Title: Competition Prescription Act of 2019
Policy area: Health

Summary:
Competition Prescription Act of 2019  This bill revises various requirements related to the development, production, and sale of prescription drugs and biological products.
First, the bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved product if the license holder has declined to make available sufficient quantities of the approved product for the developer's testing.
The bill also requires the Food and Drug Administration (FDA) to establish a process for developers of generic complex drugs to request and receive expedited development and priority review. Further, upon request by a drug sponsor, a drug that treats a life-threatening disease or condition must be designated for expedited review if there are fewer than three drugs currently available for such treatment.
States are prohibited from placing restrictions on dispensing substitute biological products that have been determined to be interchangeable with another product by the FDA.
Additionally, the bill prohibits sponsors of Medicare Part D prescription drug plans from reducing a payment to a pharmacy after a claim without defect has been submitted by such pharmacy. The bill establishes requirements for pricing standards for pharmacy benefits managers under Medicare and other federal prescription drug benefits programs. Starting in 2025, the bill removes the cap on rebates paid by manufacturers of outpatient prescription drugs under Medicaid.
Further, the bill requires the publication of specified information regarding licensed biological products, exempts from antitrust prohibitions specified drug-price negotiation strategies, and establishes a Chief Pharmaceutical Negotiator in the Office of the U.S. Trade Representative.


[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3947 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 3947

    To lower the cost of prescription drugs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 24, 2019

 Mr. Meadows introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
   Ways and Means, the Judiciary, Armed Services, and Oversight and 
 Reform, for a period to be subsequently determined by the Speaker, in 
   each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
    To lower the cost of prescription drugs, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Competition 
Prescription Act of 2019''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
  TITLE I--ELIMINATING DELAYS OF GENERIC DRUGS AND BIOSIMILAR PRODUCTS

Sec. 101. Actions for delays of generic drugs and biosimilar biological 
                            products.
Sec. 102. REMS approval process for subsequent filers.
      TITLE II--INCREASING ACCESS TO DRUGS AND BIOSIMILAR PRODUCTS

Sec. 201. Expedited development and priority review for generic complex 
                            drug products.
Sec. 202. Increasing pharmaceutical options to treat an unmet medical 
                            need.
Sec. 203. Preemption of State barriers to the substitution of 
                            biosimilar products.
Sec. 204. Expedited process for biological products authorized for 
                            marketing in European Union.
          TITLE III--PRESCRIPTION DRUG PRICING AND COMPETITION

Sec. 301. Medicare drug coverage.
Sec. 302. Fee transparency between pharmacies and PBMs.
Sec. 303. Sunset of limit on maximum rebate amount for single source 
                            drugs and innovator multiple source drugs.
Sec. 304. Regulation of manufacturer-sponsored copay contributions.
                TITLE IV--PATENT DISCLOSURE REQUIREMENTS

Sec. 401. Patent disclosure and transparency requirements.
Sec. 402. Antitrust exemption for health insurance issuers to negotiate 
                            wholesale acquisition prices of 
                            prescription drugs purchased from drug 
                            manufacturers.
Sec. 403. Fair treatment of Medicare part B billing codes for the 
                            prescribing of biosimilars.
                   TITLE V--FIXING GLOBAL FREELOADING

Sec. 501. Chief Pharmaceutical Negotiator in the Office of the United 
                            States Trade Representative.

  TITLE I--ELIMINATING DELAYS OF GENERIC DRUGS AND BIOSIMILAR PRODUCTS

SEC. 101. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL 
              PRODUCTS.

