delayed; and
``(ii) the Secretary shall not classify the assessment as
late or delayed in any report, database, or public
posting.''; and
(iii) in subparagraph (D), as redesignated, by amending
clause (ii) to read as follows:
``(ii) Public availability.--Not later than 60 days after
the submission to the Secretary of the information submitted
through the annual review under clause (i), the Secretary
shall make available to the public in an easily accessible
manner, including through the Web site of the Food and Drug
Administration--
``(I) such information;
``(II) the name of the applicant for the product subject to
the assessment;
``(III) the date on which the product was approved; and
``(IV) the date of each deferral or deferral extension
under this paragraph for the product.''; and
(C) in paragraph (4)(C)--
(i) in the first sentence, by inserting ``partial'' before
``waiver is granted''; and
(ii) in the second sentence, by striking ``either a full or
partial waiver'' and inserting ``a partial waiver'';
(2) in subsection (b)(1), by striking ``After providing
notice in the form of a letter (that, for a drug approved
under section 505, references a declined written request
under section 505A for a labeled indication which written
request is not referred under section 505A(n)(1)(A) to the
Foundation of the National Institutes of Health for the
pediatric studies), the Secretary'' and inserting ``The
Secretary'';
(3) by amending subsection (d) to read as follows:
``(d) Failure To Meet Requirements.--If a person fails to
submit a required assessment described in subsection (a)(2),
fails to meet the applicable requirements in subsection
(a)(3), or fails to submit a request for approval of a
pediatric formulation described in subsection (a) or (b), in
accordance with applicable provisions of subsections (a) and
(b)--
``(1)(A) the Secretary shall issue a letter to such person
informing such person of such failure;
``(B) not later than 30 calendar days after the issuance of
a letter under subparagraph (A), the person who receives such
letter shall submit to the Secretary a written response to
such letter; and
``(C) not later than 45 calendar days after the issuance of
a letter under subparagraph (A), the Secretary shall make
such letter, and any response to such letter under
subparagraph (B), available to the public on the Web site of
the Food and Drug Administration, with appropriate redactions
made to protect trade secrets and confidential commercial
information, except that, if the Secretary determines that
the letter under subparagraph (A) was issued in error, the
requirements of this subparagraph shall not apply with
respect to such letter; and
``(2)(A) the drug or biological product that is the subject
of the required assessment, applicable requirements in
subsection (a)(3), or required request for approval of a
pediatric formulation may be considered misbranded solely
because of that failure and subject to relevant enforcement
action (except that the drug or biological product shall not
be subject to action under section 303); but
``(B) the failure to submit the required assessment, meet
the applicable requirements in subsection (a)(3), or submit
the required request for approval of a pediatric formulation
shall not be the basis for a proceeding--
``(i) to withdraw approval for a drug under section 505(e);
or
``(ii) to revoke the license for a biological product under
section 351 of the Public Health Service Act.'';
(4) by amending subsection (e) to read as follows:
``(e) Initial Pediatric Plan.--
``(1) In general.--
``(A) Submission.--An applicant who is required to submit
an assessment under subsection (a)(1) shall submit an initial
pediatric plan.
``(B) Timing.--An applicant shall submit the initial
pediatric plan under paragraph (1)--
``(i) before the date on which the applicant submits the
assessments under subsection (a)(2); and
``(ii) not later than--
``(I) 60 calendar days after the date of end-of-Phase 2
meeting (as such term is used in section 312.47 of title 21,
Code of Federal Regulations, or successor regulations); or
``(II) such other time as may be agreed upon between the
Secretary and the applicant.
Nothing in this section shall preclude the Secretary from
accepting the submission of an initial pediatric plan earlier
than the date otherwise applicable under this subparagraph.
``(C) Contents.--The initial pediatric plan shall include--
``(i) an outline of the pediatric studies that the
applicant plans to conduct;
``(ii) any request for a deferral, partial waiver, or
waiver under this section, along with supporting information;
and
``(iii) other information the Secretary determines
necessary, including any information specified in regulations
under paragraph (5).
``(2) Meeting.--
``(A) In general.--Subject to subparagraph (B), not later
than 90 calendar days after receiving an initial pediatric
plan under paragraph (1), the Secretary shall meet with the
applicant to discuss the plan.
``(B) Written response.--If the Secretary determines that a
written response to the initial pediatric plan is sufficient
to communicate comments on the initial pediatric plan, and
that no meeting is necessary the Secretary shall, not later
than 90 days after receiving an initial pediatric plan under
paragraph (1)--
``(i) notify the applicant of such determination; and
``(ii) provide to the applicant the Secretary's written
comments on the plan.
``(3) Agreed initial pediatric plan.--
``(A) Submission.--The applicant shall submit to the
Secretary a document reflecting the agreement between the
Secretary and the applicant on the initial pediatric plan
(referred to in this subsection as an `agreed initial
pediatric plan').
``(B) Confirmation.--Not later than 30 days after receiving
the agreed initial pediatric plan under subparagraph (A), the
Secretary shall provide written confirmation to the applicant
that such plan reflects the agreement of the Secretary.
``(C) Deferral and waiver.--If the agreed initial pediatric
plan contains a request from the applicant for a deferral,
partial waiver, or waiver under this section, the written
confirmation under subparagraph (B) shall include a
recommendation from the Secretary as to whether such request
meets the standards under paragraphs (3) or (4) of subsection
(a).
``(D) Amendments to the plan.--At the initiative of the
Secretary or the applicant, the agreed initial pediatric plan
may be amended at any time. The requirements of paragraph (2)
shall apply to any such proposed amendment in the same manner
and to the same extent as such requirements apply to an
initial pediatric plan under paragraph (1). The requirements
of subparagraphs (A) through (C) of this paragraph shall
apply to any agreement resulting from such proposed amendment
in the same manner and to the same extent as such
requirements apply to an agreed initial pediatric plan.
``(4) Internal committee.--The Secretary shall consult the
internal committee under section 505C on the review of the
initial pediatric plan, greed initial pediatric plan, and any
amendments to such plans.
``(5) Mandatory rulemaking.--Not later than one year after
the date of enactment of the Food and Drug Administration
Reform Act of 2012, the Secretary shall promulgate proposed
regulations and guidance to implement the provisions of this
subsection.
``(6) Effective date.--The provisions of this subsection
shall take effect 180 calendar days after the date of
enactment of the Food and Drug Administration Reform Act of
2012, irrespective of whether the Secretary has promulgated
final regulations to carry out this subsection by such
date.'';
(5) in subsection (f)--
(A) in the subsection heading, by inserting ``Deferral
Extensions,'' after ``Deferrals,'';
(B) in paragraph (4)--
(i) in the paragraph heading, by inserting ``deferral
extensions,'' after ``deferrals,''; and
(ii) in the second sentence, by inserting ``, deferral
extensions,'' after ``deferrals''; and
(C) in paragraph (6)(D)--
(i) by inserting ``and deferral extensions'' before
``requested and granted''; and
(ii) by inserting ``and deferral extensions'' after ``the
reasons for such deferrals'';
(6) in subsection (g)--
(A) in paragraph (1)(A), by striking ``after the date of
the submission of the application or supplement'' and
inserting ``after the date of the submission of an
application or supplement that receives a priority review or
330 days after the date of the submission of an application
or supplement that receives a standard review''; and
(B) in paragraph (2), by striking ``the label of such
product'' and inserting ``the labeling of such product'';
(7) in subsection (h)(1)--
(A) by inserting ``an application (or supplement to an
application) that contains'' after ``date of submission of'';
and
[[Page H3207]]
(B) by inserting ``if the application (or supplement)
receives a priority review, or not later than 330 days after
the date of submission of an application (or supplement to an
application) that contains a pediatric assessment under this
section, if the application (or supplement) receives a
standard review,'' after ``under this section,'';
(8) in subsection (i)--
(A) in paragraph (1)--
(i) in the paragraph heading, by striking ``year one'' and
inserting ``first 18-month period''; and
(ii) by striking ``one-year'' and inserting ``18-month'';
(B) in paragraph (2)--
(i) in the paragraph heading, by striking ``years'' and
inserting ``periods''; and
(ii) by striking ``one-year period'' and inserting ``18-
month period'';
(C) by redesignating paragraph (3) as paragraph (4); and
(D) by inserting after paragraph (2) the following:
``(3) Preservation of authority.--Nothing in this
subsection shall prohibit the Office of Pediatric
Therapeutics from providing for the review of adverse event
reports by the Pediatric Advisory Committee prior to the 18-
month period referred to in paragraph (1), if such review is
necessary to ensure safe use of a drug in a pediatric
population.'';
(9) by striking subsection (m) (relating to integration
with other pediatric studies); and
(10) by redesignating subsection (n) as subsection (m).
(d) Pediatric Studies of Biological Products in PHSA.--
Section 351(m)(1) of the Public Health Service Act (42 U.S.C.
262(m)(1)) is amended by striking ``(f), (i), (j), (k), (l),
(p), and (q)'' and inserting ``(f), (h), (i), (j), (k), (l),
(n), and (p)''.
(e) Application; Transition Rule.--
(1) Application.--Notwithstanding any provision of section
505A and 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a, 355c) stating that a provision applies beginning
on the date of the enactment of the Best Pharmaceuticals for
Children Act of 2007 or the date of the enactment of the
Pediatric Research Equity Act of 2007, any amendment made by
this Act to such a provision applies beginning on the date of
the enactment of this Act.
(2) Transitional rule for adverse event reporting.--With
respect to a drug for which a labeling change described under
section 505A(l)(1) or 505B(i)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is
approved or made, respectively, during the one-year period
that ends on the day before the date of enactment of this
Act, the Secretary shall apply section 505A(l) and section
505B(i), as applicable, to such drug, as such sections were
in effect on such day.
(f) Conforming Amendment.--Section 499(c)(1)(C) of the
Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is
amended by striking ``for which the Secretary issues a
certification in the affirmative under section 505A(n)(1)(A)
of the Federal Food, Drug, and Cosmetic Act''.
(g) Public Meeting on Pediatric Cancers.--Not later than
December 31, 2013, the Secretary of Health and Human Services
shall hold a public meeting on the impact of sections 505A
and 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a, 355c) on the development of new therapies for
children with cancer.
SEC. 502. FOOD AND DRUG ADMINISTRATION REPORT.
(a) In General.--Not later than four years after the date
of enactment of this Act and every five years thereafter, the
Secretary of Health and Human Services shall prepare and
submit to the Committee on Health, Education, Labor and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, and make publicly
available, including through posting on the Web site of the
Food and Drug Administration, a report on the implementation
of section 505A and 505B.
(b) Contents.--The report described in paragraph (1) shall
include--
(1) an assessment of the effectiveness of sections 505A and
505B in improving information about pediatric uses for
approved drugs and biologics, including the number and type
of labeling changes made since the date of enactment of this
Act;
(2) the number of waivers and partial waivers granted under
section 505B since the date of enactment of this Act, and the
reasons such waivers and partial waivers were granted;
(3) the number of deferrals and deferral extensions granted
under section 505B since the date of enactment of this Act,
and the reasons such deferrals and deferral extensions were
granted;
(4) the number of letters issued under section 505B(d);
(5) an assessment of the timeliness and effectiveness of
pediatric study planning since the date of enactment of this
Act, including the number of pediatric plans not submitted in
accordance with the requirements of section 505B(e) and any
resulting rulemaking;
(6) the number of written requests issued, accepted, and
declined under section 505A since the date of enactment of
this Act, and a listing of any important gaps in pediatric
information as a result of such declined requests;
(7) a description and current status of referrals made
under section 505A(n);
(8) an assessment of the effectiveness of studying drugs
for rare diseases under 505A;
(9) an assessment of the effectiveness of studying drugs
for children with cancer under 505A and 505B, and any
recommendations for modifications to the programs under such
sections that would lead to new and better therapies for
children with cancer;
(10) an assessment of the effectiveness of studying drugs
in the neonate population under 505A and 505B;
(11) an assessment of the effectiveness of studying
biological products in pediatric populations under 505A and
505B;
(12) an assessment of the Secretary's efforts to address
the suggestions and options described in the report required
under 505A(p); and
(13) any suggestions for modification to the programs that
would improve pediatric drug research and increase pediatric
labeling of drugs and biologics that the Secretary determines
to be appropriate.
(c) Stakeholder Comment.--At least 180 days prior to the
submission of the report required in paragraph (1), the
Secretary shall consult with representatives of patient
groups, including pediatric patient groups, consumer groups,
regulated industry, academia, and other interested parties to
obtain any recommendations or information relevant to the
study and report including suggestions for modifications that
would improve pediatric drug research and pediatric labeling
of drugs and biologics.
SEC. 503. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS,
ASSESSMENTS, DEFERRALS, DEFERRAL EXTENSIONS,
AND WAIVERS.
Section 505C (21 U.S.C. 355d) is amended--
(1) in the section heading, by inserting ``DEFERRAL
EXTENSIONS,'' after ``DEFERRALS,''; and
(2) by inserting ``neonatology'' after ``pediatric
ethics''.
SEC. 504. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.
Section 6(c) of the Best Pharmaceuticals for Children Act
(21 U.S.C. 393a(c)) is amended--
(1) in paragraph (1), by striking ``and'' at the end;
(2) by redesignating paragraph (2) as paragraph (4);
(3) by inserting after paragraph (1) the following:
``(2) one or more additional individuals with expertise in
neonatology;
``(3) one or more additional individuals with expertise in
pediatric epidemiology; and''.
SEC. 505. CONTINUATION OF OPERATION OF PEDIATRIC ADVISORY
COMMITTEE.
Section 14(d) of the Best Pharmaceuticals for Children Act
(42 U.S.C. 284m note) is amended by striking ``during the
five-year period beginning on the date of the enactment of
the Best Pharmaceuticals for Children Act of 2007'' and
inserting ``to carry out the advisory committee's
responsibilities under sections 505A, 505B, and 520(m) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c,
and 360j(m))''.
SEC. 506. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS
ADVISORY COMMITTEE.
Section 15(a) of the Best Pharmaceuticals for Children Act
(Public Law 107 109), as amended by section 502(e) of the
Food and Drug Administration Amendments Act of 2007 (Public
Law 110 85), is amended--
(1) in paragraph (1)(D), by striking ``section 505B(f)''
and inserting ``section 505C''; and
(2) in paragraph (3), by striking ``during the five-year
period beginning on the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007'' and inserting ``to
carry out the Subcommittee's responsibilities under this
section''.
TITLE VI--FOOD AND DRUG ADMINISTRATION ADMINISTRATIVE REFORMS
SEC. 601. PUBLIC PARTICIPATION IN ISSUANCE OF FDA GUIDANCE
DOCUMENTS.
Section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended by
striking subparagraph (C) and inserting the following:
``(C) For any guidance document that sets forth initial
interpretations of a statute or regulation, sets forth
changes in interpretation or policy that are of more than a
minor nature, includes complex scientific issues, or covers
highly controversial issues--
``(i) the Secretary--
``(I) at least 30 days before issuance of a draft of such
guidance document, shall publish notice in the Federal
Register of the Secretary's intent to prepare such guidance
document; and
``(II) during preparation and before issuance of such
guidance document, may meet with interested stakeholders,
including industry, medical, and scientific experts and
others, and solicit public comment;
``(ii) if the Secretary for good cause finds that, with
respect to such guidance document, compliance with clause (i)
is impracticable, unnecessary, or contrary to the public
interest--
``(I) the Secretary shall publish such finding and a brief
statement of the reasons for such finding in the Federal
Register;
``(II) clause (i) shall not apply with respect to such
guidance document; and
``(III) during a 90-day period beginning not later than the
date of issuance of such guidance document, the Secretary may
meet with interested stakeholders, including industry,
medical, and scientific experts and others, and shall solicit
public comment;
``(iii) beginning on the date of enactment of the Food and
Drug Administration Reform Act of 2012, upon issuance of a
draft guidance
[[Page H3208]]
document under clause (i) or (ii), the Secretary shall--
``(I) designate the document as draft or final; and
``(II) not later than 18 months after the close of the
comment period for such guidance, issue a final version of
such guidance document in accordance with clauses (i) and
(ii);
``(iv) the Secretary may extend the deadline for issuing
final guidance under clause (iii)(II) by not more than 180
days upon submission by the Secretary of a notification of
such extension in the Federal Register;
``(v) if the Secretary issues a draft guidance document and
fails to finalize the draft by the deadline determined under
clause (iii)(II), as extended under clause (iv), the
Secretary shall, beginning on the date of such deadline,
treat the draft as null and void; and
``(vi) not less than every 5 years after the issuance of a
final guidance document in accordance with clause (iii), the
Secretary shall--
``(I) conduct a retrospective analysis of such guidance
document to ensure it is not outmoded, ineffective,
insufficient, or excessively burdensome; and
``(II) based on such analysis, modify, streamline, expand,
or repeal the guidance document in accordance with what has
been learned.
``(D) With respect to devices, a notice to industry
guidance letter, a notice to industry advisory letter, and
any similar notice that sets forth initial interpretations of
a statute or regulation or sets forth changes in
interpretation or policy shall be treated as a guidance
document for purposes of subparagraph (C).
``(E) The following shall not be treated as a guidance
document for purposes of subparagraph (C):
``(i) Any document that does not set forth an initial
interpretation or a reinterpretation of a statute or
regulation.
``(ii) Any document that sets forth or changes a policy
relating to internal procedures of the Food and Drug
Administration.
``(iii) Agency reports, general information documents
provided to consumers or health professionals, speeches,
journal articles and editorials, media interviews, press
materials, warning letters, memoranda of understanding, or
communications directed to individual persons or firms.''.
SEC. 602. CONFLICTS OF INTEREST.
(a) In General.--Section 712 (21 U.S.C. 379d 1) is
amended--
(1) by striking subsections (b) and (c) and inserting the
following subsections:
``(b) Recruitment for Advisory Committees.--
``(1) In general.--The Secretary shall--
``(A) develop and implement strategies on effective
outreach to potential members of advisory committees at
universities, colleges, other academic research centers,
professional and medical societies, and patient and consumer
groups;
``(B) seek input from professional medical and scientific
societies to determine the most effective informational and
recruitment activities;
``(C) at least every 180 days, request referrals for
potential members of advisory committees from a variety of
stakeholders, including--
``(i) product developers, patient groups, and disease
advocacy organizations; and
``(ii) relevant--
``(I) professional societies;
``(II) medical societies;
``(III) academic organizations; and
``(IV) governmental organizations; and
``(D) in carrying out subparagraphs (A) and (B), take into
account the levels of activity (including the numbers of
annual meetings) and the numbers of vacancies of the advisory
committees.
``(2) Recruitment activities.--The recruitment activities
under paragraph (1) may include--
``(A) advertising the process for becoming an advisory
committee member at medical and scientific society
conferences;
``(B) making widely available, including by using existing
electronic communications channels, the contact information
for the Food and Drug Administration point of contact
regarding advisory committee nominations; and
``(C) developing a method through which an entity receiving
funding from the National Institutes of Health, the Agency
for Healthcare Research and Quality, the Centers for Disease
Control and Prevention, or the Veterans Health Administration
can identify a person whom the Food and Drug Administration
can contact regarding the nomination of individuals to serve
on advisory committees.
``(3) Expertise.--In carrying out this subsection, the
Secretary shall seek to ensure that the Secretary has access
to the most current expert advice.
``(c) Disclosure of Determinations and Certifications.--
Notwithstanding section 107(a)(2) of the Ethics in Government
Act of 1978, the following shall apply:
``(1) 15 or more days in advance.--As soon as practicable,
but (except as provided in paragraph (2)) not later than 15
days prior to a meeting of an advisory committee to which a
written determination as referred to in section 208(b)(1) of
title 18, United States Code, or a written certification as
referred to in section 208(b)(3) of such title, applies, the
Secretary shall disclose (other than information exempted
from disclosure under section 552 or section 552a of title 5,
United States Code (popularly known as the Freedom of
Information Act and the Privacy Act of 1974, respectively))
on the Internet Website of the Food and Drug Administration--
``(A) the type, nature, and magnitude of the financial
interests of the advisory committee member to which such
determination or certification applies; and
``(B) the reasons of the Secretary for such determination
or certification, including, as appropriate, the public
health interest in having the expertise of the member with
respect to the particular matter before the advisory
committee.
``(2) Less than 30 days in advance.--In the case of a
financial interest that becomes known to the Secretary less
than 30 days prior to a meeting of an advisory committee to
which a written determination as referred to in section
208(b)(1) of title 18, United States Code, or a written
certification as referred to in section 208(b)(3) of such
title applies, the Secretary shall disclose (other than
information exempted from disclosure under section 552 or
552a of title 5, United States Code) on the Internet Website
of the Food and Drug Administration, the information
described in subparagraphs (A) and (B) of paragraph (1) as
soon as practicable after the Secretary makes such
determination or certification, but in no case later than the
date of such meeting.'';
(2) in subsection (d), by striking ``subsection (c)(3)''
and inserting ``subsection (c)'';
(3) by amending subsection (e) to read as follows:
``(e) Annual Report.--
``(1) In general.--Not later than February 1 of each year,
the Secretary shall submit to the Committee on Appropriations
and the Committee on Health, Education, Labor, and Pensions
of the Senate, and the Committee on Appropriations and the
Committee on Energy and Commerce of the House of
Representatives, a report that describes--
``(A) with respect to the fiscal year that ended on
September 30 of the previous year, the number of persons
nominated for participation at meetings for each advisory
committee, the number of persons so nominated, and willing to
serve, the number of vacancies on each advisory committee,
and the number of persons contacted for service as members on
each advisory committee meeting for each advisory committee
who did not participate because of the potential for such
participation to constitute a disqualifying financial
interest under section 208 of title 18, United States Code;
``(B) with respect to such year, the number of persons
contacted for services as members for each advisory committee
meeting for each advisory committee who did not participate
because of reasons other than the potential for such
participation to constitute a disqualifying financial
interest under section 208 of title 18, United States Code;
``(C) with respect to such year, the number of members
attending meetings for each advisory committee; and
``(D) with respect to such year, the aggregate number of
disclosures required under subsection (d) and the percentage
of individuals to whom such disclosures did not apply who
served on such committee.
``(2) Public availability.--Not later than 30 days after
submitting any report under paragraph (1) to the committees
specified in such paragraph, the Secretary shall make each
such report available to the public.''; and
(4) in subsection (f), by striking ``shall review
guidance'' and all that follows through the end of the
subsection and inserting the following: ``shall--
``(1) review guidance of the Food and Drug Administration
with respect to advisory committees regarding disclosure of
conflicts of interest and the application of section 208 of
title 18, United States Code; and
``(2) update such guidance as necessary to ensure that the
Food and Drug Administration receives appropriate access to
needed scientific expertise, with due consideration of the
requirements of such section 208.''.
(b) Applicability.--The amendments made by subsection (a)
apply beginning on October 1, 2012.
SEC. 603. ELECTRONIC SUBMISSION OF APPLICATIONS.
Subchapter D of chapter VII (21 U.S.C. 379k et seq.) is
amended by inserting after section 745 the following:
``SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS.
``(a) Drugs and Biologics.--
``(1) In general.--Beginning no earlier than 24 months
after the issuance of a final guidance issued after public
notice and opportunity for comment, submissions under
subsection (b), (i), or (j) of section 505 of this Act or
subsection (a) or (k) of section 351 of the Public Health
Service Act shall be submitted in such electronic format as
specified by the Secretary in such guidance.
``(2) Guidance contents.--In the guidance under paragraph
(1), the Secretary may--
``(A) provide a timetable for establishment by the
Secretary of further standards for electronic submission as
required by such paragraph; and
``(B) set forth criteria for waivers of and exemptions from
the requirements of this subsection.
``(3) Exception.--This subsection shall not apply to
submissions described in section 561.
``(b) Devices.--
``(1) In general.--Beginning after the issuance of final
guidance implementing this paragraph, pre-submissions and
submissions
[[Page H3209]]
for devices under section 510(k), 513(f)(2)(A), 515(c),
515(d), 515(f), 520(g), 520(m), or 564 of this Act or section
351 of the Public Health Service Act, and any supplements to
such pre-submissions or submissions, shall include an
electronic copy of such pre-submissions or submissions.
``(2) Guidance contents.--In the guidance under paragraph
(1), the Secretary may--
``(A) provide standards for the electronic copy required
under such paragraph; and
``(B) set forth criteria for waivers of and exemptions from
the requirements of this subsection.''.
SEC. 604. NOTIFICATION OF FDA INTENT TO REGULATE LABORATORY-
DEVELOPED TESTS.
