[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3187 Placed on Calendar Senate (PCS)]
Calendar No. 400
112th CONGRESS
2d Session
S. 3187
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs and medical devices, to
establish user-fee programs for generic drugs and biosimilars, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 15, 2012
Mr. Harkin (for himself and Mr. Enzi) introduced the following bill;
which was read the first time
May 16, 2012
Read the second time and placed on the calendar
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs and medical devices, to
establish user-fee programs for generic drugs and biosimilars, and for
other purposes.
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 Safety
and Innovation Act''.
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.
(a) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title.
Sec. 2. Table of contents; 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--FEES RELATING TO DEVICES
Sec. 201. Short title; findings.
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 dates.
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 of the Food and Drug
Administration 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--PEDIATRIC DRUGS AND DEVICES
Sec. 501. Permanence.
Sec. 502. Written requests.
Sec. 503. Communication with Pediatric Review Committee.
Sec. 504. Access to data.
Sec. 505. Ensuring the completion of pediatric studies.
Sec. 506. Pediatric study plans.
Sec. 507. Reauthorizations.
Sec. 508. Report.
Sec. 509. Technical amendments.
Sec. 510. Relationship Between Pediatric Labeling and New Clinical
Investigation Exclusivity.
Sec. 511. Pediatric rare diseases.
TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS
Sec. 601. Reclassification procedures.
Sec. 602. Condition of approval studies.
Sec. 603. Postmarket surveillance.
Sec. 604. Sentinel.
Sec. 605. Recalls.
Sec. 606. Clinical holds on investigational device exemptions.
Sec. 607. Unique device identifier.
Sec. 608. Clarification of least burdensome standard.
Sec. 609. Custom devices.
Sec. 610. Agency documentation and review of certain decisions
regarding devices.
Sec. 611. Good guidance practices relating to devices.
Sec. 612. Modification of de novo application process.
Sec. 613. Humanitarian device exemptions.
Sec. 614. Reauthorization of third-party review and inspections.
Sec. 615. 510(k) device modifications.
Sec. 616. Health information technology.
TITLE VII--DRUG SUPPLY CHAIN
Sec. 701. Registration of domestic drug establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with product
listing.
Sec. 704. Electronic system for registration and listing.
Sec. 705. Risk-based inspection frequency.
Sec. 706. Records for inspection.
Sec. 707. Failure to allow foreign inspection.
Sec. 708. Exchange of information.
Sec. 709. Enhancing the safety and quality of the drug supply.
Sec. 710. Accreditation of third-party auditors for drug
establishments.
Sec. 711. Standards for admission of imported drugs.
Sec. 712. Notification.
Sec. 713. Protection against intentional adulteration.
Sec. 714. Enhanced criminal penalty for counterfeiting drugs.
Sec. 715. Extraterritorial jurisdiction.
Sec. 716. Compliance with international agreements.
TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW
Sec. 801. Extension of exclusivity period for drugs.
Sec. 802. Priority review.
Sec. 803. Fast track product.
Sec. 804. GAO study.
Sec. 805. Clinical trials.
Sec. 806. Regulatory certainty and predictability.
TITLE IX--DRUG APPROVAL AND PATIENT ACCESS
Sec. 901. Enhancement of accelerated patient access to new medical
treatments.
Sec. 902. Breakthrough therapies.
Sec. 903. Consultation with external experts on rare diseases, targeted
therapies, and genetic targeting of
treatments.
Sec. 904. Accessibility of information on prescription drug container
labels by visually-impaired and blind
consumers.
Sec. 905. Risk-benefit framework.
Sec. 906. Independent study on medical innovation inducement model.
Sec. 907. Orphan product grants program.
TITLE X--DRUG SHORTAGES
Sec. 1001. Drug shortages.
TITLE XI--OTHER PROVISIONS
Subtitle A--Reauthorizations
Sec. 1101. Reauthorization of provision relating to exclusivity of
certain drugs containing single
enantiomers.
Sec. 1102. Reauthorization of the Critical Path Public-Private
Partnerships.
Subtitle B--Medical Gas Product Regulation
Sec. 1111. Regulation of medical gas products.
Sec. 1112. Regulations.
Sec. 1113. Applicability.
Subtitle C--Miscellaneous Provisions
Sec. 1121. Advisory committee conflicts of interest.
Sec. 1122. Guidance document regarding product promotion using the
Internet.
Sec. 1123. Electronic submission of applications.
Sec. 1124. Combating prescription drug abuse.
Sec. 1125. Tanning bed labeling.
Sec. 1126. Optimizing global clinical trials.
Sec. 1127. Advancing regulatory science to promote public health
innovation.
Sec. 1128. Information technology.
Sec. 1129. Reporting requirements.
Sec. 1130. Strategic integrated management plan.
Sec. 1131. Drug development and bioequivalence testing.
Sec. 1132. Patient participation in medical product discussions.
(b) 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.
Paragraph (7) of section 735 (21 U.S.C. 379g) is amended, in the
matter preceding subparagraph (A), by striking ``incurred''.
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), in clauses (i) and (ii) of
subparagraph (A), by striking ``subsection (c)(5)''
each place such term appears and inserting ``subsection
(c)(4)'';
(C) in the matter following clause (ii) in
paragraph (2)(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 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''; and
(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 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.'';
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) 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);
``(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 matter preceding subparagraph
(A), by striking ``fiscal years 2008 through
2012'' and inserting ``fiscal years 2013
through 2017'';
(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 paragraph 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) in clause (i), by striking
``shall be retained'' and inserting
``subject to subparagraph (C), shall be
collected and available''; and
(II) in clause (ii), by striking
``shall only be collected and
available'' and inserting ``shall be
available''; and
(ii) 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)--
(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
though 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.--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 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. 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 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective
October 1, 2017.
(b) Reporting Requirements.--Section 736B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective
January 31, 2018.
(c) Previous Sunset Provision.--Section 106 of the Prescription
Drug User Fee Amendments of 2007 (Title I of Public Law 110-85) is
repealed.
(d) Technical Clarifications.--
(1) Effective September 30, 2007, section 509 of the
Prescription Drug User Fee Amendments Act of 2002 (Title V of
Public Law 107-188) is repealed.
(2) Effective September 30, 2002, section 107 of the Food
and Drug Administration Modernization Act of 1997 (Public Law
105-115) is repealed.
(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--FEES RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDINGS.
(a) Short Title.--This title 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)--
(i) by inserting ``and subsection (f)''
after ``subparagraph (B)''; and
(ii) by striking ``2008'' and inserting
``2013''; 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.--For purposes of paragraph (1), the
base fee amounts specified in this paragraph are as follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2013 Year 2014 Year 2015 Year 2016 Year 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);
(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) 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 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) by amending paragraph (3) 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) Reports.--Section 738A(a) (21 U.S.C. 379j-1(a)) is amended--
(1) by striking ``2008 through 2012'' each place it appears
and inserting ``2013 through 2017''; and
(2) by striking ``section 201(c) of the Food and Drug
Administration Amendments Act of 2007'' and inserting ``section
201(b) of the Medical Device User Fee Amendments of 2012''.
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 submissions described in section 738(a)(2)(A) of the Federal
Food, Drug, and Cosmetic Act (as in effect 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 submissions
described in section 738(a)(2)(A) of the Federal Food, Drug, and
Cosmetic Act received on or after October 1, 2012, regardless of the
date of the enactment of this Act.
SEC. 207. SUNSET DATES.
(a) Authorizations.--Sections 737 and 738 (21 U.S.C. 739i; 739j)
shall cease to be effective October 1, 2017.
(b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) shall
cease to be effective January 31, 2018.
(c) Previous Sunset Provision.--Section 217 of the Medical Device
User Fee Amendments of 2007 (Title II of Public Law 110-85) is
repealed.
(d) Technical Clarification.--Effective September 30, 2007, section
107 of the Medical Device User Fee and Modernization Act of 2002
(Public Law 107- 250) is repealed.
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), 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.
``(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 publish 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 publish
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 publish 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 publish
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 publish 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 publish 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 publish 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
``(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 Act, 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; or
``(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 publish 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 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, as 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.
``(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.--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.
``(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.--The amendments made by section 302 cease to be
effective October 1, 2017.
(b) Reporting Requirements.--The amendments made by section 303
cease to be effective 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 OF THE FOOD AND DRUG
ADMINISTRATION TO SUPPORT ACTIVITIES RELATED TO HUMAN
GENERIC DRUGS.
Section 714 of the Federal Food, Drug, and Cosmetic Act, as added
by section 208, is amended--
(1) in subsection (b)--
(A) by striking ``are activities'' and inserting
``are--
``(1) activities'';
(B) by striking the period at the end and inserting
``; and''; and
(C) by adding at the end the following:
``(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 performance goals with respect to section 744A
(regarding assessment and use of human generic drug fees), as
set forth in the letters described in section 301(b) of the
Generic Drug User Fee Amendments of 2012.''.
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, 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 described 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 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; 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 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, 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 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.--The amendment made by section 402 shall cease
to be effective October 1, 2017.
(b) Reporting Requirements.--The amendment made by section 403
shall cease to be effective 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--PEDIATRIC DRUGS AND DEVICES
SEC. 501. PERMANENCE.
(a) Pediatric Studies of Drugs.--Subsection (q) of section 505A (21
U.S.C. 355a) is amended--
(1) in the subsection heading, by striking ``Sunset'' and
inserting ``Permanence'';
(2) in paragraph (1), by striking ``on or before October 1,
2012,''; and
(3) in paragraph (2), by striking ``on or before October 1,
2012,''.
(b) Research Into Pediatric Uses for Drugs and Biological
Products.--Section 505B (21 U.S.C. 355c) is amended--
(1) by striking subsection (m); and
(2) by redesignating subsection (n) as subsection (m).
SEC. 502. WRITTEN REQUESTS.
(a) Federal Food, Drug, and Cosmetic Act.--Subsection (h) of
section 505A (21 U.S.C. 355a) is amended 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.''.
(b) Public Health Service Act.--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)''.
SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.
Not later than 1 year after the date of enactment of this Act, the
Secretary of Health and Human Services (referred to in this title as
the ``Secretary'') shall issue internal standard operating procedures
that provide for the review by the internal review committee
established under section 505C of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355d) of any significant modifications to initial
pediatric study plans, agreed initial pediatric study plans, and
written requests under sections 505A and 505B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355c). Such internal standard
operating procedures shall be made publicly available on the Internet
website of the Food and Drug Administration.
SEC. 504. ACCESS TO DATA.
Not later than 3 years after the date of enactment of this Act, the
Secretary shall make available to the public, including through posting
on the Internet website of the Food and Drug Administration, the
medical, statistical, and clinical pharmacology reviews of, and
corresponding written requests issued to an applicant, sponsor, or
holder for, pediatric studies submitted between January 4, 2002 and
September 27, 2007 under subsection (b) or (c) of section 505A of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6
months of market exclusivity was granted and that resulted in a
labeling change. The Secretary shall make public the information
described in the preceding sentence in a manner consistent with how the
Secretary releases information under section 505A(k) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).
SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC STUDIES.
(a) Extension of Deadline for Deferred Studies.--Section 505B (21
U.S.C. 355c) is amended--
(1) in subsection (a)(3)--
(A) by redesignating subparagraph (B) as
subparagraph (C);
(B) by inserting after subparagraph (A) the
following:
``(B) Deferral extension.--
``(i) In general.--On the initiative of the
Secretary or at the request of the applicant,
the Secretary may grant an extension of a
deferral approved under subparagraph (A) for
submission of some or all assessments required
under paragraph (1) if--
``(I) the Secretary determines that
the conditions described in subclause
(II) or (III) of subparagraph (A)(i)
continue to be met; and
``(II) the applicant submits a new
timeline under subparagraph (A)(ii)(IV)
and any significant updates to the
information required under subparagraph
(A)(ii).
``(ii) Timing and information.--If the
deferral extension under this subparagraph is
requested by the applicant, the applicant shall
submit the deferral extension request
containing the information described in this
subparagraph not less than 90 days prior to the
date that the deferral would expire. The
Secretary shall respond to such request not
later than 45 days after the receipt of such
letter. If the Secretary grants such an
extension, the specified date shall be the
extended date. The sponsor of the required
assessment under paragraph (1) shall not be
issued a letter described in subsection (d)
unless the specified or extended date of
submission for such required studies has passed
or if the request for an extension is pending.
For a deferral that has expired prior to the
date of enactment of the Food and Drug
Administration Safety and Innovation Act or
that will expire prior to 270 days after the
date of enactment of such Act, a deferral
extension shall be requested by an applicant
not later than 180 days after the date of
enactment of such Act. The Secretary shall
respond to any such request as soon as
practicable, but not later than 1 year after
the date of enactment of such Act. Nothing in
this clause shall prevent the Secretary from
updating the status of a study or studies
publicly if components of such study or studies
are late or delayed.''; and
(C) in subparagraph (C), as so redesignated--
(i) in clause (i), by adding at the end the
following:
``(III) Projected completion date
for pediatric studies.
``(IV) The reason or reasons why a
deferral or deferral extension
continues to be necessary.''; and
(ii) in clause (ii)--
(I) by inserting ``, as well as the
date of each deferral or deferral
extension, as applicable,'' after
``clause (i)''; and
(II) by inserting ``not later than
90 days after submission to the
Secretary or with the next routine
quarterly update'' after
``Administration''; and
(2) in subsection (f)--
(A) in the subsection heading, by inserting
``Deferral Extensions,'' after ``Deferrals,'';
(B) in paragraph (1), by inserting ``, deferral
extension,'' after ``deferral''; and
(C) in paragraph (4)--
(i) in the paragraph heading, by inserting
``deferral extensions,'' after ``deferrals,'';
and
(ii) by inserting ``, deferral
extensions,'' after ``deferrals''.
(b) Tracking of Extensions; Annual Information.--Section
505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as follows:
``(D) aggregated on an annual basis--
``(i) the total number of deferrals and
deferral extensions requested and granted under
this section and, if granted, the reasons for
each such deferral or deferral extension;
``(ii) the timeline for completion of the
assessments; and
``(iii) the number of assessments completed
and pending;''.
(c) Action on Failure to Complete Studies.--
(1) Issuance of letter.--Subsection (d) of section 505B (21
U.S.C. 355c) is amended to read as follows:
``(d) Submission of Assessments.--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), the following shall apply:
``(1) Beginning 270 days after the date of enactment of the
Food and Drug Administration Safety and Innovation Act, the
Secretary shall issue a non-compliance letter to such person
informing them of such failure to submit or meet the
requirements of the applicable subsection. Such letter shall
require the person to respond in writing within 45 calendar
days of issuance of such letter. Such response may include the
person's request for a deferral extension if applicable. Such
letter and the person's written response to such letter shall
be made publicly available on the Internet Web site of the Food
and Drug Administration 45 calendar days after issuance, with
redactions for any trade secrets and confidential commercial
information. If the Secretary determines that the letter was
issued in error, the requirements of this paragraph shall not
apply.
``(2) The drug or biological product that is the subject of
an assessment described in subsection (a)(2), applicable
requirements in subsection (a)(3), or 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 such failure shall
not be the basis for a proceeding--
``(A) to withdraw approval for a drug under section
505(e); or
``(B) to revoke the license for a biological
product under section 351 of the Public Health Service
Act.''.
(2) Tracking of letters issued.--Subparagraph (D) of
section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by
subsection (b), is further amended--
(A) in clause (ii), by striking ``; and'' and
inserting a semicolon;
(B) in clause (iii), by adding ``and'' at the end;
and
(C) by adding at the end the following:
``(iv) the number of postmarket non-
compliance letters issued pursuant to
subsection (d), and the recipients of such
letters;''.
SEC. 506. PEDIATRIC STUDY PLANS.
(a) In General.--Subsection (e) of section 505B (21 U.S.C. 355c) is
amended to read as follows:
``(e) Pediatric Study Plans.--
``(1) In general.--An applicant subject to subsection (a)
shall submit to the Secretary an initial pediatric study plan
prior to the submission of the assessments described under
subsection (a)(2).
``(2) Timing; content; meeting.--
``(A) Timing.--An applicant shall submit an initial
pediatric study plan to the Secretary not later than 60
calendar days after the date of the end of phase II
meeting or such other equivalent time agreed upon
between the Secretary and the applicant. Nothing in
this paragraph shall preclude the Secretary from
accepting the submission of an initial pediatric study
plan earlier than the date described under the
preceding sentence.
``(B) Content of initial plan.--The initial
pediatric study plan shall include--
``(i) an outline of the pediatric study or
studies that the applicant plans to conduct
(including, to the extent practicable study
objectives and design, age groups, relevant
endpoints, and statistical approach);
``(ii) any request for a deferral, partial
waiver, or waiver under this section, if
applicable, along with any supporting
information; and
``(iii) other information specified in the
regulations promulgated under paragraph (4).
``(C) Meeting.--The Secretary--
``(i) shall meet with the applicant to
discuss the initial pediatric study plan as
soon as practicable, but not later than 90
calendar days after the receipt of such plan
under subparagraph (A);
``(ii) may determine that a written
response to the initial pediatric study plan is
sufficient to communicate comments on the
initial pediatric study plan, and that no
meeting is necessary; and
``(iii) if the Secretary determines that no
meeting is necessary, shall so notify the
applicant and provide written comments of the
Secretary as soon as practicable, but not later
than 90 calendar days after the receipt of the
initial pediatric study plan.
``(3) Agreed initial pediatric study plan.--Not later than
90 calendar days following the meeting under paragraph
(2)(C)(i) or the receipt of a written response from the
Secretary under paragraph (2)(C)(iii), the applicant shall
document agreement on the initial pediatric study plan in a
submission to the Secretary marked `Agreed Initial Pediatric
Study Plan', and the Secretary shall confirm such agreement to
the applicant in writing not later than 30 calendar days of
receipt of such agreed initial pediatric study plan.
``(4) Deferral and waiver.--If the agreed initial pediatric
study plan contains a request from the applicant for a
deferral, partial waiver, or waiver under this section, the
written confirmation under paragraph (3) shall include a
recommendation from the Secretary as to whether such request
meets the standards under paragraphs (3) or (4) of subsection
(a).
