No official summary available for this bill.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8848 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 8848
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 HOUSE OF REPRESENTATIVES
June 26, 2024
Ms. Schakowsky (for herself, Mr. Cohen, Mr. Doggett, Mr. Grijalva, Ms.
Norton, Ms. Omar, Ms. Pingree, and Mr. Pocan) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
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 of 2024''.
SEC. 2. FINDINGS; SENSE OF CONGRESS.
(a) Findings.--Congress finds the following:
(1) Prescription drug prices are, on average, 2.78 times
more expensive in the United States compared to comparable
countries in the Organisation for Economic Co-operation and
Development (OECD). Drugs that are still under a patent are
4.22 times more expensive in the United States than those in
comparable nations in the OECD.
(2) Multiple studies have demonstrated that tens of
millions of Americans have opted to not fill a prescription due
to the prohibitive cost of the prescription.
(3) The Food and Drug Administration has entered into
Mutual Recognition Agreements with the United Kingdom, the
European Union, and Switzerland to recognize drug manufacturing
inspections conducted by each entity as valid and equivalent to
an inspection conducted by their own inspectors.
(4) The Food and Drug Administration, in testimony provided
to Congress, acknowledged that fewer negative inspection
outcomes were assessed to drug manufacturers in the European
Union than in the United States, representing a drug
manufacturing industry that is comparably safe and effective to
that of the United States.
(5) In 2022, the Food and Drug Administration found that 57
percent of all finished dosage form manufacturing sites for
drugs categorized as essential medicines were located in
foreign nations and relied on importation to reach American
patients.
(6) Millions of Americans every year already benefit from
safely importing their prescription drugs for personal use,
which Federal law permits through enforcement discretion and
waivers, but such importation remains technically illegal under
most circumstances because many foreign drugs do not have the
exact same formulations as the Food and Drug Administration-
approved versions. Despite Federal law recognizing that
``patients and their families sometimes have reason to import
into the United States drugs that have been approved by the
Food and Drug Administration'' the existing restrictions mean
Americans who are able to obtain relief from high prescription
drug costs by importing prescription drugs for personal use may
occasionally lose access to these drugs as they are seized upon
importation.
(b) Sense of Congress.--It is the sense of Congress that--
(1) the cost of prescription drugs in the United States
represents a crisis that endangers the safety of millions of
Americans who must choose between their health and financial
stability;
(2) prohibitions on drug importation originally intended to
protect American consumers have resulted in artificially raised
prices that harm the American people, even while the same drugs
sell for significantly less in other countries;
(3) since the initial prohibitions on drug importation were
put in place, foreign nations, including Canada, the United
Kingdom, Switzerland, and members of the European Union, have
significantly advanced their ability to safely approve,
manufacture, and transport prescription drugs, including small
molecules and biologics;
(4) the American pharmaceutical supply chain already
heavily relies on drugs that are manufactured overseas and then
imported to American patients, a process that has been done
safely for decades and with exporting nations with which the
Food and Drug Administration does not have a Mutual Recognition
Agreement; and
(5) it is possible for the American people, with
appropriate oversight from the Secretary of Health and Human
Services and the Food and Drug Administration, to safely engage
in a global pharmaceutical marketplace in order to obtain
prescription drugs for fair prices.
SEC. 3. 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 1 year after the date of
enactment of the Affordable and Safe Prescription Drug Importation Act
of 2024, 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, the
United Kingdom, a member state of the European Union,
Switzerland, or subject to subsection (e), another applicable
country, that--
``(A) operates in accordance with applicable
pharmacy standards set forth by the pharmacy laws and
regulations of the country in which the pharmacy is
located; and
``(B) is licensed to operate and dispense
prescription drugs to individuals in the 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, the United Kingdom, a
member state of the European Union,
Switzerland, or subject to subsection (e), in
another permitted country;
``(ii) 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
``(iii) is labeled in accordance with--
``(I) the laws of Canada, the
United Kingdom, a member state of the
European Union, Switzerland, 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
practitioner who has conducted at least one in-person medical
evaluation of the patient.
``(c) Publication of Certified Foreign Sellers.--The Secretary
shall publish on a dedicated internet website a list of certified
foreign sellers, including the internet website 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,
the United Kingdom, a member state of the
European Union, Switzerland, 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) 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);
``(iv) 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 the country in which the seller
is located and has implemented policies
designed to monitor ongoing compliance with
such laws and regulations;
``(v) 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;
``(vi) 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;
``(vii) agrees to notify the Secretary,
importers, and individuals of product recalls
in the country in which the seller is located,
and agrees to cease, or refrain from, exporting
such product;
``(viii) 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;
``(ix) except as otherwise permitted under
this section, does not sell products that the
seller could not otherwise legally sell in the
country in which the seller is located to
customers in the United States; and
``(x) 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, the
United Kingdom, a member state of the European Union,
Switzerland, or another country pursuant to subsection (e) if
such drug--
``(A) is dispensed, including a drug ordered from
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 1 year 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 of 2024, that importation of qualifying prescription drugs from
Canada, the United Kingdom, a member state of the European Union, and
Switzerland under this section was conducted safely, the Secretary
shall have the authority to permit importation of qualifying
prescription drugs by importers and individuals from, in addition to
Canada, the United Kingdom, a member state of the European Union, and
Switzerland, any country that--
``(1) has statutory or regulatory standards for the
approval and sale of prescription drugs that would enable safe
importation of prescription drugs into the United States;
``(2) 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;
``(3) requires that any determination of safety and
effectiveness described in paragraph (2) 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;
``(4) 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
``(5) 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)(iii)
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, the United Kingdom, a member state of the European
Union, Switzerland, 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) Enforcement Discretion and Waiver Authority for Importation
by Individuals.--
``(1) Declarations.--Congress declares that in the
enforcement against individuals of the prohibition of
importation of prescription drugs and devices, the Secretary
should--
``(A) focus enforcement on cases in which the
importation by an individual poses a significant threat
to public health; and
``(B) exercise discretion to permit individuals to
make such importations in circumstances in which--
``(i) the importation is clearly for
personal use; and
``(ii) the prescription drug or device
imported does not appear to present an
unreasonable risk to the individual.
``(2) Waiver authority.--
``(A) In general.--The Secretary may grant to
individuals, by regulation or on a case-by-case basis,
a waiver of the prohibition of importation of a
prescription drug or device or class of prescription
drugs or devices, under such conditions as the
Secretary determines to be appropriate.
``(B) Guidance on case-by-case waivers.--The
Secretary shall publish, and update as necessary,
guidance that accurately describes circumstances in
which the Secretary will consistently grant waivers on
a case-by-case basis under subparagraph (A), so that
individuals may know with the greatest practicable
degree of certainty whether a particular importation
for personal use will be permitted.
``(j) 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.
``(k) 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.
``(l) 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, the United
Kingdom, a member state of the European Union,
Switzerland, or another permitted country, subject to
subsection (e), 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 the respective 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, the United Kingdom, the European
Union, Switzerland, and each country from which
importation is permitted under subsection (e).
``(2) Importation tracing.--Certified foreign sellers shall
provide importers with the name and address of 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.
``(m) 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.
``(n) 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 Sales.--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 or utilizing 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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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