The Food and Drug Administration may not issue any draft or
final guidance on the regulation of laboratory-developed
tests under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) without, at least 60 days prior to such
issuance--
(1) notifying the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate of the
Administration's intent to take such action; and
(2) including in such notification the anticipated details
of such action.
TITLE VII--MEDICAL DEVICE REGULATORY IMPROVEMENTS
Subtitle A--Premarket Predictability
SEC. 701. INVESTIGATIONAL DEVICE EXEMPTIONS.
Section 520(g) (21 U.S.C. 360j(g)) is amended--
(1) in paragraph (2)(B)(ii), by inserting ``safety or
effectiveness'' before ``data obtained''; and
(2) in paragraph (4), by adding at the end the following:
``(C) Consistent with paragraph (1), the Secretary shall
not disapprove an application under this subsection because
the Secretary determines that--
``(i) the investigation may not support a substantial
equivalence or de novo classification determination or
approval of the device;
``(ii) the investigation may not meet a requirement,
including a data requirement, relating to the approval or
clearance of a device; or
``(iii) an additional or different investigation may be
necessary to support clearance or approval of the device.''.
SEC. 702. CLARIFICATION OF LEAST BURDENSOME STANDARD.
(a) Premarket Approval.--Section 513(a)(3)(D) (21 U.S.C.
360c(a)(3)(D)) is amended--
(1) by redesignating clause (iii) as clause (v); and
(2) by inserting after clause (ii) the following:
``(iii) For purposes of clause (ii), the term `necessary'
means the minimum required information that would support a
determination by the Secretary that an application provides
reasonable assurance of the effectiveness of the device.
``(iv) Nothing in this subparagraph shall alter the
criteria for evaluating an application for premarket approval
of a device.''.
(b) Premarket Notification Under Section 510(k).--Section
513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended--
(1) by striking ``(D) Whenever'' and inserting ``(D)(i)
Whenever''; and
(2) by adding at the end the following:
``(ii) For purposes of clause (i), the term `necessary'
means the minimum required information that would support a
determination of substantial equivalence between a new device
and a predicate device.
``(iii) Nothing in this subparagraph shall alter the
standard for determining substantial equivalence between a
new device and a predicate device.''.
SEC. 703. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT
DECISIONS.
Chapter V is amended by inserting after section 517 (21
U.S.C. 360g) the following:
``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT
DECISIONS REGARDING DEVICES.
``(a) Documentation of Rationale for Significant
Decisions.--
``(1) In general.--The Secretary shall completely document
the scientific and regulatory rationale for any significant
decision of the Center for Devices and Radiological Health
regarding submission or review of a report under section
510(k), an application under section 515, or an application
for an exemption under section 520(g), including
documentation of significant controversies or differences of
opinion and the resolution of such controversies or
differences of opinion.
``(2) Provision of documentation.--Upon request, the
Secretary shall furnish such complete documentation to the
person who is seeking to submit, or who has submitted, such
report or application.
``(b) Review of Significant Decisions.--
``(1) Request for supervisory review of significant
decision.--Any person may request a supervisory review of the
significant decision described in subsection (a)(1). Such
review may be conducted at the next supervisory level or
higher above the individual who made the significant
decision.
``(2) Submission of request.--A person requesting a
supervisory review under paragraph (1) shall submit such
request to the Secretary not later than 30 days after such
decision and shall indicate in the request whether such
person seeks an in-person meeting or a teleconference review.
``(3) Timeframe.--
``(A) In general.--Except as provided in subparagraph (B),
the Secretary shall schedule an in-person or teleconference
review, if so requested, not later than 30 days after such
request is made. The Secretary shall issue a decision to the
person requesting a review under this subsection not later
than 45 days after the request is made under paragraph (1),
or, in the case of a person who requests an in-person meeting
or teleconference, 30 days after such meeting or
teleconference.
``(B) Exception.--Subparagraph (A) shall not apply in cases
that are referred to experts outside of the Food and Drug
Administration.''.
SEC. 704. TRANSPARENCY IN CLEARANCE PROCESS.
(a) Publication of Detailed Decision Summaries.--Section
520(h) (21 U.S.C. 360j(h)) is amended by adding at the end
the following:
``(5) Subject to subsection (c) and section 301(j), the
Secretary shall regularly publish detailed decision summaries
for each clearance of a device under section 510(k) requiring
clinical data.''.
(b) Application.--The requirement of section 520(h)(5) of
the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), applies only with respect to clearance of a
device occurring after the date of the enactment of this Act.
SEC. 705. DEVICE MODIFICATIONS REQUIRING PREMARKET
NOTIFICATION PRIOR TO MARKETING.
Section 510(n) (21 U.S.C. 360(n)) is amended by--
(1) striking ``(n) The Secretary'' and inserting ``(n)(1)
The Secretary''; and
(2) by adding at the end the following:
``(2)(A) Not later than 18 months after the enactment of
this paragraph, the Secretary shall submit to the Committee
on Energy and Commerce of the House of Representatives and
the Committee on Health, Education, Labor, and Pensions of
the Senate a report regarding when a premarket notification
under subsection (k) should be submitted for a modification
or change to a legally marketed device. The report shall
include the Secretary's interpretation of the following
terms: `could significantly affect the safety or
effectiveness of the device', `a significant change or
modification in design, material, chemical composition,
energy source, or manufacturing process,', and `major change
or modification in the intended use of the device'. The
report also shall discuss possible processes for industry to
use to determine whether a new submission under subsection
(k) is required and shall analyze how to leverage existing
quality system requirements to reduce premarket burden,
facilitate continual device improvement. and provide
reasonable assurance of safety and effectiveness of modified
devices. In developing such report, the Secretary shall
consider the input of interested stakeholders.
``(B) The Secretary shall withdraw the Food and Drug
Administration draft guidance entitled `Guidance for Industry
and FDA Staff--510(k) Device Modifications: Deciding When to
Submit a 510(k) for a Change to an Existing Device', dated
July 27, 2011, and shall not use this draft guidance as part
of, or for the basis of, any premarket review or any
compliance or enforcement decisions or actions. The Secretary
shall not issue--
``(i) any draft guidance or proposed regulation that
addresses when to submit a premarket notification submission
for changes and modifications made to a manufacturer's
previously cleared device before the receipt by the Committee
on Energy and Commerce of the House of Representatives and
the Committee on Health, Education, Labor, and Pensions of
the Senate of the report required in subparagraph (A); and
``(ii) any final guidance or regulation on that topic for
one year after date of receipt of such report by the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate.
``(C) The Food and Drug Administration guidance entitled
`Deciding When to Submit a 510(k) for a Change to an Existing
Device', dated January 10, 1997, shall be in effect until the
subsequent issuance of guidance or promulgation, if
appropriate, of a regulation described in subparagraph (B),
and the Secretary shall interpret such guidance in a manner
that is consistent with the manner in which the Secretary has
interpreted such guidance since 1997.''.
Subtitle B--Patients Come First
SEC. 711. ESTABLISHMENT OF SCHEDULE AND PROMULGATION OF
REGULATION.
(a) Establishment of Schedule.--Not later than 90 days
after the date of enactment of this Act, the Secretary of
Health and Human Services shall establish the schedule
referred to in section 515(i)(3) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e(i)(3)).
(b) Regulation.--Not later than one year after the date
that the schedule is established under such section 515(i)(3)
(as required by subsection (a)) the Secretary shall issue a
final regulation under section 515(b) of such Act for each
device that the Secretary requires to remain in class III
through a determination under section 515(i)(2) of such Act.
SEC. 712. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.
Chapter V is amended by inserting after section 518 (21
U.S.C. 360h) the following:
[[Page H3210]]
``SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.
``(a) In General.--The Secretary shall--
``(1) establish a program to routinely and systematically
assess information relating to device recalls and use such
information to proactively identify strategies for mitigating
health risks presented by defective or unsafe devices;
``(2) clarify procedures for conducting device recall audit
checks to improve the ability of investigators to perform
those checks in a consistent manner;
``(3) develop detailed criteria for assessing whether a
person performing a device recall has performed an effective
correction or action plan for the recall; and
``(4) document the basis for each termination by the Food
and Drug Administration of a device recall.
``(b) Assessment Content.--The program established under
subsection (a)(1) shall, at a minimum, identify--
``(1) trends in the number and types of device recalls;
``(2) devices that are most frequently the subject of a
recall; and
``(3) underlying causes of device recalls.
``(c) Definition.--In this section, the term `recall'
means--
``(1) the removal from the market of a device pursuant to
an order of the Secretary under subsection (b) or (e) of
section 518; or
``(2) the correction or removal from the market of a device
at the initiative of the manufacturer or importer of the
device that is required to be reported to the Secretary under
section 519(g).''.
Subtitle C--Novel Device Regulatory Relief
SEC. 721. MODIFICATION OF DE NOVO APPLICATION PROCESS.
(a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2))
is amended--
(1) by inserting ``(i)'' after ``(2)(A)'';
(2) in subparagraph (A)(i), as so designated by paragraph
(1), by striking ``under the criteria set forth'' and all
that follows through the end of subparagraph (A) and
inserting a period;
(3) by adding at the end of subparagraph (A) the following:
``(ii) In lieu of submitting a report under section 510(k)
and submitting a request for classification under clause (i)
for a device, if a person determines there is no legally
marketed device upon which to base a determination of
substantial equivalence (as defined in subsection (i)), a
person may submit a request under this clause for the
Secretary to classify the device.
``(iii) Upon receipt of a request under clause (i) or (ii),
the Secretary shall classify the device subject to the
request under the criteria set forth in subparagraphs (A)
through (C) of subsection (a)(1) within 120 days.
``(iv) Notwithstanding clause (iii), the Secretary may
decline to undertake a classification of a device pursuant to
a request under clause (ii) if the Secretary--
``(I) identifies a legally marketed device that would
permit a substantial equivalence determination under
paragraph (1) for the device; or
``(II) determines that the device submitted is not of low-
moderate risk or special controls to mitigate the risks
cannot be developed for the device.
``(v) The person submitting the request for classification
under this subparagraph may recommend to the Secretary a
classification for the device and shall, if recommending
classification in class II, include in the request an initial
draft proposal for applicable special controls, as described
in subsection (a)(1)(B), that are necessary, in conjunction
with general controls, to provide reasonable assurance of
safety and effectiveness and a description of how the special
controls provide such assurance. Any such request shall
describe the device and provide detailed information and
reasons for the recommended classification.''; and
(4) in subparagraph (B), by striking ``Not later than 60
days after the date of the submission of the request under
subparagraph (A), the Secretary'' and inserting ``The
Secretary''.
(b) Conforming Amendments.--Section 513(f) of such Act (21
U.S.C. 360c(f)) is amended in paragraph (1)--
(1) in subparagraph (A), by striking ``, or'' at the end
and inserting a semicolon;
(2) in subparagraph (B), by striking the period and
inserting ``; or''; and
(3) by inserting after subparagraph (B) the following:
``(C) the device is classified pursuant to a request
submitted under paragraph (2).''.
Subtitle D--Keeping America Competitive Through Harmonization
SEC. 731. HARMONIZATION OF DEVICE PREMARKET REVIEW,
INSPECTION, AND LABELING SYMBOLS; REPORT.
(a) In General.--Paragraph (4) of section 803(c) (21 U.S.C.
383(c)) is amended to read as follows:
``(4) With respect to devices, the Secretary may, when
appropriate, enter into arrangements with nations regarding
methods and approaches to harmonizing regulatory requirements
for activities, including inspections and common
international labeling symbols.''.
(b) Report.--Not later than 3 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report on the
Food and Drug Administration's harmonization activities,
itemizing methods and approaches that have been harmonized
pursuant to section 803(c)(4) of the Federal Food, Drug, and
Cosmetic Act, as amended by subsection (a).
SEC. 732. PARTICIPATION IN INTERNATIONAL FORA.
Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) is
amended--
(1) by striking ``(3)'' and inserting ``(3)(A)''; and
(2) by adding at the end the following:
``(B) In carrying out subparagraph (A), the Secretary may
participate in appropriate fora, including the International
Medical Device Regulators Forum, and may--
``(i) provide guidance to such fora on strategies,
policies, directions, membership, and other activities of a
forum as appropriate;
``(ii) to the extent appropriate, solicit, review, and
consider comments from industry, academia, health care
professionals, and patient groups regarding the activities of
such fora; and
``(iii) to the extent appropriate, inform the public of the
Secretary's activities within such fora, and share with the
public any documentation relating to a forum's strategies,
policies, and other activities of such fora.''.
Subtitle E--FDA Renewing Efficiency From Outside Reviewer Management
SEC. 741. REAUTHORIZATION OF THIRD PARTY REVIEW.
(a) Periodic Reaccreditation.--Section 523(b)(2) (21 U.S.C.
360m(b)(2)) is amended by adding at the end of the following:
``(E) Periodic reaccreditation.--
``(i) Period.--Subject to suspension or withdrawal under
subparagraph (B), any accreditation under this section shall
be valid for a period of 3 years after its issuance.
``(ii) Response to reaccreditation request.--Upon the
submission of a request by an accredited person for
reaccreditation under this section, the Secretary shall
approve or deny such request not later than 60 days after
receipt of the request.
``(iii) Criteria.--Not later than 120 days after the date
of the enactment of this subparagraph, the Secretary shall
establish and publish in the Federal Register criteria to
reaccredit or deny reaccreditation to persons under this
section. The reaccreditation of persons under this section
shall specify the particular activities under subsection (a),
and the devices, for which such persons are reaccredited.''.
(b) Duration of Authority.--Section 523(c) (21 U.S.C.
360m(c)) is amended by striking ``October 1, 2012'' and
inserting ``October 1, 2017''.
SEC. 742. REAUTHORIZATION OF THIRD PARTY INSPECTION.
Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by
striking ``October 1, 2012'' and inserting ``October 1,
2017''.
Subtitle F--Humanitarian Device Reform
SEC. 751. EXPANDED ACCESS TO HUMANITARIAN USE DEVICES.
(a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is
amended--
(1) in paragraph (6)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by striking
``subparagraph (D)'' and inserting ``subparagraph (C)'';
(ii) by striking clause (i) and inserting the following:
``(i) The device with respect to which the exemption is
granted--
``(I) is intended for the treatment or diagnosis of a
disease or condition that occurs in pediatric patients or in
a pediatric subpopulation, and such device is labeled for use
in pediatric patients or in a pediatric subpopulation in
which the disease or condition occurs; or
``(II) is intended for the treatment or diagnosis of a
disease or condition that does not occur in pediatric
patients or that occurs in pediatric patients in such numbers
that the development of the device for such patients is
impossible, highly impracticable, or unsafe.'';
(iii) by striking clause (ii) and inserting the following:
``(ii) During any calendar year, the number of such devices
distributed during that year under each exemption granted
under this subsection does not exceed the number of such
devices needed to treat, diagnose, or cure a population of
4,000 individuals in the United States (referred to in this
paragraph as the `annual distribution number').''; and
(iv) in clause (iv), by striking ``2012'' and inserting
``2017'';
(B) by striking subparagraph (C);
(C) by redesignating subparagraphs (D) and (E) as
subparagraphs (C) and (D), respectively; and
(D) in subparagraph (C), as so redesignated, by striking
``and modified under subparagraph (C), if applicable,'';
(2) in paragraph (7), by striking ``regarding a device''
and inserting ``regarding a device described in paragraph
(6)(A)(i)(I)''; and
(3) in paragraph (8), by striking ``of all devices
described in paragraph (6)'' and inserting ``of all devices
described in paragraph (6)(A)(i)(I)''.
(b) Applicability to Existing Devices.--A sponsor of a
device for which an exemption was approved under paragraph
(2) of section 520(m) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360j(m)) before the date of enactment of this
Act may seek a determination under subclause (I) or (II) of
paragraph (6)(A)(i) of such section 520(m) (as amended by
subsection (a)). If the Secretary determines that such
subclause (I) or (II) applies with respect to a device, then
clauses
[[Page H3211]]
(ii), (iii), and (iv) of subparagraph (A) and subparagraphs
(B), (C), and (D) of paragraph (6) of such section 520(m)
shall apply to such device.
(c) Report.--Not later than January 1, 2017, the
Comptroller General of the United States shall submit to
Congress a report that evaluates and describes--
(1) the effectiveness of the amendments made by subsection
(a) in stimulating innovation with respect to medical
devices, including any favorable or adverse impact on
pediatric device development;
(2) the impact of such amendments on pediatric device
approvals for devices that received a humanitarian use
designation under section 520(m) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j(m)) prior to the date of
enactment of this Act;
(3) the status of public and private insurance coverage of
devices granted an exemption under paragraph (2) of such
section 520(m) and costs to patients of such devices;
(4) the impact that paragraph (4) of such section 520(m)
has had on access to and insurance coverage of devices
granted an exemption under paragraph (2) of such section
520(m); and
(5) the effect of the amendments made by subsection (a) on
patients described in such section 520(m).
Subtitle G--Records and Reports on Devices
SEC. 761. UNIQUE DEVICE IDENTIFICATION SYSTEM REGULATIONS.
Not later than 120 days after the date of enactment of this
Act, the Secretary of Health and Human Services shall
promulgate the regulations required by section 519(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)).
SEC. 762. EFFECTIVE DEVICE SENTINEL PROGRAM.
(a) Inclusion of Devices in Postmarket Risk Identification
and Analysis System.--Section 519 (21 U.S.C. 360i) is amended
by adding at the end the following:
``(h) Inclusion of Devices in Postmarket Risk
Identification and Analysis System.--
``(1) In general.--The Secretary shall amend the procedures
established and maintained under clauses (i), (ii), (iii),
and (v) of section 505(k)(3)(C) in order to expand the
postmarket risk identification and analysis system
established under such section to include and apply to
devices.
``(2) Data.--In expanding the system as described in
paragraph (1), the Secretary shall use relevant data with
respect to devices cleared under section 510(k) or approved
under section 515, which may include claims data, patient
survey data, and standardized analytic files that allow for
the pooling and analysis of data from disparate data
environments.
``(3) Stakeholder input.--To help ensure effective
implementation of the system as described in paragraph (1)
with respect to devices, the Secretary shall engage outside
stakeholders in development of the system, and gather
information from outside stakeholders regarding the content
of an effective sentinel program, through a public hearing,
advisory committee meeting, maintenance of a public docket,
or other similar public measures.
``(4) Voluntary surveys.--Chapter 35 of title 44, United
States Code, shall not apply to the collection of voluntary
information from health care providers, such as voluntary
surveys or questionnaires, initiated by the Secretary for
purposes of postmarket risk identification, mitigation, and
analysis for devices.''.
(b) Amendments to Postmarket Risk Identification and
Analysis System.--Section 505(k)(3)(C)(i) (21 U.S.C.
355(k)(3)(C)(i)) is amended--
(1) by striking subclause (II);
(2) by redesignating subclauses (III) through (VI) as
subclauses (II) through (V), respectively; and
(3) in item (bb) of subclause (II), as so redesignated, by
striking ``pharmaceutical purchase data and health insurance
claims data'' and inserting ``medical device utilization
data, health insurance claims data, and procedure and device
registries''.
Subtitle H--Miscellaneous
SEC. 771. CUSTOM DEVICES.
Section 520(b) (21 U.S.C. 360j) is amended to read as
follows:
``(b) Custom Devices.--
``(1) In general.--The requirements of sections 514 and 515
shall not apply to a device that--
``(A) is created or modified in order to comply with the
order of an individual physician or dentist (or any other
specially qualified person designated under regulations
promulgated by the Secretary after an opportunity for an oral
hearing);
``(B) in order to comply with an order described in
subparagraph (A), necessarily deviates from an otherwise
applicable performance standard under section 514 or
requirement under section 515;
``(C) is not generally available in the United States in
finished form through labeling or advertising by the
manufacturer, importer, or distributor for commercial
distribution;
``(D) is designed to treat a unique pathology or
physiological condition that no other device is domestically
available to treat;
``(E)(i) is intended to meet the special needs of such
physician or dentist (or other specially qualified person so
designated) in the course of the professional practice of
such physician or dentist (or other specially qualified
person so designated); or
``(ii) is intended for use by an individual patient named
in such order of such physician or dentist (or other
specially qualified person so designated);
``(F) is assembled from components or manufactured and
finished on a case-by-case basis to accommodate the unique
needs of individuals described in clause (i) or (ii) of
subparagraph (E); and
``(G) may have common, standardized design characteristics,
chemical and material compositions, and manufacturing
processes as commercially distributed devices.
``(2) Limitations.--Paragraph (1) shall apply to a device
only if--
``(A) such device is for the purpose of treating a
sufficiently rare condition, such that conducting clinical
investigations on such device would be impractical;
``(B) production of such device under paragraph (1) is
limited to no more than 5 units per year of a particular
device type, provided that such replication otherwise
complies with this section; and
``(C) the manufacturer of such device notifies the
Secretary on an annual basis, in a manner prescribed by the
Secretary, of the manufacture of such device.
``(3) Guidance.--Not later than 2 years after the date of
enactment of this section, the Secretary shall issue final
guidance on replication of multiple devices described in
paragraph (2)(B).''.
SEC. 772. PEDIATRIC DEVICE REAUTHORIZATION.
(a) Final Rule Relating To Tracking of Pediatric Uses of
Devices.--The Secretary of Health and Human Services shall
issue--
(1) a proposed rule implementing section 515A(a)(2) of the
Federal Food, Drug and Cosmetic Act (21 U.S.C. 360e 1(a)(2))
not later than December 31, 2012; and
(2) a final rule implementing such section not later than
December 31, 2013.
(b) Demonstration Grants To Improve Pediatric Device
Availability.--Section 305(e) of the Pediatric Medical Device
Safety and Improvement Act of 2007 (Title III of Public Law
110 85) is amended by striking ``2008 through 2012'' and
inserting ``2013 through 2017''.
SEC. 773. REPORT ON REGULATION OF HEALTH INFORMATION
TECHNOLOGY.
(a) Report.--Not later than 18 months after the date of the
enactment of this Act, the Secretary of Health and Human
Services, in consultation with the Commissioner of Food and
Drugs, the National Coordinator for Health Information
Technology, and the Chairman of the Federal Communications
Commission, shall submit to the Committee on Energy and
Commerce of the House of Representatives and the appropriate
committees of the Senate a report that contains--
(1) a strategy for coordinating the regulation of health
information technology in order to avoid regulatory
duplication; and
(2) recommendations on an appropriate regulatory framework
for health information technology, including a risk-based
framework.
(b) Definition.--In this section, the terms ``health
information technology'' has the meaning given such term in
section 3000(5) of the Public Health Service Act and includes
technologies such as electronic health records, personal
health records, mobile medical applications, computerized
health care provider order entry systems, and clinical
decision support.
TITLE VIII--DRUG REGULATORY IMPROVEMENTS
Subtitle A--Drug Supply Chain
SEC. 801. REGISTRATION OF PRODUCERS OF DRUGS.
(a) Timing.--Section 510 (21 U.S.C. 360) is amended--
(1) in subsection (b)(1), by striking ``On or before'' and
inserting ``During the period beginning on October 1 and
ending on''; and
(2) in subsection (i)(1)(B)(i), by striking ``on or
before'' and inserting ``during the period beginning on
October 1 and ending on''.
(b) Establishments Not Duly Registered; Misbranding.--
Section 502(o) (21 U.S.C. 352(o)) is amended by striking ``in
any State''.
SEC. 802. INSPECTION OF DRUGS.
Subsection (h) of section 510 (21 U.S.C. 360) is amended--
(1) by striking ``(h)'' and inserting ``(h)(1)'';
(2) by inserting ``with respect to the manufacture,
preparation, propagation, compounding, or processing of a
device'' after ``registered with the Secretary pursuant to
this section'';
(3) by striking ``of a drug or drugs or''; and
(4) by adding at the end the following:
``(2) Inspections With Respect to Drug Establishments.--
With respect to the manufacture, preparation, propagation,
compounding, or processing of a drug:
``(A) In general.--Every establishment that is required to
be registered with the Secretary under this section shall be
subject to inspection pursuant to section 704.
``(B) Risk-based schedule.--In the case of an establishment
that is engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or drugs (referred to in
this subsection as a `drug establishment'), the inspections
required under subparagraph (A) shall be conducted by
officers or employees duly designated by the Secretary, on a
risk-based schedule established by the Secretary.
``(C) Risk factors.--In establishing the risk-based
schedule under subparagraph (B), the Secretary shall allocate
resources to inspect establishments according to the known
safety risks of such establishments, based on the following
factors:
[[Page H3212]]
``(i) The compliance history of the establishment.