``(5) Amendments to the plan.--At the initiative of the
Secretary or the applicant, the agreed initial pediatric study
plan may be amended at any time. The requirements of paragraph
(2)(C) shall apply to any such proposed amendment in the same
manner and to the same extent as such requirements apply to an
initial pediatric study plan under paragraph (1). The
requirements of paragraphs (3) and (4) 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 study plan.
``(6) Internal committee.--The Secretary shall consult the
internal committee under section 505C on the review of the
initial pediatric study plan, agreed initial pediatric plan,
and any significant amendments to such plans.
``(7) Required rulemaking.--Not later than 1 year after the
date of enactment of the Food and Drug Administration Safety
and Innovation Act, the Secretary shall promulgate proposed
regulations and issue proposed guidance to implement the
provisions of this subsection.''.
(b) Conforming Amendments.--Section 505B (21 U.S.C. 355c)is
amended--
(1) by amending subclause (II) of subsection (a)(3)(A)(ii)
to read as follows:
``(II) a pediatric study plan as
described in subsection (e);''; and
(2) in subsection (f)--
(A) in the subsection heading, by striking
``pediatric Plans,'' and inserting ``pediatric Study
Plans,'';
(B) in paragraph (1), by striking ``all pediatric
plans'' and inserting ``initial pediatric study plans,
agreed initial pediatric study plans,''; and
(C) in paragraph (4)--
(i) in the paragraph heading, by striking
``pediatric Plans,'' and inserting ``pediatric
Study Plans,''; and
(ii) by striking ``pediatric plans'' and
inserting ``initial pediatric study plans,
agreed initial pediatric study plans,''.
(c) Effective Dates.--
(1) Pediatric study plans.--Subsection (e) of section 505B
of the Federal Food, Drug, and Cosmetic Act (other than
paragraph (4) of such subsection), as amended by subsection
(a), shall take effect 180 days after the date of enactment of
this Act, without regard to whether the Secretary has
promulgated final regulations under paragraph (4) of such
subsection by such date.
(2) Conforming amendments.--The amendments made by
subsection (b) shall take effect 180 days after the date of
enactment of this Act.
SEC. 507. REAUTHORIZATIONS.
(a) Pediatric Advisory Committee.--Section 14(d) of the Best
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended by
striking ``Notwithstanding section 14 of the Federal Advisory Committee
Act, the advisory committee shall continue to operate during the five-
year period beginning on the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007'' and inserting ``Section 14
of the Federal Advisory Committee Act shall not apply to the advisory
committee''.
(b) Pediatric Subcommittee of the Oncologic Drugs Advisory
Committee.--Section 15(a)(3) 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 ``for the
duration of the operation of the Oncologic Drugs Advisory Committee''.
(c) Humanitarian Device Exemption Extension.--Section
520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360j(m)(6)(A)(iv)) is amended by striking ``2012'' and inserting
``2017''.
(d) Demonstration Grants to Improve Pediatric Device
Availability.--Section 305(e) of Pediatric Medical Device Safety and
Improvement Act (Public Law 110-85; 42 U.S.C. 282 note)) is amended by
striking ``$6,000,000 for each of fiscal years 2008 through 2012'' and
inserting ``$4,500,000 for each of fiscal years 2013 through 2017''.
(e) Program for Pediatric Study of Drugs in PHSA.--Section
409I(e)(1) of the Public Health Service Act (42 U.S.C. 284m(e)(1)) is
amended by striking ``to carry out this section'' and all that follows
through the end of paragraph (1) and inserting ``to carry out this
section $25,000,000 for each of fiscal years 2012 through 2017.''.
SEC. 508. REPORT.
(a) In General.--Not later than October 31, 2016, and at the end of
each subsequent 5-year period, the Secretary shall submit to Congress a
report that evaluates the effectiveness of sections 505A and 505B of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and
section 409I of the Public Health Service Act (42 U.S.C. 284m) in
ensuring that medicines used by children are tested in pediatric
populations and properly labeled for use in children.
(b) Contents.--The report under subsection (a) shall include--
(1) the number and importance of drugs and biological
products for children for which studies have been requested or
required (as of the date of such report) under 505A and 505B of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c)
and section 409I of the Public Health Service Act (42 U.S.C.
284m), including--
(A) the number of labeling changes made to drugs
and biological products pursuant to such sections since
the date of enactment of this Act; and
(B) the importance of such drugs and biological
products in the improvement of the health of children;
(2) the number of required studies under such section 505B
that have not met the initial deadline provided under such
section, including--
(A) the number of deferrals and deferral extensions
granted and the reasons such extensions were granted;
(B) the number of waivers and partial waivers
granted; and
(C) the number of letters issued under subsection
(d) of such section 505B;
(3) the number of written requests issued, declined, and
referred to the National Institutes of Health under such
section 505A since the date of enactment of this Act (including
the reasons for such declination), and a description and status
of referrals made under subsection (n) of such section 505A;
(4) the number of proposed pediatric study plans submitted
and agreed to as identified in the marketing application under
such section 505B;
(5) any labeling changes recommended by the Pediatric
Advisory Committee as a result of the review by such Committee
of adverse events reports;
(6) the number and current status of pediatric
postmarketing requirements;
(7) the number and importance of drugs and biological
products for children that are not being tested for use in
pediatric populations, notwithstanding the existence of the
programs under such sections 505A and 505B and section 409I of
the Public Health Service Act;
(8) the possible reasons for the lack of testing reported
under paragraph (7);
(9) the number of drugs and biological products for which
testing is being done (as of the date of the report) and for
which a labeling change is required under the programs
described in paragraph (7), including--
(A) the date labeling changes are made;
(B) which labeling changes required the use of the
dispute resolution process; and
(C) for labeling changes that required such dispute
resolution process, a description of--
(i) the disputes;
(ii) the recommendations of the Pediatric
Advisory Committee; and
(iii) the outcomes of such process; and
(D) an assessment of the effectiveness in improving
information about pediatric uses of drugs and
biological products;
(10)(A) the efforts made by the Secretary to increase the
number of studies conducted in the neonatal population
(including efforts made to encourage the conduct of appropriate
studies in neonates by companies with products that have
sufficient safety and other information to make the conduct of
the studies ethical and safe); and
(B) the results of such efforts;
(11)(A) the number and importance of drugs and biological
products for children with cancer that are being tested as a
result of the programs described in paragraph (7); and
(B) any recommendations for modifications to such programs
that would lead to new and better therapies for children with
cancer, including a detailed rationale for each recommendation;
(12) an assessment of progress made in addressing the
recommendations and findings of any prior report issued by the
Comptroller General, the Institute of Medicine, or the
Secretary regarding the topics addressed in the report under
this section, including with respect to--
(A) improving public access to information from
pediatric studies conducted under such sections 505A
and 505B; and
(B) improving the timeliness of pediatric studies
and pediatric study planning under such sections 505A
and 505B;
(13) any recommendations for modification to the programs
that would improve pediatric drug research and increase
pediatric labeling of drugs and biological products; and
(14) an assessment of the successes of and limitations to
studying drugs for rare diseases under such sections 505A and
505B.
(c) Consultation on Recommendations.--At least 180 days before the
report is due under subsection (a), and no sooner than 4 years after
the date of enactment of this Act, the Secretary shall consult with
representatives of patient groups, including pediatric patient groups,
consumer groups, regulated industry, scientific and medical
communities, academia, and other interested parties to obtain any
recommendations or information relevant to the effectiveness of the
programs described in subsection (b)(7), including suggestions for
modifications to such programs.
SEC. 509. TECHNICAL AMENDMENTS.
(a) Pediatric Studies of Drugs in FFDCA.--Section 505A (21 U.S.C.
355a) is amended--
(1) in subsection (k)(2), by striking ``subsection
(f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
(2) in subsection (n)--
(A) in the subsection heading, by striking
``completed'' and inserting ``submitted''; and
(B) in paragraph (1)--
(i) in the matter preceding subparagraph
(A), by striking ``have not been completed''
and inserting ``have not been submitted by the
date specified in the written request issued or
if the applicant or holder does not agree to
the request'';
(ii) in subparagraph (A)--
(I) in the first sentence, by
inserting ``, or for which a period of
exclusivity eligible for extension
under subsection (b)(1) or (c)(1) of
this section or under subsection (m)(2)
or (m)(3) of section 351 of the Public
Health Service Act has not ended''
after ``expired''; and
(II) by striking ``Prior to'' and
all that follows through the period at
the end; and
(iii) in subparagraph (B), by striking ``no
listed patents or has 1 or more listed patents
that have expired,'' and inserting ``no
unexpired listed patents and for which no
unexpired periods of exclusivity eligible for
extension under subsection (b)(1) or (c)(1) of
this section or under subsection (m)(2) or
(m)(3) of section 351 of the Public Health
Service Act apply,''; and
(3) in subsection (o)(2), by amendment 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.''.
(b) 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)--
(i) in the matter preceding subparagraph
(A), by inserting ``for a drug'' after ``(or
supplement to an application)'';
(ii) in subparagraph (A), by striking ``for
a'' and inserting ``, including, with respect
to a drug, an application (or supplement to an
application) for a'';
(iii) in subparagraph (B), by striking
``for a'' and inserting ``, including, with
respect to a drug, an application (or
supplement to an application) for a''; and
(iv) in the matter following subparagraph
(B), by inserting ``(or supplement)'' after
``application''; and
(B) 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'' and inserting ``such a'';
(2) in subsection (b)(1), in the matter preceding
subparagraph (A), by striking ``After providing notice'' and
all that follows through ``studies), the'' and inserting
``The'';
(3) in subsection (g)--
(A) in paragraph (1)(A), by inserting ``that
receives a priority review or 330 days after the date
of the submission of an application or supplement that
receives a standard review'' after ``after the date of
the submission of the application or supplement''; and
(B) in paragraph (2), by striking ``the label of
such product'' and inserting ``the labeling of such
product''; and
(4) in subsection (h)(1)--
(A) by inserting ``an application (or supplement to
an application) that contains'' after ``date of
submission of''; and
(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,''.
(c) Internal Review Committee.--The heading of section 505C (21
U.S.C. 355d) is amended by inserting ``and deferral extensions'' after
``deferrals''.
(d) 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 paragraph (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) there remains no patent listed pursuant to
section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act, and 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''; and
(2) in paragraph (2)--
(A) in the paragraph heading, by striking ``for
drugs lacking exclusivity''; and
(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''.
(e) Pediatric Subcommittee of the Oncologic 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
in paragraph (1)(D), by striking ``section 505B(f)'' and inserting
```section 505C'''.
(f) Foundation of National Institutes of Health.--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) 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 title to such a provision applies beginning on the date of
the enactment of this Act.
SEC. 510. RELATIONSHIP BETWEEN PEDIATRIC LABELING AND NEW CLINICAL
INVESTIGATION EXCLUSIVITY.
(a) In General.--Section 505 (21 U.S.C. 351) is amended by adding
at the end the following:
``(w) Relationship Between Pediatric Labeling and New Clinical
Investigation Exclusivity.--The period of market exclusivity described
in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and
(iv) of subsection (j)(5)(F) shall not apply to a pediatric study
conducted under section 505A or 505B that results, pursuant to section
505B(g)(2), in the inclusion in the labeling of the product a
determination that the product is not indicated for use in pediatric
populations or subpopulations or information indicating that the
results of a study were inconclusive or did not demonstrate that the
product is safe or effective in pediatric populations or
subpopulations.''.
(b) Pediatric Studies of Drugs.--Section 505A(m) (21 U.S.C.
355a(m)) is amended--
(1) by striking ``(m) Clarification of Interaction of
Market Exclusivity Under This Section and Market Exclusivity
Awarded to An Applicant for Approval of A Drug Under Section
505(j).--If a'' and all that follows through the end of the
matter that precedes paragraph (1) and inserting the following:
``(m) Clarification of Interaction of Market Exclusivity Under This
Section and Market Exclusivity Awarded to An Application or Supplement
Under Subsection (c) or (j) of Section 505.--
``(1) 180-day exclusivity period.--If a 180-day period
under section 505(j)(5)(B)(iv) overlaps with a 6-month
exclusivity period under this section, so that the applicant
for approval of a drug under section 505(j) entitled to the
180-day period under that section loses a portion of the 180-
day period to which the applicant is entitled for the drug, the
180-day period shall be extended from--'';
(2) by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B) and moving such subparagraphs, as so
redesignated, 2 ems to the right; and
(3) by adding at the end the following:
``(2) 3-year exclusivity period.--The 3-year period of
exclusivity under clauses (iii) and (iv) of subsection
505(c)(3)(E) and clauses (iii) and (iv) of subsection
505(j)(5)(F) are not available for approval of applications or
supplements to applications based on reports of pediatric
studies conducted under sections 505A or 505B that resulted,
pursuant to section 505A(j) or 505B(g)(2), in the inclusion in
the labeling of the product a determination that the product is
not indicated for use in pediatric populations or
subpopulations or information indicating that the results of an
assessment were inconclusive or did not demonstrate that the
product is safe or effective in pediatric populations or
subpopulation.''.
(c) Prompt Approval of Drugs.--Section 505A(o) (21 U.S.C. 355a(o))
is amended--
(1) in the heading, by striking ``section 505(j)'' and
inserting ``subsections (c) and (j) of Section 505'';
(2) in paragraph (1), by striking ``under section 505(j)''
and inserting ``under subsection (b)(2), (c), or (j) of section
505'';
(3) in paragraph (2), in the matter preceding subparagraph
(A), by inserting ``clauses (iii) and (iv) of section
505(c)(3)(E) or'' after ``Notwithstanding''; and
(4) in paragraph (3)--
(A) in subparagraph (B), by inserting ``that differ
from adult formulations'' before the semicolon at the
end; and
(B) in subparagraph (C)--
(i) by striking ``under section 505(j)''
and inserting ``under subsection (c) or (j) of
section 505''; and
(ii) by inserting ``clauses (iii) or (iv)
of section 505(c)(3)(E) or'' after
``exclusivity under''.
SEC. 511. PEDIATRIC RARE DISEASES.
(a) Public Meeting.--Not later than 18 months after the date of
enactment of this Act, the Secretary shall hold a public meeting to
discuss ways to encourage and accelerate the development of new
therapies for pediatric rare diseases.
(b) Report.--Not later than 180 days after the date of the public
meeting under subsection (a), the Secretary shall issue a report that
includes a strategic plan for encouraging and accelerating the
development of new therapies for treating pediatric rare diseases.
TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS
SEC. 601. RECLASSIFICATION PROCEDURES.
(a) Classification Changes.--
(1) In general.--Section 513(e)(1) (21 U.S.C. 360c(e)(1))
is amended to read as follows:
``(e)(1)(A) Based on new information respecting a device, the
Secretary may, upon the initiative of the Secretary or upon petition of
an interested person, change the classification of such device, and
revoke, on account of the change in classification, any regulation or
requirement in effect under section 514 or 515 with respect to such
device, by administrative order published in the Federal Register
following publication of a proposed reclassification order in the
Federal Register, a meeting of a device classification panel described
in subsection (b), and consideration of comments to a public docket,
notwithstanding subchapter II of Chapter 5 of title 5 of the United
States Code. An order under this subsection changing the classification
of a device from class III to class II may provide that such
classification shall not take effect until the effective date of a
performance standard established under section 514 for such device.
``(B) Authority to issue such administrative order shall not be
delegated below the Commissioner. The Commissioner shall issue such an
order as proposed by the Director of the Center for Devices and
Radiological Health unless the Commissioner, in consultation with the
Office of the Secretary of Health and Human Services, concludes that
the order exceeds the legal authority of the Food and Drug
Administration or that the order would be lawful, but unlikely to
advance the public health.''.
(2) Technical and conforming amendments.--
(A) Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is
amended by striking ``regulation promulgated'' and
inserting ``an order issued''.
(B) Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is
amended by striking ``under a regulation under section
513(e) but such regulation'' and inserting ``under an
administrative order under section 513(e) (or a
regulation promulgated under such section prior to the
date of enactment of the Food and Drug Administration
Safety and Innovation Act) but such order (or
regulation)'';
(C) Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is
amended by striking ``or changing the classification of
a device to class I'' and inserting ``, an
administrative order changing the classification of a
device to class I,''.
(3) Devices reclassified prior to the date of enactment of
this act.--
(A) In general.--The amendments made by this
subsection shall have no effect on a regulation
promulgated with respect to the classification of a
device under section 513(e) of the Federal Food, Drug,
and Cosmetic Act prior to the date of enactment of this
Act.
(B) Applicability of other provisions.--In the case
of a device reclassified under section 513(e) of the
Federal Food, Drug, and Cosmetic Act by regulation
prior to the date of enactment of this Act, section
517(a)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360g(a)(1)) shall apply to such regulation
promulgated under section 513(e) of such Act with
respect to such device in the same manner such section
517(a)(1) applies to an administrative order issued
with respect to a device reclassified after the date of
enactment of this Act.
(b) Devices Marketed Before May 28, 1976.--
(1) Premarket approval.--Section 515 (21 U.S.C. 360e) is
amended--
(A) in subsection (a), by striking ``regulation
promulgated under subsection (b)'' and inserting ``an
order issued under subsection (b) (or a regulation
promulgated under such subsection prior to the date of
enactment of the Food and Drug Administration Safety
and Innovation Act)'';
(B) in subsection (b)--
(i) in paragraph (1)--
(I) in the heading, by striking
``Regulation'' and inserting ``Order'';
and
(II) in the matter following
subparagraph (B)--
(aa) by striking ``by
regulation, promulgated in
accordance with this
subsection'' and inserting ``by
administrative order following
publication of a proposed order
in the Federal Register, a
meeting of a device
classification panel described
in section 513(b), and
consideration of comments from
all affected stakeholders,
including patients, payors, and
providers, notwithstanding
subchapter II of chapter 5 of
title 5, United States Code'';
and
(bb) by adding at the end
the following:
``Authority to issue such administrative order shall not be delegated
below the Commissioner. Before publishing such administrative order,
the Commissioner shall consult with the Office of the Secretary. The
Commissioner shall issue such an order as proposed by the Director of
the Center for Devices and Radiological Health unless the Commissioner,
in consultation with the Office of the Secretary, concludes that the
order exceeds the legal authority of the Food and Drug Administration
or that the order would be lawful, but unlikely to advance the public
health.'';
(ii) in paragraph (2)--
(I) by striking subparagraph (B);
and
(II) in subparagraph (A)--
(aa) by striking ``(2)(A) A
proceeding for the promulgation
of a regulation under paragraph
(1) respecting a device shall
be initiated by the publication
in the Federal Register of a
notice of proposed rulemaking.
