[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 469 Introduced in Senate (IS)]
<DOC>
115th CONGRESS
1st Session
S. 469
To amend the Federal Food, Drug, and Cosmetic Act to allow for the
importation of affordable and safe drugs by wholesale distributors,
pharmacies, and individuals.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 28, 2017
Mr. Sanders (for himself, Mr. Booker, Mr. Casey, Mr. Heinrich, Mr.
King, Mr. Whitehouse, Ms. Klobuchar, Mrs. Gillibrand, Mr. Brown, Mr.
Reed, Mr. Franken, Ms. Baldwin, Ms. Hassan, Mr. Udall, Ms. Stabenow,
Mrs. Shaheen, Ms. Cantwell, Mr. Van Hollen, Mr. Blumenthal, and Mr.
Manchin) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to allow for the
importation of affordable and safe drugs by wholesale distributors,
pharmacies, and individuals.
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 ``Affordable and Safe Prescription
Drug Importation Act''.
SEC. 2. IMPORTING AFFORDABLE AND SAFE DRUGS.
(a) In General.--Section 804 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384) is amended to read as follows:
``SEC. 804. IMPORTATION OF SAFE AND AFFORDABLE DRUGS BY WHOLESALE
DISTRIBUTORS, PHARMACIES, AND INDIVIDUALS.
``(a) In General.--Not later than 180 days after the date of
enactment of this section, the Secretary shall promulgate regulations
permitting the importation of qualifying prescription drugs into the
United States, in accordance with this section.
``(b) Definitions.--For purposes of this section:
``(1) Certified foreign seller.--The term `certified
foreign seller' means a licensed foreign pharmacy or foreign
wholesale distributor that the Secretary certifies under
subsection (d)(1)(B), that pays the fee required under
subsection (d)(1)(C), and that is included on the list
described in subsection (c).
``(2) Foreign wholesale distributor.--The term `foreign
wholesale distributor' means a person (other than a
manufacturer, a manufacturer's co-licensed partner, a third-
party logistics provider, or a repackager) engaged in wholesale
distribution.
``(3) Importer.--The term `importer' means a dispenser (as
defined in section 581(3)) or wholesale distributor registered
under section 503(e) who imports prescription drugs into the
United States in accordance with this section.
``(4) Licensed foreign pharmacy.--The term `licensed
foreign pharmacy' means a pharmacy located in Canada, or
subject to subsection (e), another applicable country, that--
``(A) operates in accordance with applicable
pharmacy standards set forth by the provincial pharmacy
rules and regulations enacted in Canada, or, subject to
subsection (e), such applicable rules and regulations
of the permitted country in which such seller is
located; and
``(B) is licensed to operate and dispense
prescription drugs to individuals in Canada, or,
subject to subsection (e), the permitted country in
which the pharmacy is located.
``(5) Qualifying prescription drug.--The term `qualifying
prescription drug'--
``(A) means a prescription drug that--
``(i) is approved for use in patients, and
marketed, in Canada, or subject to subsection
(e), approved for use in patients, and
marketed, in another permitted country;
``(ii) is manufactured in a facility
registered under subsection (b)(1) or (i) of
section 510 that is in compliance with good
manufacturing practices regulations of the Food
and Drug Administration;
``(iii) has the same active ingredient or
ingredients, route of administration, and
strength as a prescription drug approved under
chapter V, or, for purposes of subparagraph
(B)(iv), is biosimilar to an approved
biological product and has the same route of
administration and strength as the approved
biological product; and
``(iv) is labeled in accordance with--
``(I) the laws of Canada, or
another country from which importation
is permitted pursuant to subsection
(e); and
``(II) the requirements promulgated
by the Secretary, which shall include
labeling in English;
``(B) with respect to importers only, includes--
``(i) peritoneal dialysis solution;
``(ii) insulin;
``(iii) a drug for which a risk evaluation
and mitigation strategy is required under
section 505-1;
``(iv) biological products, as defined in
section 351 of the Public Health Service Act
that are proteins (except any chemically
synthesized polypeptides) or analogous
products; and
``(v) intravenously infused drugs; and
``(C) does not include--
``(i) a controlled substance (as defined in
section 102 of the Controlled Substances Act);
``(ii) an anesthetic drug inhaled during
surgery; or
``(iii) a compounded drug.