``(ii) The inspection frequency and history of the
establishment, including whether it has been inspected
pursuant to section 704 within the last four years.
``(iii) The record, history, and nature of recalls linked
to the establishment.
``(iv) The inherent risk of the drug manufactured,
prepared, propagated, compounded, or processed at the
establishment.
``(v) Any other criteria deemed necessary and appropriate
by the Secretary for purposes of allocating inspection
resources.
``(D) Effect of status.--In determining the risk associated
with an establishment for purposes of establishing a risk-
based schedule under subparagraph (B), the Secretary shall
not consider whether the drugs manufactured, prepared,
propagated, compounded, or processed by such establishment
are drugs described in section 503(b)(1).
``(E) Annual report on inspections of establishments.--Not
later than February 1 of each year, the Secretary shall
submit to Congress a report that contains the following:
``(i) The number of domestic and foreign establishments
registered pursuant to this section in the previous calendar
year.
``(ii) The number of such registered domestic and foreign
establishments that the Secretary inspected in the previous
calendar year.
``(iii) The number of such registered establishments that
list one or more drugs approved pursuant to an application
filed under section 505(j).
``(iv) The number of such registered establishments that
list one or more drugs approved pursuant to an application
filed under section 505(b).
``(v) The number of registered establishments that list
both drug products approved pursuant to an application filed
under section 505(j) and drug products approved pursuant to
an application filed under section 505(b).
``(vi) A description of how the Secretary implemented the
risk-based schedule under subparagraph (B) utilizing the
factors under subparagraph (C).
``(F) Public availability of annual reports.--The Secretary
shall make the report required under subparagraph (E)
available to the public on the Internet Web site of the Food
and Drug Administration.''.
SEC. 803. DRUG SUPPLY QUALITY AND SAFETY.
Paragraph (a) of section 501 (21 U.S.C. 351) is amended by
adding at the end the following: ``For purposes of
subparagraph (2)(B), the term `current good manufacturing
practice' includes the implementation of oversight and
controls over the manufacture of drugs to ensure quality,
including managing the risk of and establishing the safety of
raw materials, materials used in the manufacturing of drugs,
and finished drug products.''.
SEC. 804. PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR
REFUSING INSPECTION.
(a) In General.--Section 501 (21 U.S.C. 351) is amended by
adding at the end the following:
``(j) If it is a drug and it has been manufactured,
processed, packed, or held in any factory, warehouse, or
establishment and the owner, operator, or agent of such
factory, warehouse, or establishment delays, denies, or
limits an inspection, or refuses to permit entry or
inspection.''.
(b) Guidance.--Not later than 1 year after the date of
enactment of this section, the Secretary of Health and Human
Services shall issue guidance that defines the circumstances
that would constitute delaying, denying, or limiting
inspection, or refusing to permit entry or inspection, for
purposes of section 501(j) of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a)).
SEC. 805. DESTRUCTION OF ADULTERATED, MISBRANDED, OR
COUNTERFEIT DRUGS OFFERED FOR IMPORT.
(a) In General.--The sixth sentence of section 801(a) (21
U.S.C. 381(a)) is amended by inserting before the period at
the end the following: ``, except that the Secretary of
Health and Human Services, in consultation with the Secretary
of Homeland Security, may cause the destruction, without the
opportunity for export, of any drug refused admission that
has reasonable probability of causing serious adverse health
consequences or death, as determined by the Secretary of
Health and Human Services, or that is valued at an amount
that is $2,000 or less (or such higher amount as the
Secretary of Homeland Security may set by regulation pursuant
to section 498 of the Tariff Act of 1930 (19 U.S.C. 1498))''.
(b) Notice.--Section 801(a) (21 U.S.C. 381(a)), as amended
by subsection (a), is further amended by inserting after the
sixth sentence the following: ``The Secretary of Health and
Human Services shall issue regulations providing for notice
and an opportunity for a hearing on the destruction of a drug
under the previous sentence. For a drug with a value less
than and or equal to $2,000 (or, as described in the sixth
sentence of this subsection, such higher amount as the
Secretary of Homeland Security may set by regulation pursuant
to section 498 of the Tariff Act of 1930 (19 U.S.C. 1498))
the regulations under the previous sentence shall provide for
prompt notice and an opportunity for a hearing for the owner
or consignee before or after the destruction has occurred.
For a drug with a value greater than $2,000 (or, as described
in the sixth sentence of this subsection, such higher amount
as the Secretary of Homeland Security may set by regulation
pursuant to section 498 of the Tariff Act of 1930 (19 U.S.C.
1498)) that has reasonable probability of causing serious
adverse health consequences or death as determined by the
Secretary of Health and Human Services, the regulations under
the seventh sentence of this subsection shall provide for
notice and an opportunity for a hearing to the owner or
consignee before the destruction occurs.''.
(c) Restitution.--In the regulations described in the
seventh sentence of section 801(a) of the Federal Food, Drug,
and Cosmetic Act (as added by subsection (b)), the Secretary
of Health and Human Services shall establish an
administrative process whereby an owner or consignee of a
drug destroyed without an opportunity for a hearing on
destruction may obtain restitution for the value of the drug
destroyed under the sixth sentence of such section upon
demonstration that such drug was wrongfully destroyed.
(d) Conforming Amendment.--The first sentence of section
801(a) (21 U.S.C. 381(a)) is amended by inserting ``, except
as otherwise described in the sixth and seventh sentences of
this subsection,'' after ``giving notice thereof''.
SEC. 806. ADMINISTRATIVE DETENTION.
(a) In General.--Section 304(g) (21 U.S.C. 335a(g)) is
amended--
(1) in paragraph (1), by inserting ``, drug,'' after
``device'', each place it appears;
(2) in paragraph (2)(A), by inserting ``, drug,'' after
``(B), a device''; and
(3) in paragraph (2)(B), by inserting ``or drug'' after
``device'' each place it appears.
(b) Regulation.--Not later than 2 years after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall promulgate regulations to implement
administrative detention authority with respect to drugs, as
authorized by the amendments made by subsection (a). Before
promulgating such regulations, the Secretary shall consult
with stakeholders, including manufacturers of drugs.
(c) Effective Date.--The amendments made by subsection (a)
shall not take effect until the Secretary has issued a final
regulation under subsection (b).
SEC. 807. ENHANCED CRIMINAL PENALTY FOR COUNTERFEIT DRUGS.
(a) In General.--Section 303(a) (21 U.S.C. 333(a)) is
amended by adding at the end the following:
``(3) Notwithstanding paragraph (2), any person who engages
in any conduct described in section 301(i)(2) knowing or
having reason to know that the conduct concerns the rendering
of a drug as a counterfeit drug, or who engages in conduct
described in section 301(i)(3) knowing or having reason to
know that the conduct will cause a drug to be a counterfeit
drug or knowing or having reason to know that a drug held,
sold, or dispensed is a counterfeit drug, shall be fined in
accordance with title 18, United States Code, or imprisoned
not more than 20 years, or both, except that if the use of
the counterfeit drug by a consumer is the proximate cause of
the death of the consumer, the term of imprisonment shall be
any term of years or for life.''.
(b) Conforming Amendment.--Section 201(g)(2) (21 U.S.C.
321(g)(2)) is amended by adding at the end the following
sentence: ``The term `counterfeit drug' shall not include a
drug or placebo intended for use in a clinical trial that is
intentionally labeled or marked to maintain proper blinding
of the study.''.
SEC. 808. UNIQUE FACILITY IDENTIFICATION NUMBER.
(a) Domestic Establishments.--Section 510 (21 U.S.C. 360)
is amended--
(1) in subsection (b)(1), by striking ``and all such
establishments'' and inserting ``all such establishments, and
the unique facility identifier of each such establishment'';
and
(2) in subsection (c), by striking ``and such
establishment'' and inserting ``such establishment, and the
unique facility identifier of such establishment''.
(b) Foreign Establishments.--Subparagraph (A) of section
510(i)(1) (21 U.S.C. 360(i)(1)) is amended by inserting ``the
unique facility identifier of the establishment,'' after
``the name and place of business of the establishment,''.
(c) Guidance.--Section 510 (21 U.S.C. 360) is amended by
adding at the end the following:
``(q) Guidance on Submission of Unique Facility
Identifiers.--
``(1) In general.--Not later than 2 years after the date of
the enactment of this subsection, the Secretary shall, by
guidance, specify--
``(A) the unique facility identifier system to be used to
meet the requirements of--
``(i) subsections (b)(1), (c), and (i)(1)(A) of this
section; and
``(ii) section 801(s) (relating to registration of
commercial importers); and
``(B) the form, manner, and timing of submissions of unique
facility identifiers under the provisions specified in
subparagraph (A).
``(2) Consideration.--In developing the guidance under
paragraph (1), the Secretary shall take into account the
utilization of existing unique identification schemes and
compatibility with customs automated systems.''.
(d) Importation.--Section 801(a) (21 U.S.C. 381(a)) is
amended by inserting ``or (5) for an article that is a drug,
the appropriate unique facility identifiers under subsection
(s) (relating to commercial importers) and section
[[Page H3213]]
510(i) (relating to foreign establishments), as specified by
the Secretary, are not provided,'' before ``then such article
shall be refused admission''.
SEC. 809. DOCUMENTATION FOR ADMISSIBILITY OF IMPORTS.
Section 801 (21 U.S.C. 381) is amended by adding at the end
the following:
``(r) Documentation.--
``(1) Submission.--The Secretary may require, in
consultation with the Secretary of Homeland Security acting
through U.S. Customs and Border Protection as determined
appropriate by the Secretary, the submission of documentation
or other information for a drug that is imported or offered
for import into the United States.
``(2) Refusal of admission.--A drug imported or offered for
import into the United States shall be refused admission
unless all documentation and information the Secretary
requires under this Act, the Public Health Service Act, or
both, as appropriate, for such article is submitted.
``(3) Regulations.--
``(A) Documents and information.--The Secretary shall issue
a regulation to specify the documentation or other
information that is described in paragraph (1). Such
information may include--
``(i) information demonstrating the regulatory status of
the drug, such as the new drug application, abbreviated new
drug application, or investigational new drug or Drug Master
File number;
``(ii) facility information, such as proof of registration
and the unique facility identifier; and
``(iii) indication of compliance with current good
manufacturing practice, such as satisfactory testing results,
certifications relating to satisfactory inspections, and
compliance with the country of export regulations.
``(B) Exemption.--The Secretary may, by regulation, exempt
drugs imported for research purposes only and other types of
drug imports from some or all of the requirements of this
subsection.
``(4) Effective date.--The final rule under paragraph
(3)(A) shall take effect not less than 180 days after the
Secretary promulgates such final rule.''.
SEC. 810. REGISTRATION OF COMMERCIAL IMPORTERS.
(a) Prohibitions.--Section 301 (21 U.S.C. 331) is amended
by adding at the end the following:
``(aaa) The failure to register in accordance with section
801(s).''.
(b) Registration.--Section 801 (21 U.S.C. 381), as amended
by section 809, is further amended by adding at the end the
following:
``(s) Registration of Commercial Importers.--
``(1) Registration.--The Secretary shall require a
commercial importer of drugs--
``(A) to be registered with the Secretary in a form and
manner specified by the Secretary; and
``(B) consistent with the guidance under section 510(q), to
submit, at the time of registration, a unique identifier for
the principal place of business for which the importer is
required to register under this subsection.
``(2) Regulations.--
``(A) In general.--The Secretary, in consultation with the
Secretary of Homeland Security acting through U.S. Customs
and Border Protection, shall promulgate regulations to
establish good importer practices that specify the measures
an importer shall take to ensure imported drugs are in
compliance with the requirements of this Act and the Public
Health Service Act.
``(B) Expedited clearance for certain importers.--In
promulgating good importer practice regulations under
subparagraph (A), the Secretary may, as appropriate, take
into account differences among importers and types of
imports, and, based on the level of risk posed by the
imported drug, provide for expedited clearance for those
importers that volunteer to participate in partnership
programs for highly compliant companies.
``(3) Discontinuance of registration.--The Secretary shall
discontinue the registration of any commercial importer of
drugs that fails to comply with the regulations promulgated
under this subsection.
``(4) Exemptions.--The Secretary, by notice in the Federal
Register, may establish exemptions from the requirements of
this subsection.''.
(c) Misbranding.--Section 502(o) (21 U.S.C. 352) is amended
by inserting ``if it is a drug and was imported or offered
for import by a commercial importer of drugs not duly
registered under section 801(s),'' after ``not duly
registered under section 510,''.
(d) Regulations.--
(1) In general.--Not later than 36 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services, in consultation with the Secretary of Homeland
Security acting through U.S. Customs and Border Protection,
shall promulgate the regulations required to carry out
section 801(s) of the Federal Food, Drug, and Cosmetic Act,
as added by subsection (b).
(2) Effective date.--In establishing the effective date of
the regulations under paragraph (1), the Secretary of Health
and Human Services shall, in consultation with the Secretary
of Homeland Security acting through U.S. Customs and Border
Protection, as determined appropriate by the Secretary of
Health and Human Services, provide a reasonable period of
time for an importer of a drug to comply with good importer
practices, taking into account differences among importers
and types of imports, including based on the level of risk
posed by the imported product.
SEC. 811. NOTIFICATION.
(a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as
amended by section 810, is further amended by adding at the
end the following:
``(bbb) The failure to notify the Secretary in violation of
section 568.''.
(b) Notification.--Subchapter E of chapter V (21 U.S.C.
360bbb et seq.) is amended by adding at the end the
following:
``SEC. 568. NOTIFICATION.
``(a) Notification to Secretary.--With respect to a drug,
the Secretary may require notification to the Secretary by a
regulated person if the regulated person knows--
``(1) that the use of such drug in the United States may
result in serious injury or death;
``(2) of a significant loss or known theft of such drug
intended for use in the United States; or
``(3) that--
``(A) such drug has been or is being counterfeited; and
``(B)(i) the counterfeit product is in commerce in the
United States or could be reasonably expected to be
introduced into commerce; or
``(ii) such drug has been or is being imported into the
United States or may reasonably be expected to be offered for
import into the United States.
``(b) Manner of Notification.--Notification under this
section shall be made in such manner and by such means as the
Secretary may specify by regulation or guidance.
``(c) Savings Clause.--Nothing in this section shall be
construed as limiting any other authority of the Secretary to
require notifications related to a drug under any other
provision of this Act or the Public Health Service Act.
``(d) Definition.--In this section, the term `regulated
person' means--
``(1) a person who is required to register under section
510 or 801(s);
``(2) a wholesale distributor of a drug product; or
``(3) any other person that distributes drugs except a
person that distributes drugs exclusively for retail sale.''.
SEC. 812. EXCHANGE OF INFORMATION.
Section 708 (21 U.S.C. 379) is amended--
(1) by striking ``The Secretary may provide'' and inserting
the following:
``(a) Contractors.--The Secretary may provide''; and
(2) by adding at the end the following:
``(b) Ability To Receive and Protect Confidential
Information.--Except pursuant to an order of a court of the
United States, the Secretary shall not be required to
disclose under section 552 of title 5, United States Code, or
any other provision of law, any information relating to drugs
obtained from a Federal, State, or local government agency,
or from a foreign government agency, if the agency has
requested that the information be kept confidential. For
purposes of section 552 of title 5, United States Code, this
subsection shall be considered a statute described in section
552(b)(3)(B).
``(c) Authority To Enter Into Memoranda of Understanding
for Purposes of Information Exchange.--The Secretary may
enter into written agreements regarding the exchange of
information referenced in section 301(j) subject to the
following criteria:
``(1) Certification.--The Secretary may only enter into
written agreements under this subsection with foreign
governments that the Secretary has certified as having the
authority and demonstrated ability to protect trade secret
information from disclosure. Responsibility for this
certification shall not be delegated to any officer or
employee other than the Commissioner of Food and Drugs.
``(2) Written agreement.--The written agreement under this
subsection shall include a commitment by the foreign
government to protect information exchanged under this
subsection from disclosure unless and until the sponsor gives
written permission for disclosure or the Secretary makes a
declaration of a public health emergency pursuant to section
319 of the Public Health Service Act that is relevant to the
information.
``(3) Information exchange.--The Secretary may provide to a
foreign government that has been certified under paragraph
(1), and that has executed a written agreement under
paragraph (2), information referenced in section 301(j) in
the following circumstances:
``(A) Information concerning the inspection of a facility
may be provided if--
``(i) the Secretary reasonably believes, or the written
agreement described in paragraph (2) establishes, that the
government has authority to otherwise obtain such
information; and
``(ii) the written agreement executed under paragraph (2)
limits the recipient's use of the information to the
recipient's civil regulatory purposes.
``(B) Information not described in subparagraph (A) may be
provided as part of an investigation, or to alert the foreign
government to the potential need for an investigation, if the
Secretary has reasonable grounds to believe that a drug has a
reasonable probability of causing serious adverse health
consequences or death.
``(d) No Limitation on Authority.--This section shall not
affect the authority of the Secretary to provide or disclose
information under any other provision of law.''.
[[Page H3214]]
SEC. 813. EXTRATERRITORIAL JURISDICTION.
Chapter III (21 U.S.C. 331 et seq.) is amended by adding at
the end the following:
``SEC. 311. EXTRATERRITORIAL JURISDICTION.
``There is extraterritorial jurisdiction over any violation
of this Act relating to any article regulated under this Act
if such article was intended for import into the United
States or if any act in furtherance of the violation was
committed in the United States.''.
SEC. 814. PROTECTION AGAINST INTENTIONAL ADULTERATION.
Section 303(b) (21 U.S.C. 333(b)) is amended by adding at
the end the following:
``(7) Notwithstanding subsection (a)(2), any person that
knowingly and intentionally engages in an activity that
results in a drug becoming adulterated under subsection
(a)(1), (b), (c), or (d) of section 501 and having a
reasonable probability of causing serious adverse health
consequences or death shall be imprisoned for not more than
20 years or fined not more than $1,000,000, or both.''.
SEC. 815. RECORDS FOR INSPECTION.
Section 704(a) (21 U.S.C. 374(a)) is amended by adding at
the end the following:
``(4)(A) Any records or other information that the
Secretary may inspect under this section from a person that
owns or operates an establishment that is engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug shall, upon the request of the
Secretary, be provided to the Secretary by such person, in
advance of or in lieu of an inspection, within a reasonable
timeframe, within reasonable limits, and in a reasonable
manner, and in either electronic or physical form, at the
expense of such person. The Secretary's request shall include
a sufficient description of the records requested.
``(B) Upon receipt of the records requested under
subparagraph (A), the Secretary shall provide to the person
confirmation of receipt.
``(C) Nothing in this paragraph supplants the authority of
the Secretary to conduct inspections otherwise permitted
under this Act in order to ensure compliance with this
Act.''.
Subtitle B--Medical Gas Safety
SEC. 821. REGULATION OF MEDICAL GASES.
Chapter V (21 U.S.C. 351 et seq.) is amended by adding at
the end the following:
``Subchapter G--Medical Gases
``SEC. 575. DEFINITIONS.
``In this subchapter:
``(1) The term `designated medical gas' means any of the
following:
``(A) Oxygen that meets the standards set forth in an
official compendium.
``(B) Nitrogen that meets the standards set forth in an
official compendium.
``(C) Nitrous oxide that meets the standards set forth in
an official compendium.
``(D) Carbon dioxide that meets the standards set forth in
an official compendium.
``(E) Helium that meets the standards set forth in an
official compendium.
``(F) Carbon monoxide that meets the standards set forth in
an official compendium.
``(G) Medical air that meets the standards set forth in an
official compendium.
``(H) Any other medical gas deemed appropriate by the
Secretary, after taking into account any investigational new
drug application or investigational new animal drug
application for the same medical gas submitted in accordance
with regulations applicable to such applications in title 21
of the Code of Federal Regulations, unless any period of
exclusivity under section 505(c)(3)(E)(ii) or section
505(j)(5)(F)(ii), or the extension of any such period under
section 505A, applicable to such medical gas has not expired.
``(2) The term `medical gas' means a drug that--
``(A) is manufactured or stored in a liquefied,
nonliquefied, or cryogenic state; and
``(B) is administered as a gas.
``SEC. 576. REGULATION OF MEDICAL GASES.
``(a) Certification of Designated Medical Gases.--
``(1) Submission.--Beginning 180 days after the date of
enactment of this section, any person may file with the
Secretary a request for certification of a medical gas as a
designated medical gas. Any such request shall contain the
following information:
``(A) A description of the medical gas.
``(B) The name and address of the sponsor.
``(C) The name and address of the facility or facilities
where the medical gas is or will be manufactured.
``(D) Any other information deemed appropriate by the
Secretary to determine whether the medical gas is a
designated medical gas.
``(2) Grant of certification.--The certification requested
under paragraph (1) is deemed to be granted unless, within 60
days of the filing of such request, the Secretary finds
that--
``(A) the medical gas subject to the certification is not a
designated medical gas;
``(B) the request does not contain the information required
under paragraph (1) or otherwise lacks sufficient information
to permit the Secretary to determine that the medical gas is
a designated medical gas; or
``(C) denying the request is necessary to protect the
public health.
``(3) Effect of certification.--
``(A) In general.--
``(i) Approved uses.--A designated medical gas for which a
certification is granted under paragraph (2) is deemed, alone
or in combination, as medically appropriate, with another
designated medical gas or gases for which a certification or
certifications have been granted, to have in effect an
approved application under section 505 or 512, subject to all
applicable post-approval requirements, for the following
indications for use:
``(I) In the case of oxygen, the treatment or prevention of
hypoxemia or hypoxia.
``(II) In the case of nitrogen, use in hypoxic challenge
testing.
``(III) In the case of nitrous oxide, analgesia.
``(IV) In the case of carbon dioxide, use in extracorporeal
membrane oxygenation therapy or respiratory stimulation.
``(V) In the case of helium, the treatment of upper airway
obstruction or increased airway resistance.
``(VI) In the case of medical air, to reduce the risk of
hyperoxia.
``(VII) In the case of carbon monoxide, use in lung
diffusion testing.
``(VIII) Any other indication for use for a designated
medical gas or combination of designated medical gases deemed
appropriate by the Secretary, unless any period of
exclusivity under clause (iii) or (iv) of section
505(c)(3)(E), clause (iii) or (iv) of section 505(j)(5)(F),
or section 527, or the extension of any such period under
section 505A, applicable to such indication for use for such
gas or combination of gases has not expired.
``(ii) Labeling.--The requirements of sections 503(b)(4)
and 502(f) are deemed to have been met for a designated
medical gas if the labeling on final use container for such
medical gas bears--
``(I) the information required by section 503(b)(4);
``(II) a warning statement concerning the use of the
medical gas as determined by the Secretary by regulation; and
``(III) appropriate directions and warnings concerning
storage and handling.
``(B) Inapplicability of exclusivity provisions.--
``(i) No exclusivity for a certified medical gas.--No
designated medical gas deemed under subparagraph (A)(i) to
have in effect an approved application is eligible for any
period of exclusivity under section 505(c), 505(j), or 527,
or the extension of any such period under section 505A, on
the basis of such deemed approval.
``(ii) Effect on certification.--No period of exclusivity
under section 505(c), 505(j), or section 527, or the
extension of any such period under section 505A, with respect
to an application for a drug product shall prohibit, limit,
or otherwise affect the submission, grant, or effect of a
certification under this section, except as provided in
subsection (a)(3)(A)(i)(VIII) and section 575(1)(H).
``(4) Withdrawal, suspension, or revocation of approval.--
``(A) Withdrawal, suspension of approval.--Nothing in this
subchapter limits the Secretary's authority to withdraw or
suspend approval of a drug product, including a designated
medical gas deemed under this section to have in effect an
approved application under section 505 or section 512 of this
Act.
``(B) Revocation of certification.--The Secretary may
revoke the grant of a certification under paragraph (2) if
the Secretary determines that the request for certification
contains any material omission or falsification.
``(b) Prescription Requirement.--
``(1) In general.--A designated medical gas shall be
subject to the requirements of section 503(b)(1) unless the
Secretary exercises the authority provided in section
503(b)(3) to remove such medical gas from the requirements of
section 503(b)(1), the gas is approved for use without a
prescription pursuant to an application under section 505 or
512, or the use in question is authorized pursuant to another
provision of this Act relating to use of medical products in
emergencies.
``(2) Oxygen.--
``(A) No prescription required for certain uses.--
Notwithstanding paragraph (1), oxygen may be provided without
a prescription for the following uses:
``(i) For use in the event of depressurization or other
environmental oxygen deficiency.
``(ii) For oxygen deficiency or for use in emergency
resuscitation, when administered by properly trained
personnel.
