119-hr3162

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3162 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 3162

 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

 May 1, 2025

 Ms. Schakowsky (for herself, Mr. Cohen, Mr. Doggett, 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 2025''.

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 2025, 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 2025, 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.
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