``(6) Valid prescription.--The term `valid prescription'
means a prescription that is issued for a legitimate medical
purpose in the usual course of professional practice by--
``(A) a practitioner who has conducted at least one
in-person medical evaluation of the patient; or
``(B) a covering practitioner.
``(c) Publication of Certified Foreign Sellers.--The Secretary
shall publish on a dedicated Internet Web site a list of certified
foreign sellers, including the Internet Web site address, physical
address, and telephone number of each such certified foreign seller.
``(d) Additional Criteria.--
``(1) Certified foreign sellers.--
``(A) In general.--To be a certified foreign
seller, such seller shall--
``(i) be certified by the Secretary in
accordance with subparagraph (B);
``(ii) pay the registration fee established
under subparagraph (C); and
``(iii) sell only qualifying prescription
drugs to importers or individuals who import
prescription drugs into the United States in
accordance with this section.
``(B) Certification.--To be a certified foreign
seller, the Secretary shall certify that such seller--
``(i) is a foreign wholesale distributor or
licensed foreign pharmacy operating an
establishment, which may include an online
foreign pharmacy, that is located in Canada,
or, subject to subsection (e), another
permitted country;
``(ii) is engaged in the distribution or
dispensing of a prescription drug that is
imported or offered for importation into the
United States;
``(iii) has been in existence for a period
of at least 5 years preceding the date of such
certification and has a purpose other than to
participate in the program established under
this section;
``(iv) in the case of a certified foreign
seller that is a licensed foreign pharmacy,
agrees to dispense a qualifying prescription
drug to an individual in the United States only
after receiving a valid prescription, as
described in paragraph (2)(C);
``(v) has processes established by the
seller, or participates in another established
process, to certify that the physical premises
and data reporting procedures and licenses are
in compliance with all applicable laws and
regulations of Canada, or, subject to
subsection (e), the permitted country in which
the seller is located, and has implemented
policies designed to monitor ongoing compliance
with such laws and regulations;
``(vi) conducts or commits to participate
in ongoing and comprehensive quality assurance
programs and implements such quality assurance
measures, including blind testing, to ensure
the veracity and reliability of the findings of
the quality assurance program;
``(vii) agrees that, pursuant to subsection
(g), laboratories approved by the Secretary may
be authorized to conduct product testing to
determine the chemical authenticity of sample
pharmaceutical products;
``(viii) agrees to notify the Secretary,
importers, and individuals of product recalls
in Canada, or pursuant to subsection (e), the
permitted country in which the seller is
located, and agrees to cease, or refrain from,
exporting such product;
``(ix) has established, or will establish
or participate in, a process for resolving
grievances, as defined by the Secretary, and
will be held accountable for violations of
established guidelines and rules;
``(x) except as otherwise permitted under
this section, does not sell products that the
seller could not otherwise legally sell in
Canada, or, subject to subsection (e), the
permitted country in which such seller is
located to customers in the United States; and
``(xi) meets any other criteria established
by the Secretary.
``(C) Certification fee.--Not later than 30 days
before the start of each fiscal year, the Secretary
shall establish a fee to be collected from foreign
sellers for such fiscal year that are certified under
subparagraph (B), in an amount that is sufficient, and
not more than necessary, to pay the costs of
administering the program under this section, and
enforcing this section pursuant to section 303(h), for
that fiscal year.
``(D) Recertification.--A certification under
subparagraph (B) shall be in effect for a period of 2
years, or until there is a material change in the
circumstances under which the foreign seller meets the
requirements under such subparagraph, whichever occurs
earlier. A foreign seller may reapply for certification
under such subparagraph (B), in accordance with a
process established by the Secretary.
``(2) Individuals.--An individual may import a qualifying
prescription drug described in subsection (b) from Canada or
another country pursuant to subsection (e) if such drug--
``(A) is dispensed, including through an online
pharmacy, by a certified foreign seller that is a
licensed foreign pharmacy;
``(B) is purchased for personal use by the
individual, not for resale, in quantities that do not
exceed a 90-day supply; and
``(C) is filled only after providing to the
licensed foreign pharmacy a valid prescription issued
by a health care practitioner licensed to practice in a
State in the United States.