    (a) Definitions.--In this section--
            (1) the term ``commercially reasonable, market-based 
        terms'' means--
                    (A) a nondiscriminatory price for the sale of the 
                covered product at or below, but not greater than, the 
                most recent wholesale acquisition cost for the drug, as 
                defined in section 1847A(c)(6)(B) of the Social 
                Security Act (42 U.S.C. 1395w-3a(c)(6)(B));
                    (B) a schedule for delivery that results in the 
                transfer of the covered product to the eligible product 
                developer consistent with the timing under subsection 
                (b)(2)(A)(iv); and
                    (C) no additional conditions are imposed on the 
                sale of the covered product;
            (2) the term ``covered product''--
                    (A) means--
                            (i) any drug approved under subsection (c) 
                        or (j) of section 505 of the Federal Food, 
                        Drug, and Cosmetic Act (21 U.S.C. 355) or 
                        biological product licensed under subsection 
                        (a) or (k) of section 351 of the Public Health 
                        Service Act (42 U.S.C. 262);
                            (ii) any combination of a drug or 
                        biological product described in clause (i); or
                            (iii) when reasonably necessary to support 
                        approval of an application under section 505 of 
                        the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355), or section 351 of the Public 
                        Health Service Act (42 U.S.C. 262), as 
                        applicable, or otherwise meet the requirements 
                        for approval under either such section, any 
                        product, including any device, that is marketed 
                        or intended for use with such a drug or 
                        biological product; and
                    (B) does not include any drug or biological product 
                that appears on the drug shortage list in effect under 
                section 506E of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 356e), unless--
                            (i) the drug or biological product has been 
                        on the drug shortage list in effect under such 
                        section 506E continuously for more than 6 
                        months; or
                            (ii) the Secretary determines that 
                        inclusion of the drug or biological product as 
                        a covered product is likely to contribute to 
                        alleviating or preventing a shortage;
            (3) the term ``device'' has the meaning given the term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321);
            (4) the term ``eligible product developer'' means a person 
        that seeks to develop a product for approval pursuant to an 
        application for approval under subsection (b)(2) or (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) or for licensing pursuant to an application under 
        section 351(k) of the Public Health Service Act (42 U.S.C. 
        262(k));
            (5) the term ``license holder'' means the holder of an 
        application approved under subsection (c) or (j) of section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
        the holder of a license under subsection (a) or (k) of section 
        351 of the Public Health Service Act (42 U.S.C. 262) for a 
        covered product;
            (6) the term ``REMS'' means a risk evaluation and 
        mitigation strategy under section 505-1 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355-1);
            (7) the term ``REMS with ETASU'' means a REMS that contains 
        elements to assure safe use under section 505-1(f) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f));
            (8) the term ``Secretary'' means the Secretary of Health 
        and Human Services;
            (9) the term ``single, shared system of elements to assure 
        safe use'' means a single, shared system of elements to assure 
        safe use under section 505-1(f) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355-1(f)); and
            (10) the term ``sufficient quantities'' means an amount of 
        a covered product that the eligible product developer 
        determines allows it to--
                    (A) conduct testing to support an application 
                under--
                            (i) subsection (b)(2) or (j) of section 505 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355); or
                            (ii) section 351(k) of the Public Health 
                        Service Act (42 U.S.C. 262(k)); and
                    (B) fulfill any regulatory requirements relating to 
                approval of such an application.
    (b) Civil Action for Failure To Provide Sufficient Quantities of a 
Covered Product.--
            (1) In general.--An eligible product developer may bring a 
        civil action against the license holder for a covered product 
        seeking relief under this subsection in an appropriate district 
        court of the United States alleging that the license holder has 
        declined to provide sufficient quantities of the covered 
        product to the eligible product developer on commercially 
        reasonable, market-based terms.
            (2) Elements.--
                    (A) In general.--To prevail in a civil action 
                brought under paragraph (1), an eligible product 
                developer shall prove, by a preponderance of the 
                evidence--
                            (i) that--
                                    (I) the covered product is not 
                                subject to a REMS with ETASU; or
                                    (II) if the covered product is 
                                subject to a REMS with ETASU--
                                            (aa) the eligible product 
                                        developer has obtained a 
                                        covered product authorization 
                                        from the Secretary in 
                                        accordance with subparagraph 
                                        (B); and
                                            (bb) the eligible product 
                                        developer has provided a copy 
                                        of the covered product 
                                        authorization to the license 
                                        holder;
                            (ii) that, as of the date on which the 
                        civil action is filed, the product developer 
                        has not obtained sufficient quantities of the 
                        covered product on commercially reasonable, 
                        market-based terms;
                            (iii) that the eligible product developer 
                        has requested to purchase sufficient quantities 
                        of the covered product from the license holder; 
                        and
                            (iv) that the license holder has not 
                        delivered to the eligible product developer 
                        sufficient quantities of the covered product on 
                        commercially reasonable, market-based terms--
                                    (I) for a covered product that is 
                                not subject to a REMS with ETASU, by 
                                the date that is 31 days after the date 
                                on which the license holder received 
                                the request for the covered product; 
                                and
                                    (II) for a covered product that is 
                                subject to a REMS with ETASU, by 31 
                                days after the later of--
                                            (aa) the date on which the 
                                        license holder received the 
                                        request for the covered 
                                        product; or
                                            (bb) the date on which the 
                                        license holder received a copy 
                                        of the covered product 
                                        authorization issued by the 