``(B) Labeling.--For oxygen provided pursuant to
subparagraph (A), the requirements of section 503(b)(4) shall
be deemed to have been met if its labeling bears a warning
that the oxygen can be used for emergency use only and for
all other medical applications a prescription is required.
``SEC. 577. INAPPLICABILITY OF DRUG FEES TO DESIGNATED
MEDICAL GASES.
``A designated medical gas, alone or in combination with
another designated gas or gases (as medically appropriate)
deemed under section 576 to have in effect an approved
application shall not be assessed fees under section 736(a)
on the basis of such deemed approval.''.
SEC. 822. CHANGES TO REGULATIONS.
(a) Report.--Not later than 18 months after the date of the
enactment of this Act, the Secretary, after obtaining input
from medical gas manufacturers and any other interested
members of the public, shall--
(1) determine whether any changes to the Federal drug
regulations are necessary for medical gases; and
(2) submit to the Committee on Health, Education, Labor and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report regarding
any such changes.
[[Page H3215]]
(b) Regulations.--If the Secretary determines under
subsection (a) that changes to the Federal drug regulations
are necessary for medical gases, the Secretary shall issue
final regulations revising the Federal drug regulations with
respect to medical gases not later than 48 months after the
date of the enactment of this Act.
(c) Definitions.--In this section:
(1) The term ``Federal drug regulations'' means regulations
in title 21 of the Code of Federal Regulations pertaining to
drugs.
(2) The term ``medical gas'' has the meaning given to such
term in section 575 of the Federal Food, Drug, and Cosmetic
Act, as added by section 821 of this Act.
(3) The term ``Secretary'' means the Secretary of Health
and Human Services, acting through the Commissioner of Food
and Drugs.
SEC. 823. RULES OF CONSTRUCTION.
Nothing in this subtitle and the amendments made by this
subtitle applies with respect to--
(1) a drug that is approved prior to May 1, 2012, pursuant
to an application submitted under section 505 or 512 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b);
(2) any gas listed in subparagraphs (A) through (G) of
section 575(1) of the Federal Food, Drug, and Cosmetic Act,
as added by section 821 of this Act, or any combination of
any such gases, for an indication that--
(A) is not included in, or is different from, those
specified in subclauses (I) through (VII) of section
576(a)(3)(A)(i) of such Act; and
(B) is approved on or after May 1, 2012, pursuant to an
application submitted under Section 505 or 512; or
(3) any designated medical gas added pursuant to
subparagraph (H) of section 575(1) of such Act for an
indication that--
(A) is not included in, or is different from, those
originally added pursuant to subparagraph (H) of section
575(1) and section 576(a)(3)(A)(i)(VIII); and
(B) is approved on or after May 1, 2012, pursuant to an
application submitted under section 505 or 512 of such Act.
Subtitle C--Generating Antibiotic Incentives Now
SEC. 831. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.
(a) In General.--The Federal Food, Drug, and Cosmetic Act
is amended by inserting after section 505D (21 U.S.C. 355e)
the following:
``SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW
QUALIFIED INFECTIOUS DISEASE PRODUCTS.
``(a) Extension.--If the Secretary approves an application
pursuant to section 505 for a drug that has been determined
to be a qualified infectious disease product under subsection
(d), then the four- and five-year periods described in
subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505,
the three-year periods described in clauses (iii) and (iv) of
subsection (c)(3)(E) and clauses (iii) and (iv) of subsection
(j)(5)(F) of section 505, or the seven year period described
in section 527, as applicable, shall be extended by five
years.
``(b) Relation to Pediatric Exclusivity.--Any extension
under subsection (a) of a period shall be in addition to any
extension of the period under section 505A with respect to
the drug.
``(c) Limitations.--Subsection (a) does not apply to the
approval of--
``(1) a supplement to an application under section 505(b)
for any qualified infectious disease product for which an
extension described in subsection (a) is in effect or has
expired;
``(2) a subsequent application filed by the same sponsor or
manufacturer of a qualified infectious disease product
described in paragraph (1) (or a licensor, predecessor in
interest, or other related entity) for--
``(A) a change (not including a modification to the active
moiety of the qualified infectious disease product) that
results in a new indication, route of administration, dosing
schedule, dosage form, delivery system, delivery device, or
strength; or
``(B) a modification to the active moiety of the qualified
infectious disease product that does not result in a change
in safety or effectiveness; or
``(3) a product that does not meet the definition of a
qualified infectious disease product under subsection (f)
based upon its approved uses.
``(d) Determination.--The manufacturer or sponsor of a drug
may request that the Secretary designate a drug as a
qualified infectious disease product at any time in the drug
development process prior to the submission of an application
under section 505(b) for the drug, but not later than 45 days
before the submission of such application. The Secretary
shall, not later than 30 days after the submission of such
request, determine whether the drug is a qualified infectious
disease product.
``(e) Regulations.--The Secretary shall promulgate
regulations for carrying out this section. The Secretary
shall promulgate the initial regulations for carrying out
this section not later than 12 months after the date of the
enactment of this section.
``(f) Definitions.--In this section:
``(1) Qualified infectious disease product.--The term
`qualified infectious disease product' means an antibacterial
or antifungal drug for human use that treats or prevents an
infection caused by a qualifying pathogen.
``(2) Qualifying pathogen.--The term `qualifying pathogen'
means--
``(A) resistant gram-positive pathogens, including
methicillin-resistant Staphylococcus aureus (MRSA),
vancomycin-resistant Staphylococcus aureus (VRSA), and
vancomycin-resistant enterococcus (VRE);
``(B) multidrug resistant gram-negative bacteria, including
Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;
``(C) multi-drug resistant tuberculosis; or
``(D) any other infectious pathogen identified for purposes
of this section by the Secretary.''.
(b) Application.--Section 505E of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies only
with respect to a drug that is first approved under section
505(c) of such Act (21 U.S.C. 355(c)) on or after the date of
the enactment of this Act.
SEC. 832. STUDY ON INCENTIVES FOR QUALIFIED INFECTIOUS
DISEASE BIOLOGICAL PRODUCTS.
(a) In General.--The Comptroller General of the United
States shall--
(1) conduct a study on the need for incentives to encourage
research on and development and marketing of qualified
infectious disease biological products; and
(2) not later than 1 year after the date of the enactment
of this Act, submit a report to the Congress on the results
of such study, including any recommendations of the
Comptroller General on appropriate incentives for addressing
such need.
(b) Definitions.--In this section:
(1) The term ``biological product'' has the meaning given
to such term in section 351 of the Public Health Service Act
(42 U.S.C. 262).
(2) The term ``qualified infectious disease biological
product'' means a biological product for human use that
treats or prevents an infection caused by a qualifying
pathogen.
(3) The term ``qualifying pathogen'' has the meaning given
to such term in section 505E of the Federal Food, Drug, and
Cosmetic Act, as added by section 831 of this Act.
SEC. 833. CLINICAL TRIALS.
(a) Review and Revision of Guidelines.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, and not later than 4 years
thereafter, the Secretary shall--
(A) review the guidance of the Food and Drug Administration
for the conduct of clinical trials with respect to
antibacterial and antifungal drugs; and
(B) as appropriate, revise such guidance to reflect
developments in scientific and medical information and
technology and to ensure clarity regarding the procedures and
requirements for approval of an antibiotic and antifungal
drug under chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.).
(2) Issues for review.--At a minimum, the review under
paragraph (1) shall address the appropriate animal models of
infection, in vitro techniques, valid microbiological
surrogate markers, the use of noninferiority versus
superiority trials, and appropriate delta values for
noninferiority trials.
(3) Rule of construction.--Except to the extent to which
the Secretary of Health and Human Services makes revisions
under paragraph (1)(B), nothing in this section shall be
construed to repeal or otherwise affect the guidance of the
Food and Drug Administration.
(b) Recommendations for Investigations.--
(1) Request.--The sponsor of a drug intended to be used to
treat or prevent a qualifying pathogen may request that the
Secretary provide written recommendations for nonclinical and
clinical investigations which may be conducted with the drug
before it may be approved for such use under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).
(2) Recommendations.--If the Secretary has reason to
believe that a drug for which a request is made under this
subsection is a qualified infectious disease product, the
Secretary shall provide the person making the request written
recommendations for the nonclinical and clinical
investigations which the Secretary believes, on the basis of
information available to the Secretary at the time of the
request, would be necessary for approval under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of
such drug for the use described in paragraph (1).
(c) Definitions.--In this section:
(1) The term ``drug'' has the meaning given to such term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321).
(2) The term ``qualified infectious disease product'' has
the meaning given to such term in section 505E of the Federal
Food, Drug, and Cosmetic Act, as added by section 831 of this
Act.
(3) The term ``qualifying pathogen'' has the meaning given
to such term in section 505E of the Federal Food, Drug, and
Cosmetic Act, as added by section 831 of this Act.
(4) The term ``Secretary'' means the Secretary of Health
and Human Services, acting through the Commissioner of Food
and Drugs.
SEC. 834. REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE
PRODUCT INCENTIVES IN 5 YEARS.
Not later than five years after the date of enactment of
this Act, the Secretary of Health and Human Services shall,
in consultation with the Food and Drug Administration,
Centers for Disease Control and Prevention and other
appropriate agencies, submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report
that contains the following:
[[Page H3216]]
(1)(A) The number of initial designations of drugs as
qualified infectious disease products under section 505E of
the Federal Food, Drug, and Cosmetic Act;
(B) the number of qualified infectious disease products
approved under this program; and
(C) whether such products address the need for
antibacterial and antifungal drugs to treat serious and life-
threatening infections.
(2) Recommendations--
(A) based on the information in paragraph (1) and any other
relevant data, on any changes that should be made to the list
of pathogens that are defined as qualifying pathogens under
section 505E(f)(2) of the Federal Food, Drug, and Cosmetic
Act, as added by section 831; and
(B) on whether any additional program (such as the
development of public-private collaborations to advance
antibacterial drug innovation) or changes to the incentives
under this subtitle may be needed to promote the development
of antibacterial drugs.
(3) An examination of--
(A) the adoption of programs to measure the use of
antibacterial drugs in health care settings; and
(B) the implementation and effectiveness of antimicrobial
stewardship protocols across all health care settings.
(4) Any recommendations for ways to encourage further
development and establishment of stewardship programs.
SEC. 835. GUIDANCE ON PATHOGEN-FOCUSED ANTIBACTERIAL DRUG
DEVELOPMENT.
(a) Draft Guidance.--Not later than June 30, 2013, in order
to facilitate the development of antibacterial drugs for
serious or life-threatening bacterial infections,
particularly in areas of unmet need, the Secretary of Health
and Human Services shall publish draft guidance that--
(1) specifies how preclinical and clinical data can be
utilized to inform an efficient and streamlined pathogen-
focused antibacterial drug development program that meets the
approval standards of the Food and Drug Administration; and
(2) provides advice on approaches for the development of
antibacterial drugs that target a more limited spectrum of
pathogens.
(b) Final Guidance.--Not later than December 31, 2014,
after notice and opportunity for public comment on the draft
guidance under subsection (a), the Secretary of Health and
Human Services shall publish final guidance consistent with
this section.
Subtitle D--Accelerated Approval
SEC. 841. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-
THREATENING DISEASES OR CONDITIONS.
(a) Findings; Sense of Congress.--
(1) Findings.--The Congress finds as follows:
(A) The Food and Drug Administration (referred to in this
subsection as the ``FDA'') serves a critical role in helping
to assure that new medicines are safe and effective.
Regulatory innovation is 1 element of the Nation's strategy
to address serious and life-threatening diseases or
conditions by promoting investment in and development of
innovative treatments for unmet medical needs.
(B) During the 2 decades following the establishment of the
accelerated approval mechanism, advances in medical sciences,
including genomics, molecular biology, and bioinformatics,
have provided an unprecedented understanding of the
underlying biological mechanism and pathogenesis of disease.
A new generation of modern, targeted medicines is under
development to treat serious and life-threatening diseases,
some applying drug development strategies based on biomarkers
or pharmacogenomics, predictive toxicology, clinical trial
enrichment techniques, and novel clinical trial designs, such
as adaptive clinical trials.
(C) As a result of these remarkable scientific and medical
advances, the FDA should be encouraged to implement more
broadly effective processes for the expedited development and
review of innovative new medicines intended to address unmet
medical needs for serious or life-threatening diseases or
conditions, including those for rare diseases or conditions,
using a broad range of surrogate or clinical endpoints and
modern scientific tools earlier in the drug development cycle
when appropriate. This may result in fewer, smaller, or
shorter clinical trials for the intended patient population
or targeted subpopulation without compromising or altering
the high standards of the FDA for the approval of drugs.
(D) Patients benefit from expedited access to safe and
effective innovative therapies to treat unmet medical needs
for serious or life-threatening diseases or conditions.
(E) For these reasons, the statutory authority in effect on
the day before the date of enactment of this Act governing
expedited approval of drugs for serious or life-threatening
diseases or conditions should be amended in order to enhance
the authority of the FDA to consider appropriate scientific
data, methods, and tools, and to expedite development and
access to novel treatments for patients with a broad range of
serious or life-threatening diseases or conditions.
(2) Sense of congress.--It is the sense of the Congress
that the FDA should apply the accelerated approval and fast
track provisions set forth in section 506 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356), as amended by
this section, to help expedite the development and
availability to patients of treatments for serious or life-
threatening diseases or conditions while maintaining safety
and effectiveness standards for such treatments.
(b) Expedited Approval.--Section 506 (21 U.S.C. 356) is
amended to read as follows:
``SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-
THREATENING DISEASES OR CONDITIONS.
``(a) Designation of Drug as a Fast Track Product.--
``(1) In general.--The Secretary shall, at the request of
the sponsor of a new drug, facilitate the development and
expedite the review of such drug if it is intended, whether
alone or in combination with one or more other drugs, for the
treatment of a serious or life-threatening disease or
condition, and it demonstrates the potential to address unmet
medical needs for such a disease or condition. In this
section, such a drug is referred to as a `fast track
product'.
``(2) Request for designation.--The sponsor of a new drug
may request the Secretary to designate the drug as a fast
track product. A request for the designation may be made
concurrently with, or at any time after, submission of an
application for the investigation of the drug under section
505(i) of this Act or section 351(a)(3) of the Public Health
Service Act.
``(3) Designation.--Within 60 calendar days after the
receipt of a request under paragraph (2), the Secretary shall
determine whether the drug that is the subject of the request
meets the criteria described in paragraph (1). If the
Secretary finds that the drug meets the criteria, the
Secretary shall designate the drug as a fast track product
and shall take such actions as are appropriate to expedite
the development and review of the application for approval of
such product.
``(b) Accelerated Approval of a Drug for a Serious or Life-
Threatening Disease or Condition, Including a Fast Track
Product.--
``(1) In general.--The Secretary may approve an application
for approval of a product for a serious or life-threatening
disease or condition, including a fast track product, under
section 505(c) of this Act or section 351(a) of the Public
Health Service Act upon making a determination that the
product has an effect on--
``(A) a surrogate endpoint that is reasonably likely to
predict clinical benefit; or
``(B) a clinical endpoint that can be measured earlier than
irreversible morbidity or mortality, that is reasonably
likely to predict an effect on irreversible morbidity or
mortality or other clinical benefit,
taking into account the severity or rarity of the disease or
condition and the availability of alternative treatments. The
evidence to support that an endpoint is reasonably likely to
predict clinical benefit may include epidemiological,
pathophysiologic, pharmacologic, therapeutic or other
evidence developed using, for example, biomarkers, or other
scientific methods or tools.
``(2) Limitation.--Approval of a product under this
subsection may, as determined by the Secretary, be subject to
the following requirements--
``(A) that the sponsor conduct appropriate post-approval
studies to verify and describe the predicted effect of the
product on irreversible morbidity or mortality or other
clinical benefit; and
``(B) that the sponsor submit copies of all promotional
materials related to the product, at least 30 days prior to
dissemination of the materials--
``(i) during the preapproval review period; and
``(ii) following approval, for a period that the Secretary
determines to be appropriate.
``(3) Expedited withdrawal of approval.--The Secretary may
withdraw approval of a product approved pursuant to this
subsection using expedited procedures (as prescribed by the
Secretary in regulations, which shall include an opportunity
for an informal hearing) if--
``(A) the sponsor fails to conduct any required post-
approval study of the product with due diligence;
``(B) a study required to verify and describe the predicted
effect on irreversible morbidity or mortality or other
clinical benefit of the product fails to verify and describe
such effect or benefit;
``(C) other evidence demonstrates that the product is not
safe or effective under the conditions of use; or
``(D) the sponsor disseminates false or misleading
promotional materials with respect to the product.
``(c) Review of Incomplete Applications for Approval of a
Fast Track Product.--
``(1) In general.--If the Secretary determines, after
preliminary evaluation of clinical data submitted by the
sponsor, that a fast track product may be effective, the
Secretary shall evaluate for filing, and may commence review
of portions of, an application for the approval of the
product before the sponsor submits a complete application.
The Secretary shall commence such review only if the
applicant--
``(A) provides a schedule for submission of information
necessary to make the application complete; and
``(B) pays any fee that may be required under section 736.
``(2) Exception.--Any time period for review of human drug
applications that has been agreed to by the Secretary and
that has been set forth in goals identified in letters of the
Secretary (relating to the use of fees collected under
section 736 to expedite the drug
[[Page H3217]]
development process and the review of human drug
applications) shall not apply to an application submitted
under paragraph (1) until the date on which the application
is complete.
``(d) Awareness Efforts.--The Secretary shall--
``(1) develop and disseminate to physicians, patient
organizations, pharmaceutical and biotechnology companies,
and other appropriate persons a description of the provisions
of this section applicable to accelerated approval and fast
track products; and
``(2) establish a program to encourage the development of
surrogate and clinical endpoints, including biomarkers, and
other scientific methods and tools that can assist the
Secretary in determining whether the evidence submitted in an
application is reasonably likely to predict clinical benefit
for serious or life-threatening conditions for which there
exist significant unmet medical needs.''.
SEC. 842. GUIDANCE; AMENDED REGULATIONS.
(a) Initial Guidance.--Not later than one year after the
date of enactment of this Act, the Secretary of Health and
Human Services (in this subtitle referred to as the
``Secretary'') shall issue draft guidance to implement the
amendment made by section 841.
(b) Final Guidance.--Not later than one year after the
issuance of draft guidance under subsection (a), after an
opportunity for public comment, the Secretary shall--
(1) issue final guidance to implement the amendment made by
section 841; and
(2) amend the regulations governing accelerated approval in
parts 314 and 601 of title 21, Code of Federal Regulations,
as necessary to conform such regulations with the amendments
made by section 841.
(c) Considerations.--In developing the guidance under
subsections (a) and (b)(1) and the amendments under
subsection (b)(2), the Secretary shall consider--
(1) issues arising under the accelerated approval and fast
track processes under section 506 of the Federal Food, Drug,
and Cosmetic Act (as amended by section 841) for drugs
designated for a rare disease or condition under section 526
of the Federal, Food, Drug, and Cosmetic Act; and
(2) how to incorporate novel approaches to the review of
surrogate endpoints based on pathophysiologic and
pharmacologic evidence in such guidance, especially in
instances where the low prevalence of a disease renders the
existence or collection of other types of data unlikely or
impractical.
(d) No Delay in Review or Approval.--The issuance (or non-
issuance) of guidance or conforming regulations implementing
the amendments made by section 841 shall not preclude the
review of, or action on, a request for designation or an
application for approval submitted pursuant to section 506 of
the Federal Food, Drug, and Cosmetic Act, as amended by
section 841.
SEC. 843. INDEPENDENT REVIEW.
(a) In General.--The Secretary may, in conjunction with
other planned reviews of the new drug review process,
contract with an independent entity with expertise in
assessing the quality and efficiency of biopharmaceutical
development and regulatory review programs, to evaluate the
Food and Drug Administration's application of the processes
described in section 506 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 841, and the impact of
such processes on the development and timely availability of
innovative treatments for patients suffering from serious or
life-threatening conditions.
(b) Consultation.--Any evaluation under subsection (a)
shall include consultation with regulated industries, patient
advocacy and disease research foundations, and relevant
academic medical centers.
Subtitle E--Critical Path Reauthorization
SEC. 851. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIPS.
Subsection (f) of section 566 (21 U.S.C. 360bbb 5) is
amended to read as follows:
``(f) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $6,000,000
for each of fiscal years 2013 through 2017.''.
Subtitle F--Miscellaneous
SEC. 861. REAUTHORIZATION OF PROVISION RELATING TO
EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE
ENANTIOMERS.
Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended by
striking ``2012'' and inserting ``2017''.
SEC. 862. EXTENSION OF PERIOD FOR FIRST APPLICANT TO OBTAIN
TENTATIVE APPROVAL WITHOUT FORFEITING 180-DAY
EXCLUSIVITY PERIOD.
(a) Extension.--
(1) In general.--If a first applicant files an application
during the 30-month period ending on the date of enactment of
this Act and such application initially contains a
certification described in paragraph (2)(A)(vii)(IV) of
section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)), or if a first applicant files an
application and the application is amended during such period
to first contain such a certification, the phrase ``30
months'' in paragraph (5)(D)(i)(IV) of such section shall,
with respect to such application, be read as meaning--
(A) during the period beginning on the date of enactment of
this Act, and ending on September 30, 2013, ``45 months'';
(B) during the period beginning on October 1, 2013, and
ending on September 30, 2014, ``42 months'';
(C) during the period beginning on October 1, 2014, and
ending on September 30, 2015, ``39 months''; and
(D) during the period beginning on October 1, 2015, and
ending on September 30, 2016, ``36 months''.
(2) Conforming amendment.--In the case of an application to
which an extended period under paragraph (1) applies, the
reference to the 30-month period under section 505(q)(1)(G)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(q)(1)(G)) shall be read to be the applicable period under
paragraph (1).
(b) Period for Obtaining Tentative Approval of Certain
Applications.--If an application is filed on or before the
date of enactment of this Act and such application is amended
during the period beginning on the day after the date of
enactment of this Act and ending on September 30, 2017, to
first contain a certification described in paragraph
(2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)), the date of the filing
of such amendment (rather than the date of the filing of such
application) shall be treated as the beginning of the 30-
month period described in paragraph (5)(D)(i)(IV) of such
section 505(j).
(c) Definitions.--For the purposes of this section, the
terms ``application'' and ``first applicant'' mean
application and first applicant, as such terms are used in
section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)).
SEC. 863. FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL
ACTIONS.
Section 505(q) (21 U.S.C. 355(q)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by striking ``subsection (b)(2) or
(j)'' inserting ``subsection (b)(2) or (j) of the Act or
351(k) of the Public Health Service Act''; and
(B) in subparagraph (F), by striking ``180 days'' and
inserting ``150 days'';
(2) in paragraph (2)(A)--
(A) in the subparagraph heading, by striking ``180'' and
inserting ``150''; and
(B) in clause (i), by striking ``180-day'' and inserting
``150-day''; and
(3) in paragraph (5), by striking ``subsection (b)(2) or
(j)'' inserting ``subsection (b)(2) or (j) of the Act or
351(k) of the Public Health Service Act''.
SEC. 864. DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.
(a) In General.--Section 505 (21 U.S.C. 355) is amended by
adding at the end the following:
``(w) Deadline for Determination on Certain Petitions.--The
Secretary shall issue a final, substantive determination on a
petition submitted pursuant to subsection (b) of section
314.161 of title 21, Code of Federal Regulations (or any
successor regulations), no later than 270 days after the date
the petition is submitted.''.
(b) Application.--The amendment made by subsection (a)
shall apply to any petition that is submitted pursuant to
subsection (b) of section 314.161 of title 21, Code of
Federal Regulations (or any successor regulations), on or
after the date of enactment of this Act.
SEC. 865. RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER
INCENTIVE PROGRAM.
Subchapter B of Chapter V (21 U.S.C. 360aa et seq.) is
amended by adding at the end the following:
``SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE
PEDIATRIC DISEASES.
``(a) Definitions.--In this section:
``(1) Priority review.--The term `priority review', with
respect to a human drug application as defined in section
735(1), means review and action by the Secretary on such
application not later than 6 months after receipt by the
Secretary of such application, as described in the Manual of
Policies and Procedures of the Food and Drug Administration
and goals identified in the letters described in section
101(b) of the Prescription Drug User Fee Amendments of 2012.
``(2) Priority review voucher.--The term `priority review
voucher' means a voucher issued by the Secretary to the
sponsor of a rare pediatric disease product application that
entitles the holder of such voucher to priority review of a
single human drug application submitted under section
505(b)(1) or section 351(a) of the Public Health Service Act
after the date of approval of the rare pediatric disease
product application.