``(e) Importation From Other Countries.--Beginning on the date that
is 2 years after the date on which final regulations are promulgated to
carry out this section, if, based on a review of the evidence obtained
after such effective date, including the reports submitted under
section 2(d) of the Affordable and Safe Prescription Drug Importation
Act, that importation of qualifying prescription drugs from Canada
under this section resulted in cost savings for consumers in the United
States and increased access to safe medication, the Secretary shall
have the authority to permit importation of qualifying prescription
drugs by importers and individuals from, in addition to Canada, any
country that--
``(1) is a member of the Organisation for Economic Co-
operation and Development; and
``(2) has statutory or regulatory standards for the
approval and sale of prescription drugs that are comparable to
the standards in the United States and that--
``(A) authorizes the approval of drugs only if a
drug has been determined to be safe and effective by
experts employed by or acting on behalf of a
governmental entity and qualified by scientific
training and experience to evaluate the safety and
effectiveness of drugs;
``(B) requires that any determination of safety and
effectiveness described in subparagraph (A) be made on
the basis of adequate and well-controlled
investigations, including clinical investigations, as
appropriate, conducted by experts qualified by
scientific training and experience to evaluate the
safety and effectiveness of drugs;
``(C) requires the methods used in, and the
facilities and controls used for, the manufacture,
processing, and packing of drugs in the country to be
adequate to preserve the identity, quality, purity, and
strength of the drugs; and
``(D) requires the reporting of adverse reactions
to drugs and establish procedures to recall, and
withdraw approval of, drugs found not to be safe or
effective.
``(f) Labeling.--Any qualifying prescription drug imported that
meets the labeling requirements described in subsection (b)(5)(A)(iv)
is deemed not misbranded for purposes of section 502.
``(g) Drug Testing Laboratories.--The Secretary may approve one or
more laboratories to conduct random testing of prescription drugs sold
by certified foreign sellers to assess the chemical authenticity of
such drugs.
``(h) Unfair and Discriminatory Acts and Practices.--It is unlawful
for a manufacturer, directly or indirectly (including by being a party
to a licensing agreement or other agreement)--
``(1) to discriminate by charging a higher price for a
prescription drug sold to a certified foreign seller that sells
such drug to an importer in accordance with this section than
the price that is charged, inclusive of rebates or other
incentives to the country from which the drug is exported, to
another person that is in the same country and that does not
import such a drug into the United States in accordance with
this section;
``(2) except with respect to a prescription drug on the
drug shortage list under section 506E, discriminate by denying,
restricting, or delaying supplies of a prescription drug to a
certified foreign seller, on account of such seller's status as
a certified foreign seller, that sells such drug to an importer
in accordance with this section, or by publicly, privately, or
otherwise refusing to do business with such a certified foreign
seller on account of such seller's status as a certified
foreign seller;
``(3) cause there to be a difference (including a
difference in active ingredient, route of administration,
bioequivalence, strength, formulation, manufacturing
establishment, manufacturing process, or person that
manufactures the drug) between a prescription drug for
distribution in the United States and the drug for distribution
in Canada or another permitted country, subject to subsection
(e), for the purpose of avoiding sales by certified foreign
sellers; or
``(4) except with respect to a prescription drug on the
drug shortage list under section 506E, engage in any other
action to restrict, prohibit, or delay the importation of a
prescription drug under this section.
``(i) Information and Records.--
``(1) Biannual reports.--Each importer shall submit
biannual reports to the Secretary which shall contain, for each
qualifying prescription drug imported into the United States--
``(A) the unique facility identifier of the
manufacturer of the drug, described in section 510;
``(B) the transaction information described in
section 581(26) (other than the information described
in subparagraph (C)); and
``(C) the price paid by the importer for the drug.
``(2) Maintenance of records by secretary.--The Secretary
shall maintain information and documentation submitted under
paragraph (1) for such period of time as the Secretary
determines to be appropriate.
``(j) Suspension of Importation.--
``(1) Patterns of noncompliance.--The Secretary shall
require that importation of a specific qualifying prescription
drug or importation by a specific certified foreign seller or
importer pursuant to this section be immediately suspended if
the Secretary determines that there is a pattern of importation
of such specific drug or by such specific seller or importer
that involves counterfeit drugs, drugs that have been recalled
or withdrawn, or drugs in violation of any requirement of this
section, until an investigation is completed and the Secretary
determines that importation of such drug or by such seller or
importer does not endanger the public health.