Such notice shall contain--''
and inserting ``(2) A proposed
order required under paragraph
(1) shall contain--'';
(bb) by redesignating
clauses (i) through (iv) as
subparagraphs (A) through (D),
respectively;
(cc) in subparagraph (A),
as so redesignated, by striking
``regulation'' and inserting
``order''; and
(dd) in subparagraph (C),
as so redesignated, by striking
``regulation'' and inserting
``order'';
(iii) in paragraph (3)--
(I) by striking ``proposed
regulation'' each place such term
appears and inserting ``proposed
order'';
(II) by striking ``paragraph (2)
and after'' and inserting ``paragraph
(2),'';
(III) by inserting ``and a meeting
of a device classification panel
described in section 513(b),'' after
``such proposed regulation and
findings,'';
(IV) by striking ``(A) promulgate
such regulation'' and inserting ``(A)
issue an administrative order under
paragraph (1)'';
(V) by striking ``paragraph
(2)(A)(ii)'' and inserting ``paragraph
(2)(B)''; and
(VI) by striking ``promulgation of
the regulation'' and inserting
``issuance of the administrative
order''; and
(iv) by striking paragraph (4); and
(C) in subsection (i)--
(i) in paragraph (2)--
(I) in the matter preceding
subparagraph (A)--
(aa) by striking ``December
1, 1995'' and inserting ``the
date that is 2 years after the
date of enactment of the Food
and Drug Administration Safety
and Innovation Act''; and
(bb) by striking ``publish
a regulation in the Federal
Register'' and inserting
``issue an administrative order
following publication of a
proposed order in the Federal
Register, a meeting of a device
classification panel described
in section 513(b), and
consideration of comments from
all affected stakeholders,
including patients, payors, and
providers, notwithstanding
subchapter II of chapter 5 of
title 5, United States Code,'';
(II) in subparagraph (B), by
striking ``final regulation has been
promulgated under section 515(b)'' and
inserting ``administrative order has
been issued under subsection (b) (or no
regulation has been promulgated under
such subsection prior to the date of
enactment of the Food and Drug
Administration Safety and Innovation
Act)'';
(III) in the matter following
subparagraph (B), by striking
``regulation requires'' and inserting
``administrative order issued under
this paragraph requires''; and
(IV) by striking the third and
fourth sentences; and
(ii) in paragraph (3)--
(I) by striking ``regulation
requiring'' each place such term
appears and inserting ``order
requiring''; and
(II) by striking ``promulgation of
a section 515(b) regulation'' and
inserting ``issuance of an
administrative order under subsection
(b)''.
(2) Technical and conforming amendments.--Section 501(f)
(21 U.S.C. 351(f)) is amended--
(A) in subparagraph (1)(A)--
(i) in subclause (i), by striking ``a
regulation promulgated'' and inserting ``an
order issued''; and
(ii) in subclause (ii), by striking
``promulgation of such regulation'' and
inserting ``issuance of such order'';
(B) in subparagraph (2)(B)--
(i) by striking ``a regulation
promulgated'' and inserting ``an order
issued''; and
(ii) by striking ``promulgation of such
regulation'' and inserting ``issuance of such
order''; and
(C) by adding at the end the following:
``(3) In the case of a device with respect to which a regulation
was promulgated under section 515(b) prior to the date of enactment of
the Food and Drug Administration Safety and Innovation Act, a reference
in this subsection to an order issued under section 515(b) shall be
deemed to include such regulation.''.
(3) Approval by regulation prior to the date of enactment
of this act.--The amendments made by this subsection shall have
no effect on a regulation that was promulgated prior to the
date of enactment of this Act requiring that a device have an
approval under section 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e) of an application for premarket
approval.
(c) Reporting.--The Secretary of Health and Human Services shall
annually post on the Internet web site of the Food and Drug
Administration--
(1) the number and type of class I and class II devices
reclassified as class II or class III in the previous calendar
year under section 513(e)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(e)(1));
(2) the number and type of class II and class III devices
reclassified as class I or class II in the previous calendar
year under such section 513(e)(1); and
(3) the number and type of devices reclassified in the
previous calendar year under section 515 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360e).
SEC. 602. CONDITION OF APPROVAL STUDIES.
Section 515(d)(1)(B)(ii) (21 U.S.C. 360e(d)(1)(B)(ii)) is amended--
(1) by striking ``(ii)'' and inserting ``(ii)(I)''; and
(2) by adding at the end the following:
``(II) An order approving an application for a device may require
as a condition to such approval that the applicant conduct a postmarket
study regarding the device.''.
SEC. 603. POSTMARKET SURVEILLANCE.
Section 522 (21 U.S.C. 360l) is amended--
(1) in subsection (a)(1)(A), in the matter preceding clause
(i), by inserting ``, at the time of approval or clearance of a
device or at any time thereafter,'' after ``by order''; and
(2) in subsection (b)(1), by inserting ``The manufacturer
shall commence surveillance under this section not later than
15 months after the day on which the Secretary issues an order
under this section.'' after the second sentence.
SEC. 604. SENTINEL.
Section 519 (21 U.S.C. 360i) is amended by adding at the end the
following:
``(h) Inclusion of Devices in the Postmarket Risk Identification
and Analysis System.--
``(1) In general.--
``(A) Application to devices.--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.
``(B) Exception.--Subclause (II) of clause (i) of
section 505(k)(3)(C) shall not apply to devices.
``(C) Clarification.--With respect to devices, the
private sector health-related electronic data provided
under section 505(k)(3)(C)(i)(III)(bb) may include
medical device utilization data, health insurance
claims data, and procedure and device registries.
``(2) Data.--In expanding the system as described in
paragraph (1)(A), the Secretary shall use relevant data with
respect to devices cleared under section 510(k) or approved
under section 515, including claims data, patient survey data,
and any other data deemed appropriate by the Secretary.
``(3) Stakeholder input.--To help ensure effective
implementation of the system described in paragraph (1)(A), the
Secretary shall engage outside stakeholders in development of
the system through a public hearing, advisory committee
meeting, public docket, or other like public measures, as
appropriate.
``(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 for devices.''.
SEC. 605. RECALLS.
(a) Assessment of Device Recall Information.--
(1) In general.--
(A) Assessment program.--The Secretary of Health
and Human Services (referred to in this section as the
``Secretary'') shall enhance the Food and Drug
Administration's recall program to routinely and
systematically assess--
(i) information submitted to the Secretary
pursuant to a device recall order under section
518(e) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360h(e)); and
(ii) information required to be reported to
the Secretary regarding a correction or removal
of a device under section 519(g) of such Act
(21 U.S.C. 360i(g)).
(B) Use.--The Secretary shall use the assessment of
information described under subparagraph (A) to
proactively identify strategies for mitigating health
risks presented by defective or unsafe devices.
(2) Design.--The program under paragraph (1) shall, at a
minimum, identify--
(A) trends in the numbers and types of device
recalls;
(B) the types of devices in each device class that
are most frequently recalled;
(C) the causes of device recalls; and
(D) any other information as the Secretary
determines appropriate.
(b) Audit Check Procedures.--The Secretary shall clarify procedures
for conducting device recall audit checks to improve the ability of
investigators to perform these checks in a consistent manner.
(c) Assessment Criteria.--The Secretary shall develop explicit
criteria for assessing whether a person subject to a recall order under
section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360h(e)) or to a requirement under section 519(g) of such Act (21
U.S.C. 360i(g)) has performed an effective recall under such section
518(e) or an effective correction or removal action under such section
519(g), respectively.
(d) Termination of Recalls.--The Secretary shall document the basis
for the termination by the Food and Drug Administration of--
(1) an individual device recall ordered under section
518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360h(e)); and
(2) any correction or removal action for which a report is
required to be submitted to the Secretary under section 519(g)
of such Act (21 U.S.C. 360i(g)).
SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE EXEMPTIONS.
Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end
the following:
``(8)(A) At any time, the Secretary may prohibit the sponsor of an
investigation from conducting the investigation (referred to in this
paragraph as a `clinical hold') if the Secretary makes a determination
described in subparagraph (B). The Secretary shall specify the basis
for the clinical hold, including the specific information available to
the Secretary which served as the basis for such clinical hold, and
confirm such determination in writing.
``(B) For purposes of subparagraph (A), a determination described
in this subparagraph with respect to a clinical hold is a determination
that--
``(i) the device involved represents an unreasonable risk
to the safety of the persons who are the subjects of the
clinical investigation, taking into account the qualifications
of the clinical investigators, information about the device,
the design of the clinical investigation, the condition for
which the device is to be investigated, and the health status
of the subjects involved; or
``(ii) the clinical hold should be issued for such other
reasons as the Secretary may by regulation establish.
``(C) Any written request to the Secretary from the sponsor of an
investigation that a clinical hold be removed shall receive a decision,
in writing and specifying the reasons therefor, within 30 days after
receipt of such request. Any such request shall include sufficient
information to support the removal of such clinical hold.''.
SEC. 607. UNIQUE DEVICE IDENTIFIER.
Section 519(f) (21 U.S.C. 360i(f)) is amended--
(1) by striking ``The Secretary shall promulgate'' and
inserting ``Not later than December 31, 2012, the Secretary
shall issue proposed''; and
(2) by adding at the end the following: ``The Secretary
shall finalize the proposed regulations not later than 6 months
after the close of the comment period and shall implement the
final regulations with respect to devices that are implantable,
life-saving, and life sustaining not later than 2 years after
the regulations are finalized.''.
SEC. 608. 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. 609. CUSTOM DEVICES.
Section 520(b) (21 U.S.C. 360j(b)) 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 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 created or
modified as described in paragraph (1) notifies the
Secretary on an annual basis, in a manner prescribed by
the Secretary, of the manufacture of such device.
``(3) Exception.--Paragraph (1) shall not apply to oral
facial devices.
``(4) 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. 610. AGENCY DOCUMENTATION AND REVIEW OF CERTAIN DECISIONS
REGARDING DEVICES.
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after
section 517 the following:
``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF CERTAIN DECISIONS
REGARDING DEVICES.
``(a) Documentation of Rationale for Denial.--If the Secretary
renders a final decision to deny clearance of a premarket notification
under section 510(k) or approval of a premarket application under
section 515, or when the Secretary disapproves an application for an
investigational exemption under 520(g), the written correspondence to
the applicant communicating that decision shall provide a substantive
summary of the scientific and regulatory rationale for the decision.
``(b) Review of Denial.--
``(1) In general.--A person who has submitted a report
under section 510(k), an application under section 515, or an
application for an exemption under section 520(g) and for whom
clearance of the report or approval of the application is
denied may request a supervisory review of the decision to deny
such clearance or approval. Such review shall be conducted by
an individual at the organizational level above the
organization level at which the decision to deny the clearance
of the report or approval of the application is made.
``(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
denial 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 involve consultation with experts outside
of the Food and Drug Administration, or in cases in
which the sponsor seeks to introduce evidence not
already in the administrative record at the time the
denial decision was made.''.
SEC. 611. GOOD GUIDANCE PRACTICES RELATING TO DEVICES.
Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1)) is
amended--
(1) by striking ``(C) For guidance documents'' and
inserting ``(C)(i) For guidance documents''; and
(2) by adding at the end the following:
``(ii) With respect to devices, if a notice to industry
guidance letter, a notice to industry advisory letter, or any
similar notice sets forth initial interpretations of a
regulation or policy or sets forth changes in interpretation or
policy, such notice shall be treated as a guidance document for
purposes of this subparagraph.''.
SEC. 612. MODIFICATION OF DE NOVO APPLICATION PROCESS.
(a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2)) is
amended--
(1) by redesignating subparagraphs (B) and (C) as
subparagraphs (C) and (D), respectively;
(2) by amending subparagraph (A) to read as follows:
``(A) In the case of a type of device that has not previously been
classified under this Act, a person may do one of the following:
``(i) Submit a report under section 510(k), and, if the
device is classified into class III under paragraph (1), such
person may request, not later than 30 days after receiving
written notice of such a classification, the Secretary to
classify the device under the criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1). The person
may, in the request, recommend to the Secretary a
classification for the device. Any such request shall describe
the device and provide detailed information and reasons for the
recommended classification.
``(ii) Submit a request for initial classification of the
device under this subparagraph, if the person declares that
there is no legally marketed device upon which to base a
substantial equivalence determination as that term is defined
in subsection (i). Subject to subparagraph (B), the Secretary
shall classify the device under the criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1). 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. Requests under this clause shall be
subject to the electronic copy requirements of section
745A(b).'';
(3) by inserting after subparagraph (A) the following:
``(B) The Secretary may decline to undertake a classification
request submitted under clause (2)(A)(ii) if the Secretary identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence under paragraph (1), or when the
Secretary determines that the device submitted is not of low-moderate
risk or that general controls would be inadequate to control the risks
and special controls to mitigate the risks cannot be developed.''; and
(4) in subparagraph (C), as so redesignated--
(A) in clause (i), by striking ``Not later than 60
days after the date of the submission of the request
under subparagraph (A),'' and inserting ``Not later
than 120 days after the date of the submission of the
request under subparagraph (A)(i) or 150 days after the
date of the submission of the request under
subparagraph (A)(ii),''; and
(B) in clause (ii), by inserting ``or is classified
in'' after ``remains in''.
(b) GAO Report.--Not later than 2 years after the date of enactment
of this Act, the Comptroller General of the United States shall
complete a study and submit to Congress a report on the effectiveness
of the review pathway under section 513(f)(2)(A) of the Federal Food,
Drug, and Cosmetic Act, as amended by this Act.
(c) Conforming Amendment.--Section 513(f)(1)(B) (21 U.S.C.
360c(f)(1)(B)) is amended by inserting ``a request under paragraph (2)
or'' after ``response to''.
SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS.
(a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (6)--
(A) in subparagraph (A)--
(i) 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.''; and
(ii) 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 annual distribution number
for such device. In this paragraph, the term `annual
distribution number' means the number of such devices
reasonably needed to treat, diagnose, or cure a population of
4,000 individuals in the United States. The Secretary shall
determine the annual distribution number when the Secretary
grants such exemption.''; and
(B) by amending subparagraph (C) to read as
follows:
``(C) A person may petition the Secretary to modify the annual
distribution number determined by the Secretary under subparagraph
(A)(ii) with respect to a device if additional information arises, and
the Secretary may modify such annual distribution number.'';
(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 section 520(m)(6)(A)(i) (as amended by
subsection (a)). If the Secretary of Health and Human Services
determines that such subclause (I) or (II) applies with respect to a
device, clauses (ii), (iii), and (iv) of subparagraph (A) and
subparagraphs (B), (C), (D), and (E) of paragraph (6) of such section
520(m) shall apply to such device, and the Secretary shall determine
the annual distribution number for purposes of clause (ii) of such
subparagraph (A) when making the determination under this subsection.
(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) (as amended by subsection (a)) 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).
SEC. 614. REAUTHORIZATION OF THIRD-PARTY REVIEW AND INSPECTIONS.
(a) Third Party Review.--Section 523(c) (21 U.S.C. 360m(c)) is
amended by striking ``2012'' and inserting ``2017''.
(b) Third Party Inspections.--Section 704(g)(11) (21 U.S.C.
374(g)(11)) is amended by striking ``2012'' and inserting ``2017''.
SEC. 615. 510(K) DEVICE MODIFICATIONS.
Having acknowledged to Congress potential unintended consequences
that may result from the implementation of the Food and Drug
Administration 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'', the Secretary of Health and Human
Services shall withdraw such guidance promptly and ensure that, before
any future guidance document on this issue is made final, affected
stakeholders are provided with an opportunity to comment.
SEC. 616. HEALTH INFORMATION TECHNOLOGY.
(a) Limitation.--Notwithstanding any other provision of law, the
Secretary of Health and Human Services (referred to in this section as
the ``Secretary'') may issue final guidance on medical mobile
applications only after the requirements under subsections (b) and (c)
are met.
(b) Report.--Not later than 18 months after the date of enactment
of this Act, the Secretary, 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 Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce of the House of
Representatives a report that contains a proposed strategy and
recommendations on an appropriate, risk-based regulatory framework
pertaining to medical device regulation and health information
technology software, including mobile applications, that promotes
innovation and protects patient safety.
(c) Working Group.--
(1) In general.--In carrying out subsection (b), the
Secretary shall convene a working group of external
stakeholders and experts to provide appropriate input on the
strategy and recommendations required for the report under
subsection (b).
(2) Representatives.--The Secretary shall determine the
number of representatives participating in the working group,
and shall ensure that the working group is geographically
diverse and includes representatives of patients, consumers,
health care providers, startup companies, health plans or other
third-party payers, venture capital investors, information
technology vendors, small businesses, purchasers, employers,
and other stakeholders with relevant expertise, as determined
by the Secretary.
(3) Other requirements.--
(A) FACA.--The Federal Advisory Committee Act (5
U.S.C. App.) shall apply to the working group under
this section.
(B) FFDCA advisory committees.--The requirements
for advisory committees under section 712 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d-
1), as amended by section 1121, shall not apply to the
working group under this section.
TITLE VII--DRUG SUPPLY CHAIN
SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS.
Section 510 (21 U.S.C. 360) is amended--
(1) in subsection (b)--
(A) in paragraph (1), by striking ``On or before''
and all that follows through the period at the end and
inserting the following: ``During the period beginning
on October 1 and ending on December 31 of each year,
every person who owns or operates any establishment in
any State engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug or
drugs shall register with the Secretary--
``(A) the name of such person, places of business of such
person, all such establishments, the unique facility identifier
of each such establishment, and a point of contact e-mail
address; and
``(B) the name and place of business of each importer that
takes physical possession of and supplies a drug (other than an
excipient) to such person, including all establishments of each
such drug importer, the unique facility identifier of each such
drug importer establishment, and a point of contact e-mail
address for each such drug importer.''; and
(B) by adding at the end the following:
``(3) The Secretary may specify the unique facility identifier
system that shall be used by registrants under paragraph (1).''; and
(2) in subsection (c), by striking ``with the Secretary his
name, place of business, and such establishment'' and inserting
``with the Secretary--
``(1) with respect to drugs, the information described
under subsection (b)(1); and
``(2) with respect to devices, the information described
under subsection (b)(2).''.
SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS.
(a) Enforcement of Registration of Foreign Establishments.--Section
502(o) (21 U.S.C. 352(o)) is amended by striking ``in any State''.
(b) Registration of Foreign Drug Establishments.--Section 510(i)
(U.S.C. 360(i)) is amended--
(1) in paragraph (1)--
(A) by amending the matter preceding subparagraph
(A) to read as follows: ``Every person who owns or
operates any establishment within any foreign country
engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or device that is
imported or offered for import into the United States
shall, through electronic means in accordance with the
criteria of the Secretary--'';
(B) by amending subparagraph (A) to read as
follows:
``(A) upon first engaging in any such activity, immediately
submit a registration to the Secretary that includes--
``(i) with respect to drugs, the name and place of
business of such person, all such establishments, the
unique facility identifier of each such establishment,
a point of contact e-mail address, the name of the
United States agent of each such establishment, the
name and place of business of each drug importer with
which such person conducts business to import or offer
to import drugs into the United States, including all
establishments of each such drug importer, the unique
facility identifier of each such establishment, and a
point of contact e-mail address for each such drug
importer; and
``(ii) with respect to devices, the name and place
of business of the establishment, the name of the
United States agent for the establishment, the name of
each importer of such device in the United States that
is known to the establishment, and the name of each
person who imports or offers for import such device to
the United States for purposes of importation; and'';
and
(C) by amending subparagraph (B) to read as
follows:
``(B) each establishment subject to the requirements of
subparagraph (A) shall thereafter register with the Secretary
during the period beginning on October 1 and ending on December
31 of each year.''; and
(2) by adding at the end the following:
``(4) The Secretary may specify the unique facility identifier
system that shall be used by registrants under paragraph (1) with
respect to drugs.''.
SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH PRODUCT
LISTING.
Section 510(j)(1) (21 U.S.C. 360(j)(1)) is amended--
(1) in subparagraph (C), by striking ``; and'' and
inserting a semicolon;
(2) in subparagraph (D), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following:
``(E) in the case of a drug contained in the applicable
list, the name and place of business of each manufacturer of an
excipient of the listed drug with which the person listing the
drug conducts business, including all establishments used in
the production of such excipient, the unique facility
identifier of each such establishment, and a point of contact
e-mail address for each such excipient manufacturer.''.
SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.
Section 510(p) (21 U.S.C. 360(p)) is amended--
(1) by striking ``(p) Registrations and listings'' and
inserting the following:
``(p) Electronic Registration and Listing.--
``(1) In general.--Registration and listing''; and
(2) by adding at the end the following:
``(2) Electronic database.--Not later than 2 years after
the Secretary specifies a unique facility identifier system
under subsections (b) and (i), the Secretary shall maintain an
electronic database, which shall not be subject to inspection
under subsection (f), populated with the information submitted
as described under paragraph (1) that--
``(A) enables personnel of the Food and Drug
Administration to search the database by any field of
information submitted in a registration described under
paragraph (1), or combination of such fields; and
``(B) uses the unique facility identifier system to
link with other relevant databases within the Food and
Drug Administration, including the database for
submission of information under section 801(r).
``(3) Risk-based information and coordination.--The
Secretary shall ensure the accuracy and coordination of
relevant Food and Drug Administration databases in order to
identify and inform risk-based inspections under section
510(h).''.
SEC. 705. RISK-BASED INSPECTION FREQUENCY.
Section 510(h) (21 U.S.C. 360(h)) is amended to read as follows:
``(h) Inspections.--
``(1) 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.
``(2) Biennial inspections for devices.--Every
establishment described in paragraph (1) that is engaged in the
manufacture, propagation, compounding, or processing of a
device or devices classified in class II or III shall be so
inspected by one or more officers or employees duly designated
by the Secretary, or by persons accredited to conduct
inspections under section 704(g), at least once in the 2-year
period beginning with the date of registration of such
establishment pursuant to this section and at least once in
every successive 2-year period thereafter.
``(3) Risk-based schedule for drugs.--The Secretary, acting
through one or more officers or employees duly designated by
the Secretary, shall inspect establishments described in
paragraph (1) that are engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs
(referred to in this subsection as `drug establishments') in
accordance with a risk-based schedule established by the
Secretary.
``(4) Risk factors.--In establishing the risk-based
scheduled under paragraph (3), the Secretary shall inspect
establishments according to the known safety risks of such
establishments, which shall be based on the following factors:
``(A) The compliance history of the establishment.
``(B) The record, history, and nature of recalls
linked to the establishment.
``(C) The inherent risk of the drug manufactured,
prepared, propagated, compounded, or processed at the
establishment.
``(D) The certifications described under sections
801(r) and 809 for the establishment.
``(E) Whether the establishment has been inspected
in the preceding 4-year period.
``(F) Any other criteria deemed necessary and
appropriate by the Secretary for purposes of allocating
inspection resources.
``(5) Effect of status.--In determining the risk associated
with an establishment for purposes of establishing a risk-based
schedule under paragraph (3), the Secretary shall not consider
whether the drugs manufactured, prepared, propagated,
compounded, or processed by such establishment are drugs
described in section 503(b).
``(6) Annual report on inspections of establishments.--Not
later than February 1 of each year, the Secretary shall submit
a report to Congress regarding--
``(A)(i) the number of domestic and foreign
establishments registered pursuant to this section in
the previous fiscal year; and
``(ii) the number of such domestic establishments
and the number of such foreign establishments that the
Secretary inspected in the previous fiscal year;
``(B) with respect to establishments that
manufacture, prepare, propagate, compound, or process
an active ingredient of a drug, a finished drug
product, or an excipient of a drug, the number of each
such type of establishment; and
``(C) the percentage of the budget of the Food and
Drug Administration used to fund the inspections
described under subparagraph (A).
``(7) Public availability of annual reports.--The Secretary
shall make the report required under paragraph (6) available to
the public on the Internet Web site of the Food and Drug
Administration.''.
SEC. 706. 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 is
entitled to 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 within a reasonable time frame, within reasonable limits and in
a reasonable manner, and in electronic form, at the expense of such
person. The Secretary's request shall include a clear description of
the records requested.
``(B) Upon receipt of the records requested under subparagraph (A),
the Secretary shall provide to the person confirmation of the receipt
of such records.
``(C) Nothing in this paragraph supplants the authority of the
Secretary to conduct inspections otherwise permitted under this Act in
order to ensure compliance by an establishment with this Act.''.
SEC. 707. FAILURE TO ALLOW FOREIGN INSPECTION.
Section 801(a) (21 U.S.C. 381(a)) is amended by adding at the end
the following: ``Notwithstanding any other provision of this
subsection, the Secretary of Homeland Security shall, upon request from
the Secretary of Health and Human Services refuse to admit into the
United States any article if the article was manufactured, prepared,
propagated, compounded, processed, or held at an establishment that has
refused to permit the Secretary of Health and Human Services to enter
or inspect the establishment in the same manner and to the same extent
as the Secretary may inspect establishments under section 704.''.
SEC. 708. EXCHANGE OF INFORMATION.
Section 708 (21 U.S.C. 379) is amended--
(1) by striking ``confidential information'' and all that
follows through ``The Secretary'' and inserting ``confidential
information.
``(a) Contractors.--The Secretary''; and
(2) by adding at the end the following:
``(b) Ability to Receive and Protect Confidential Information.--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, except pursuant to
an order of a court of the United States. 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.
``(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
that 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 to humans or animals.
``(4) Effect of subsection.--Nothing in this subsection
affects the ability of the Secretary to enter into any written
agreement authorized by other provisions of law to share
confidential information.''.
SEC. 709. ENHANCING THE SAFETY AND QUALITY OF THE DRUG SUPPLY.
Section 501 (21 U.S.C. 351) is amended by adding at the end the
following flush text:
``For purposes of subsection (a)(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. 710. ACCREDITATION OF THIRD-PARTY AUDITORS FOR DRUG
ESTABLISHMENTS.
(a) In General.--Chapter VIII (21 U.S.C. 381 et seq.) is amended by
adding at the end the following:
``SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS FOR DRUG
ESTABLISHMENTS.
``(a) Definitions.--In this section:
``(1) Accreditation body.--The term `accreditation body'
means an authority that performs accreditation of third-party
auditors.
``(2) Accredited third-party auditor.--The term `accredited
third-party auditor' means a third-party auditor (which may be
an individual) accredited by an accreditation body to conduct
drug safety and quality audits.
``(3) Audit agent.--The term `audit agent' means an
individual who is an employee or agent of an accredited third-
party auditor and, although not individually accredited, is
qualified to conduct drug safety and quality audits on behalf
of an accredited third-party auditor.
``(4) Consultative audit.--The term `consultative audit'
means an audit of an eligible entity intended for internal
purposes only to determine whether an establishment is in
compliance with the provisions of this Act and applicable
industry practices, or any other such service.
``(5) Drug safety and quality audit.--The term `drug safety
and quality audit'--
``(A) means an audit of an eligible entity to
certify that the eligible entity meets the requirements
of this Act applicable to drugs, including the
requirements of section 501 with respect to drugs; and
``(B) is not a consultative audit.
``(6) Eligible entity.--The term `eligible entity' means an
entity, including a foreign drug establishment registered under
section 510(c), in the drug supply chain that chooses to be
audited by an accredited third-party auditor or the audit agent
of such accredited third-party auditor.
``(7) Third-party auditor.--The term `third-party auditor'
means a foreign government, agency of a foreign government or
any other third party (which may be an individual), as the
Secretary determines appropriate in accordance with the
criteria described in subsection (c)(1), that is eligible to be
considered for accreditation to conduct drug safety and quality
audits.
``(b) Accreditation System.--
``(1) Recognition of accreditation bodies.--
``(A) In general.--Not later than 2 years after
date of enactment of the Food and Drug Administration
Safety and Innovation Act, the Secretary shall
establish a system for the recognition of accreditation
bodies that accredit third-party auditors to conduct
drug safety and quality audits.
``(B) Direct accreditation.--
``(i) In general.--If, by the date that is
2 years after the date of establishment of the
system described in subparagraph (A), the
Secretary has not identified and recognized an
accreditation body to meet the requirements of
this section, the Secretary may directly
accredit third-party auditors.
``(ii) Certain direct accreditations.--
Notwithstanding subparagraph (A) or clause (i),
the Secretary may directly accredit any foreign
government or any agency of a foreign
government as a third-party auditor at any time
after the date of enactment of the Food and
Drug Administration Safety and Innovation Act.
``(2) Notification.--Each accreditation body recognized by
the Secretary shall submit to the Secretary--
``(A) a list of all accredited third-party auditors
accredited by such body (including the name, contact
information, and scope and duration of accreditation
for each such auditor), and the audit agents of such
auditors; and
``(B) updated lists as needed to ensure the list
held by the Secretary is accurate.
``(3) Revocation of recognition as an accreditation body.--
The Secretary shall promptly revoke, after the opportunity for
an informal hearing, the recognition of any accreditation body
found not to be in compliance with the requirements of this
section.
``(4) Reinstatement.--The Secretary shall establish
procedures to reinstate recognition of an accreditation body if
the Secretary determines, based on evidence presented by such
accreditation body, that revocation was inappropriate or that
the body meets the requirements for recognition under this
section.
``(5) Model accreditation standards.--
``(A) In general.--Not later than 18 months after
the date of enactment of the Food and Drug
Administration Safety and Innovation Act, the Secretary
shall develop model standards, including standards for
drug safety and quality audit results, reports, and
certifications, and each recognized accreditation body
shall ensure that third-party auditors and audit agents
of such auditors meet such standards in order to
qualify such third-party auditors as accredited third-
party auditors under this section.
``(B) Content.--The standards developed under
subparagraph (A) may--
``(i) include a description of required
standards relating to the training procedures,
competency, management responsibilities,
quality control, and conflict of interest
requirements of accredited third-party
auditors; and
``(ii) set forth procedures for the
periodic renewal of the accreditation of
accredited third-party auditors.
``(C) Requirement to provide results and reports to
the secretary.--An accreditation body (or, in the case
of direct accreditation under subsection (b)(1)(B), the
Secretary) may not accredit a third-party auditor
unless such third-party auditor agrees to provide to
the Secretary, upon request, the results and reports of
any drug safety and quality audit conducted pursuant to
the accreditation provided under this section.
``(6) Disclosure.--The Secretary shall maintain on the
Internet Web site of the Food and Drug Administration a list of
recognized accreditation bodies and accredited third-party
auditors under this section.
``(c) Accredited Third-party Auditors.--
``(1) Requirements for accreditation as a third-party
auditor.--
``(A) Foreign governments.--Prior to accrediting a
foreign government or an agency of a foreign government
as an accredited third-party auditor, the accreditation
body (or, in the case of direct accreditation under
subsection (b)(1)(B), the Secretary) shall perform such
reviews and audits of drug safety programs, systems,
and standards of the government or agency of the
government as the Secretary deems necessary, including
requirements under the standards developed under
subsection (b)(5), to determine that the foreign
government or agency of the foreign government is
capable of adequately ensuring that eligible entities
or drugs certified by such government or agency meet
the requirements of this Act.
``(B) Other third parties.--Prior to accrediting
any other third party to be an accredited third-party
auditor, the accreditation body (or, in the case of
direct accreditation under subsection (b)(1)(B), the
Secretary) shall perform such reviews and audits of the
training and qualifications of audit agents used by
that party and conduct such reviews of internal systems
and such other investigation of the party as the
Secretary deems necessary, including requirements under
the standards developed under subsection (b)(5), to
determine that the third-party auditor is capable of
adequately ensuring that an eligible entity or drug
certified by such third-party auditor meets the
requirements of this Act.
``(2) Use of audit agents.--An accredited third-party
auditor may conduct drug safety and quality audits and may
employ or use audit agents to conduct drug safety and quality
audits, but must ensure that such audit agents comply with all
requirements the Secretary deems necessary, including
requirements under paragraph (1) and subsection (b)(5).
``(3) Revocation of accreditation.--
``(A) In general.--The Secretary shall promptly
revoke, after the opportunity for an informal hearing,
the accreditation of an accredited third-party
auditor--
``(i) if, following an evaluation, the
Secretary finds that the accredited third-party
auditor is not in compliance with the
requirements of this section; or
``(ii) following a refusal to allow United
States officials to conduct such audits and
investigations as may be necessary to determine
compliance with the requirements set forth in
this section.
``(B) Additional basis for revocation of
accreditation.--The Secretary may revoke accreditation
from an accredited third-party auditor in the case that
such third-party auditor is accredited by an
accreditation body for which recognition as an
accreditation body under subsection (b)(3) is revoked,
if the Secretary determines that there is good cause
for the revocation of accreditation.
``(4) Reaccreditation.--The Secretary shall establish
procedures to reinstate the accreditation of a third-party
auditor for which accreditation has been revoked under
paragraph (3)--
``(A) if the Secretary determines, based on
evidence presented, that--
``(i) the third-party auditor satisfies the
requirements of this section; and
``(ii) adequate grounds for revocation no
longer exist; and
``(B) in the case of a third-party auditor
accredited by an accreditation body for which
recognition as an accreditation body is revoked under
subsection (b)(3)--
``(i) if the third-party auditor becomes
accredited not later than 1 year after
revocation of accreditation under paragraph
(3), through direct accreditation under
subsection (b)(1)(B), or by an accreditation
body in good standing; or
``(ii) under such other conditions as the
Secretary may require.
``(5) Requirement to issue certification of eligible
entities for compliance with current good manufacturing
practice.--
``(A) In general.--An accreditation body (or, in
the case of direct accreditation under subsection
(b)(1)(B), the Secretary) may not accredit a third-
party auditor unless such third-party auditor agrees to
issue a written and, as appropriate, electronic,
document or certification, as the Secretary may require
under this Act, regarding compliance with section 501.
The Secretary may consider any such document or
certification to satisfy requirements under section
801(r) and to target inspection resources under section
510(h).
``(B) Requirements for issuing certification.--
``(i) In general.--An accredited third-
party auditor shall issue a drug certification
described in subparagraph (A) only after
conducting a drug safety and quality audit and
such other activities that may be necessary to
establish compliance with the provisions of
section 501.
``(ii) Provision of certification.--Only an
accredited third-party auditor or the Secretary
may provide a drug certification described in
subparagraph (A).
``(C) Records.--Following any accreditation of a
third-party auditor, the Secretary may, at any time,
require the accredited third-party auditor or any audit
agent of such auditor to submit to the Secretary a drug
safety and quality audit report and such other reports
or documents required as part of the drug safety and
quality audit process, for any eligible entity for
which the accredited third-party auditor or audit agent
of such auditor performed a drug safety and quality
audit. The Secretary may require documentation that the
eligible entity is in compliance with any applicable
registration requirements.
``(D) Limitation.--The requirement under
subparagraph (C) shall not include any report or other
documents resulting from a consultative audit, except
that the Secretary may access the results of a
consultative audit in accordance with section 704.
``(E) Declaration of audit type.--Before an
accredited third-party auditor begins any audit or
provides any consultative service to an eligible
entity, both the accredited third-party auditor and
eligible entity shall establish in writing whether the
audit is intended to be a drug safety and quality
audit. Any audit, inspection, or consultative service
of any type provided by an accredited third-party
auditor on behalf of an eligible entity shall be
presumed to be a drug safety and quality audit in the
absence of such a written agreement. Once a drug safety
and quality audit is initiated, it shall be subject to
the requirements of this section, and no person may
withhold from the Secretary any document subject to
subparagraph (C) on the grounds that the audit was a
consultative audit or otherwise not a drug safety and
quality audit.
``(F) Rule of construction.--Nothing in this
section shall be construed to limit the authority of
the Secretary under section 704.
