Title: Affordable and Safe Prescription Drug Importation Act
Policy area: Health

Summary:
Affordable and Safe Prescription Drug Importation Act
This bill addresses the importation of drugs 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 prescription drugs from Canada. After two years, The FDA, may permit the importation of prescription drugs from other countries.
The bill establishes a process for certifying foreign sellers—a licensed foreign pharmacy or foreign wholesale distributor.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 97 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  1st Session
                                 S. 97

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 10, 2019

   Mr. Sanders (for himself, Mr. Booker, Mr. Casey, Ms. Baldwin, Mr. 
 Blumenthal, Mr. Brown, Ms. Cantwell, Mrs. Gillibrand, Ms. Harris, Ms. 
Hassan, Mr. Heinrich, Mr. King, Mr. Leahy, Ms. Klobuchar, Mr. Manchin, 
   Mr. Merkley, Mr. Reed, Mrs. Shaheen, Ms. Smith, Ms. Stabenow, Mr. 
 Udall, Mr. Van Hollen, Ms. Warren, and Mr. Whitehouse) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Affordable and Safe Prescription 
Drug Importation Act''.

SEC. 2. IMPORTING AFFORDABLE AND SAFE DRUGS.

    (a) In General.--Section 804 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 384) is amended to read as follows:

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

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