``(3) Rare pediatric disease.--The term `rare pediatric
disease' means a disease that meets each of the following
criteria:
``(A) The disease primarily affects individuals aged from
birth to 18 years, including age groups often called
neonates, infants, children, and adolescents.
``(B) The disease is a rare disease or condition, within
the meaning of section 526.
``(4) Rare pediatric disease product application.--The term
`rare pediatric disease product application' means a human
drug application, as defined in section 735(1), that--
``(A) is for a drug or biological product--
``(i) that is for the prevention or treatment of a rare
pediatric disease; and
``(ii) that contains no active ingredient (including any
ester or salt of the active ingredient) that has been
previously approved in any other application under section
505(b)(1), 505(b)(2), or 505(j) of this Act or section 351(a)
or 351(k) of the Public Health Service Act;
``(B) is submitted under section 505(b)(1) of this Act or
section 351(a) of the Public Health Service Act;
[[Page H3218]]
``(C) the Secretary deems eligible for priority review;
``(D) that relies on clinical data derived from studies
examining a pediatric population and dosages of the drug
intended for that population;
``(E) that does not seek approval for an adult indication
in the original rare pediatric disease product application;
and
``(F) is approved after the date of the enactment of the
Prescription Drug User Fee Amendments of 2012.
``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a rare pediatric disease
product application upon approval by the Secretary of such
rare pediatric disease product application.
``(2) Transferability.--
``(A) In general.--The sponsor of a rare pediatric disease
product application that receives a priority review voucher
under this section may transfer (including by sale) the
entitlement to such voucher. There is no limit on the number
of times a priority review voucher may be transferred before
such voucher is used.
``(B) Notification of transfer.--Each person to whom a
voucher is transferred shall notify the Secretary of such
change in ownership of the voucher not later than 30 days
after such transfer.
``(3) Limitation.--A sponsor of a rare pediatric disease
product application may not receive a priority review voucher
under this section if the rare pediatric disease product
application was submitted to the Secretary prior to the date
that is 90 days after the date of enactment of the
Prescription Drug User Fee Amendments of 2012.
``(4) Notification.--
``(A) In general.--The sponsor of a human drug application
shall notify the Secretary not later than 90 days prior to
submission of the human drug application that is the subject
of a priority review voucher of an intent to submit the human
drug application, including the date on which the sponsor
intends to submit the application. Such notification shall be
a legally binding commitment to pay for the user fee to be
assessed in accordance with this section.
``(B) Transfer after notice.--The sponsor of a human drug
application that provides notification of the intent of such
sponsor to use the voucher for the human drug application
under subparagraph (A) may transfer the voucher after such
notification is provided, if such sponsor has not yet
submitted the human drug application described in the
notification.
``(5) Termination of authority.--The Secretary may not
award any priority review vouchers under paragraph (1) after
the last day of the 1-year period that begins on the date
that the Secretary awards the third rare pediatric disease
priority voucher under this section.
``(c) Priority Review User Fee.--
``(1) In general.--The Secretary shall establish a user fee
program under which a sponsor of a human drug application
that is the subject of a priority review voucher shall pay to
the Secretary a fee determined under paragraph (2). Such fee
shall be in addition to any fee required to be submitted by
the sponsor under chapter VII.
``(2) Fee amount.--The amount of the priority review user
fee shall be determined each fiscal year by the Secretary,
based on the difference between--
``(A) the average cost incurred by the Food and Drug
Administration in the review of a human drug application
subject to priority review in the previous fiscal year; and
``(B) the average cost incurred by the Food and Drug
Administration in the review of a human drug application that
is not subject to priority review in the previous fiscal
year.
``(3) Annual fee setting.--The Secretary shall establish,
before the beginning of each fiscal year beginning after
September 30, 2012, the amount of the priority review user
fee for that fiscal year.
``(4) Payment.--
``(A) In general.--The priority review user fee required by
this subsection shall be due upon the notification by a
sponsor of the intent of such sponsor to use the voucher, as
specified in subsection (b)(4)(A). All other user fees
associated with the human drug application shall be due as
required by the Secretary or under applicable law.
``(B) Complete application.--An application described under
subparagraph (A) for which the sponsor requests the use of a
priority review voucher shall be considered incomplete if the
fee required by this subsection and all other applicable user
fees are not paid in accordance with the Secretary's
procedures for paying such fees.
``(C) No waivers, exemptions, reductions, or refunds.--The
Secretary may not grant a waiver, exemption, reduction, or
refund of any fees due and payable under this section.
``(5) Offsetting collections.--Fees collected pursuant to
this subsection for any fiscal year--
``(A) shall be deposited and credited as offsetting
collections to the account providing appropriations to the
Food and Drug Administration; and
``(B) shall not be collected for any fiscal year except to
the extent provided in advance in appropriation Acts.
``(d) Designation Process.--
``(1) In general.--Upon the request of the manufacturer or
the sponsor of a new drug, the Secretary may designate--
``(A) the new drug as a drug for a rare pediatric disease;
and
``(B) the application for the new drug as a rare pediatric
disease product application.
``(2) Request for designation.--The request for a
designation under paragraph (1), shall be made at the same
time a request for designation of orphan disease status under
section 526 or fast-track designation under section 506 is
made. Requesting designation under this subsection is not a
prerequisite to receiving a priority review voucher under
this section.
``(3) Determination by secretary.--Not later than 60 days
after a request is submitted under paragraph (1), the
Secretary shall determine whether--
``(A) the disease or condition that is the subject of such
request is a rare pediatric disease; and
``(B) the application for the new drug is a rare pediatric
disease product application.
``(e) Marketing of Rare Pediatric Disease Products.--
``(1) In general.--The Secretary shall deem a rare
pediatric disease product application incomplete if such
application does not contain a description of the plan of the
sponsor of such application to market the product in the
United States.
``(2) Revocation.--The Secretary may revoke any priority
review voucher awarded under subsection (b) if the rare
pediatric disease product for which such voucher was awarded
is not marketed in the United States within the 365 day
period beginning on the date of the approval of such drug
under section 505 of this Act or section 351 of the Public
Health Service Act.
``(3) Postapproval production report.--The sponsor of an
approved rare pediatric disease product shall submit a report
to the Secretary not later than 5 years after the approval of
the applicable rare pediatric disease product application.
Such report shall provide the following information, with
respect to each of the first 4 years after approval of such
product:
``(A) The estimated population in the United States
suffering from the rare pediatric disease.
``(B) The estimated demand in the United States for such
rare pediatric disease product.
``(C) The actual amount of such rare pediatric disease
product distributed in the United States.
``(f) Notice and Report.--
``(1) Notice of issuance of voucher and approval of
products under voucher.--The Secretary shall publish a notice
in the Federal Register and on the Web site of the Food and
Drug Administration not later than 30 days after the
occurrence of each of the following:
``(A) The Secretary issues a priority review voucher under
this section.
``(B) The Secretary approves a drug pursuant to an
application submitted under section 505(b) of this Act or
section 351(a) of the Public Health Service Act for which the
sponsor of the application used a priority review voucher
under this section.
``(2) Report.--If, after the last day of the 1-year period
that begins on the date that the Secretary awards the third
rare pediatric disease priority voucher under this section, a
sponsor of an application submitted under section 505(b) of
this Act or section 351(a) of the Public Health Service Act
for a drug uses a priority review voucher under this section
for such application, the Secretary shall submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a document--
``(A) notifying such Committees of the use of such voucher;
and
``(B) identifying the drug for which such priority review
voucher is used.
``(g) Eligibility for Other Programs.--Nothing in this
section precludes a sponsor who seeks a priority review
voucher under this section from participating in any other
incentive program, including under this Act.
``(h) Relation to Other Provisions.--The provisions of this
section shall supplement, not supplant, any other provisions
of this Act or the Public Health Service Act that encourage
the development of drugs for tropical diseases and rare
pediatric diseases.
``(i) GAO Study and Report.--
``(1) Study.--
``(A) In general.--Beginning on the date that the Secretary
awards the third rare pediatric disease priority voucher
under this section, the Comptroller General of the United
States shall conduct a study of the effectiveness of awarding
rare pediatric disease priority vouchers under this section
in the development of on human drug products that treat or
prevent such diseases.
``(B) Contents of study.--In conducting the study under
subparagraph (A), the Comptroller General shall examine the
following:
``(i) The indications for which each rare disease product
for which a priority review voucher was awarded was approved
under section 505 or section 351 of the Public Health Service
Act.
``(ii) Whether, and to what extent, an unmet need related
to the treatment or prevention of a rare pediatric disease
was met through the approval of such a rare disease product.
``(iii) The value of the priority review voucher if
transferred.
``(iv) Identification of each drug for which a priority
review voucher was used.
``(v) The length of the period of time between the date on
which a priority review voucher was awarded and the date on
which it was used.
[[Page H3219]]
``(2) Report.--Not later than 1 year after the date under
paragraph (1)(A), the Comptroller General shall submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate, a report containing the
results of the study under paragraph (1).''.
SEC. 866. COMBATING PRESCRIPTION DRUG ABUSE.
(a) In General.--To combat the significant rise in
prescription drug abuse and the consequences of such abuse,
the Secretary of Health and Human Services (referred to in
this section as the ``Secretary''), acting through the
Commissioner of Food and Drugs (referred to in this section
as the ``Commissioner'') and in coordination with other
Federal agencies, as appropriate, shall review current
Federal initiatives and identify gaps and opportunities with
respect to ensuring the safe use of prescription drugs with
the potential for abuse.
(b) Report.--Not later than 1 year after the date of
enactment of this Act, the Secretary shall issue a report to
Congress on the findings of the review under subsection (a).
Such report shall include recommendations on--
(1) how best to leverage and build upon existing Federal
and federally funded data sources, such as prescription drug
monitoring program data and the sentinel initiative of the
Food and Drug Administration under section 505(k)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)),
as it relates to collection of information relevant to
adverse events, patient safety, and patient outcomes, to
create a centralized data clearinghouse and early warning
tool;
(2) how best to develop and disseminate widely best
practices models and suggested standard requirements to
States for achieving greater interoperability and
effectiveness of prescription drug monitoring programs,
especially with respect to producing standardized data on
adverse events, patient safety, and patient outcomes; and
(3) how best to develop provider and patient education
tools and a strategy to widely disseminate such tools and
assess the efficacy of such tools.
(c) Guidance on Tamper-Deterrent Products.--Not later than
6 months after the date of enactment of this Act, the
Secretary, acting through the Commissioner, shall promulgate
guidance on the development of tamper-deterrent drug
products.
SEC. 867. ASSESSMENT AND MODIFICATION OF REMS.
(a) Assessment and Modification of Approved Strategy.--
Section 505 1(g) (21 U.S.C. 355 1(g)) is amended--
(1) in paragraph (1), by striking ``, and propose a
modification to,'';
(2) in paragraph (2)--
(A) in the matter before subparagraph (A)--
(i) by striking ``, subject to paragraph (5),''; and
(ii) by striking ``, and may propose a modification to,'';
(B) in subparagraph (C), by striking ``new safety or
effectiveness information indicates that'' and all that
follows and inserting the following: ``an assessment is
needed to evaluate whether the approved strategy should be
modified to--
``(i) ensure the benefits of the drug outweigh the risks of
the drug; or
``(ii) minimize the burden on the health care delivery
system of complying with the strategy.''; and
(C) by striking subparagraph (D);
(3) in paragraph (3), by striking ``for a drug shall
include--'' and all that follows and inserting the following
``for a drug shall include, with respect to each goal
included in the strategy, an assessment of the extent to
which the approved strategy, including each element of the
strategy, is meeting the goal or whether 1 or more such goals
or such elements should be modified.''; and
(4) by amending paragraph (4) to read as follows:
``(4) Modification.--
``(A) On initiative of responsible person.--After the
approval of a risk evaluation and mitigation strategy by the
Secretary, the responsible person may, at any time, submit to
the Secretary a proposal to modify the approved strategy.
Such proposal may propose the addition, modification, or
removal of any goal or element of the approved strategy and
shall include an adequate rationale to support such proposed
addition, modification, or removal of any goal or element of
the strategy.
``(B) On initiative of secretary.--After the approval of a
risk evaluation and mitigation strategy by the Secretary, the
Secretary may, at any time, require a responsible person to
submit a proposed modification to the strategy within 120
days or within such reasonable time as the Secretary
specifies, if the Secretary, in consultation with the offices
described in subsection (c)(2), determines that 1 or more
goals or elements should be added, modified, or removed from
the approved strategy to--
``(i) ensure the benefits of the drug outweigh the risks of
the drug; or
``(ii) minimize the burden on the health care delivery
system of complying with the strategy.''.
(b) Review of Proposed Strategies; Review of Assessments
and Modifications of Approved Strategies.--Section 505 1(h)
(21 U.S.C. 355 1(h)) is amended--
(1) in the subsection heading by inserting ``and
Modifications'' after ``Review of Assessments'';
(2) in paragraph (1)--
(A) by inserting ``and proposed modification to'' after
``under subsection (a) and each assessment of''; and
(B) by inserting ``, and, if necessary, promptly initiate
discussions with the responsible person about such proposed
strategy, assessment, or modification'' after ``subsection
(g)'';
(3) by striking paragraph (2);
(4) by redesignating paragraphs (3) through (9) as
paragraphs (2) through (8), respectively;
(5) in paragraph (2), as redesignated by paragraph (4)--
(A) by amending subparagraph (A) to read as follows:
``(A) In general.--
``(i) Timeframe.--Unless the dispute resolution process
described under paragraph (3) or (4) applies, and, except as
provided in clause (ii) or clause (iii) below, the Secretary,
in consultation with the offices described in subsection
(c)(2), shall review and act on the proposed risk evaluation
and mitigation strategy for a drug or any proposed
modification to any required strategy within 180 days of
receipt of the proposed strategy or modification.
``(ii) Minor modifications.--The Secretary shall review and
act on a proposed minor modification, as defined by the
Secretary in guidance, within 60 days of receipt of such
modification.
``(iii) REMS modification due to safety label changes.--Not
later than 60 days after the Secretary receives a proposed
modification to an approved risk evaluation and mitigation
strategy to conform the strategy to approved safety label
changes, including safety labeling changes initiated by the
sponsor in accordance with FDA regulatory requirements, or to
a safety label change that the Secretary has directed the
holder of the application to make pursuant to section
505(o)(4), the Secretary shall review and act on such
proposed modification to the approved strategy.
``(iv) Guidance.--The Secretary shall establish, through
guidance, that responsible persons may implement certain
modifications to an approved risk evaluation and mitigation
strategy following notification to the Secretary.''; and
(B) by amending subparagraph (C) to read as follows:
``(C) Public availability.--Upon acting on a proposed risk
evaluation and mitigation strategy or proposed modification
to a risk evaluation and mitigation strategy under
subparagraph (A), the Secretary shall make publicly available
an action letter describing the actions taken by the
Secretary under such subparagraph (A).''.
(6) in paragraph (4), as redesignated by paragraph (4)--
(A) in subparagraph (A)(i)--
(i) by striking ``Not earlier than 15 days, and not later
than 35 days, after discussions under paragraph (2) have
begun, the'' and inserting ``The''; and
(ii) by inserting ``, after the sponsor is required to make
a submission under subsection (a)(2) or (g),'' before
``request in writing''; and
(B) in subparagraph (I)--
(i) by striking clauses (i) and (ii); and
(ii) by striking ``if the Secretary--'' and inserting ``if
the Secretary has complied with the timing requirements of
scheduling review by the Drug Safety Oversight Board,
providing a written recommendation, and issuing an action
letter under subparagraphs (B), (F), and (G),
respectively.'';
(7) in paragraph (5), as redesignated by paragraph (4)--
(A) in subparagraph (A), by striking ``any of subparagraphs
(B) through (D)'' and inserting ``subparagraph (B) or (C)'';
and
(B) in subparagraph (C), by striking ``paragraph (4) or
(5)'' and inserting ``paragraph (3) or (4)''; and
(8) in paragraph (8), as redesignated by paragraph (4), by
striking ``paragraphs (7) and (8)'' and inserting
``paragraphs (6) and (7).''.
(c) Guidance.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue guidance that, for purposes of section
505 1(h)(2)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355 1(h)(2)(A)), describes the types of
modifications to approved risk evaluation and mitigation
strategies that shall be considered to be minor modifications
of such strategies.
SEC. 868. CONSULTATION WITH EXTERNAL EXPERTS ON RARE
DISEASES, TARGETED THERAPIES, AND GENETIC
TARGETING OF TREATMENTS.
Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as
amended by section 811(b), is further amended by adding at
the end the following:
``SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON RARE
DISEASES, TARGETED THERAPIES, AND GENETIC
TARGETING OF TREATMENTS.
``(a) In General.--For the purpose of promoting the
efficiency of and informing the review by the Food and Drug
Administration of new drugs and biological products for rare
diseases and drugs and biological products that are
genetically targeted, the following shall apply:
``(1) Consultation with stakeholders.--Consistent with
sections X.C and IX.E.4 of the PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years 2013 through
2017, as referenced in the letters described in section
101(b) of the Prescription
[[Page H3220]]
Drug User Fee Amendments of 2012, the Secretary shall ensure
that opportunities exist, at a time the Secretary determines
appropriate, for consultations with stakeholders on the
topics described in subsection (b).
``(2) Consultation with external experts.--
``(A) In general.--The Secretary shall develop and maintain
a list of external experts who, because of their special
expertise, are qualified to provide advice on rare disease
issues, including topics described in subsection (c). The
Secretary may, when appropriate to address a specific
regulatory question, consult such external experts on issues
related to the review of new drugs and biological products
for rare diseases and drugs and biological products that are
genetically targeted, including the topics described in
subsection (b), when such consultation is necessary because
the Secretary lacks the specific scientific, medical, or
technical expertise necessary for the performance of the
Secretary's regulatory responsibilities and the necessary
expertise can be provided by the external experts.
``(B) External experts.--For purposes of subparagraph (A),
external experts are individuals who possess scientific or
medical training that the Secretary lacks with respect to one
or more rare diseases.
``(b) Topics for Consultation.--Topics for consultation
pursuant to this section may include--
``(1) rare diseases;
``(2) the severity of rare diseases;
``(3) the unmet medical need associated with rare diseases;
``(4) the willingness and ability of individuals with a
rare disease to participate in clinical trials;
``(5) an assessment of the benefits and risks of therapies
to treat rare diseases;
``(6) the general design of clinical trials for rare
disease populations and subpopulations; and
``(7) the demographics and the clinical description of
patient populations.
``(c) Classification as Special Government Employees.--The
external experts who are consulted under this section may be
considered special government employees, as defined under
section 202 of title 18, United States Code.
``(d) Protection of Confidential Information and Trade
Secrets.--
``(1) Rule of construction.--Nothing in this section shall
be construed to alter the protections offered by laws,
regulations, and policies governing disclosure of
confidential commercial or trade secret information, and any
other information exempt from disclosure pursuant to section
552(b) of title 5, United States Code, as such provisions
would be applied to consultation with individuals and
organizations prior to the date of enactment of this section.
``(2) Consent required for disclosure.--The Secretary shall
not disclose confidential commercial or trade secret
information to an expert consulted under this section without
the written consent of the sponsor unless the expert is a
special government employee (as defined under section 202 of
title 18, United States Code) or the disclosure is otherwise
authorized by law.
``(e) Other Consultation.--Nothing in this section shall be
construed to limit the ability of the Secretary to consult
with individuals and organizations as authorized prior to the
date of enactment of this section.
``(f) No Right or Obligation.--
``(1) No right to consultation.--Nothing in this section
shall be construed to create a legal right for a consultation
on any matter or require the Secretary to meet with any
particular expert or stakeholder.
``(2) No altering of goals.--Nothing in this section shall
be construed to alter agreed upon goals and procedures
identified in the letters described in section 101(b) of the
Prescription Drug User Fee Amendments of 2012.
``(3) No change to number of review cycles.--Nothing in
this section is intended to increase the number of review
cycles as in effect before the date of enactment of this
section.
``(g) No Delay in Product Review.--Prior to a consultation
with an external expert, as described in this section,
relating to an investigational new drug application under
section 505(i), a new drug application under section 505(b),
or a biologics license application under section 351 of the
Public Health Service Act, the Director of the Center for
Drug Evaluation and Research or the Director of the Center
for Biologics Evaluation and Research (or appropriate
Division Director), as appropriate, shall determine that--
``(1) such consultation will--
``(A) facilitate the Secretary's ability to complete the
Secretary's review;
``(B) address outstanding deficiencies in the application;
and
``(C) increase the likelihood of an approval decision in
the current review cycle; or
``(2) the sponsor authorized such consultation.''.
SEC. 869. BREAKTHROUGH THERAPIES.
(a) In General.--Section 506 (21 U.S.C. 356), as amended by
section 841, is further amended--
(1) by redesignating subsection (d) as subsection (e);
(2) by redesignating subsections (a) through (c) as
subsections (b) through (d), respectively;
(3) by inserting before subsection (b), as so redesignated,
the following:
``(a) Designation of a Drug as a Breakthrough Therapy.--
``(1) In general.--The Secretary shall, at the request of
the sponsor of a drug, expedite the development and review of
such drug if the drug is intended, alone or in combination
with 1 or more other drugs, to treat a serious or life-
threatening disease or condition and preliminary clinical
evidence indicates that the drug may demonstrate substantial
improvement over existing therapies on 1 or more clinically
significant endpoints, such as substantial treatment effects
observed early in clinical development. In this section, such
a drug is referred to as a `breakthrough therapy'.
``(2) Request for designation.--The sponsor of a drug may
request the Secretary to designate the drug as a breakthrough
therapy. A request for the designation may be made
concurrently with, or at any time after, the submission of an
application for the investigation of the drug under section
505(i) or section 351(a)(3) of the Public Health Service Act.
``(3) Designation.--
``(A) In general.--Not later than 60 calendar days after
the receipt of a request under paragraph (2), the Secretary
shall determine whether the drug that is the subject of the
request meets the criteria described in paragraph (1). If the
Secretary finds that the drug meets the criteria, the
Secretary shall designate the drug as a breakthrough therapy
and shall take such actions as are appropriate to expedite
the development and review of the application for approval of
such drug.
``(B) Actions.--The actions to expedite the development and
review of an application under subparagraph (A) may include,
as appropriate--
``(i) holding meetings with the sponsor and the review team
throughout the development of the drug;
``(ii) providing timely advice to, and interactive
communication with, the sponsor regarding the development of
the drug to ensure that the development program to gather the
non-clinical and clinical data necessary for approval is as
efficient as practicable;
``(iii) involving senior managers and experienced review
staff, as appropriate, in a collaborative, cross-disciplinary
review;
``(iv) assigning a cross-disciplinary project lead for the
Food and Drug Administration review team to facilitate an
efficient review of the development program and to serve as a
scientific liaison between the review team and the sponsor;
and
``(v) taking steps to ensure that the design of the
clinical trials is as efficient as practicable, when
scientifically appropriate, such as by minimizing the number
of patients exposed to a potentially less efficacious
treatment.'';
(4) in subsection (e)(1), as so redesignated, by striking
``applicable to accelerated approval'' and inserting
``applicable to breakthrough therapies, accelerated
approval,''; and
(5) by adding at the end the following:
``(f) Report.--Beginning in fiscal year 2013, the Secretary
shall annually prepare and submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, and make publicly available, with respect to
this section for the previous fiscal year--
``(1) the number of drugs for which a sponsor requested
designation as a breakthrough therapy;
``(2) the number of products designated as a breakthrough
therapy; and
``(3) for each product designated as a breakthrough
therapy, a summary of the actions taken under subsection
(a)(3).''.
(b) Guidance; Amended Regulations.--
(1) In general.--
(A) Guidance.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall issue draft guidance on implementing the requirements
with respect to breakthrough therapies, as set forth in
section 506(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 356(a)), as amended by this section. The Secretary
shall issue final guidance not later than 1 year after the
close of the comment period for the draft guidance.
(B) Amended regulations.--
(i) In general.--If the Secretary determines that it is
necessary to amend the regulations under title 21, Code of
Federal Regulations in order to implement the amendments made
by this section to section 506(a) of the Federal Food, Drug,
and Cosmetic Act, the Secretary shall amend such regulations
not later than 2 years after the date of enactment of this
Act.
(ii) Procedure.--In amending regulations under clause (i),
the Secretary shall--
(I) issue a notice of proposed rulemaking that includes the
proposed regulation;
(II) provide a period of not less than 60 days for comments
on the proposed regulation; and
(III) publish the final regulation not less than 30 days
before the effective date of the regulation.