``(6) Requirements regarding serious risks to the public
health.--If, at any time during a drug safety and quality
audit, an accredited third-party auditor or an audit agent of
such auditor discovers a condition that could cause or
contribute to a serious risk to the public health, such auditor
shall immediately notify the Secretary of--
``(A) the identity and location of the eligible
entity subject to the drug safety and quality audit;
and
``(B) such condition.
``(7) Limitations.--
``(A) In general.--An audit agent of an accredited
third-party auditor may not perform a drug safety and
quality audit of an eligible entity if such audit agent
has performed a drug safety and quality audit or
consultative audit of such eligible entity during the
previous 13-month period.
``(B) Waiver.--The Secretary may waive the
application of subparagraph (A) if the Secretary
determines that there is insufficient access to
accredited third-party auditors in a country or region
or that the use of the same audit agent or accredited
third-party auditor is otherwise necessary.
``(8) Conflicts of interest.--
``(A) Accreditation bodies.--A recognized
accreditation body shall--
``(i) not be owned, managed, or controlled
by any person that owns or operates a third-
party auditor to be accredited by such body;
``(ii) in carrying out accreditation of
third-party auditors under this section, have
procedures to ensure against the use of any
officer or employee of such body that has a
financial conflict of interest regarding a
third-party auditor to be accredited by such
body; and
``(iii) annually make available to the
Secretary disclosures of the extent to which
such body and the officers and employees of
such body have maintained compliance with
clauses (i) and (ii) relating to financial
conflicts of interest.
``(B) Accredited third-party auditors.--An
accredited third-party auditor shall--
``(i) not be owned, managed, or controlled
by any person that owns or operates an eligible
entity to be certified by such auditor;
``(ii) in carrying out drug safety and
quality audits of eligible entities under this
section, have procedures to ensure against the
use of any officer or employee of such auditor
that has a financial conflict of interest
regarding an eligible entity to be certified by
such auditor; and
``(iii) annually make available to the
Secretary disclosures of the extent to which
such auditor and the officers and employees of
such auditor have maintained compliance with
clauses (i) and (ii) relating to financial
conflicts of interest.
``(C) Audit agents.--An audit agent shall--
``(i) not own or operate an eligible entity
to be audited by such agent;
``(ii) in carrying out audits of eligible
entities under this section, have procedures to
ensure that such agent does not have a
financial conflict of interest regarding an
eligible entity to be audited by such agent;
and
``(iii) annually make available to the
Secretary disclosures of the extent to which
such agent has maintained compliance with
clauses (i) and (ii) relating to financial
conflicts of interest.
``(d) False Statements.--Any statement or representation made--
``(1) by an employee or agent of an eligible entity to an
accredited third-party auditor or audit agent; or
``(2) by an accreditation body, accredited third-party
auditor, or audit agent of such auditor to the Secretary, shall
be subject to section 1001 of title 18, United States Code.
``(e) Monitoring.--To ensure compliance with the requirements of
this section, the Secretary--
``(1) shall periodically, or at least once every 4 years,
reevaluate the accreditation bodies described in subsection
(b)(1);
``(2) shall periodically, or at least once every 4 years,
evaluate the performance of each accredited third-party
auditor, through the review of regulatory audit reports by such
auditors, the compliance history as available of eligible
entities certified by such auditors, and any other measures
deemed necessary by the Secretary;
``(3) may at any time, conduct an onsite audit of any
eligible entity certified by an accredited third-party auditor,
with or without the auditor present; and
``(4) shall take any other measures deemed necessary by the
Secretary.
``(f) Effect of Audit.--The results of a drug safety and quality
audit by an accredited third-party auditor under this section--
``(1) may be used by the eligible entity--
``(A) as documentation of compliance with section
501(a)(2)(B) or section 801(r); and
``(B) for other purposes as determined appropriate
by the Secretary; and
``(2) shall be used by the Secretary in establishing the
risk-based inspection schedules under section 510(h).
``(g) Costs.--
``(1) Authorized fees of secretary.--The Secretary may
assess fees on accreditation bodies and accredited third-party
auditors in such an amount necessary to establish and
administer the recognition and accreditation program under this
section. The Secretary may require accredited third-party
auditors and audit agents to reimburse the Food and Drug
Administration for the work performed to carry out this
section. The Secretary shall not generate surplus revenue from
such a reimbursement mechanism. Fees authorized under this
paragraph shall be collected and available for obligation only
to the extent and in the amount provided in advance in
appropriation Acts. Such fees are authorized to remain
available until expended.
``(2) Authorized fees for recognized accreditation
bodies.--An accreditation body recognized by the Secretary
under subsection (b) may assess a reasonable fee to accredit
third-party auditors.
``(h) Limitations.--
``(1) No effect on section 704 inspections.--The drug
safety and quality audits performed under this section shall
not be considered inspections under section 704.
``(2) No effect on inspection authority.--Nothing in this
section affects the authority of the Secretary to inspect any
eligible entity pursuant to this Act.
``(i) Regulations.--
``(1) In general.--Not later than 18 months after the date
of enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt final regulations
implementing this section.
``(2) Procedure.--In promulgating the regulations
implementing this section, the Secretary shall--
``(A) issue a notice of proposed rulemaking that
includes the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30
days before the effective date of the regulation.
``(3) Content.--Such regulations shall include--
``(A) requirements that, to the extent practicable,
drug safety and quality audits performed under this
section be unannounced;
``(B) a structure to decrease the potential for
conflicts of interest, including timing and public
disclosure, for fees paid by eligible entities to
accredited third-party auditors; and
``(C) appropriate limits on financial affiliations
between an accredited third-party auditor or audit
agents of such auditor and any person that owns or
operates an eligible entity to be audited by such
auditor, as described in subparagraphs (A) and (B).
``(4) Restrictions.--Notwithstanding any other provision of
law, the Secretary shall promulgate regulations implementing
this section only as described in paragraph (2).''.
(b) Report on Accredited Third-party Auditors.--Not later than
January 20, 2017, the Comptroller General of the United States shall
submit to Congress a report that addresses the following, with respect
to the period beginning on the date of implementation of section 809 of
the Federal Food, Drug, and Cosmetic Act (as added by subsection (a))
and ending on the date of such report:
(1) The extent to which drug safety and quality audits
completed by accredited third-party auditors under such section
809 are being used by the Secretary of Health and Human
Services (referred to in this subsection as the ``Secretary'')
in establishing or applying the risk-based inspection schedules
under section 510(h) of such Act (as amended by section 705).
(2) The extent to which drug safety and quality audits
completed by accredited third-party auditors or agents are
assisting the Food and Drug Administration in evaluating
compliance with sections 501(a)(2)(B) of such Act (21 U.S.C.
351(a)(2)(B)) and 801(r) of such Act (as added by section 711).
(3) Whether the Secretary has been able to access drug
safety and quality audit reports completed by accredited third-
party auditors under such section 809.
(4) Whether accredited third-party auditors accredited
under such section 809 have adhered to the conflict of interest
provisions set forth in such section.
(5) The extent to which the Secretary has audited
recognized accreditation bodies or accredited third-party
auditors to ensure compliance with the requirements of such
section 809.
(6) The number of waivers under subsection (c)(7)(B) of
such section 809 issued during the most recent 12-month period
and the official justification by the Secretary for each
determination that there was insufficient access to an
accredited third-party auditor.
(7) The number of times a manufacturer has used the same
accredited third-party auditor for 2 or more consecutive drug
safety and quality audits under such section 809.
(8) Recommendations to Congress regarding the accreditation
program under such section 809, including whether Congress
should continue, modify, or terminate the program.
SEC. 711. STANDARDS FOR ADMISSION OF IMPORTED DRUGS.
Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (o), by striking ``drug or''; and
(2) by adding at the end the following:
``(r)(1) The Secretary may require, as a condition of granting
admission to a drug imported or offered for import into the United
States, that the importer electronically submit information
demonstrating that the drug complies with applicable requirements of
this Act.
``(2) The information described under paragraph (1) may include--
``(A) 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;
``(B) facility information, such as proof of registration
and the unique facility identifier;
``(C) indication of compliance with current good
manufacturing practice, testing results, certifications
relating to satisfactory inspections, and compliance with the
country of export regulations; and
``(D) any other information deemed necessary and
appropriate by the Secretary to assess compliance of the
article being offered for import.
``(3) Information requirements referred to in paragraph (2)(C) may,
at the discretion of the Secretary, be satisfied--
``(A) by certifications from accredited third parties, as
described under section 809;
``(B) through representation by a foreign government, if
such inspection is conducted using standards and practices as
determined appropriate by the Secretary; or
``(C) other appropriate documentation or evidence as
described by the Secretary.
``(4)(A) Not later than 18 months after the date of enactment of
the Food and Drug Administration Safety and Innovation Act, the
Secretary shall adopt final regulations implementing this subsection.
Such requirements shall be appropriate for the type of import, such as
whether the drug is for import into the United States for use in
preclinical research or in a clinical investigation under an
investigational new drug exemption under 505(i).
``(B) In promulgating the regulations implementing this subsection,
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.
``(C) Notwithstanding any other provision of law, the Secretary
shall promulgate regulations implementing this subsection only as
described in subparagraph (B).''.
SEC. 712. NOTIFICATION.
(a) Prohibited Acts.--Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:
``(aaa) The failure to notify the Secretary in violation of section
568.''.
(b) Notification.--
(1) In general.--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 covered person
if the covered person knows--
``(1) of a substantial loss or theft of such drug; or
``(2) that such drug--
``(A) has been or is being counterfeited; and
``(B)(i) is a counterfeit product in commerce in
the United States; or
``(ii) is offered for import into the United
States.
``(b) Manner of Notification.--Notification under this section
shall be made in a reasonable time, in such reasonable manner, and by
such reasonable means as the Secretary may require by regulation or
specify in guidance.
``(c) Definition.--In this section, the term `covered person'
means--
``(1) a person who is required to register under section
510 with respect to an establishment engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug; or
``(2) a person engaged in the wholesale distribution (as
defined in section 503(e)(3)(B)) of a drug.''.
(2) Applicability.--Notifications under section 568 of the
Federal Food, Drug, and Cosmetic Act (as added by paragraph
(1)) apply to losses, thefts, or counterfeiting, as described
in subsection (a) of such section 568, that occur on or after
the date of enactment of this Act.
SEC. 713. 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 adulterates a drug such that the drug is adulterated
under subsection (a)(1), (b), (c), or (d) of section 501 and has a
reasonable probability of causing serious adverse health consequences
or death to humans or animals shall be imprisoned for not more than 20
years or fined not more than $1,000,000, or both.''.
SEC. 714. ENHANCED CRIMINAL PENALTY FOR COUNTERFEITING DRUGS.
Section 303(b) (21 U.S.C. 333(b)), as amended by section 713, is
further amended by adding at the end the following:
``(8) Notwithstanding subsection (a)(2), any person who knowingly
and intentionally violates section 301(i) shall be imprisoned for not
more than 20 years or fined not more than $4,000,000 or both.''.
SEC. 715. 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. 716. COMPLIANCE WITH INTERNATIONAL AGREEMENTS.
Nothing in this title (or an amendment made by this title) shall be
construed in a manner inconsistent with the obligations of the United
States under the Agreement Establishing the World Trade Organization,
or any other treaty or international agreement to which the United
States is a party.
TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW
SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.
(a) In General.--Chapter V (21 U.S.C. 351 et seq.) is amended by
inserting after section 505D 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 designated as a qualified
infectious disease product under subsection (d), the 4- and 5-year
periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of
section 505, the 3-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 7-year period described in section 527, as
applicable, shall be extended by 5 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 with respect to a
product approved under section 505 for a change that results in
a new indication, route of administration, dosing schedule,
dosage form, delivery system, delivery device, or strength; or
``(3) an application for a product that is not approved for
the use for which it received a designation under subsection
(d).
``(d) Designation.--
``(1) In general.--The manufacturer or sponsor of a drug
may request the Secretary to designate a drug as a qualified
infectious disease product at any time before the submission of
an application under section 505(b) for such drug. The
Secretary shall, not later than 60 days after the submission of
such a request, determine whether the drug is a qualified
infectious disease product.
``(2) Limitation.--Except as provided in paragraph (3), a
designation under this subsection shall not be withdrawn for
any reason, including modifications to the list of qualifying
pathogens under subsection (f)(2)(C).
``(3) Revocation of designation.--The Secretary may revoke
a designation of a drug as a qualified infectious disease
product if the Secretary finds that the request for such
designation contained an untrue statement of material fact.
``(e) Regulations.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt final regulations
implementing this section.
``(2) Procedure.--In promulgating a regulation implementing
this section, the Secretary shall--
``(A) issue a notice of proposed rulemaking that
includes the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30
days before the effective date of the regulation.
``(3) Restrictions.--Notwithstanding any other provision of
law, the Secretary shall promulgate regulations implementing
this section only as described in paragraph (2), except that
the Secretary may issue interim guidance for sponsors seeking
designation under subsection (d) prior to the promulgation of
such regulations.
``(4) Designation prior to regulations.--The Secretary may
designate drugs as qualified infectious disease products under
subsection (d) prior to the promulgation of regulations under
this subsection.
``(f) Qualifying Pathogen.--
``(1) Definition.--In this section, the term `qualifying
pathogen' means a pathogen identified and listed by the
Secretary under paragraph (2) that has the potential to pose a
serious threat to public health, such as--
``(A) resistant gram positive pathogens, including
methicillin-resistant Staphylococcus aureus,
vancomycin-resistant Staphylococcus aureus, and
vancomycin-resistant enterococcus;
``(B) multi-drug resistant gram negative bacteria,
including Acinetobacter, Klebsiella, Pseudomonas, and
E. coli species;
``(C) multi-drug resistant tuberculosis; and
``(D) Clostridium difficile.
``(2) List of qualifying pathogens.--
``(A) In general.--The Secretary shall establish
and maintain a list of qualifying pathogens, and shall
make public the methodology for developing such list.
``(B) Considerations.--In establishing and
maintaining the list of pathogens described under this
section the Secretary shall--
``(i) consider--
``(I) the impact on the public
health due to drug-resistant organisms
in humans;
``(II) the rate of growth of drug-
resistant organisms in humans;
``(III) the increase in resistance
rates in humans; and
``(IV) the morbidity and mortality
in humans; and
``(ii) consult with experts in infectious
diseases and antibiotic resistance, including
the Centers for Disease Control and Prevention,
the Food and Drug Administration, medical
professionals, and the clinical research
community.
``(C) Review.--Every 5 years, or more often as
needed, the Secretary shall review, provide
modifications to, and publish the list of qualifying
pathogens under subparagraph (A) and shall by
regulation revise the list as necessary, in accordance
with subsection (e).
``(g) Qualified Infectious Disease Product.--The term `qualified
infectious disease product' means an antibacterial or antifungal drug
for human use intended to treat serious or life-threatening infections,
including those caused by--
``(1) an antibacterial or antifungal resistant pathogen,
including novel or emerging infectious pathogens; or
``(2) qualifying pathogens listed by the Secretary under
subsection (f).''.
(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. 802. PRIORITY REVIEW.
(a) Amendment.--Chapter V (21 U.S.C. 351 et seq.) is amended by
inserting after section 524 the following:
``SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.
``If the Secretary designates a drug under section 505E(d) as a
qualified infectious disease product, then the Secretary shall give
priority review to any application submitted for approval for such drug
under section 505(b).''.
(b) Application.--Section 524A of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), applies only with respect to
an application that is submitted under section 505(b) of such Act (21
U.S.C. 355(b)) on or after the date of the enactment of this Act.
SEC. 803. FAST TRACK PRODUCT.
Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended by section
901(b), is amended by inserting ``, or if the Secretary designates the
drug as a qualified infectious disease product under section 505E(d)''
before the period at the end of the first sentence.
SEC. 804. GAO STUDY.
(a) In General.--The Comptroller General of the United States
shall--
(1) conduct a study--
(A) on the need for, and public health impact of,
incentives to encourage the research, development, and
marketing of qualified infectious disease biological
products and antifungal products; and
(B) consistent with trade and confidentiality data
protections, assessing, for all antibacterial and
antifungal drugs, including biological products, the
average or aggregate--
(i) costs of all clinical trials for each
phase;
(ii) percentage of success or failure at
each phase of clinical trials; and
(iii) public versus private funding levels
of the trials for each phase; and
(2) not later than 1 year after the date of enactment of
this Act, submit a report to Congress on the results of such
study, including any recommendations of the Comptroller General
on appropriate incentives for addressing such need.
(b) Contents.--The part of the study described in subsection
(a)(1)(A) shall include--
(1) an assessment of any underlying regulatory issues
related to qualified infectious disease products, including
qualified infectious disease biological products;
(2) an assessment of the management by the Food and Drug
Administration of the review of qualified infectious disease
products, including qualified infectious disease biological
products and the regulatory certainty of related regulatory
pathways for such products;
(3) a description of any regulatory impediments to the
clinical development of new qualified infectious disease
products, including qualified infectious disease biological
products, and the efforts of the Food and Drug Administration
to address such impediments; and
(4) recommendations with respect to--
(A) improving the review and predictability of
regulatory pathways for such products; and
(B) overcoming any regulatory impediments
identified in paragraph (3).
(c) 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 intended to treat a
serious or life-threatening infection described in section
505E(g) of the Federal Food, Drug, and Cosmetic Act, as added
by section 801.
(3) The term ``qualified infectious disease product'' has
the meaning given such term in section 505E(g) of the Federal
Food, Drug, and Cosmetic Act, as added by section 801.
SEC. 805. CLINICAL TRIALS.
(a) Review and Revision of Guidance Documents.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall review
and, as appropriate, revise not fewer than 3 guidance documents
per year, which shall include--
(A) reviewing the guidance documents of the Food
and Drug Administration for the conduct of clinical
trials with respect to antibacterial and antifungal
drugs; and
(B) as appropriate, revising such guidance
documents to reflect developments in scientific and
medical information and technology and to ensure
clarity regarding the procedures and requirements for
approval of antibacterial and antifungal drugs 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 micro-biological
surrogate markers, the use of non-inferiority versus
superiority trials, trial enrollment, data requirements, and
appropriate delta values for non-inferiority trials.
