[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>