(iii) Restrictions.--Notwithstanding any other provision of
law, the Secretary shall promulgate regulations implementing
the amendments made by section only as described in clause
(ii).
(2) Requirements.--Guidance issued under this section
shall--
(A) specify the process and criteria by which the Secretary
makes a designation
[[Page H3221]]
under section 506(a)(3) of the Federal Food, Drug, and
Cosmetic Act; and
(B) specify the actions the Secretary shall take to
expedite the development and review of a breakthrough therapy
pursuant to such designation under such section 506(a)(3),
including updating good review management practices to
reflect breakthrough therapies.
(c) Independent Review.--Not later than 3 years after the
date of enactment of this Act, the Comptroller General of the
United States, in consultation with appropriate experts,
shall assess the manner by which the Food and Drug
Administration has applied the processes described in section
506(a) of the Federal Food, Drug, and Cosmetic Act, as
amended by this section, and the impact of such processes on
the development and timely availability of innovative
treatments for patients affected by serious or life-
threatening conditions. Such assessment shall be made
publicly available upon completion.
(d) Conforming Amendments.--Section 506B(e) (21 U.S.C.
356b) is amended by striking ``section 506(b)(2)(A)'' each
place such term appears and inserting ``section
506(c)(2)(A)''.
SEC. 870. GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN
DRUGS.
(a) Qualified Testing Definition.--Section 5(b)(1)(A)(ii)
of the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is
amended by striking ``after the date such drug is designated
under section 526 of such Act and''.
(b) Authorization of Appropriations.--Section 5(c) of the
Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as
follows:
``(c) Authorization of Appropriations.--For grants and
contracts under subsection (a), there is authorized to be
appropriated $30,000,000 for each of fiscal years 2013
through 2017.''.
TITLE IX--DRUG SHORTAGES
SEC. 901. DISCONTINUANCE AND INTERRUPTIONS OF MANUFACTURING
OF CERTAIN DRUGS.
(a) In General.--Section 506C (21 U.S.C. 356c) is amended
to read as follows:
``SEC. 506C. DISCONTINUANCE AND INTERRUPTIONS OF
MANUFACTURING OF CERTAIN DRUGS.
``(a) In General.--A manufacturer of a drug subject to
section 503(b)(1)--
``(1) that is--
``(A) life-supporting;
``(B) life-sustaining; or
``(C) intended for use in the prevention or treatment of a
debilitating disease or condition; and
``(2) that is not a radio pharmaceutical drug product, a
product derived from human plasma protein and their
recombinant analogs, or any other product as designated by
the Secretary,
shall notify the Secretary of a discontinuance of the
manufacture of the drug, or an interruption of the
manufacture of the drug that is likely to lead to a
meaningful disruption in the manufacturer's supply of the
drug, and the reason for such discontinuance or interruption,
in accordance with subsection (b).
``(b) Timing.--A notice required by subsection (a) shall be
submitted to the Secretary--
``(1) at least 6 months prior to the date of the
discontinuance or interruption; or
``(2) if compliance with paragraph (1) is not possible, as
soon as practicable.
``(c) Distribution.--To the maximum extent practicable, the
Secretary shall distribute information on the discontinuation
or interruption of the manufacture of the drugs described in
subsection (a) to appropriate organizations, including
physician, health provider, and patient organizations, as
described in section 506D.
``(d) Confidentiality.--Nothing in this section shall be
construed as authorizing the Secretary to disclose any
information that is a trade secret or confidential
information subject to section 552(b)(4) of title 5, United
States Code, or section 1905 of title 18, United States Code.
``(e) Coordination With Attorney General.--Not later than
30 days after the receipt of a notification described in
subsection (a), the Secretary shall--
``(1) determine whether the notification pertains to a
controlled substance subject to a production quota under
section 306 of the Controlled Substances Act; and
``(2) if necessary, as determined by the Secretary--
``(A) notify the Attorney General that the Secretary has
received such a notification;
``(B) request that the Attorney General increase the
aggregate and individual production quotas under section 306
of the Controlled Substances Act applicable to such
controlled substance and any ingredient therein to a level
the Secretary deems necessary to address a shortage of a
controlled substance based on the best available market data;
and
``(C) if the Attorney General determines that the level
requested is not necessary to address a shortage of a
controlled substance, the Attorney General shall provide to
the Secretary a written response detailing the basis for the
Attorney General's determination.
The Secretary shall make the written response provided under
subparagraph (C) available to the public on the Web site of
the Food and Drug Administration.
``(f) Failure To Meet Requirements.--If a person fails to
submit information required under subsection (a) in
accordance with subsection (b)--
``(1) the Secretary shall issue a letter to such person
informing such person of such failure;
``(2) not later than 30 calendar days after the issuance of
a letter under paragraph (1), the person who receives such
letter shall submit to the Secretary a written response to
such letter setting forth the basis for noncompliance and
providing information required under subsection (a); and
``(3) not later than 45 calendar days after the issuance of
a letter under paragraph (1), the Secretary shall make such
letter and any response to such letter under paragraph (2)
available to the public on the Web site of the Food and Drug
Administration, with appropriate redactions made to protect
information described in subsection (d), except that, if the
Secretary determines that the letter under paragraph (1) was
issued in error or, after review of such response, the person
had a reasonable basis for not notifying as required under
subsection (a), the requirements of this paragraph shall not
apply.''.
(b) Regulations.--
(1) In general.--Not later than 18 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services, after issuing a notice of proposed rule and holding
a public hearing, shall promulgate final regulations that
implement the amendment made by subsection (a).
(2) Contents.--Such regulations shall, for purposes of
section 506C of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356c)--
(A) define the terms ``life-supporting'', ``life-
sustaining'', and ``intended for use in the prevention or
treatment of a debilitating disease or condition''; and
(B) define the term ``interruption of the manufacture of
the drug that is likely to lead to a meaningful disruption in
the manufacturer's supply of the drug'' to mean a change in
production that is highly likely to lead to more than a
negligible reduction in the supply of the drug and affects
the ability of the manufacturer to meet demand for such drug,
but not to include a change in production due to matters such
as routine maintenance or insignificant changes in
manufacturing so long as the manufacturer expects to resume
operations in a short period of time.
SEC. 902. DRUG SHORTAGE LIST.
Title V (21 U.S.C. 351 et seq.) is amended by inserting
after section 506C the following new section:
``SEC. 506D. DRUG SHORTAGE LIST.
``(a) Establishment.--The Secretary shall maintain an up-
to-date list of drugs that are determined by the Secretary to
be in shortage in the United States.
``(b) Contents.--For each drug on such list, the Secretary
shall include the following information:
``(1) The name of the drug in shortage.
``(2) The name of each manufacturer of such drug.
``(3) The reason for the shortage, as determined by the
Secretary, selecting from the following categories:
``(A) Requirements related to complying with good
manufacturing practices.
``(B) Regulatory delay.
``(C) Shortage of an active ingredient.
``(D) Shortage of an inactive ingredient component.
``(E) Discontinuation of the manufacture of the drug.
``(F) Delay in shipping of the drug.
``(G) Demand increase for the drug.
``(4) The estimated duration of the shortage as determined
by the Secretary.
``(c) Public Availability.--
``(1) In general.--Subject to paragraphs (2) and (3), the
Secretary shall make the information in such list publicly
available.
``(2) Trade secrets and confidential information.--Nothing
in this section alters or amends section 1905 of title 18,
United States Code, or section 552(b)(4) of title 5 of such
Code.
``(3) Public health exception.--The Secretary may choose
not to make information collected under this section publicly
available under paragraph (1) if the Secretary determines
that disclosure of such information would adversely affect
the public health (such as by increasing the possibility of
hoarding or other disruption of the availability of drug
products to patients).''.
SEC. 903. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE.
Section 306 of the Controlled Substances Act (21 U.S.C.
826) is amended by adding at the end the following:
``(h)(1) Not later than 30 days after the receipt of a
request described in paragraph (2), the Attorney General
shall--
``(A) complete review of such request; and
``(B)(i) as necessary to address a shortage of a controlled
substance, increase the aggregate and individual production
quotas under this section applicable to such controlled
substance and any ingredient therein to the level requested;
or
``(ii) if the Attorney General determines that the level
requested is not necessary to address a shortage of a
controlled substance, the Attorney General shall provide a
written response detailing the basis for the Attorney
General's determination.
The Secretary shall make the written response provided under
subparagraph (B)(ii) available to the public on the Web site
of the Food and Drug Administration.
``(2) A request is described in this paragraph if--
``(A) the request pertains to a controlled substance on the
list of drugs in shortage
[[Page H3222]]
maintained under section 506D of the Federal Food, Drug, and
Cosmetic Act;
``(B) the request is submitted by the manufacturer of the
controlled substance; and
``(C) the controlled substance is in schedule II.''.
SEC. 904. EXPEDITED REVIEW OF MAJOR MANUFACTURING CHANGES FOR
POTENTIAL AND VERIFIED SHORTAGES OF DRUGS THAT
ARE LIFE-SUPPORTING, LIFE-SUSTAINING, OR
INTENDED FOR USE IN THE PREVENTION OF A
DEBILITATING DISEASE OR CONDITION.
Subsection (c) of section 506A (21 U.S.C. 356a) is amended
by adding at the end the following new paragraph:
``(3) Changes addressing a drug shortage.--
``(A) Certification.--
``(i) Description.--A certification is described in this
subparagraph if the manufacturer, having notified the
Secretary of an interruption or discontinuance of a drug in
accordance with Section 506C, certifies (in such
certification) that the major manufacturing change for which
approval is being sought may prevent or alleviate a
discontinuance or interruption of such drug.
``(ii) Bad faith exception.--Subparagraphs (B) and (C) do
not apply in the case of a certification which the Secretary
determines to be made in bad faith.
``(B) Expedited review.--If a certification described in
subparagraph (A) is submitted in connection with a
supplemental application for a major manufacturing change,
the Secretary shall--
``(i) expedite any technical review or inspection necessary
for consideration of the supplemental application;
``(ii) provide any technical assistance necessary to
facilitate approval of the supplemental application; and
``(iii) not later than 60 days after receipt of the
certification, complete review of the supplemental
application.''.
SEC. 905. STUDY ON DRUG SHORTAGES.
(a) Study.--The Comptroller General of the United States
shall conduct a study to examine the cause of drug shortages
and formulate recommendations on how to prevent or alleviate
such shortages.
(b) Consideration.--In conducting the study under this
section, the Comptroller General shall consider the following
questions:
(1) What are the dominant characteristics of drugs that
have gone into actual shortage over the preceding three
years?
(2) Are there systemic high-risk factors (such as drug
pricing structure, including Federal reimbursements, or the
number of manufacturers producing a drug product) that have
led to the concentration of drug shortages in certain drug
products that have made such products vulnerable to drug
shortages?
(3) Is there a reason why drug shortages have occurred
primarily in the sterile injectable market and in certain
therapeutic areas?
(4) How have regulations, guidance documents, regulatory
practices, and other actions of Federal departments and
agencies (including the effectiveness of interagency and
intraagency coordination, communication, strategic planning,
and decision-making) affected drug shortages?
(5) How does hoarding affect drug shortages?
(6) How would incentives alleviate or prevent drug
shortages?
(7) How are healthcare providers, including hospitals and
physicians responding to drug shortages, to what extent are
such providers able to adjust care effectively to compensate
for such shortages, and what impediments exist that hinder
provider ability to adjust to such shortages?
(c) Consultation With Stakeholders.--In conducting the
study under this section, the Comptroller General shall
consult with relevant stakeholders, including physicians,
pharmacists, hospitals, patients, drug manufacturers, and
other health providers.
(d) Report.--Note later than 18 months after the date of
the enactment of this Act, the Comptroller General shall
submit a report to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate on the results
of the study under this section.
SEC. 906. ANNUAL REPORT ON DRUG SHORTAGES.
Not later than 18 months after the date of the enactment of
this Act, and annually thereafter, the Secretary of Health
and Human Services shall submit to the Committee on Energy
and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report on drug shortages that--
(1) describes the communication between the field
investigators of the Food and Drug Administration and the
staff of the Center for Drug Evaluation and Research's Office
of Compliance and Drug Shortage Program, including the Food
and Drug Administration's procedures for enabling and
ensuring such communication;
(2) describes the Food and Drug Administration's efforts to
expedite the review of new manufacturing sites, new
suppliers, and specification changes to prevent or alleviate
a drug shortage;
(3) describes the coordination between the Food and Drug
Administration and the Drug Enforcement Administration on
efforts to prevent or alleviate drug shortages;
(4) identifies the number of, and describes the instances
in which the Food and Drug Administration exercised
regulatory flexibility and discretion to prevent or alleviate
a drug shortage;
(5) identifies the number of instances in which the Food
and Drug Administration asked firms to increase production to
prevent or alleviate a shortage;
(6) identifies the number of notifications submitted to the
Secretary under section 506C of the Federal Food, Drug, and
Cosmetic Act, as amended by section 901 of this Act,
including the percentage of such notifications for a drug
that is a sterile injectable;
(7) describes the Food and Drug Administration's
implementation of section 506D of the Federal Food, Drug, and
Cosmetic Act (relating to a drug shortage list), as added by
section 902 of this Act, and identifies--
(A) the name of each drug on the list under such section
506D at any point during the period covered by the report;
(B) the name of each manufacturer of each such drug;
(C) the reason for the shortage of each such drug; and
(D) the anticipated or, if known, actual duration of the
shortage of each such drug;
(8) identifies whether, and how, the Food and Drug
Administration expedited the review of regulatory submissions
to prevent or alleviate shortages, including how the
Administration utilized the authority in section 506A(c)(3)
of the Federal Food, Drug, and Cosmetic Act, as added by
section 904 of this Act;
(9) identifies the number of certifications submitted under
such section 506A(c)(3) and, for each such certification,
whether the Food and Drug Administration completed expedited
review within 60 days as required by subparagraph (B) of such
section 506A(c)(3);
(10) describes the Secretary's public engagement on drug
shortages with stakeholders, including physicians,
pharmacists, patients, hospitals, drug manufacturers, and
other health providers; and
(11) contains the Secretary's plan for addressing drug
shortages in the upcoming year, including with respect to the
issues described in paragraphs (1) through (10).
SEC. 907. ATTORNEY GENERAL REPORT ON DRUG SHORTAGES.
Not later than 6 months after the date of the enactment of
this Act, and annually thereafter, the Attorney General shall
submit to the Committee on Energy and Commerce of the House
of Representatives and the Committee on the Judiciary of the
Senate a report on drug shortages that--
(1) identifies the number of requests received under
section 306(h) of the Controlled Substances Act (as added by
section 903 of this Act), the average review time for such
requests, the number of requests granted and denied under
such section, and, for each of the requests denied under such
section, the basis for such denial;
(2) describes the coordination between the Drug Enforcement
Administration and Food and Drug Administration on efforts to
prevent or alleviate drug shortages; and
(3) identifies drugs containing a controlled substance
subject to section 306 of the Controlled Substances Act when
such a drug is determined by the Secretary of Health and
Human Services to be in shortage.
SEC. 908. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.
Chapter V (21 U.S.C. 351 et seq.), as amended by section
902 of this Act, is further amended by inserting after
section 506D the following:
``SEC. 506E. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.
``(a) Definitions.--In this section:
``(1) Drug.--The term `drug' excludes any controlled
substance (as such term is defined in section 102 of the
Controlled Substances Act).
``(2) Health system.--The term `health system' means a
collection of hospitals that are owned and operated by the
same entity and that share access to databases with drug
order information for their patients.
``(3) Repackage.--For the purposes of this section only,
the term `repackage', with respect to a drug, means to divide
the volume of a drug into smaller amounts in order to--
``(A) extend the supply of a drug in response to the
placement of the drug on a drug shortage list described in
subsection (b); and
``(B) facilitate access to the drug by hospitals within the
same health system.
``(b) Exclusion From Registration.--Notwithstanding any
other provision of this Act, a hospital shall not be
considered an establishment for which registration is
required under section 510 solely because it repackages a
drug and transfers it to another hospital within the same
health system in accordance with the conditions in subsection
(c)--
``(1) during any period in which the drug is listed on the
Drug Shortage List of the Food and Drug Administration; or
``(2) during the 60-day period following any period
described in paragraph (1).
``(c) Conditions.--Subsection (b) shall only apply to a
hospital, with respect to the repackaging of a drug for
transfers to another hospital within the same health system,
if the following conditions are met:
``(1) Drug for intrasystem use only.--In no case may a drug
that has been repackaged in accordance with this section be
sold or otherwise distributed by the health system or a
hospital within the system to an entity or individual that is
not a hospital within such health system.
[[Page H3223]]
``(2) Compliance with state rules.--Repackaging of a drug
under this section shall be done in compliance with
applicable State requirements in which the health system is
located.
``(d) Termination.--This section shall not apply on or
after the date on which the Secretary issues final guidance
that clarifies the policy of the Food and Drug Administration
regarding hospital pharmacies repackaging and safely
transferring repackaged drugs to other hospitals within the
same health system during a drug shortage.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Michigan (Mr. Upton) and the gentleman from New Jersey (Mr. Pallone)
each will control 20 minutes.
The Chair recognizes the gentleman from Michigan.
General Leave
Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days in which to revise and extend their remarks and
insert extraneous materials into the Record.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Michigan?
There was no objection.
Mr. UPTON. Mr. Speaker, I yield myself 2 minutes.
Mr. Speaker, I want to thank, first of all, Chairman Pitts, Dr.
Burgess, Mr. Barton, Mr. Waxman, Mr. Pallone, Mr. Dingell, and other
committee members on both sides of the aisle for their bipartisanship
through this process. H.R. 5651 is a reflection of their hard work,
dedication, and willingness to work together. And because of that
outstanding work, we have a bill today that will help American patients
and innovators, and it will support millions of jobs, believe it or
not, millions of jobs in an important sector of our economy.
As I've said since the beginning of this Congress, we need to enact
this user fee by the end of June, and I believe that we're on track to
accomplish that goal.
And as we put this user-fee package together, I wanted to ensure that
it fostered American innovation by improving the predictability,
consistency, transparency, and efficiency of FDA regulation. Fostering
innovation is essential in getting new treatments to patients and
creating American jobs.
This bill will foster American innovation because it includes
significant accountability and reform measures designed to hold the FDA
responsible for its performance. The measures include independent
assessments of FDA's drug-and-device review process. It also requires
quarterly reporting from the device center so that we don't have to
wait a year to find out their progress.
I commit today that our committee will continue its vigorous
oversight of the FDA. For example, we're going to use the independent
assessments to determine where the review process can be improved, and
we will ensure FDA fixes the problems. Also, we'll use the quarterly
data on device reviews and bring the FDA before our committee to
explain how it's doing.
This bill will give us the information that we need to understand how
the FDA is performing. It is up to us to ensure that we use that
information to hold the FDA accountable for their performance.
Together, the committee members have produced a bill that will help
American patients, while supporting innovation and job creators. I
thank the committee for their participation.
I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Today marks a very exceptional day in this body, one that deserves
great praise. The bill before us, H.R. 5651, the FDA Reform Act of
2012, is the product of bipartisanship, collaboration, and compromise
that I'm very proud of. The bill is a result of more than a year of
negotiations between industry, FDA, and Congress.
In the Energy and Commerce Committee, we held a number of hearings on
the critical issues within the bill, and earlier this month it passed
unanimously in both subcommittee and full committee. The bill is
slightly modified from the bill reported by committee, as it now
includes a bipartisan provision which results in the bill reducing the
deficit by $370 million over the next 10 years.
The FDA Reform Act will ensure that Americans have access to safe and
effective new medicines and medical devices by reauthorizing the user-
fee programs for prescription drugs and medical devices. It will reduce
drug costs for consumers by speeding the approval of lower-cost generic
drugs with the establishment of new user-fee programs for generic drugs
and for lower-cost versions of biotech drugs.
The bill will also reform and revitalize many FDA programs to improve
its regulatory scheme to facilitate a more efficient and predictable
review process.
Mr. Speaker, the bill also makes permanent two complementary
programs, the Best Pharmaceuticals for Children Act and the Pediatric
Research Equity Act, which both help to foster the development and safe
use of prescription drugs for children.
In addition, a significant improvement was made to the FDA's ability
to police an ever-growing global drug supply chain to improve patient
safety, and these provisions will give the FDA critical tools it needs
to keep our medicine safer.
It also includes important provisions to help prevent and mitigate
drug shortages by requiring that drugmakers notify the FDA in advance
of any expected disruption in the supply of certain critical drugs, and
for the FDA to inform health care providers of the potential drug
shortage.
I want to thank Chairman Upton and Chairman Pitts, Ranking Member
Waxman, Mr. Dingell, and my other colleagues on the committee for their
leadership and dedication to this important piece of legislation, a
special thanks to the staffs, in particular my staff person, Tiffany
Guarascio, who's to my right. But on both sides of the aisle, the staff
worked hard, and they should be very proud of what we've accomplished.
Reauthorizing and revitalizing the FDA user-fee system is a critical
investment to our Nation's public health.
Mr. Speaker, I urge all Members of the House to vote ``aye.''
I reserve the balance of my time.
Mr. UPTON. Mr. Speaker, I yield 3 minutes to the gentleman from
Pennsylvania (Mr. Pitts), chairman of the Health Subcommittee on the
Energy and Commerce Committee.
Mr. PITTS. Mr. Speaker, the Food and Drug Administration Reform Act
of 2012 is a product of nearly a year and a half of work in the Energy
and Commerce Health Subcommittee. H.R. 5651 is the result of bipartisan
negotiations. The bill passed out of the Health Subcommittee by a
unanimous voice vote and passed out of the full committee 46 0.
I would especially like to thank Clay Alspach, Ryan Long, and Paul
Edattel and the other staffers for their dedication and hard work in
making this bill possible. I know they've put in a lot of hours; and
because of that work, we have brought this bill to the floor in a
timely manner.
The FDA Reform Act is critical to saving lives and sustaining a
dynamic American industry. American companies are the leading
developers of new medical devices and drugs to save and sustain life.
To ensure that products are both safe and effective, we've tasked the
Food and Drug Administration with reviewing products before they make
their way into the market. This is a big job. The device and drug
industries are dynamic and innovative. Companies spend tens of millions
of dollars and years of work to develop products.
The review stage is a critical time for any company. Inconsistent
reviews mean that the true cost of developing a new product is hidden,
making it difficult to properly prepare.
{time} 1640
When we began considering this legislation last year, we heard from a
number of individuals involved in the medical device industry about the
increasing difficulty of working through the review process. American
patients were waiting almost 4 years longer for new devices that had
already been approved in Europe, and despite the slow review process,
the safety outcomes were comparable.
The FDA Reform Act contains critical reforms to the Medical Device
User Fee Act which will hold the FDA accountable and keep the reviews
on schedule. Under the fourth version of the Prescription Drug User Fee
Act, the median time of approval was 9
[[Page H3224]]
months. With the reauthorization, we set the goal of reducing the
review time to 8 months. Currently, generic drugs have an average
approval time of 32 months. Included in this legislation is a new user-
fee program that should be able to gradually reduce review times to 10
months for most products. A separate user-fee program for biosimilars
has the goal of 10-month approval times for most products. Finally, we
also include language to help patients, doctors, and hospitals to deal
with drug shortages.
Mr. Speaker, I am proud of the work we have done here. I would like
especially to thank full committee Chairman Upton as well as Health
Subcommittee Ranking Member Frank Pallone, full committee Ranking
Member Henry Waxman, and their staffs for patiently working with us on
the FDA Reform Act.
This is legislation to help save lives and create jobs, which are two
goals that we can all agree on. It is a bipartisan effort, and I urge
all Members to support the legislation.
Mr. PALLONE. Mr. Speaker, I would like to yield 3 minutes to our
chairman emeritus, Mr. Dingell, who has worked so hard and who has been
so much a part of this legislation.
Mr. DINGELL. I thank the gentleman from New Jersey.
Mr. Speaker, I rise in strong support of H.R. 5651, to reauthorize
the prescription drug and medical device user-fee programs, to
establish new user-fee programs for generic drugs and biosimilars, and
also to give substantial new authorities to the Food and Drug
Administration, with the support of the industry, to provide broad
additional protections to American consumers.
H.R. 5651 is an excellent example of the great good that can be done
when both parties come together in the spirit of bipartisanship,
cooperation, and compromise, and when they work with consumers and the
industry to achieve a bill supported by all.