(3) Rule of construction.--Except to the extent to which
the Secretary makes revisions under paragraph (1)(B), nothing
in this section shall be construed to repeal or otherwise
effect the guidance documents of the Food and Drug
Administration.
(b) Recommendations for Investigations.--
(1) Request.--The sponsor of a drug intended to be
designated as a qualified infectious disease product may
request that the Secretary provide written recommendations for
nonclinical and clinical investigations which the Secretary
believes may be necessary to be conducted with the drug before
such drug may be approved under section 505 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in
treating, detecting, preventing, or identifying a qualifying
pathogen, as defined in section 505E of such Act.
(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) GAO Study.--Not later than January 1, 2016, the Comptroller
General of the United States shall submit to Congress a report--
(1) regarding the review and revision of the clinical trial
guidance documents required under subsection (a) and the impact
such review and revision has had on the review and approval of
qualified infectious disease products;
(2) assessing--
(A) the effectiveness of the results-oriented
metrics managers employ to ensure that reviewers of
such products are familiar with, and consistently
applying, clinical trial guidance documents; and
(B) the predictability of related regulatory
pathways and review;
(3) identifying any outstanding regulatory impediments to
the clinical development of qualified infectious disease
products;
(4) reporting on the progress the Food and Drug
Administration has made in addressing the impediments
identified under paragraph (3); and
(5) containing recommendations regarding how to improve the
review of, and regulatory pathway for, such products.
(d) Qualified Infectious Disease Product.--For purposes of this
section, the term ``qualified infectious disease product'' has the
meaning given such term in section 505E(g) of the Federal Food, Drug,
and Cosmetic Act, as added by section 801.
SEC. 806. REGULATORY CERTAINTY AND PREDICTABILITY.
(a) Initial Strategy and Implementation Plan.--Not later than 1
year after the date of enactment of this Act, the Secretary of Health
and Human Services (referred to in this section as the ``Secretary'')
shall submit to Congress a strategy and implementation plan with
respect to the requirements of this Act. The strategy and
implementation plan shall include--
(1) a description of the regulatory challenges to clinical
development, approval, and licensure of qualified infectious
disease products;
(2) the regulatory and scientific priorities of the
Secretary with respect to such challenges; and
(3) the steps the Secretary will take to ensure regulatory
certainty and predictability with respect to qualified
infectious disease products, including steps the Secretary will
take to ensure managers and reviewers are familiar with related
regulatory pathways, requirements of the Food and Drug
Administration, guidance documents related to such products,
and applying such requirements consistently.
(b) Subsequent Report.--Not later than 3 years after the date of
enactment of this Act, the Secretary shall submit to Congress a report
on--
(1) the progress made toward the priorities identified
under subsection (a)(2);
(2) the number of qualified infectious disease products
that have been submitted for approval or licensure on or after
the date of enactment of this Act;
(3) a list of qualified infectious disease products with
information on the types of exclusivity granted for each
product, consistent with the information published under
section 505(j)(7)(A)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(7)(A)(iii));
(4) the number of such qualified infectious disease
products and that have been approved or licensed on or after
the date of enactment of this Act; and
(5) the number of calendar days it took for the approval or
licensure of the qualified infectious disease products approved
or licensed on or after the date of enactment of this Act.
(c) Qualified Infectious Disease Product.--For purposes of this
section, the term ``qualified infectious disease product'' has the
meaning given such term in section 505E(g) of the Federal Food, Drug,
and Cosmetic Act, as added by section 801.
TITLE IX--DRUG APPROVAL AND PATIENT ACCESS
SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW MEDICAL
TREATMENTS.
(a) Findings; Sense of Congress.--
(1) Findings.--Congress finds as follows:
(A) The Food and Drug Administration (referred to
in this section 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 Congress that
the Food and Drug Administration 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 of Drugs for Serious or Life-Threatening
Diseases or Conditions.--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 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) 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.--
``(A) Accelerated approval.--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) or
section 351(a) of the Public Health Service Act upon a
determination that the product has an effect on a
surrogate endpoint that is reasonably likely to predict
clinical benefit, or on 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,
rarity, or prevalence of the condition and the
availability or lack of alternative treatments. The
approval described in the preceding sentence is
referred to in this section as `accelerated approval'.
``(B) Evidence.--The evidence to support that an
endpoint is reasonably likely to predict clinical
benefit under subparagraph (A) may include
epidemiological, pathophysiological, therapeutic,
pharmacologic, or other evidence developed using
biomarkers, for example, or other scientific methods or
tools.
``(2) Limitation.--Approval of a product under this
subsection may be subject to 1 or both of the following
requirements:
``(A) That the sponsor conduct appropriate post-
approval studies to verify and describe the predicted
effect on irreversible morbidity or mortality or other
clinical benefit.
``(B) That the sponsor submit copies of all
promotional materials related to the product during the
preapproval review period and, following approval and
for such period thereafter as the Secretary determines
to be appropriate, at least 30 days prior to
dissemination of the materials.
``(3) Expedited withdrawal of approval.--The Secretary may
withdraw approval of a product approved under accelerated
approval 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 drug 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 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
significant unmet medical needs exist.
``(e) Construction.--
``(1) Purpose.--The amendments made by the Food and Drug
Administration Safety and Innovation Act to this section are
intended to encourage the Secretary to utilize innovative and
flexible approaches to the assessment of products under
accelerated approval for treatments for patients with serious
or life-threatening diseases or conditions and unmet medical
needs.
``(2) Construction.--Nothing in this section shall be
construed to alter the standards of evidence under subsection
(c) or (d) of section 505 (including the substantial evidence
standard in section 505(d)) of this Act or under section 351(a)
of the Public Health Service Act. Such sections and standards
of evidence apply to the review and approval of products under
this section, including whether a product is safe and
effective. Nothing in this section alters the ability of the
Secretary to rely on evidence that does not come from adequate
and well-controlled investigations for the purpose of
determining whether an endpoint is reasonably likely to predict
clinical benefit as described in subsection (b)(1)(B).''.
(c) Guidance; Amended Regulations.--
(1) Draft guidance.--Not later than 1 year 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 to implement the amendments made by
this section. In developing such guidance, the Secretary shall
specifically consider issues arising under the accelerated
approval and fast track processes under section 506 of the
Federal Food, Drug, and Cosmetic Act, as amended by subsection
(b), for drugs designated for a rare disease or condition under
section 526 of such Act (21 U.S.C. 360bb) and shall also
consider any unique issues associated with very rare diseases.
(2) Final guidance.--Not later than 1 year after the
issuance of draft guidance under paragraph (1), and after an
opportunity for public comment, the Secretary shall issue final
guidance.
(3) Conforming changes.--The Secretary shall issue, as
necessary, conforming amendments to the applicable regulations
under title 21, Code of Federal Regulations, governing
accelerated approval.
(4) No effect of inaction on requests.--If the Secretary
fails to issue final guidance or amended regulations as
required by this subsection, such failure 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
subsection (b).
(d) Independent Review.--The Secretary may, in conjunction with
other planned reviews, 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
subsection (b), and the impact of such processes on the development and
timely availability of innovative treatments for patients suffering
from serious or life-threatening conditions. Any such evaluation shall
include consultation with regulated industries, patient advocacy and
disease research foundations, and relevant academic medical centers.
SEC. 902. BREAKTHROUGH THERAPIES.
(a) In General.--Section 506 (21 U.S.C. 356), as amended by section
901, is further amended--
(1) by redesignating subsections (a) through (c) as
subsections (b) through (d), respectively;
(2) by redesignating subsection (d) as subsection (f);
(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 (f)(1), as so redesignated, by striking
``applicable to accelerated approval'' and inserting
``applicable to breakthrough therapies, accelerated approval,
and''; and
(5) by adding at the end the following:
``(g) 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 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. 903. 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 712, 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 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 (c).
``(2) Consultation with external experts.--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 (c), when such consultation is necessary because
the Secretary lacks specific scientific, medical, or technical
expertise necessary for the performance of its regulatory
responsibilities and the necessary expertise can be provided by
the external experts.
``(b) External Experts.--For purposes of subsection (a)(2),
external experts are those who possess scientific or medical training
that the Secretary lacks with respect to one or more rare diseases.
``(c) 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) demographics and the clinical description of patient
populations.
``(d) 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.
``(e) Protection of Proprietary Information.--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.
``(f) 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.
``(g) No Right or Obligation.--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. 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.
Nothing in this section is intended to increase the number of review
cycles as in effect before the date of enactment of this section.''.
SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG CONTAINER
LABELS BY VISUALLY-IMPAIRED AND BLIND CONSUMERS.
(a) Establishment of Working Group.--
(1) In general.--The Architectural and Transportation
Barriers Compliance Board (referred to in this section as the
``Access Board'') shall convene a stakeholder working group
(referred to in this section as the ``working group'') to
develop best practices on access to information on prescription
drug container labels for individuals who are blind or visually
impaired.
(2) Members.--The working group shall be comprised of
representatives of national organizations representing blind
and visually-impaired individuals, national organizations
representing the elderly, and industry groups representing
stakeholders, including retail, mail order, and independent
community pharmacies, who would be impacted by such best
practices. Representation within the working group shall be
divided equally between consumer and industry advocates.
(3) Best practices.--
(A) In general.--The working group shall develop,
not later than 1 year after the date of the enactment
of this Act, best practices for pharmacies to ensure
that blind and visually-impaired individuals have safe,
consistent, reliable, and independent access to the
information on prescription drug container labels.
(B) Public availability.--The best practices
developed under subparagraph (A) may be made publicly
available, including through the Internet Web sites of
the working group participant organizations, and
through other means, in a manner that provides access
to interested individuals, including individuals with
disabilities.
(C) Limitations.--The best practices developed
under subparagraph (A) shall not be construed as
accessibility guidelines or standards of the Access
Board, and shall not confer any rights or impose any
obligations on working group participants or other
persons. Nothing in this section shall be construed to
limit or condition any right, obligation, or remedy
available under the Americans with Disabilities Act of
1990 (42 U.S.C. 12101 et seq.) or any other Federal or
State law requiring effective communication, barrier
removal, or nondiscrimination on the basis of
disability.
(4) Considerations.--In developing and issuing the best
practices under paragraph (3)(A), the working group shall
consider--
(A) the use of--
(i) Braille;
(ii) auditory means, such as--
(I) ``talking bottles'' that
provide audible container label
information;
(II) digital voice recorders
attached to the prescription drug
container; and
(III) radio frequency
identification tags;
(iii) enhanced visual means, such as--
(I) large font labels or large font
``duplicate'' labels that are affixed
or matched to a prescription drug
container;
(II) high-contrast printing; and
(III) sans-serf font; and
(iv) other relevant alternatives as
determined by the working group;
(B) whether there are technical, financial,
manpower, or other factors unique to pharmacies with 20
or fewer retail locations which may pose significant
challenges to the adoption of the best practices; and
(C) such other factors as the working group
determines to be appropriate.
(5) Information campaign.--Upon completion of development
of the best practices under subsection (a)(3), the National
Council on Disability, in consultation with the working group,
shall conduct an informational and educational campaign
designed to inform individuals with disabilities, pharmacists,
and the public about such best practices.
(6) FACA waiver.--The Federal Advisory Committee Act (5
U.S.C. App.) shall not apply to the working group.
(b) GAO Study.--
(1) In general.--Beginning 18 months after the completion
of the development of best practices under subsection
(a)(3)(A), the Comptroller General of the United States shall
conduct a review of the extent to which pharmacies are
utilizing such best practices, and the extent to which barriers
to accessible information on prescription drug container labels
for blind and visually-impaired individuals continue.
(2) Report.--Not later than September 30, 2016, the
Comptroller General of the United States shall submit to
Congress a report on the review conducted under paragraph (1).
Such report shall include recommendations about how best to
reduce the barriers experienced by blind and visually-impaired
individuals to independently accessing information on
prescription drug container labels.
(c) Definitions.--In this section--
(1) the term ``pharmacy'' includes a pharmacy that receives
prescriptions and dispenses prescription drugs through an
Internet Web site or by mail;
(2) the term ``prescription drug'' means a drug subject to
section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(b)(1)); and
(3) the term ``prescription drug container label'' means
the label with the directions for use that is affixed to the
prescription drug container by the pharmacist and dispensed to
the consumer.
SEC. 905. RISK-BENEFIT FRAMEWORK.
Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end
the following: ``The Secretary shall implement a structured risk-
benefit assessment framework in the new drug approval process to
facilitate the balanced consideration of benefits and risks, a
consistent and systematic approach to the discussion and regulatory
decisionmaking, and the communication of the benefits and risks of new
drugs. Nothing in the preceding sentence shall alter the criteria for
evaluating an application for premarket approval of a drug.''.
SEC. 906. INDEPENDENT STUDY ON MEDICAL INNOVATION INDUCEMENT MODEL.
(a) In General.--The Secretary of Health and Human Services shall
enter into an agreement with the National Academies to provide expert
consultation and conduct a study that evaluates the feasibility and
possible consequences of the use of innovation inducement prizes to
reward successful medical innovations. Under the agreement, the
National Academies shall submit to the Secretary a report on such study
not later than 15 months after the date of enactment of this Act.
(b) Requirements.--
(1) In general.--The study conducted under subsection (a)
shall model at least 3 separate segments on the medical
technologies market as candidate targets for the new incentive
system and consider different medical innovation inducement
prize design issues, including the challenges presented in the
implementation of prizes for end products, open source dividend
prizes, and prizes for upstream research.
(2) Market segments.--The segments on the medical
technologies market that shall be considered under paragraph
(1) include--
(A) all pharmaceutical and biologic drugs and
vaccines;
(B) drugs and vaccines used solely for the
treatment of HIV/AIDS; and
(C) antibiotics.
(c) Elements.--The study conducted under subsection (a) shall
include consideration of each of the following:
(1) Whether a system of large innovation inducement prizes
could work as a replacement for the existing product monopoly/
patent-based system, as in effect on the date of enactment of
this Act.
(2) How large the innovation prize funds would have to be
in order to induce at least as much research and development
investment in innovation as is induced under the current system
of time-limited market exclusivity, as in effect on the date of
enactment of this Act.
(3) Whether a system of large innovation inducement prizes
would be more or less expensive than the current system of
time-limited market exclusivity, as in effect on the date of
enactment of this Act, calculated over different time periods.
(4) Whether a system of large innovation inducement prizes
would expand access to new products and improve health
outcomes.
(5) The type of information and decisionmaking skills that
would be necessary to manage end product prizes.
(6) Whether there would there be major advantages in
rewarding the incremental impact of innovations, as benchmarked
against existing products.
(7) How open-source dividend prizes could be managed, and
whether such prizes would increase access to knowledge,
materials, data and technologies.
(8) Whether a system of competitive intermediaries for
interim research prizes would provide an acceptable solution to
the valuation challenges for interim prizes.
SEC. 907. ORPHAN PRODUCT GRANTS PROGRAM.
(a) Reauthorization of Program.--Section 5(c) of the Orphan Drug
Act (21 U.S.C. 360ee(c)) is amended by striking ``2008 through 2012''
and inserting ``2013 through 2017''.
(b) Human Clinical Testing.--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''.
TITLE X--DRUG SHORTAGES
SEC. 1001. DRUG SHORTAGES.
(a) In General.--Section 506C (21 U.S.C. 356c) is amended to read
as follows:
``SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-
SAVING DRUGS.
``(a) In General.--A manufacturer of a drug--
``(1) that is--
``(A) life-supporting;
``(B) life-sustaining;
``(C) intended for use in the prevention of a
debilitating disease or condition;
``(D) a sterile injectable product; or
``(E) used in emergency medical care or during
surgery; and
``(2) that is not a radio pharmaceutical drug product, a
human tissue replaced by a recombinant product, a product
derived from human plasma protein, or any other product as
designated by the Secretary,
shall notify the Secretary, in accordance with subsection (b), of a
permanent discontinuance in the manufacture of the drug or an
interruption of the manufacture of the drug that could lead to a
meaningful disruption in the supply of that drug in the United States.
``(b) Timing.--A notice required under 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) Expedited Inspections and Reviews.--If, based on
notifications described in subsection (a) or any other relevant
information, the Secretary concludes that there is, or is likely to be,
a drug shortage of a drug described in subsection (a), the Secretary
may--
``(1) expedite the review of a supplement to a new drug
application submitted under section 505(b), an abbreviated new
drug application submitted under section 505(j), or a
supplement to such an application submitted under section
505(j) that could help mitigate or prevent such shortage; or
``(2) expedite an inspection or reinspection of an
establishment that could help mitigate or prevent such drug
shortage.
``(d) Coordination.--
``(1) Task force and strategic plan.--
``(A) In general.--
``(i) Task force.--As soon as practicable
after the date of enactment of the Food and
Drug Administration Safety and Innovation Act,
the Secretary shall establish a Task Force to
develop and implement a strategic plan for
enhancing the Secretary's response to
preventing and mitigating drug shortages.
``(ii) Strategic plan.--The strategic plan
described in clause (i) shall include--
``(I) plans for enhanced
interagency and intraagency
coordination, communication, and
decisionmaking;
``(II) plans for ensuring that drug
shortages are considered when the
Secretary initiates a regulatory action
that could precipitate a drug shortage
or exacerbate an existing drug
shortage;
``(III) plans for effective
communication with outside
stakeholders, including who the
Secretary should alert about potential
or actual drug shortages, how the
communication should occur, and what
types of information should be shared;
and
``(IV) plans for considering the
impact of drug shortages on research
and clinical trials.
``(iii) Consultation.--In carrying out this
subparagraph, the Task Force shall ensure
consultation with the appropriate offices
within the Food and Drug Administration,
including the Office of the Commissioner, the
Center for Drug Evaluation and Research, the
Office of Regulatory Affairs, and employees
within the Department of Health and Human
Services with expertise regarding drug
shortages. The Secretary shall engage external
stakeholders and experts as appropriate.
``(B) Timing.--Not later than 1 year after the date
of enactment Food and Drug Administration Safety and
Innovation Act, the Task Force shall--
``(i) publish the strategic plan described
in subparagraph (A); and
``(ii) submit such plan to Congress.
