Title: Affordable Insulin Act of 2019
Policy area: Health

Summary:
Affordable Insulin Act of 2019
This bill addresses the importation of insulin from Canada and other foreign countries.
The bill requires the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting wholesalers, pharmacies, and individuals to import certain insulin from Canada. The FDA may also permit the importation of insulin from certain other countries under specified circumstances.
The bill also establishes a process for certifying licensed foreign pharmacies and foreign wholesale distributors.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1478 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 1478

  To amend the Federal Food, Drug, and Cosmetic Act to allow for the 
 importation of affordable and safe insulin by wholesale distributors, 
                      pharmacies, and individuals.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 28, 2019

   Mr. Welch (for himself and Mr. Rooney of Florida) 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 insulin 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 Insulin Act of 2019''.

SEC. 2. IMPORTING AFFORDABLE AND SAFE INSULIN.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 804 of such Act (21 U.S.C. 384) the 
following:

``SEC. 804A. IMPORTATION OF SAFE AND AFFORDABLE INSULIN BY WHOLESALE 
              DISTRIBUTORS, PHARMACIES, AND INDIVIDUALS.

    ``(a) In General.--
            ``(1) Regulation.--Not later than 180 days after the date 
        of enactment of this section, the Secretary shall promulgate 
        regulations permitting the importation of qualifying insulin 
        into the United States, in accordance with this section.
            ``(2) Relation to section 804.--Nothing in section 804 
        shall be construed to supercede or limit the provisions of 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 insulin 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 insulin 
                to individuals in Canada, or, subject to subsection 
                (e), the permitted country in which the pharmacy is 
                located.
            ``(5) Qualifying insulin.--The term `qualifying insulin' 
        means insulin that--
                    ``(A) 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;
                    ``(B) 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;
                    ``(C) has the same active ingredient or 
                ingredients, route of administration, and strength as 
                an insulin approved under chapter V, or is biosimilar 
                to an approved biological product and has the same 
                route of administration and strength as the approved 
                biological product; and
                    ``(D) 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;
            ``(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 1 
                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 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 insulin to 
                        importers or individuals who import insulin 
                        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 an insulin 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 qualifying insulin 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 insulin testing to 
                        determine the chemical authenticity of sample 
                        insulin products;
                            ``(viii) agrees to notify the Secretary, 
                        importers, and individuals of insulin 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 insulin;
                            ``(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 
        insulin described in subsection (b) from Canada or another 
        country pursuant to subsection (e) if such qualifying insulin--
                    ``(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; 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 Insulin Act of 2019, that importation of 
qualifying insulin from Canada under this section resulted in cost 
savings for consumers in the United States and increased access to safe 
insulin, the Secretary shall have the authority to permit importation 
of qualifying insulin 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 insulin that are comparable to the 
        standards in the United States and that--
                    ``(A) authorize 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) require 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) require 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) require 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 insulin imported that meets the 
labeling requirements described in subsection (b)(5)(A)(iv) is deemed 
not misbranded for purposes of section 502.
    ``(g) Insulin Testing Laboratories.--The Secretary may approve one 
or more laboratories to conduct random testing of insulin sold by 
certified foreign sellers to assess the chemical authenticity of such 
insulin.
    ``(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 an 
        insulin sold to a certified foreign seller that sells such 
        insulin 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 insulin is exported, to another 
        person that is in the same country and that does not import 
        such insulin into the United States in accordance with this 
        section;
            ``(2) except with respect to an insulin on the drug 
        shortage list under section 506E, discriminate by denying, 
        restricting, or delaying supplies of an insulin to a certified 
        foreign seller, on account of such seller's status as a 
        certified foreign seller, that sells such insulin 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 insulin) between an insulin for distribution 
        in the United States and the insulin 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 an insulin on the drug 
        shortage list under section 506E, engage in any other action to 
        restrict, prohibit, or delay the importation of an insulin 
        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 insulin imported into the United States--
                    ``(A) the unique facility identifier of the 
                manufacturer of the insulin, 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 
                insulin.
            ``(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 insulin 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 insulin 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 insulin or importation by 
        a specific certified foreign seller or importer pursuant to 
        this section be temporarily suspended if, with respect to such 
        insulin, seller, or importer, there is a violation of any 
        requirement of this section or if the Secretary determines that 
        importation of such insulin 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 insulin 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 insulin for importation into the United 
                States pursuant to this section may purchase such 
                insulin only from manufacturers or entities registered 
                under section 510 or other certified foreign sellers.
                    ``(B) Exception.--Certified foreign sellers who 
                sell qualifying insulin for importation into the United 
                States pursuant to this section may purchase such 
                insulin 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 insulin 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 insulin, upon request.
    ``(l) REMs.--In the case of an importer that imports a qualifying 
insulin, where the insulin has the same active ingredient or 
ingredients, route of administration, and strength as an insulin 
approved under chapter V, or is biosimilar to an approved biological 
product and has the same route of administration and strength as the 
approved biological product, and where the approved product 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 insulin, 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 804A of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384), as 
        added 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 insulin 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 
        804A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        384), as added 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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