This legislation will ensure the timely access to safe and effective
drugs and medical devices, encourage the development of the innovative
drug treatments for our children, and improve the Food and Drug
Administration's current authority to deal with drug shortages. More
importantly, this legislation will provide FDA with much-needed new
authorities to secure the safety of our drug supply and to help prevent
another incident like that unfortunate one involving heparin, in which
over 80 people died from a blood thinner which was contaminated from
where it came, in China, and which also sickened over 100 people of
whom we know.
H.R. 5651's drug supply chain provisions will improve information FDA
has about domestic and foreign drug manufacturers. It will, for the
first time in history, provide FDA with information about importers and
will enable FDA to control imported pharmaceuticals and devices. It
will also allow FDA to detain or to destroy counterfeit or adulterated
drugs, prohibit the entry of imported drugs that have been delayed or
been denied inspection by FDA, and will encourage parity in the
inspections of the domestic and foreign drug establishments. It will
permit, for the first time, the real inspection of foreign producers,
and it will treat all manufacturers alike.
These provisions mirror those in drug legislation which I authored
earlier. The new authorities provided to FDA for our drug supply will
enable the leveling of the playing field for our domestic drug
manufacturers and will give American families the peace of mind that
FDA can and will--and will have the authority to--respond to unsafe,
misbranded, counterfeit, or contaminated drugs.
I want to thank my colleagues on the committee for the fine way this
legislation was worked on, particularly Energy and Commerce Committee
Chairman Upton, Ranking Member Waxman, Subcommittee on Health Chairman
Pitts, Ranking Member Pallone, and their staffs--Clay Alspach, Ryan
Long, Rachel Sher, Eric Flamm, Arun Patel, and Tiffany Guarascio, as
well as Kimberlee Trzeciak of my staff--for their hard work and their
commitment through this process to producing a bipartisan bill.
Mr. Speaker, I am pleased to be a coauthor of this important
legislation. We have built upon the good work that FDA is already doing
as well as the strong agreements negotiated by industry and FDA, and I
urge the House to pass this bill.
I look forward to working with my colleagues in the Senate to swiftly
pass legislation this summer that can be signed into law by the
President.
Mr. UPTON. I yield myself 1\1/2\ minutes for the purpose of a
colloquy, and I yield to the gentleman from Florida (Mr. Buchanan).
Mr. BUCHANAN. Mr. Chairman, I would like to thank you for working
with me to advance my pill mill crackdown legislation and for your
commitment to curbing prescription drug abuse. This crisis has created
enormous pain and suffering on our families and communities, killing
tens of thousands of Americans every year--tens of thousands.
I am pleased that the Senate FDA bill contains the central component
of my bill to reschedule hydrocodone combination drugs--one of the most
addictive and deadly drug mixtures. By reclassifying these drugs from a
schedule III to a schedule II drug, we will be making them much more
difficult to obtain and abuse. This provision has the support of the
medical and the law enforcement communities as well.
I look forward to working with you, Mr. Chairman, to ensure that the
final bill addresses this critical issue and contains the Buchanan pill
mill provision.
Mr. UPTON. I appreciate your constant leadership on the national
problem of prescription drug abuse. I appreciated your input during
your phone call to me last week back in Michigan when the Senate passed
this amendment. Our committee has focused on this issue, and you have
been an outstanding partner with Congressman Ed Whitfield and
Congresswoman Bono Mack on this.
When used properly, we know that these medications provide needed
therapies for those suffering from pain. However, the abuse of some of
those products has devastated communities and destroyed families across
the country. So, as we move forward on this bill in our discussions
with the Senate, I hope that we can continue the partnership and be
able to work this issue out.
At this point, Mr. Speaker, I ask unanimous consent that the balance
of my time be controlled by the gentleman from Pennsylvania (Mr.
Pitts).
The SPEAKER pro tempore. Without objection, the gentleman from
Pennsylvania (Mr. Pitts) will control the remainder of the time.
There was no objection.
Mr. PALLONE. I yield 3 minutes to the gentlewoman from California
(Mrs. Capps).
Mrs. CAPPS. I thank my colleague for yielding me time.
I rise today in strong support of the FDA Reform Act of 2012. I must
say it is an honor to associate myself with the remarks of our chairman
emeritus, Mr. Dingell, who worked tirelessly over the years with regard
to the Food and Drug Administration in making it a good institution
that can only become better.
This bill represents the spirit of compromise--compromise across the
aisle and also among the many stakeholders that work toward innovations
to improve our health. It demonstrates that at a time when most of the
country believes that we in Congress can't work together at all or pass
a piece of legislation without a long and bitter fight, we can come
together to improve health, protect the safety of the American people
and, at the same time, to support good jobs and innovation in our
health care industry.
I am especially pleased that two of my provisions have been included
in this legislation. For example, the SAFE Devices Act will improve the
postmarket surveillance of medical devices and the implementation of
the unique device identifier program. This is an essential provision
that will let us know that our devices work, and it will allow us to
identify potential problems early on, protecting patients and
identifying issues when they are easier and less costly to address.
Additionally, the bill includes the simplification of FDA's de novo
process--an important step to helping both medical devices
manufacturers and patients.
I thank Chairmen Upton and Pitts and Ranking Members Pallone and
Waxman for their leadership on this bill. I also thank the numerous
advocates, the many patients and other
[[Page H3225]]
stakeholders who came together and contributed to this bill so that it
would come to fruition today.
Of course, there is more work in front of us that remains to be done,
but this bill before us is an important step in ensuring that our drug
and device pipelines continue to produce needed cures and treatments in
order to keep us all healthy, which is why I urge my colleagues to
support it.
{time} 1650
Mr. PITTS. Mr. Speaker, I yield 2 minutes to a gentleman who showed
great leadership in the development of this legislation, in the
negotiations, and has been a very integral part, the vice-chair of the
Health Subcommittee, the gentleman from Texas, Dr. Burgess.
Mr. BURGESS. I thank the gentleman for yielding.
Mr. Speaker, this is not a perfect bill, but it's a good bill, and
it's a solid bill. It is worthy of the support of everyone on this
floor. This bill reauthorizes the FDA's user-fee programs for
prescription drugs and medical devices and, in fact, authorizes two new
programs for generic devices and what are known as biosimilars.
Together, all of these products provide powerful tools to prevent and
alleviate human suffering.
The Food and Drug Administration must have the infrastructure and the
resources to ensure patient safety and to approve new products in a
straightforward and predictable fashion. Delayed reviews increase
costs, hurt innovation, cost jobs, and deny patients potentially
lifesaving products. These agreements present the tremendous
opportunity to ensure that we have a strong and efficient FDA, and the
committee responded appropriately and seized that opportunity. This
bill will help the FDA build on what's working, address what isn't, and
provide resources to meet future goals.
With the ranking member on the subcommittee, Mr. Pallone, we crafted
new guidelines for how the Food and Drug Administration recruits,
approaches, and accesses relative scientific and medical expertise. I'm
also pleased that we require the Food and Drug Administration to now
notify Congress before issuing guidance regarding the regulation of
laboratory-developed tests. We still need to strengthen and improve the
oversight of laboratory-developed tests instead of promoting
duplicative regulation that delays access to lifesaving diagnostics,
but it's a good first step. Additionally, the bill takes good first
steps to address critical drug shortages. No physician wants to tell a
patient they can't receive the care that they need because the product
is unavailable.
The process was respectful and resulted from hundreds of hours of
negotiation. Certainly, Chairman Pitts and Ranking Members Waxman and
Pallone and Chairman Emeritus Dingell and their staffs should be given
tremendous credit, along with Ryan Long and Clay Alspach for the work
they did on the majority staff, and my personal staff, J.P.
Paluskiewicz, who put in long hours to get this product to the floor.
This vote is about patients. We need to get it right for them, and I
think we've come awfully close to getting it right.
Mr. PALLONE. Mr. Speaker, I want to make a special thanks to another
staff person for the committee, Rachel Sher, who is on my right here,
as well. Thank you, Rachel.
I would now like to yield 3 minutes to the gentleman from
Massachusetts (Mr. Markey).
Mr. MARKEY. I thank Chairman Upton and Chairman Pitts and I thank
Ranking Member Pallone and Ranking Member Waxman for their work in
bringing to the floor a bipartisan bill that provides FDA additional
resources to bring new drugs and medical devices to market. But today's
bill is also a huge missed opportunity. It would be a disservice to
patient safety to ignore the bill's major shortfall.
Many Americans would be surprised to learn that 90 percent of medical
devices are not required to undergo clinical testing in human beings
prior to being sold. Under current law, the FDA is required to clear
certain medical devices as long as they demonstrate their similarity to
an earlier product, even if the new device is modeled after a similar
defective device that caused serious injury or even death. Today's bill
offered an important opportunity to address this device-safety
loophole, but it doesn't. The loophole remains in place, and patients
are still, and will remain, at grave risk.
Four years ago, Jaye Nevarez, a 50-year-old mother of three, was a
healthy truck driver who earned a decent living, played in a band, and
paid her bills on time. Then her doctor implanted a bladder mesh, a
device that traces its origin back to a previous product that was
recalled for causing serious injury and in some cases death. Jaye now
lives in constant pain. She was forced to quit her job. She can't walk
without a cane. She lost her insurance and faces a growing mountain of
medical debt. The bank recently began foreclosure proceedings on her
home where she lives with her 79-year-old mother.
Jaye isn't the first to be harmed by this loophole. If we fail to fix
it, she won't be the last. There will be tens of thousands of others
who fall into this loophole who will suffer serious injury.
I introduced the SOUND Devices Act providing FDA the ability to
protect the public from these unsafe devices, but this was not included
in the bill. The bill we are voting on today is critically important,
however. It includes the EXPERRT Act, a bill that I authored to improve
communication between FDA and experts in rare diseases. It includes
bipartisan provisions that I'm proud to have worked with other Members
to promote, especially in pediatric-device development.
This bill must not be the last word on medical-device safety. I hope
that my colleagues will join with me to close this loophole so that we
can keep the American public safe from harmful medical practices.
Mr. PITTS. Mr. Speaker, at this time I am happy to yield 1\1/2\
minutes to the subcommittee chairman of O&I, the gentleman from Florida
(Mr. Stearns).
Mr. STEARNS. Mr. Speaker, the authorization of the FDA user fees will
simply provide stability at FDA's new product review as companies
submit new and innovative devices and drugs for their approval.
I'm especially proud that in this bill I had a piece of legislation
called the Faster Access to Specialized Treatments--FAST--Act, which is
H.R. 4132. It was included in the FDA Reform Act. This act modernizes
the FDA accelerated approval pathways to reflect the 20 years of
science developed since accelerated approval was first established in
1992. So think of that: since 1992, with this bill that I've included
in our FDA bill, it will accelerate approval through the FDA. It will
simply allow new drugs to get to market faster for people who are
suffering from rare diseases. There are 30 million Americans suffering
from one of over 7,000 rare diseases, but only 250 currently have any
treatment. This act will save lives.
I would like to enter, Mr. Speaker, this letter of support for FAST
signed by over 150 rare-disease groups into the Record.
I'm also glad that the FDA Reform Act includes the Expanding and
Promoting Expertise in Review of Rare Treatments Act, EXPERRT Act, H.R.
4156. This will help FDA consult with medical experts when evaluating
drugs dealing with rare disease such as cystic fibrosis. As the
cofounder of the Cystic Fibrosis Caucus, I'm glad we're giving this
tool to the FDA.
Mr. Speaker, I support passage of the FDA Reform Act.
March 23, 2012.
Hon. Cliff Stearns,
U.S. House of Representatives,
Washington, DC.
Hon. Edolphus Towns,
U.S. House of Representatives,
Washington, DC.
Dear Congressmen Stearns & Towns: On behalf of patients,
physicians, and other members of the health advocacy
community we are writing to express our support for H.R.
4132, the Faster Access to Specialized Treatments (FAST) Act.
This legislation will modernize and expand the FDA's
Accelerated Approval pathway to encompass a broader range of
diseases and leverage 21st century drug development tools and
strategies. This reform will speed the approval of much-
needed therapies and cures to patients who are facing serious
and life-threatening conditions, including Alzheimer's
disease, autoimmune diseases, multiple sclerosis, Parkinson's
disease, neuromuscular disease and hundreds of rare diseases
that remain untreated.
We commend you for championing legislation that maintains
the FDA's high standard for approval while at the same time
ensuring the Agency can help facilitate the development of
new and novel therapies to patients
[[Page H3226]]
in a more timely manner. In many cases our patients have no
available treatment for their diseases, or they are using a
therapy that is older and may not work as effectively and
safely. This is not acceptable. We believe that this
legislation will ensure patients receive the best, modern
treatment as soon as possible and we applaud your efforts on
their behalf.
Thank you for your leadership on this important bill and we
look forward to working with you as it moves forward.
Sincerely,
Abigail Alliance for Better Access to Developmental
Drugs; Advocacy for Patients with Chronic Illness,
Inc.; Affiliated American CSA Foundation; Alliance for
Aging Research; Alliance for Patient Access; American
Autoimmune Related Diseases Association; American Brain
Tumor Association; American Childhood Cancer
Organization; American College of Medical Genetics;
American Institute for Medical and Biological
Engineering; American Society of Clinical
Psychopharmacology; Batten Disease Support and Research
Association; Break Through Cancer Coalition;
Californians for Cures; Celiac Disease Center at
Columbia University; Celiac Sprue Association; Charcot-
Marie-Tooth Association (CMTA); Children's
Cardiomyopathy Foundation, Inc.; Chinese American
Association of Greater Chicago; Coalition Duchenne;
Coalition for Pulmonary Fibrosis; Colon Cancer
Alliance; Cooleys Anemia Foundation; Crohn's and
Colitis Foundation of America; Cryoglobulinemia
Vasculitis Organization; CureDuchenne; CurePSP;
Digestive Disease National Coalition; Erik Metzler
Foundation; EveryLife Foundation for Rare Diseases;
Fabry Support & Information Group; Georgia PKU Connect;
GIST Support International; Hadley Hope Fund; Hannah's
Hope Fund; Hayden's Batten Disease Foundation Inc.;
HealthHIV; Hope4Bridget Foundation; ICE Epilepsy
Alliance; I Have IIH; In Need of Diagnosis, Inc.
(INOD); Inspire; International Cancer Advocacy Network
(ICAN); Jacob's Cure, Inc.; Jain Foundation Inc.;
Jonah's Just Begun-Foundation to Cure Sanfilippo Inc.;
LAM Treatment Alliance; LGS Foundation; Liddy Shriver
Sarcoma Initiative; Little Miss Hannah Foundation; Lung
Cancer Alliance; Lupus Foundation of America;
Lymphangiomatosis & Gorham's Disease Alliance (LGDA);
Lymphatic Malformation Institute (LMI); Macular
Degeneration Support, Inc.; Madisons Foundation;
Midwest Asian Health Association (MAHA); MLD
Foundation; Mpdsupport.org--Myeloproliferative Disease
Support; Muscular Dystrophy Association; National
Family Caregivers Association; National MPS Society;
National MS Society; National Niemann-Pick Disease
Foundation, Inc.; National PKU Alliance; National Tay-
Sachs & Allied Diseases Association; National Venture
Capital Association; NBIA Disorders Association; New
Jersey Association for Biomedical Research; NKH
International Family Network; Noah's Hope--Batten Disease
Fund; Oxalosis and Hyperoxaluria Foundation; Pachyonychia
Congenita Project; Parkinson's Action Network; Parry-
Romberg Syndrome Resource, Inc.; Partnership for Cures;
Polycystic Kidney Disease Foundation; RARE Project;
Russell-Silver Syndrome Support; Scleroderma Research
Foundation; Sickle Cell Disease Association of America,
Inc.; Society for Women's Health Research; Solving Kids'
Cancer; Student Society for Stem Cell Research; Sudden
Arrhythmia Death Syndromes (SADS) Foundation; Taylor's
Tale; The Association for Frontotemporal Degeneration
(AFTD); The Children's Medical Research Foundation, Inc.;
The Erythromelalgia Association; The Focus Foundation; The
Manton Center for Orphan Disease Research, Children's
Hospital Boston; The Reflex Sympathetic Dystrophy Syndrome
Association (RSDSA); The Stop ALD Foundation; Tuberous
Sclerosis Alliance; Veterans Health Council; VHL Family
Alliance; Vietnam Veterans of America; ZERO--The Project
to End Prostate Cancer.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from
North Carolina (Mr. Butterfield).
Mr. BUTTERFIELD. I thank the gentleman for yielding, and I thank him
for his leadership on our committee.
Mr. Speaker, I rise today in support of H.R. 5651, the Food and Drug
Administration Reform Act, and want to simply highlight section 865,
the Rare Pediatric Disease Priority Review Voucher Incentive program.
I'm so pleased this section was included in the base text of the bill.
I want to thank my colleagues on the committee and my good friend
Congressman Mike McCaul of Texas for joining with me to see to its
inclusion. Actually, we joined together in seeing to its inclusion.
Also, let me give a strong thank you to Nancy Goodman with Kids vs.
Cancer, who was a strong advocate on this issue.
The program will incentivize pharmaceutical companies to develop new
drugs for children with rare pediatric diseases such as childhood
cancers and sickle cell disease by expanding the cost-neutral priority
review voucher program. Expanding the voucher program will allow
pharmaceutical companies to expedite FDA review of more profitable
drugs in return for developing treatments for rare pediatric disease.
Since 1980, the FDA has approved only one new drug for treatment of
childhood cancer while having approved 50 new cancer-fighting drugs for
adults. Children living with life-threatening conditions need access to
newly developed drugs that can treat these rare diseases.
{time} 1700
Whether a disease is rare or common, the need for effective care and
potential cures is the same. Therefore, I strongly urge its inclusion
in the final bill that will go to the President for his signature.
Mr. Speaker, on a slightly different note, I would also like to
discuss another issue of equal importance. My colleagues and I have
worked closely with the Pharmaceutical Distribution Security Alliance
to craft a consensus proposal that has the support of manufacturers,
distributors, wholesalers, and both the community and chain pharmacists
in dealing with traceability of prescription medication.
The proposal, known as RxTEC, would establish a national standard to
address the serious issue of drug traceability and pedigree. I commend
PDSA for their commitment to consumer and patient safety by working so
diligently with both Chambers on this very important issue, ultimately
securing placeholder language in the Senate FDA reform bill.
I am very supportive of this proposal, as RxTEC increases patient
access to safe medicines, improves security of the pharmaceutical
distribution chain, and lowers costs and regulatory burdens. Given the
seriousness of this issue, and to avoid additional injuries and
potential deaths from counterfeit drugs, I urge the FDA and all parties
involved in these talks to find common ground so that we can include
final supply chain integrity language into the final draft similar to
section 865.
I ask my colleagues on the committee to also voice their support for
inclusion.
Mr. PITTS. Mr. Speaker, I yield 2 minutes to the gentleman from
Pennsylvania (Mr. Murphy), a member of the Health Subcommittee, really
the author of the sections on generic drug user fees and biosimilars in
the bill.
Mr. MURPHY of Pennsylvania. I thank the chairman.
This year a typical senior will spend 15 percent of their household
income on health care, including $620 plus on prescriptions.
But that sum would be much higher if there were no FDA-approved
generic pharmaceuticals. Without generics, that same senior might pay
$1,000 for medicine, and Medicare would spend some $67 billion more.
We must always assure that any medication, brand name or generic, is
of the highest quality. But currently the Food and Drug Administration
cannot assure that medicines coming in from overseas factories such as
those in China are pure.
This bill includes my legislation, the Generic Drug and Biosimilar
User Fee Act, to authorize for the first time an FDA program that will
expedite approval of generics and clear a backlog of over 2,800 generic
applications. Currently, the FDA is supposed to make a decision on the
application within 16 months.
But the agency is taking twice that time because it lacks resources
for conducting reviews and inspecting factories. U.S. factories are
inspected perhaps once every 2 years, and more often if the FDA
decides; foreign factories perhaps 7 to 9 years. That means millions of
dosages of drugs coming in from overseas without any inspection.
Recall what happened when heparin ended up killing perhaps 100 to 200
people and causing other complications for many people. Ninety percent
of pharmaceutical ingredients are made in foreign factories, but we
cannot remain
[[Page H3227]]
dependent on drugs from other countries that are below U.S. standards.
People of all ages deserve peace of mind, and we all want to have the
highest trust for all medicines, either brand name or generic. This
bill will restore and support that trust for American consumers.
Mr. PALLONE. Mr. Speaker, I am not expecting any more speakers, and I
reserve the balance of my time.
Mr. PITTS. Mr. Speaker, I yield 2 minutes to the gentleman from
Georgia (Mr. Gingrey), another valued member of the Health
Subcommittee, the author of the GAIN Act, the section dealing with
antibiotics, and a valued participant in all these negotiations.
Mr. GINGREY of Georgia. I thank subcommittee Chairman Pitts, Chairman
Upton, subcommittee Ranking Member Pallone. The bill that we are
passing today in the House of Representatives, H.R. 5651, is an
opportunity to come to the well in support of something that we have
done in a bipartisan way. I really relish that fairly rare opportunity.
Mr. Speaker, once again we are showing the American people that we can,
when we have a need, a need and good ideas. Months and months and
months went into working on this bill, staffs on both side. I commend
them all and, of course, Ranking Member Waxman as well.
Let me just say this. Other Members are talking about the many
aspects of the bill, talking about the user-fee aspect of prescription
drugs, generic drugs, biologic, biosimilars, the drug safety chain
aspect, addressing this problem of shortage of drugs. Emeritus Member
Dingell is a big part of that aspect of the bill.
Let me just say one thing about something that I had a lot of input
into, and I am very proud of, and that is a specific drug, antibiotics,
where we have a tremendous shortage. That inclusion of my bill, the
GAIN Act, Generating Antibiotic Incentives Now, in this bill, I think,
is hugely important. We have a lack of antibiotics in this country. We
need to incentivize manufacturers to come forward with new and better
antibiotics.
Mr. Speaker, I want to just mention very briefly anecdotally, in my
district, the 11th District of Georgia, northwest Georgia, a young
college student fell recently in a stream, the little Tallapoosa River,
deeply gashed her leg. Bacteria got in that leg, which normally 99 out
of a 100 times, Mr. Speaker, would cause no problems whatsoever.
In this instance, I guess maybe because of the depth of the wound and
the amount of the trauma to the tissue, it resulted in something called
necrotizing fasciitis. This young student, 24 years old, has been
struggling for months in an Augusta hospital to recover from these
injuries. She is on the way to recovery, thank God, but not without
significant long-term disabilities. That's why things like the GAIN
aspect of the bill is so important so that we can get new and better
antibiotics to the market.
I support this bill tremendously in a bipartisan way.
Mr. PITTS. Mr. Speaker, I yield 2 minutes to the gentleman from Ohio
(Mr. LaTourette).
Mr. LaTOURETTE. I thank the gentleman very much for yielding.
I commend the Energy and Commerce Committee for producing a good
piece of legislation. I also want to applaud the efforts to enhance the
safety of America's pharmaceutical supply chain. While we are fortunate
in America to not yet have a widespread problem, counterfeit drugs pose
a serious health risk to all consumers.
The current patchwork of State requirements and licensing, however,
makes supply chain compliance and safety inconsistent and challenging,
which potentially jeopardizes the safety and welfare of millions of
Americans. Unless a uniform Federal policy covering all pharmaceutical
supply chain stakeholders is enacted, the U.S. will fail to provide the
visibility and leverage technology that will provide a superior cost-
effective consumer protection.
Third party logistic providers, or 3PLs, are playing a growing and
important role in making sure that safe medicines reach their
destinations. The term ``third party logistics provider'' refers to an
entity that provides or coordinates warehousing, distribution, or other
services on behalf of a manufacturer.
Currently, Federal law does not recognize the role of a 3PL. Only one
State today offers a license for 3PLs. Other States require a 3PL to
apply for a wholesale distributor license, even though 3PLs don't buy
or sell drugs.
The varying patchwork of inconsistent State requirements does not
provide for optimum law enforcement, and there is an added cost without
a safety benefit. 3PLs need to be defined in Federal legislation and
properly licensed. Including a 3PL definition in Federal language is a
strong first step towards the development of uniform Federal standards
and 3PL licenses.
I want to thank my colleagues on the Energy and Commerce Committee in
advance for a successful and constructive conference process, and I am
confident that we can enhance the supply chain safety in a reasonable
and cost-effective manner.
Mr. PALLONE. Mr. Speaker, I just want to say in closing that I think
it's a great example with this bill of what we can do, not only in the
Energy and Commerce Committee but in general in this House, on a
bipartisan basis when everyone works together for a common goal.