``(2) Communication.--The Secretary shall ensure that,
prior to any enforcement action or issuance of a warning letter
that the Secretary determines could reasonably be anticipated
to lead to a meaningful disruption in the supply in the United
States of a drug described under subsection (a), there is
communication with the appropriate office of the Food and Drug
Administration with expertise regarding drug shortages
regarding whether the action or letter could cause, or
exacerbate, a shortage of the drug.
``(3) Action.--If the Secretary determines, after the
communication described in paragraph (2), that an enforcement
action or a warning letter could reasonably cause or exacerbate
a shortage of a drug described under subsection (a), then the
Secretary shall evaluate the risks associated with the impact
of such shortage upon patients and those risks associated with
the violation involved before taking such action or issuing
such letter, unless there is imminent risk of serious adverse
health consequences or death to humans.
``(4) Reporting by other entities.--The Secretary shall
identify or establish a mechanism by which healthcare providers
and other third-party organizations may report to the Secretary
evidence of a drug shortage.
``(5) Review and construction.--No determination, finding,
action, or omission of the Secretary under this subsection
shall--
``(A) be subject to judicial review; or
``(B) be construed to establish a defense to an
enforcement action by the Secretary.
``(e) Recordkeeping and Reporting.--
``(1) Recordkeeping.--The Secretary shall maintain records
related to drug shortages, including with respect to each of
the following:
``(A) The number of manufacturers that submitted a
notification to the Secretary under subsection (a) in
each calendar year.
``(B) The number of drug shortages that occurred in
each calendar year and a list of drug names, drug
types, and classes that were the subject of such
shortages.
``(C) A list of the known factors contributing to
the drug shortages described in subparagraph (B).
``(D)(i) A list of major actions taken by the
Secretary to prevent or mitigate the drug shortages
described in subparagraph (B).
``(ii) The Secretary shall include in the list
under clause (i) the following:
``(I) The number of applications for which
the Secretary expedited review under subsection
(c)(1) in each calendar year.
``(II) The number of establishment
inspections or reinspections that the Secretary
expedited under subsection (c)(2) in each
calendar year.
``(E) The number of notifications submitted to the
Secretary under subsection (a) in each calendar year.
``(F) The names of manufacturers that the Secretary
has learned did not comply with the notification
requirement under subsection (a) in each calendar year.
``(G) The number of times in each calendar year
that the Secretary determined under subsection (d)(3)
that an enforcement action or a warning letter could
reasonably cause or exacerbate a shortage of a drug
described under subsection (a), but did not evaluate
the risks associated with the impact of such shortage
upon patients and those risks associated with the
violation involved before taking such action or issuing
such letter on the grounds that there was imminent risk
of serious adverse health consequences or death to
humans, and a summary of the determinations.
``(H) A summary of the communications made and
actions taken under subsection (d) in each calendar
year.
``(I) Any other information the Secretary deems
appropriate to better prevent and mitigate drug
shortages.
``(2) Trend analysis.--The Secretary is authorized to
retain a third party to conduct a study, if the Secretary
believes such a study would help clarify the causes, trends, or
solutions related to drug shortages.
``(3) Annual summary.--Not later than 18 months after the
date of enactment of the Food and Drug Administration Safety
and Innovation Act, and annually thereafter, the Secretary
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 summarizing, with
respect to the 1-year period preceding such report, the
information described in paragraph (1). Such report shall not
include any information that is exempt from disclosure under
subsection (a) of section 552 of title 5, United States Code,
by reason of subsection (b)(4) of such section.
``(f) Definitions.--For purposes of this section--
``(1) the term `drug'--
``(A) means a drug (as defined in section 201(g))
that is intended for human use; and
``(B) does not include biological products (as
defined in section 351 of the Public Health Service
Act), unless otherwise provided by the Secretary in the
regulations promulgated under subsection (h);
``(2) the term `drug shortage' or `shortage', with respect
to a drug, means a period of time when the demand or projected
demand for the drug within the United States exceeds the supply
of the drug; and
``(3) the term `meaningful disruption'--
``(A) means a change in production that is
reasonably likely to lead to a reduction in the supply
of a drug by a manufacturer that is more than
negligible and impacts the ability of the manufacturer
to fill orders or meet expected demand for its product;
and
``(B) does not include interruptions in
manufacturing 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.
``(g) Distribution.--To the maximum extent practicable, the
Secretary may distribute information on drug shortages and on the
permanent discontinuation of the drugs described in this section to
appropriate provider and patient organizations, except that any such
distribution shall not include any information that is exempt from
disclosure under section 552 of title 5, United States Code, by reason
of subsection (b)(4) of such section.
``(h) Regulations.--
``(1) In general.--Not later than 18 months after the date
of enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt a final regulation
implementing this section.
``(2) Inclusion of biological products.--
``(A) In general.--The Secretary may by regulation
apply this section to biological products (as defined
in section 351 of the Public Health Service Act) if the
Secretary determines such inclusion would benefit the
public health.
``(B) Rule for vaccines.--If the Secretary applies
this section to vaccines pursuant to subparagraph (A),
the Secretary shall--
``(i) consider whether the notification
requirement under subsection (a) may be
satisfied by submitting a notification to the
Centers for Disease Control and Prevention
under the vaccine shortage notification program
of such Centers; and
``(ii) explain the determination made by
the Secretary under clause (i) in the
regulation.
``(3) Procedure.--In promulgating a regulation implementing
this section, the Secretary shall--
``(A) issue a notice of proposed rulemaking that
includes the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30
days before the regulation's effective date.
``(4) Restrictions.--Notwithstanding any other provision of
Federal law, in implementing this section, the Secretary shall
only promulgate regulations as described in paragraph (3).''.
(b) Effect of Notification.--The submission of a notification to
the Secretary of Health and Human Services (referred to in this section
as the ``Secretary'') for purposes of complying with the requirement in
section 506C(a) of the Federal Food, Drug, and Cosmetic Act (as amended
by subsection (a)) shall not be construed--
(1) as an admission that any product that is the subject of
such notification violates any provision of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
(2) as evidence of an intention to promote or market the
product for an indication or use for which the product has not
been approved by the Secretary.
(c) Internal Review.--Not later than 2 years after the date of
enactment of this Act, the Secretary shall--
(1) analyze and review the regulations promulgated under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.), the guidances or policies issued under such Act related
to drugs intended for human use, and the practices of the Food
and Drug Administration regarding enforcing such Act related to
manufacturing of such drugs, to identify any such regulations,
guidances, policies, or practices that cause, exacerbate,
prevent, or mitigate drug shortages (as defined in section 506C
of the Federal Food, Drug, and Cosmetic Act (as amended by
subsection (a)); and
(2) determine how regulations, guidances, policies, or
practices identified under paragraph (1) should be modified,
streamlined, expanded, or discontinued in order to reduce or
prevent such drug shortages, taking into consideration the
effect of any changes on the public health.
(d) Study on Market Factors Contributing to Drug Shortages and
Stockpiling.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General of the United
States, in consultation with the Secretary, the Department of
Health and Human Services Office of the Inspector General, the
Attorney General, and Chairman of the Federal Trade Commission,
shall publish a report reviewing any findings that drug
shortages (as so defined) have led market participants to
stockpile affected drugs or sell them at significantly
increased prices, the impact of such activities on Federal
revenue, and any economic factors that have exacerbated or
created a market for such actions.
(2) Content.--The report under paragraph (1) shall
include--
(A) an analysis of the incidence of any of the
activities described in paragraph (1) and the effect of
such activities on the public health;
(B) an evaluation of whether in such cases there is
a correlation between drugs in shortage and--
(i) the number of manufacturers producing
such drugs;
(ii) the pricing structure, including
Federal reimbursements, for such drugs before
such drugs were in shortage, and to the extent
possible, revenue received by each such
manufacturer of such drugs;
(iii) pricing structure and revenue, to the
extent possible, for the same drugs when sold
under the conditions described in paragraph
(1); and
(iv) the impact of contracting practices by
market participants (including manufacturers,
distributors, group purchasing organizations,
and providers) on competition, access to drugs,
and pricing of drugs;
(C) whether the activities described in paragraph
(1) are consistent with applicable law; and
(D) recommendations to Congress on what, if any,
additional reporting or enforcement actions are
necessary.
(3) Trade secret and confidential information.--Nothing in
this subsection alters or amends section 1905 of title 18,
United States Code, or section 552(b)(4) of title 5, United
States Code.
(e) Guidance Regarding Repackaging.--Not later than 1 year after
the date of enactment of this Act, the Secretary shall issue guidance
that clarifies the policy of the Food and Drug Administration regarding
hospital pharmacies repackaging and safely transferring repackaged
drugs among hospitals within a common health system during a drug
shortage, as identified by the Secretary.
TITLE XI--OTHER PROVISIONS
Subtitle A--Reauthorizations
SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF
CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
(a) In General.--Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended
by striking ``2012'' and inserting ``2017''.
(b) Amendment.--Section 505(u)(1)(A)(ii)(II) (21 U.S.C.
355(u)(1)(A)(ii)(II)) is amended by inserting ``clinical'' after
``any''.
SEC. 1102. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIPS.
Section 566(f) (21 U.S.C. 360bbb-5(f)) is amended by striking
``2012'' and inserting ``2017''.
Subtitle B--Medical Gas Product Regulation
SEC. 1111. REGULATION OF MEDICAL GAS PRODUCTS.
(a) Regulation.--Chapter V (21 U.S.C. 351 et seq.) is amended by
adding at the end the following:
``Subchapter G--Medical Gas Products
``SEC. 575. DEFINITIONS.
``In this subchapter:
``(1) The term `designated medical gas product' 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 product deemed
appropriate by the Secretary, unless any period of
exclusivity under section 505(c)(3)(E)(ii) or
505(j)(5)(F)(ii), or the extension of any such period
under section 505A, applicable to such medical gas
product has not expired.
``(2) The term `medical gas product' 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 GAS PRODUCTS.
``(a) Certification of Designated Medical Gas Products.--
``(1) Submission.--
``(A) In general.--Beginning on the date of
enactment of this section, any person may file with the
Secretary a request for a certification of a designated
medical gas product.
``(B) Content.--A request under subparagraph (A)
shall contain--
``(i) a description of the medical gas
product;
``(ii) the name and address of the sponsor;
``(iii) the name and address of the
facility or facilities where the gas product is
or will be manufactured; and
``(iv) any other information deemed
appropriate by the Secretary to determine
whether the medical gas product is a designated
medical gas product.
``(2) Grant of certification.--A certification described
under paragraph (1)(A) shall be determined to have been granted
unless, not later than 60 days after the filing of a request
under paragraph (1), the Secretary finds that--
``(A) the medical gas product subject to the
certification is not a designated medical gas product;
``(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 gas product is a designated medical
gas product; or
``(C) granting the request would be contrary to
public health.
``(3) Effect of certification.--
``(A) In general.--
``(i) Approved uses.--A designated medical
gas product for which a certification is
granted under paragraph (2) is deemed, alone or
in combination with another designated gas
product or products as medically appropriate,
to have in effect an approved application under
section 505 or 512, subject to all applicable
postapproval requirements, for the following
indications for use:
``(I) Oxygen for the treatment or
prevention of hypoxemia or hypoxia.
``(II) Nitrogen for use in hypoxic
challenge testing.
``(III) Nitrous oxide for
analgesia.
``(IV) Carbon dioxide for use in
extracorporeal membrane oxygenation
therapy or respiratory stimulation.
``(V) Helium for the treatment of
upper airway obstruction or increased
airway resistance.
``(VI) Medical air to reduce the
risk of hyperoxia.
``(VII) Carbon monoxide for use in
lung diffusion testing.
``(VIII) Any other indication for
use for a designated medical gas
product or combination of designated
medical gas products deemed appropriate
by the Secretary, unless any period of
exclusivity under clause (iii) or (iv)
of section 505(c)(3)(E), under clause
(iii) or (iv) of section 505(j)(5)(F),
or under section 527, or the extension
of any such period under section 505A,
applicable to such indication for use
for such gas product or combination of
products has not expired.
``(ii) Labeling.--The requirements
established in sections 503(b)(4) and 502(f)
shall be deemed to have been met for a
designated medical gas product if the labeling
on final use containers of such gas product
bears the information required by section
503(b)(4) and a warning statement concerning
the use of the gas product, as determined by
the Secretary by regulation, as well as
appropriate directions and warnings concerning
storage and handling.
``(B) Inapplicability of exclusivity provisions.--
``(i) Effect on ineligibility.--No
designated medical gas product deemed under
paragraph (3)(A)(i) to have in effect an
approved application shall be eligible for any
periods of exclusivity under sections 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 sections 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 shall prohibit, limit,
or otherwise affect the submission, grant, or
effect of a certification under this section,
except as provided in paragraph
(3)(A)(i)(VIII).
``(4) Withdrawal, suspension, or revocation of approval.--
``(A) In general.--Nothing in this subchapter
limits the authority of the Secretary to withdraw or
suspend approval of a drug, including a designated
medical gas product deemed under this section to have
in effect an approved application, under section 505 or
section 512.
``(B) Revocation.--The Secretary may revoke the
grant of a certification under this section 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 product shall
be subject to section 503(b)(1) unless the Secretary exercises
the authority provided in section 503(b)(3) to remove such gas
product from the requirements of section 503(b)(1) or the use
in question is authorized pursuant to another provision of this
Act relating to use of medical products in emergencies.
``(2) Exception for oxygen.--
``(A) In general.--Notwithstanding paragraph (1),
oxygen may be provided without a prescription for the
following uses:
``(i) The use in the event of
depressurization or other environmental oxygen
deficiency.
``(ii) The use in the event of oxygen
deficiency or use in emergency resuscitation,
when administered by properly trained
personnel.
``(B) Labeling.--For oxygen provided pursuant to
subparagraph (A), the requirements established in
section 503(b)(4) shall be deemed to have been met if
the labeling of the oxygen bears a warning that the
medical gas product can be used for emergency use only
and for all other medical applications a prescription
is required.
``(c) Inapplicability of Drugs Fees to Designated Medical Gas
Products.--A designated medical gas product deemed under this section
to have in effect an approved application shall not be assessed fees
under section 736(a) on the basis of such deemed approval.''.
SEC. 1112. REGULATIONS.
(a) Review of Regulations.--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, after
obtaining input from medical gas product manufacturers, and any other
interested members of the public, submit a report to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives regarding any
changes to the Federal drug regulations in title 21, Code of Federal
Regulations that the Secretary determines to be necessary.
(b) Amended Regulations.--If the Secretary determines that changes
to the Federal drug regulations in title 21, Code of Federal
Regulations are necessary under subsection (a), the Secretary shall
issue final regulations implementing such changes not later than 4
years after the date of enactment of this Act.
SEC. 1113. APPLICABILITY.
Nothing in this subtitle or the amendments made by this subtitle
shall apply to--
(1) a drug that is covered by an application under section
505 or 512 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355, 360b) approved prior to May 1, 2012; or
(2) any of the gases listed in subparagraphs (A) through
(G) of section 575(1) of such Act (as added by section 1111),
or any mixture 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)(i) of such Act (as added by section 1111);
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--Miscellaneous Provisions
SEC. 1121. ADVISORY COMMITTEE CONFLICTS OF INTEREST.
Section 712 (21 U.S.C. 379d-1) is amended--
(1) in subsection (b)--
(A) by striking paragraph (2); and
(B) in paragraph (1)--
(i) by redesignating subparagraph (B) as
paragraph (2) and moving such paragraph, as so
redesignated, 2 ems to the left;
(ii) in subparagraph (A), by redesignating
clauses (i) through (iii) as subparagraphs (A)
through (C), respectively, and moving such
subparagraphs, as so redesignated, 2 ems to the
left;
(iii) in subparagraph (A), as so
redesignated, by inserting ``, including
strategies to increase the number of special
Government employees across medical and
scientific specialties in areas where the
Secretary would benefit from specific
scientific, medical, or technical expertise
necessary for the performance of its regulatory
responsibilities'' before the semicolon at the
end;
(iv) by striking ``(1) Recruitment.--'' and
inserting ``(1) Recruitment in general.--The
Secretary shall--'';
(v) by striking ``(A) In general.--The
Secretary shall--'';
(vi) by redesignating clauses (i) through
(iii) of paragraph (2) (as so redesignated) as
subparagraphs (A) through (C), respectively,
and moving such subparagraphs, as so
redesignated, 2 ems to the left;
(vii) in paragraph (2) (as so
redesignated), in the matter before
subparagraph (A) (as so redesignated), by
striking ``subparagraph (A)'' and inserting
``paragraph (1)''; and
(viii) by adding at the end the following:
``(3) Recruitment through referrals.--In carrying out
paragraph (1), the Secretary shall, in order to further the
goal of including in advisory committees highly qualified and
specialized experts in the specific diseases to be considered
by such advisory committees, at least every 180 days, request
referrals from a variety of stakeholders, such as the Institute
of Medicine, the National Institutes of Health, product
developers, patient groups, disease advocacy organizations,
professional societies, medical societies, including the
American Academy of Medical Colleges, and other governmental
organizations.'';
(2) by amending subsection (c)(2)(C) to read as follows:
``(C) Consideration by secretary.--The Secretary
shall ensure that each determination made under
subparagraph (B) considers the type, nature, and
magnitude of the financial interests at issue and the
public health interest in having the expertise of the
member with respect to the particular matter before the
advisory committee.'';
(3) in subsection (e), by inserting ``, and shall make
publicly available,'' after ``House of Representatives''; and
(4) by adding at the end the following:
``(g) Guidance on Reported Financial Interest or Involvement.--The
Secretary shall issue guidance that describes how the Secretary reviews
the financial interests and involvement of advisory committee members
that are reported under subsection (c)(1) but that the Secretary
determines not to meet the definition of a disqualifying interest under
section 208 of title 18, United States Code for the purposes of
participating in a particular matter.''.
SEC. 1122. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION USING THE
INTERNET.
Not later than 2 years after the date of enactment this Act, the
Secretary of Health and Human Services shall issue guidance that
describes Food and Drug Administration policy regarding the promotion,
using the Internet (including social media), of medical products that
are regulated by such Administration.
SEC. 1123. 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 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. 1124. 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. 1125. TANNING BED LABELING.