``(2) Temporary suspension.--The Secretary may require that
importation of a specific qualifying prescription drug or
importation by a specific certified foreign seller or importer
pursuant to this section be temporarily suspended if, with
respect to such drug, seller, or importer, there is a violation
of any requirement of this section or if the Secretary
determines that importation of such drug or by such seller or
importer might endanger the public health. Such temporary
suspension shall apply until the Secretary completes an
investigation and determines that importation of such drug or
by such seller or importer does not endanger the public health.
``(k) Supply Chain Security.--
``(1) Purchase from registered facilities and certified
foreign sellers.--
``(A) In general.--Except as provided in
subparagraph (B), certified foreign sellers who sell
qualifying prescription drugs for importation into the
United States pursuant to this section may purchase
such drugs only from manufacturers or entities
registered under section 510 or other certified foreign
sellers.
``(B) Exception.--Certified foreign sellers who
sell qualifying prescription drugs for importation into
the United States pursuant to this section may purchase
such drugs from foreign sellers in Canada or another
permitted country, even if such foreign seller is not a
manufacturer registered under section 510 or a
certified foreign seller, if the Secretary enters into
a memorandum of understanding or cooperative agreement
with Canada, or such other permitted country, to ensure
compliance, to the extent appropriate and feasible,
with subchapter H of chapter V. The Secretary shall
seek to enter into such a memorandum of understanding
or cooperative agreement with Canada and each country
from which importation is permitted under subsection
(e).
``(2) Importation tracing.--Certified foreign sellers shall
provide importers with the unique facility identifier
associated with the manufacturer registered under section 510
of the qualifying prescription drug and the information under
paragraph (25), paragraph (26) (other than subparagraph (C)),
and subparagraphs (D), (F), and (G) of paragraph (27) of
section 581. Certified foreign sellers shall provide such
information to individuals purchasing such drugs, upon request.
``(l) REMs.--In the case of an importer that imports a qualifying
prescription drug, where the drug with the same active ingredient or
ingredients (or that is biosimilar to an approved biological product),
route of administration, and strength that is approved under chapter V
or section 351 of the Public Health Service Act is subject to elements
to assure safe use under section 505-1, such importer shall be subject
to such elements to assure safe use, as applicable and appropriate.
``(m) Construction.--Nothing in this section limits the authority
of the Secretary relating to the importation of prescription drugs,
other than with respect to section 801(d)(1) as provided in this
section.''.
(b) Penalties With Respect to Online Pharmacies.--Section 303 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by
adding at the end the following:
``(h) In the case of person operating an Internet website, whether
in the United States or in another country, that violates section
301(aa) by--
``(1) selling, by means of the Internet, with the intent to
defraud or mislead or with reckless disregard for safety of the
public, an adulterated or counterfeit drug to an individual in
the United States; or
``(2) dispenses, by means of the Internet, a drug to an
individual in the United States who the person knows or has
reasonable cause to believe, does not possess a valid
prescription for that drug,
such person shall be imprisoned for not more than 10 years or
fined not more than $250,000.''.
(c) No Preemption.--Nothing in this Act, including the amendments
made by this Act, shall be construed to preempt, alter, displace,
abridge, or supplant any remedy available under any State or Federal
law, including common law, that provides a remedy for civil relief.
(d) Reports.--
(1) HHS.--Not later than 1 year after the date on which
final regulations are promulgated to carry out section 804 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384), as
amended by this Act, and every 2 years thereafter, the
Secretary of Health and Human Services, after consultation with
appropriate Federal agencies, shall submit to Congress and make
public a report on the importation of drugs into the United
States.
(2) GAO report.--Not later than 18 months after the date on
which final regulations are promulgated to carry out section
804 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
384), as amended by this Act, the Comptroller General of the
United States shall submit to Congress a report containing an
analysis of the implementation of the amendments made by this
Act, including a review of drug safety and cost-savings and
expenses, including cost-savings to consumers in the United
States and trans-shipment and importation tracing processes,
resulting from such implementation.
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