{time} 1710
This is actually a very important piece of legislation. It's
important for the pharmaceutical industry. It's important in terms of
job creation. It's important in terms of innovation and also bringing
low-cost drugs to the American people. Without the type of bipartisan
cooperation we had, we would not have been able to get here with this
time schedule, which is truly amazing. So I want to thank everyone. I
would like to say that I hope that we can do similar good work in the
remainder of this Congress, and I would urge my colleagues to vote
``aye.''
I yield back the balance of my time.
Mr. PITTS. Mr. Speaker, in conclusion, I want to again commend
leadership on both sides of the aisle: Ranking Member Emeritus Mr.
Dingell and Ranking Member Mr. Pallone and Mr. Waxman and Chairman
Upton and staff of both sides. They have done a terrific job and spent
countless hours. I especially want to mention Clay Alspach and Ryan
Long on our side, as well as our personal staff. They have been
absolutely terrific. Because of this, this legislation is going to save
many lives. It's going to help the United States continue to be the
world leader in the pharmaceutical and medical device industries and
mean a lot to our economy as well.
I urge all Members to support this very important legislation, and I
yield back the balance of my time.
Mr. BILBRAY. Mr. Speaker, I want to indicate my strong support of
H.R. 5651, the Food and Drug Administration Reform Act of 2012, which
we are addressing on the House floor today. This bipartisan legislation
is not only good for the health of the American public; it is also a
key component to restoring the health of our economy.
Nowhere will the impacts of this legislation be felt more than in
Southern California and the San Diego region. According to BIOCOM,
Southern California's life sciences cluster employs just over 97,000 in
five sectors: biopharmaceuticals, industrial biotechnology and
biofuels, life sciences trade, medical devices and diagnostics, and
research and lab services. Medical devices and diagnostics is the
region's largest life sciences sector, employing 33,871, followed by
research and lab services with 31,878 jobs. These two sectors account
for 68 percent of the total employment in the cluster, with over 65,000
jobs in the region. These innovative companies are on the forefront for
discoveries from everything from Cancer therapies to the latest medical
device that will prolong life.
The Food and Drug Administration Reform Act of 2012 will provide
timely and necessary improvements to the user fee programs for drugs,
medical devices, generics and biologics. Through this legislation, FDA
will now be committed to meeting their performance goals for the review
of life saving drugs--thus expediting these products to patients who
need them, create an independent review entity to hold FDA accountable
for the approval and clearance process for devices, as well as the
creation of a new user fee program for generic drug and biologics
approval all the while ensuring the safety of U.S. patients.
H.R. 5651 contains many provisions that will improve the lives of
American patients and promote the competitiveness of the U.S. life
science enterprise. However, there are two
[[Page H3228]]
provisions in this legislation that I am most proud of including.
Included in the final House draft were two pieces of bipartisan
legislation that I sponsored and worked with my colleagues on both
sides of the aisle to get included. They are:
H.R. 3203, the Novel Device Regulatory Relief Act, coauthored with
Representative Lois Capps (D-Santa Barbara) improves the FDA's third
party review and inspection of medical devices by making the process
more efficient, transparent, and beneficial to the life science
industry seeking approval.
H.R. 5334, the Breakthroughs Therapy Act, coauthored with
Representative Diana DeGette (D Denver) expedites the review of
breakthrough drugs for patients with serious or life-threatening
disease or a condition where preliminary clinical evidence shows an
improvement over existing therapies.
As we move forward in reconciling our legislation with the Senate it
is my hope that we can address another national crisis that was not
included in the House bill--the need for a reliable track and trace
system for pharmaceutical products. For years, Congress has attempted
to craft legislation that would secure the distribution chain for
pharmaceuticals. Either due to lack of consensus from industry and
patient participants or poor timing, this was never accomplished. This
lack of action has resulted in a patchwork of State laws which create
opportunities for bad actors to shop for States with the lowest safety
requirements in order to introduce unsafe products into the legitimate
supply chain. This patchwork also creates regulatory uncertainty in the
supply chain, which adds increased costs and burden to the health care
system.
But this year is different. For the first time, we have seen industry
stakeholders put aside differences and come to a consensus on a
language that is supported by me and my friend Mr. Matheson that will
create a national pedigree system which will replace a patchwork of
State laws that are currently in place. While not a perfect solution,
this legislation is a first step in creating a secure supply chain
system that will protect the U.S. public from counterfeit drugs while
preventing unwanted regulatory burden on American businesses. It is my
goal to work with my colleagues to include track and trace language in
the final legislation which will secure the drug supply chain and
address the concerns of the large pharmaceutical distributors,
secondary pharmaceutical distributors, local pharmacists, third party
logistical providers and the large scale pharmacies.
In closing, I wish to thank Full Committee Chairman Fred Upton and
Health Subcommittee Chairman Joe Pitts for their commitment to this
issue. Without their guidance and hard work, this legislation would
never have seen the light of day. I look forward to casting my vote in
support of H.R. 5651 and urge my colleagues to do the same.
Mrs. EMERSON. Mr. Speaker, I want to express my support for the
reauthorization of the Food and Drug Administration (FDA) under
consideration today. The FDA provides essential safeguards for patients
in America and around the world, while making possible new treatments
and therapies for diseases and conditions which affect millions. This
bill supports greater speed of generic medications to market and
assures much needed drugs to treat cancer will get to the patients who
need them.
However, one provision (Section 805) in this legislation causes me
special concern. The section includes the new authority for the
Secretary of Health and Human Services to consult with the Department
of Homeland Security to cause the destruction of any drug ``that has
reasonable probability of causing serious adverse health consequences
or death . . . or that is valued at an amount that is $2,000 or less.''
This section poses a serious concern to hundreds of thousands of
Americans who receive their drugs by mail from licensed and regulated
pharmacies in Canada and other foreign countries. For these patients,
these American consumers, there is often only one choice beyond a
Canadian pharmacy, and that is to not purchase the medicines they need
at all.
Patients expecting receipt of legitimate prescriptions, written by
their doctor and filled by a licensed pharmacy in Canada, could have
their shipment of medication destroyed without receiving any
notification either before or after the Federal Government takes that
action. A bus full of senior citizens which crosses the border into
Canada to visit a pharmacy where they can fill their prescriptions for
one-third the price of the same medications in the United States could
have their pill bottles seized at the border, their meager budget for
their monthly health care expenses already exhausted. This is not good
policy, nor is it what Americans expect from a free market.
This language threatens a critical, cost-effective supply of
medications and pharmaceuticals. These drugs are exactly the same as
their counterparts sold in America. I urge further discussion of this
critical issue in conference and a full examination of the consequences
of passing this provision into law.
Mr. WAXMAN. Mr. Speaker, today, the House considers a bill that
represents a significant bipartisan achievement. Our work to find a
common approach to legislation to support and strengthen the FDA is
truly remarkable. It has been a pleasure to work with Mr. Upton, Mr.
Pitts, Mr. Pallone, Mr. Dingell, and other members of the Committee to
achieve this result.
When we began this process, there were wildly divergent views on the
various issues contained in this bill. But we worked together and found
ways to address those issues in a way that protects both innovation and
patients.
This legislation contains several provisions that are critical to the
functioning of major parts of FDA. Our reauthorization of FDA's drug
and medical device user fee programs will provide resources to enable
the efficient review of applications and give patients access to
therapies at the earliest possible time. We are also reauthorizing two
pediatric programs which foster the development and safe use of
prescription drugs in children.
This year we will be establishing two new programs to help speed
FDA's review of new generics and biosimilars. These provisions
illustrate our bipartisan commitment to ensuring a vibrant generic
marketplace. All of us will see the benefits when more low-cost
generics are on the market as a result of this legislation.
The bill also includes provisions to modernize FDA's authorities with
respect to the drug supply chain. FDA has been trying to keep pace with
our increasingly globalized drug supply chain using an outdated
statute. This legislation will give FDA critical new tools to police
this dramatically different marketplace.
We also have included some important provisions that will go a long
way toward addressing drug shortages, which have unfortunately now
become an all-too-frequent occurrence.
When we began this process, I had concerns about many of the
Republican proposals relating to medical devices. But we worked
together to address those concerns and to assure that nothing in this
bill will take us backwards in terms of patient safety.
Our bipartisan work has truly paid off.
I support this bill, but I also think we can continue to improve it
in the area of antibiotics. I agree that we need to look at ways to
incentivize the development of new antibiotics. But we would more
effectively address this need if we narrowed the provisions of the GAIN
Act to target only drugs that treat serious and life-threatening
infections. Additionally, mandating that steps be taken to preserve the
effectiveness of antibiotics would strengthen the bill, in my view.
I want to thank my colleagues on both sides of the aisle, and their
staffs, for the hard work they have put into making this a strong,
bipartisan bill. I particularly want to thank Mr. Pallone's and Mr.
Dingell's staff members Tiffany Guarascio and Kim Trzeciak as well as
Mr. Upton's and Mr. Pitts' staff, Ryan Long and Clay Alspach. And,
finally, my own staff, Karen Nelson, Rachel Sher, Eric Flamm, and Arun
Patel.
I expect the same level of bipartisan cooperation will continue as we
work together with our colleagues in the Senate to get this to the
President before the 4th of July recess.
Ms. KAPTUR. Mr. Speaker, I reluctantly rise today in support of H.R.
5651, the Food and Drug Administration Reform Act of 2012.
First, I would like to commend Chairman Upton and Ranking Member
Waxman for putting together a bipartisan bill. Bipartisan bills are a
rarity in this Congress and I hope we can use the goodwill gained in
this bill to come together on additional measures, such as those that
create jobs and promote economic growth.
While this bill has support from both sides of the aisle, from my
perspective, it does not go far enough.
The Food and Drug Administration (FDA) is tasked with ensuring the
safety of $2 trillion in products produced by industry. The FDA's
approval of a company's products all but guarantees profits for that
company.
Companies that benefit from the FDA's approval should significantly
contribute to the FDA's budget to reduce the burden on taxpayers who
are already paying for tax cuts for millionaires and billionaires and
two unpaid wars. In FY 12, user fees comprised a mere 35 percent of the
FDA's budget.
The FDA is facing many challenges. Approximately half of medical
devices used in the United States come from abroad. Nearly 40 percent
of the drugs Americans take are made overseas and about 80 percent of
the active pharmaceutical ingredients are imported. Several years ago,
contaminated heparin from China caused a number of deaths and illnesses
in my Congressional District.
Additional resources are needed to properly investigate, inspect, and
police foreign products like heparin to ensure American consumers are
fully protected. Industry should be contributing more.
[[Page H3229]]
Despite my reservations, this bill is a step in the right direction.
It reauthorizes user fees for prescription drug and medical devices at
levels that should provide the FDA with sufficient resources to give
patients access to therapies at the earliest possible time.
In addition, this legislation authorizes a new user fee for generic
drug reviews. In the last decade, the use of generic drugs saved the
U.S. health care system more than $931 billion. Consequently, I'm glad
to see the underlying bill provides resources to improve review times
to ensure safe generic drugs come into the market as quickly as
possible.
Finally, the bill addresses some of my concerns regarding foreign
products. I strongly support the provisions that require drug importers
to register with the FDA, requiring sufficient information from
importers to allow the FDA to implement a risk-based approach to import
screening and barring the entry of imported drugs if deemed to have
been delayed, limited or denied a full safety inspection.
I also strongly support the section of the bill that provides
extraterritorial Federal jurisdiction to enable United States law
enforcement to hold those accountable who violate our safety laws, such
as those who are responsible for the heparin-related deaths in my
Congressional District.
Mr. TOWNS. Mr. Speaker, I rise today in support of H.R. 5651, The FDA
Reform Act of 2012. I would like to thank my colleagues for working
with me and my staff on this important piece of legislation. As we move
forward in the legislative process I would like to state the importance
of maintaining the provision in the accelerated approval section that
requests guidance from the FDA on how to implement reforms to the drug
approval process enacted by Congress. During our discussion in
subcommittee I submitted letters in support of this language from NORD,
BIO, and fifty other patient groups. I hope that we maintain this
guidance language as we continue to move through the legislative
process.
I have only a few remaining concerns that I hope we can work through
together before the bill is signed into law. One issue is regarding our
drug supply chain security and the second is regarding medical device
technologies which potentiate drugs.
For many years, creating a national standard on drug traceability, or
pedigree, has eluded Congress. Realizing that the U.S. pharmaceutical
supply chain has many safeguards in place and companies spend
significant amounts of money to ensure the integrity of their
products--criminals, thieves and other bad actors will stop at nothing
to make profit off of the high value prescription drugs that are
manufactured and sent throughout the distribution chain down to our
pharmacies, and ultimately to patients and consumers. I support efforts
to create consensus language on this issue that has the backing of
stakeholders--from manufacturers, to distributors, wholesalers on down
to pharmacists--all involved in various aspects of the U.S. supply
chain.
We know that the other chamber was able to include ``placeholder''
language in its version of the FDA bill to ensure that conversations
can continue to play out between FDA, supply chain stakeholders and
Congressional stakeholders to come to a final consensus over the course
of the coming weeks. Given the seriousness of this issue--to avoid
additional injuries and potential deaths from counterfeit and
adulterated product, and to avoid a patchwork of individual state laws
to address an issue which clearly requires a federal solution--I would
urge the FDA and all parties involved in these talks to find common
ground so that we can include final supply chain integrity language
into the final FDA user fee bill that is agreed upon between the two
chambers. I would ask my colleagues on the committee to also support
this request and signal their support as well.
My final concern is regarding medical device technologies. The
Centers for Disease Control and Prevention (CDC) estimates that more
than 70% of bacterial and fungal pathogens resist at least one of the
drugs typically used to eradicate them. The CDC estimates that these
infections are responsible for over 90,000 deaths annually and cost the
U.S. an excess of $4 billion. These life-threatening infections also
prolong hospital stays and create substantial additional costs in the
fighting of these infections.
With such knowledge, the importance of innovative treatments such as
patented laser technology that combat resistant organisms such as MRSA
is pivotal. One section of this bill addresses the critical need to
improve the pipeline of medical drugs identified as qualified
infectious disease products (QIDPs). It has been brought to my
attention that new peer-reviewed and patented laser technology is
emerging that has the potential to eradicate drug resistant bacteria
and fungus by potentiation of existing generic antimicrobial drugs
while preserving human tissue. The standard definition of
``potentiation'' is when one drug enhances a second drug so that the
combined effect is greater than the sum of the effects of each one
alone.
With these innovative technologies, we can improve post-surgical and
inpatient outcomes. Furthermore, these technologies have shown the
potential to successfully treat over 2.7 million patients annually
suffering from diabetic ulcers and lower limb and amputations. I hope
the FDA will consider medical device technology which potentiate drugs
as well QlDPs which have already been identified in this legislation in
taking steps toward eradicating bacterial and fungal infections.
Mr. Speaker, this legislation has been the model of bipartisanship. I
hope that we can continue our important work together to have these
critical provisions affecting patients included in the final bill
before it is signed into law.
Ms. DeLAURO. Mr. Speaker, while I have serious reservations, I rise
in support of the Food and Drug Administration Reform Act of 2012 that
we are considering under suspension of the rules today.
As we all know, this bill is critical to patients, consumers, and
industry across the country. It will ensure that Americans continue to
have access to safe, affordable, and effective medications and medical
devices.
And there are several positive things in this legislation. For
example, it will help to prevent drug shortages by requiring that
companies notify the FDA if certain drugs are expected to experience
manufacturing interruptions or discontinuances. Between 2005 and 2010,
the number of reported drug shortages nearly tripled--so we must act,
and the provisions in this bill are a step forward in addressing this
issue.
The bill also permanently reauthorizes pediatric drug programs,
including those originally created because of the Best Pharmaceuticals
for Children's Act. It requires the electronic submission of new drug
applications and issuance of regulations supporting a unique device
identification system. It authorizes new efforts to prevent
prescription drug abuse.
Unlike the Senate bill passed last week, this bill includes a clause
that may result in the destruction of drugs valuing less than $2,000
entering this country before notifying the individual receiving the
package--simply put, some Americans may order medications that never
arrive, placing their health at risk as they wait for their affordable
medication. We should move to the Senate position on this issue.
Unfortunately, this bill also represents a missed opportunity. We
should be going much further to ensure that medications and medical
devices are safe and effective, and to improve consumer and patient
protections. For example, the bill does not strengthen the premarket
review of medical devices, improve the agency's ability to
appropriately reclassify medical devices, or even authorize an
independent review of the drug approval process. It authorizes changes
to the agency's conflict of interest policy for Advisory Committees,
but does not strengthen them. And it does not reform the medical device
clearance process.
The bill we consider today should not be an end point. American
consumers need access to products that are safe and effective, and
numerous independent organizations have found the current system
lacking. Just last year, the Institute of Medicine found that the
510(k) clearance process is not ``a reliable premarket screen of the
safety and effectiveness'' of some devices. In sum, we should pass this
bill, but we must also do more to strengthen the pre-market and post-
market oversight of drugs and devices.
Mrs. CHRISTENSEN. Mr. Speaker, there are so many reasons that I rise
in strong support of this bipartisen legislation. Not only will it
modernize the FDA review process of new and generic prescription drugs,
biosimilars and medical devices, and ensure that Americans have
reliable access to new, safe and innovative medicines and devices, as
well as to affordable generic drugs, but it also promotes greater
equity and safety in the development and use of prescription drugs for
children--a level of importance that cannot be stressed enough.
I strongly support this legislation because it prioritizes and
protects the health and welfare of consumers, while also being fair and
just to the prescription drug and medical device industries. And, this
legislation includes incentives for the development of new antibiotics
to treat both life-threatening infections as well as those that if not
treated, snowball into life-threatening situations.
Finally, I rise in strong support of this legislation because it will
take significant steps forward to address our nation's ever-growing
challenge with drug shortages. And so, Mr. Speaker, I urge my
colleagues to join me with their strong support of this legislation so
that we may achieve what we have long hoped to accomplish: reforming
and strengthening many of the Food and Drug Administration's key
programs which--together--will ensure that Americans have greater and
more timely access to safe, affordable therapies and medical devices to
treat and manage their conditions, and improve their overall health,
quality of life and thus life opportunities.
[[Page H3230]]
Ms. McCOLLUM. Mr. Speaker, I rise today in strong support of the Food
and Drug Administration Reform Act of 2012 (H.R. 5651), which will
strengthen Minnesota's health care system and economy.
The Food and Drug Administration Reform Act reauthorizes the FDA's
drug and medical device user fee programs at a critical time. If these
user fees are not reauthorized before the end of June, the FDA will not
have the funding it needs to ensure life-saving drugs and medical
devices are available to patients in a timely fashion. This bill also
accelerates approval of treatments to address rare diseases,
reauthorizes two successful pediatric programs, and helps to prevent
drug shortages that are affecting families across the country. Overall,
the reforms in H.R. 5651 bring the FDA into the 21st century by making
the agency more responsive to changes in the U.S. health care system
and better equipped to oversee a globalized market for medical
products. This legislation will deliver safer treatments, faster
innovation and better care for millions of American patients and
families.
This legislation is especially important for America's medical device
sector. The approval process for medical devices at the FDA slowed by
as much as 60 percent since 2005, according to the General
Accountability Office. While longer approval times do not contribute to
patient safety, they have delayed or even denied life-saving treatments
to patients and undermined the international competitiveness of the
U.S. medical device industry. There is general agreement that the
broken approval process for medical devices is doing real harm to
patients and workers. This is especially concerning for Minnesota
because our state is a hub of medical device innovation; the sector
employs thousands of highly-skilled workers in our state. H.R. 5651
reforms and reauthorizes the medical device user fee program through
fiscal year 2017, providing years of stability and increased regulatory
certainty for companies that range from local small business start-ups
to global Fortune 500 enterprises. Moreover, the bill will foster
innovation in the sector by speeding market access for new and improved
medical devices without compromising patient safety.
The Food and Drug Administration Reform Act is a rare bipartisan
success story. This legislation comes to the House floor after months
of close bipartisan collaboration. The Senate approved a bill very
similar to H.R. 5651 by a vote of 96 to 1. The House Energy and
Commerce Committee voted 46 to 0 to move H.R. 5651 to the floor. Both
Democratic and Republican members of Congress understand that a high-
quality health care system requires a strong and effective FDA. Today's
bill is a major step forward for the FDA and a demonstration of
legislative compromise for the good of the American people.
I urge all my colleagues to support H.R. 5651.
Mr. CHANDLER. Mr. Speaker, I rise today to address the significant
bipartisan effort to reauthorize FDA user fee legislation. This
reauthorization provides an opportunity to update the relevant FDA laws
to reflect changes and challenges in the important area of prescription
drugs and medical devices.
One critical area that Congress must continue to focus on is the
safety and security of the pharmaceutical supply chain. Counterfeit
drugs are a growing problem and put patient safety and health at risk.
Patients who rely on certain medications should not have to live in
fear they are not receiving the treatment they need because their
medicine has been compromised.
This is unacceptable, and we must work to find a national solution to
this growing problem of counterfeit drugs. Because so much of the
pharmaceutical supply chain relies on interstate commerce, I believe
our federal government must ensure that properly licensed entities are
involved in our national pharmaceutical supply chain, particularly
third-party logistics providers (3PLs).
The way prescription drugs are moved from the manufacturer to the
consumer has changed over the past several years with the emerging role
of 3PLs. These providers are not in the business of manufacturing,
buying, selling, or dispensing prescription drugs; they provide or
coordinate warehousing, distribution, or other services on behalf of
the manufacturer, wholesaler, or dispenser. We cannot realistically
expect to have a thorough and comprehensive national supply chain
track-and-trace system without providing for a clear and accurate
definition of third party logistics providers. Our federal laws need to
reflect this new reality.
I applaud the Chairman and Ranking Member of the Energy & Commerce
Committee for their leadership and diligent work on this bill, and I
encourage them to ensure that the final product from the House-Senate
conference implements a uniform federal serialization policy covering
all pharmaceutical supply chain participants.
Mr. PASCRELL. Mr. Speaker, I stand today to support H.R. 5651--Food
and Drug Administration Reform Act of 2012, which reauthorizes the
Federal Drug Administration's (FDA) prescription drug and medical
device user fee programs through 2017. This legislation will provide
the FDA the ability to collect user fees from drug and medical device
companies to help fund its reviews of their products. These user fee
programs provide the FDA the resources to enable the efficient review
of applications and give patients access to therapies at the earliest
possible time, and most importantly, help prevent drug shortages that
threaten public health.
I am supportive of the legislation because it will authorize a new
user fee program for generic drugs, resulting in decreased review
times, and it authorizes user fee program for biosimilars, thus
ensuring parity. Additionally, the legislation reauthorizes and makes
permanent two complementary pediatric drug programs, which foster the
development and safe use of prescription drugs for children.
Further, the legislation will assist in the modernization of the
FDA's global drug supply chain authority, resulting in improved safety
of our prescription drugs The legislation will also provide new
incentives for the development of antibiotics to address the public
health threat of antibiotic resistance. Finally, the bill includes
important provisions to help prevent and mitigate drug shortages, which
have unfortunately now become an all-too-frequent occurrence.
Ultimately, the legislation will ensure that Americans have access to
crucial medicines and medical devices, improves access to new and
innovative medicines and devices, helps prevent and mitigate drug
shortages and reduces drug costs for consumers by speeding the approval
of lower-cost generic drugs.
Mr. PAULSEN. Mr. Speaker, I rise today in strong support of H.R.
5651, the Food and Drug Administration Reform Act.
The United States has led the global medical device industry for
decades. This leadership has brought hundreds of thousands of high-
paying jobs to our country and life-saving, life-improving devices to
our nation's patients. U.S. medical device-related employment totals
over 2 million jobs, and these are good, rewarding jobs.
This legislation will streamline and modernize the medical device
approval process to make it more transparent, more consistent, and more
predictable. This much needed reform will help companies bring their
products to market quicker and cheaper, ultimately increasing patient
access to life improving and life saving technologies.
I would like to highlight one portion of the bill that was taken from
my legislation, the FDA REFORM Act. This provision would expand and
clarify the FDA's ability to use accredited third party reviewers for
low risk devices.
This will free up valuable resources and allow the FDA to function
more effectively while still focusing on protecting patient safety.
I want to thank Chairman Upton and his staff for their continued
support and effort on this matter. I urge adoption of this crucial
legislation that will help bring new products to market.
The SPEAKER pro tempore (Mr. Simpson). The question is on the motion
offered by the gentleman from Michigan (Mr. Upton) that the House
suspend the rules and pass the bill, H.R. 5651, as amended.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. PITTS. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further
proceedings on this question will be postponed.
____________________