Not later than 18 months after the date of enactment of this Act,
the Secretary of Health and Human Services shall determine whether to
amend the warning label requirements for sunlamp products to include
specific requirements to more clearly and effectively convey the risks
that such products pose for the development of irreversible damage to
the eyes and skin, including skin cancer.
SEC. 1126. OPTIMIZING GLOBAL CLINICAL TRIALS.
Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by
section 903, is further amended by adding at the end the following:
``SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS.
``(a) In General.--The Secretary shall--
``(1) work with other regulatory authorities of similar
standing, medical research companies, and international
organizations to foster and encourage uniform, scientifically-
driven clinical trial standards with respect to medical
products around the world; and
``(2) enhance the commitment to provide consistent parallel
scientific advice to manufacturers seeking simultaneous global
development of new medical products in order to--
``(A) enhance medical product development;
``(B) facilitate the use of foreign data; and
``(C) minimize the need to conduct duplicative
clinical studies, preclinical studies, or non-clinical
studies.
``(b) Medical Product.--In this section, the term `medical product'
means a drug, as defined in subsection (g) of section 201, a device, as
defined in subsection (h) of such section, or a biological product, as
defined in section 351(i) of the Public Health Service Act.
``(c) Savings Clause.--Nothing in this section shall alter the
criteria for evaluating the safety or effectiveness of a medical
product under this Act.
``SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE THE UNITED
STATES.
``(a) In General.--In determining whether to approve, license, or
clear a drug or device pursuant to an application submitted under this
chapter, the Secretary shall accept data from clinical investigations
conducted outside of the United States, including the European Union,
if the applicant demonstrates that such data are adequate under
applicable standards to support approval, licensure, or clearance of
the drug or device in the United States.
``(b) Notice to Sponsor.--If the Secretary finds under subsection
(a) that the data from clinical investigations conducted outside the
United States, including in the European Union, are inadequate for the
purpose of making a determination on approval, clearance, or licensure
of a drug or device pursuant to an application submitted under this
chapter, the Secretary shall provide written notice to the sponsor of
the application of such finding and include the rationale for such
finding.''.
SEC. 1127. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC HEALTH
INNOVATION.
(a) In General.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall develop a strategy and
implementation plan for advancing regulatory science for medical
products in order to promote the public health and advance innovation
in regulatory decisionmaking.
(b) Requirements.--The strategy and implementation plan developed
under subsection (a) shall be consistent with the user fee performance
goals in the Prescription Drug User Fee Agreement commitment letter,
the Generic Drug User Fee Agreement commitment letter, and the
Biosimilar User Fee Agreement commitment letter transmitted by the
Secretary to Congress on January 13, 2012, and the Medical Device User
Fee Agreement commitment letter transmitted by the Secretary to
Congress on April 20, 2012, and shall--
(1) identify a clear vision of the fundamental role of
efficient, consistent, and predictable, science-based decisions
throughout regulatory decisionmaking of the Food and Drug
Administration with respect to medical products;
(2) identify the regulatory science priorities of the Food
and Drug Administration directly related to fulfilling the
mission of the agency with respect to decisionmaking concerning
medical products and allocation of resources towards such
regulatory science priorities;
(3) identify regulatory and scientific gaps that impede the
timely development and review of, and regulatory certainty with
respect to, the approval, licensure, or clearance of medical
products, including with respect to companion products and new
technologies, and facilitating the timely introduction and
adoption of new technologies and methodologies in a safe and
effective manner;
(4) identify clear, measurable metrics by which progress on
the priorities identified under paragraph (2) and gaps
identified under paragraph (3) will be measured by the Food and
Drug Administration, including metrics specific to the
integration and adoption of advances in regulatory science
described in paragraph (5) and improving medical product
decisionmaking, in a predictable and science-based manner; and
(5) set forth how the Food and Drug Administration will
ensure that advances in regulatory science for medical products
are adopted, as appropriate, on an ongoing basis and in an
manner integrated across centers, divisions, and branches of
the Food and Drug Administration, including by senior managers
and reviewers, including through the--
(A) development, updating, and consistent
application of guidance documents that support medical
product decisionmaking; and
(B) the adoption of the tools, methods, and
processes under section 566 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-5).
(c) Annual Performance Reports.--As part of the annual performance
reports submitted to Congress under sections 736B(a) (as amended by
section 104), 738A(a) (as amended by section 204), 744C(a) (as added by
section 303), and 744I(a) (as added by section 403) of the Federal
Food, Drug, and Cosmetic Act for each of fiscal years 2013 through
2017, the Secretary shall annually report on the progress made with
respect to--
(1) advancing the regulatory science priorities identified
under paragraph (2) of subsection (b) and resolving the gaps
identified under paragraph (3) of such subsection, including
reporting on specific metrics identified under paragraph (4) of
such subsection;
(2) the integration and adoption of advances in regulatory
science as set forth in paragraph (5) of such subsection; and
(3) the progress made in advancing the regulatory science
goals outlined in the Prescription Drug User Fee Agreement
commitment letter, the Generic Drug User Fee Agreement
commitment letter, and the Biosimilar User Fee Agreement
commitment letter transmitted by the Secretary to Congress on
January 13, 2012, and the Medical Device User Fee Agreement
transmitted by the Secretary to Congress on April 20, 2012.
(d) Independent Assessment.--Not later than January 1, 2016, the
Comptroller General of the United States shall submit to Congress a
report--
(1) detailing the progress made by the Food and Drug
Administration in meeting the priorities and addressing the
gaps identified in subsection (b), including any outstanding
gaps; and
(2) containing recommendations, as appropriate, on how
regulatory science initiatives for medical products can be
strengthened and improved to promote the public health and
advance innovation in regulatory decisionmaking.
(e) Medical Product.--In this section, the term ``medical product''
means a drug, as defined in subsection (g) of section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), a device, as
defined in subsection (h) of such section, or a biological product, as
defined in section 351(i) of the Public Health Service Act.
SEC. 1128. INFORMATION TECHNOLOGY.
(a) HHS Report.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services shall--
(1) report to Congress on--
(A) the milestones and a completion date for
developing and implementing a comprehensive information
technology strategic plan to align the information
technology systems modernization projects with the
strategic goals of the Food and Drug Administration,
including results-oriented goals, strategies,
milestones, performance measures;
(B) efforts to finalize and approve a comprehensive
inventory of the information technology systems of the
Food and Drug Administration that includes information
describing each system, such as costs, system function
or purpose, and status information, and incorporate use
of the system portfolio into the information investment
management process of the Food and Drug Administration;
(C) the ways in which the Food and Drug
Administration uses the plan described in subparagraph
(A) to guide and coordinate the modernization projects
and activities of the Food and Drug Administration,
including the interdependencies among projects and
activities; and
(D) the extent to which the Food and Drug
Administration has fulfilled or is implementing
recommendations of the Government Accountability Office
with respect to the Food and Drug Administration and
information technology; and
(2) develop--
(A) a documented enterprise architecture program
management plan that includes the tasks, activities,
and timeframes associated with developing and using the
architecture and addresses how the enterprise
architecture program management will be performed in
coordination with other management disciplines, such as
organizational strategic planning, capital planning and
investment control, and performance management; and
(B) a skills inventory, needs assessment, gap
analysis, and initiatives to address skills gaps as
part of a strategic approach to information technology
human capital planning.
(b) GAO Report.--Not later than January 1, 2016, the Comptroller
General of the United States shall issue a report regarding the
strategic plan described in subsection (a)(1)(A) and related actions
carried out by the Food and Drug Administration. Such report shall
assess the progress the Food and Drug Administration has made on--
(1) the development and implementation of a comprehensive
information technology strategic plan, including the results-
oriented goals, strategies, milestones, and performance
measures identified in subsection (a)(1)(A);
(2) the effectiveness of the comprehensive information
technology strategic plan described in subsection (a)(1)(A),
including the results-oriented goals and performance measures;
and
(3) the extent to which the Food and Drug Administration
has fulfilled recommendations of the Government Accountability
Office with respect to such agency and information technology.
SEC. 1129. REPORTING REQUIREMENTS.
Subchapter A of chapter VII (21 U.S.C. 371 et seq.), as amended by
section 208, is further amended by adding at the end the following:
``SEC. 715. REPORTING REQUIREMENTS.
``(a) New Drugs.--Beginning with fiscal year 2013 and ending with
fiscal year 2017, not later than 120 days after the end of each fiscal
year for which fees are collected under part 2 of subchapter C, 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 a report
concerning, for all applications for approval of a new drug under
section 505(b) of this Act or a new biological product under section
351(a) of the Public Health Service Act filed in the previous fiscal
year--
``(1) the number of such applications that met the goals
identified for purposes of part 2 of subchapter C 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;
``(2) the percentage of such applications that were
approved;
``(3) the percentage of such applications that were issued
complete response letters;
``(4) the percentage of such applications that were subject
to a refuse-to-file action;
``(5) the percentage of such applications that were
withdrawn; and
``(6) the average total time to decision by the Secretary
for all applications for approval of a new drug under section
505(b) of this Act or a new biological product under section
351(a) of the Public Health Service Act filed in the previous
fiscal year, including the number of calendar days spent during
the review by the Food and Drug Administration and the number
of calendar days spent by the sponsor responding to a complete
response letter.''.
``(b) Generic Drugs.--Beginning with fiscal year 2013 and ending
after fiscal year 2017, not later than 120 days after the end of each
fiscal year for which fees are collected under part 7 of subchapter C,
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 a report
concerning, for all applications for approval of a generic drug under
section 505(j), amendments to such applications, and prior approval
supplements with respect to such applications filed in the previous
fiscal year--
``(1) the number of such applications that met the goals
identified for purposes of part 7 of subchapter C, 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;
``(2) the average total time to decision by the Secretary
for applications for approval of a generic drug under section
505(j), amendments to such applications, and prior approval
supplements with respect to such applications filed in the
previous fiscal year, including the number of calendar days
spent during the review by the Food and Drug Administration and
the number of calendar days spent by the sponsor responding to
a complete response letter;
``(3) the total number of applications under section
505(j), amendments to such applications, and prior approval
supplements with respect to such applications that were pending
with the Secretary for more than 10 months on the date of
enactment of the Food and Drug Administration Safety and
Innovation Act; and
``(4) the number of applications described in paragraph (3)
on which the Food and Drug Administration took final regulatory
action in the previous fiscal year.
``(c) Biosimilar Biological Products.--
``(1) In general.--Beginning with fiscal year 2014, not
later than 120 days after the end of each fiscal year for which
fees are collected under part 8 of subchapter C, 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 a report
concerning--
``(A) the number of applications for approval filed
under section 351(k) of the Public Health Service Act;
and
``(B) the percentage of applications described in
subparagraph (A) that were approved by the Secretary.
``(2) Additional information.--As part of the performance
report described in paragraph (1), the Secretary shall include
an explanation of how the Food and Drug Administration is
managing the biological product review program to ensure that
the user fees collected under part 2 are not used to review an
application under section 351(k) of the Public Health Service
Act.''.
SEC. 1130. STRATEGIC INTEGRATED MANAGEMENT PLAN.
(a) Strategic Integrated Management Plan.--Not later than 1 year
after the date of enactment of this Act, the Secretary of Health and
Human Services (referred to in this section as the ``Secretary'') shall
submit to Congress a strategic integrated management plan for the
Center for Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, and the Center for Devices and Radiological
Health. Such strategic management plan shall--
(1) identify strategic institutional goals and priorities
for the Center for Drug Evaluation and Research, the Center for
Biologics Evaluation and Research, and the Center for Devices
and Radiological Health;
(2) describe the actions the Secretary will take to
recruit, retain, train, and continue to develop the workforce
at the Center for Drug Evaluation and Research, the Center for
Biologics Evaluation and Research, and the Center for Devices
and Radiological Health to fulfill the public health mission of
the Food and Drug Administration; and
(3) identify results-oriented, outcome-based measures that
the Secretary will use to measure the progress of achieving the
strategic goals and priorities identified under paragraph (1)
and the effectiveness of the actions identified under paragraph
(2), including metrics to ensure that managers and reviewers of
the Center for Drug Evaluation and Research, the Center for
Biologics Evaluation and Research, and the Center for Devices
and Radiological Health are familiar with and appropriately and
consistently apply the requirements under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), including new
requirements under parts 2, 3, 7, and 8 of subchapter C of
title VII of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379f et seq.).
(b) Report.--Not later than January 1, 2016, the Comptroller
General of the United States shall issue a report regarding the
strategic management plan described in subsection (a) and related
actions carried out by the Food and Drug Administration. Such report
shall--
(1) assess the effectiveness of the actions described in
subsection (a)(2) in recruiting, retaining, training, and
developing the workforce at the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, and
the Center for Devices and Radiological Health in fulfilling
the public health mission of the Food and Drug Administration;
(2) assess the effectiveness of the measures identified
under subsection (a)(3) in gauging progress against the
strategic goals and priorities identified under subsection
(a)(1);
(3) assess the extent to which the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation
and Research, and the Center for Devices and Radiological
Health are using the identified results-oriented set of
performance measures in tracking their workload by strategic
goals and the effectiveness of such measures;
(4) assess the extent to which performance information is
collected, analyzed, and acted on by managers; and
(5) make recommendations, as appropriate, regarding how the
strategic management plan and related actions of the Center for
Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, and the Center for Devices and
Radiological Health could be improved to fulfill the public
health mission of the Food and Drug Administration in as
efficient and effective manner as possible.
SEC. 1131. DRUG DEVELOPMENT AND BIOEQUIVALENCE TESTING.
(a) In General.--Section 505-1 (21 U.S.C. 355-1) is amended by
adding at the end the following:
``(k) Drug Development and Bioequivalence Testing.--
``(1) In general.--Notwithstanding any other provision of
law, if a drug is a covered drug, no elements to ensure safe
use shall prohibit, or be construed or applied to prohibit,
supply of such drug to any eligible drug developer for the
purpose of developing, or conducting bioequivalence testing
necessary to support, an application under subsection (b)(2) or
(j) of section 505 of this Act or section 351(k) of the Public
Health Service Act, if the Secretary has issued a written
notice described in paragraph (2), and the eligible drug
developer has agreed to comply with the terms of the notice.
``(2) Written notice.--For purposes of this subsection, the
Secretary shall issue a written notice to an eligible drug
developer and the holder of an application for a covered drug
authorizing the supply of a drug to such eligible drug
developer for purposes of bioequivalence testing if--
``(A) the eligible drug developer has agreed to
comply with any conditions the Secretary considers
necessary; and
``(B) the eligible drug developer has submitted and
the Secretary has approved a protocol for
bioequivalence testing that includes protections that
the Secretary finds will provide assurance of safety
comparable to the assurance of safety provided by the
elements to ensure safe use in the risk evaluation and
mitigation strategy for the covered drug.
``(3) Additional required element.--The Secretary shall
require as an element of each risk evaluation and mitigation
strategy approved by the Secretary that the holder of an
application for a covered drug shall not restrict the resale of
the covered drug to an eligible drug developer that receives a
written notice from the Secretary under paragraph (2).
``(4) Penalties.--For purposes of subsection (f)(8) and
sections 301, 303(f)(4), 502(y), and 505(p), it shall be a
violation of the risk evaluation and mitigation strategy for
the holder of the application for a covered drug to restrict
the sale of the drug to an eligible drug developer. The
Secretary shall provide written notice to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives of any penalty assessed under this subsection
within 7 days of such assessment.
``(5) Liability.--Unless the holder of the application for
a covered drug and the eligible developer are the same entity,
the holder of an application for a covered drug shall not be
liable for any claim arising out of the eligible drug
developer's testing necessary to support an application under
subsection (b)(2) or (j) of section 505 of this Act or section
351(k) of the Public Health Service Act for a drug obtained
under this subsection. Nothing in this subsection shall be
construed to expand or limit the liability of the eligible drug
developer or the holder of an application for a covered drug
for any other claim.
``(6) Definitions.--
``(A) Covered drug.--Notwithstanding subsection
(b)(2), for purposes of this subsection, the term
`covered drug' means a drug, including a biological
product licensed under section 351(a) of the Public
Health Service Act, that is subject to a risk
evaluation and mitigation strategy with elements to
ensure safe use under subsection (f), or a drug,
including a biological product licensed under section
351(a) of the Public Health Service Act, required to
have a risk evaluation and mitigation strategy with
elements to ensure safe use under section 909(b) of the
Food and Drug Administration Amendments Act of 2007.
``(B) Eligible drug developer.--For purposes of
this subsection, the term `eligible drug developer'
means a sponsor seeking to develop an application for
submission under subsection (b)(2) or (j) of section
505 of this Act or section 351(k) of the Public Health
Service Act.
``(7) Effect on other law.--Nothing in this subsection
shall affect the authority of the Federal Trade Commission to
enforce the Federal Trade Commission Act (15 U.S.C. 41-58), the
Sherman Act (15 U.S.C. 1-7)), or any other statute properly
under such Commission's jurisdiction.''.
(b) Technical and Conforming Amendment.--Section 505-1(c)(2) (21
U.S.C. 355-1(c)(2)) is amended by striking ``(e) and (f)'' and
inserting ``(e), (f), and (k)(3)''.
SEC. 1132. PATIENT PARTICIPATION IN MEDICAL PRODUCT DISCUSSIONS.
Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as amended by
section 1126, is further amended by adding at the end the following:
``SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PRODUCT DISCUSSION.
``(a) In General.--The Secretary shall develop and implement
strategies to solicit the views of patients during the medical product
development process and consider the perspectives of patients during
regulatory discussions, including by--
``(1) fostering participation of a patient representative
who may serve as a special government employee in appropriate
agency meetings with medical product sponsors and
investigators; and
``(2) exploring means to provide for identification of
patient representatives who do not have any, or have minimal,
financial interests in the medical products industry.
``(b) Financial Interest.--In this section, the term `financial
interest' means a financial interest under section 208(a) of title 18,
United States Code.''.
Calendar No. 400
112th CONGRESS
2d Session
S. 3187
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs and medical devices, to
establish user-fee programs for generic drugs and biosimilars, and for
other purposes.
_______________________________________________________________________
May 16, 2012
Read the second time and placed on the calendar