                                        Secretary in accordance with 
                                        subparagraph (B).
                    (B) Authorization for covered product subject to a 
                rems with etasu.--
                            (i) Request.--An eligible product developer 
                        may submit to the Secretary a written request 
                        for the eligible product developer to be 
                        authorized to obtain sufficient quantities of 
                        an individual covered product subject to a REMS 
                        with ETASU.
                            (ii) Authorization.--Not later than 120 
                        days after the date on which a request under 
                        clause (i) is received, the Secretary shall, by 
                        written notice, authorize the eligible product 
                        developer to obtain sufficient quantities of an 
                        individual covered product subject to a REMS 
                        with ETASU for purposes of--
                                    (I) development and testing that 
                                does not involve human clinical trials, 
                                if the eligible product developer has 
                                agreed to comply with any conditions 
                                the Secretary determines necessary; or
                                    (II) development and testing that 
                                involves human clinical trials, if the 
                                eligible product developer has--
                                            (aa)(AA) submitted 
                                        protocols, informed consent 
                                        documents, and informational 
                                        materials for testing that 
                                        include protections that 
                                        provide safety protections 
                                        comparable to those provided by 
                                        the REMS for the covered 
                                        product; or
                                            (BB) otherwise satisfied 
                                        the Secretary that such 
                                        protections will be provided; 
                                        and
                                            (bb) met any other 
                                        requirements the Secretary may 
                                        establish.
                            (iii) Notice.--A covered product 
                        authorization issued under this subparagraph 
                        shall state that the provision of the covered 
                        product by the license holder under the terms 
                        of the authorization will not be a violation of 
                        the REMS for the covered product.
            (3) Affirmative defense.--In a civil action brought under 
        paragraph (1), it shall be an affirmative defense, on which the 
        defendant has the burden of persuasion by a preponderance of 
        the evidence--
                    (A) that, on the date on which the eligible product 
                developer requested to purchase sufficient quantities 
                of the covered product from the license holder--
                            (i) neither the license holder nor any of 
                        its agents, wholesalers, or distributors was 
                        engaged in the manufacturing or commercial 
                        marketing of the covered product; and
                            (ii) neither the license holder nor any of 
                        its agents, wholesalers, or distributors 
                        otherwise had access to inventory of the 
                        covered product to supply to the eligible 
                        product developer on commercially reasonable, 
                        market-based terms;
                    (B) that--
                            (i) the license holder sells the covered 
                        product through agents, distributors, or 
                        wholesalers;
                            (ii) the license holder has placed no 
                        restrictions, explicit or implicit, on its 
                        agents, distributors, or wholesalers to sell 
                        covered products to eligible product 
                        developers; and
                            (iii) the covered product can be purchased 
                        by the eligible product developer in sufficient 
                        quantities on commercially reasonable, market-
                        based terms from the agents, distributors, or 
                        wholesalers of the license holder; or
                    (C) that the license holder made an offer to sell 
                sufficient quantities of the covered product to the 
                eligible product developer at commercially reasonable 
                market-based terms--
                            (i) for a covered product that is not 
                        subject to a REMS with ETASU, by the date that 
                        is 14 days after the date on which the license 
                        holder received the request for the covered 
                        product, and the eligible product developer did 
                        not accept such offer by the date that is 7 
                        days after the date on which the eligible 
                        product developer received such offer from the 
                        license holder; or
                            (ii) for a covered product that is subject 
                        to a REMS with ETASU, by the date that is 20 
                        days after the date on which the license holder 
                        received the request for the covered product, 
                        and the eligible product developer did not 
                        accept such offer by the date that is 10 days 
                        after the date on which the eligible product 
                        developer received such offer from the license 
                        holder.
            (4) Methods for transmission of requests for covered 
        products.--A written request for a covered product, offer to 
        sell a covered product, or acceptance of such an offer between 
        the eligible product developer and the license holder shall be 
        made by--
                    (A) certified or registered mail with return 
                receipt requested;
                    (B) personal delivery; or
                    (C) electronic means.
            (5) Remedies.--
                    (A) In general.--If an eligible product developer 
                prevails in a civil action brought under paragraph (1), 
                the court shall--
                            (i) order the license holder to provide to 
                        the eligible product developer without delay 
                        sufficient quantities of the covered product on 
                        commercially reasonable, market-based terms;
                            (ii) award to the eligible product 
                        developer reasonable attorney's fees and costs 
                        of the civil action; and
                            (iii) award to the eligible product 
                        developer a monetary amount sufficient to deter 
                        the license holder from failing to provide 
                        eligible product developers with sufficient 
                        quantities of a covered product on commercially 
                        reasonable, market-based terms, if the court 
                        finds, by a preponderance of the evidence--
                                    (I) that the license holder delayed 
                                providing sufficient quantities of the 
                                covered product to the eligible product 
                                developer without a legitimate business 
                                justification; or
                                    (II) that the license holder failed 
                                to comply with an order issued under 
                                clause (i).
                    (B) Maximum monetary amount.--A monetary amount 
                awarded under subparagraph (A)(iii) shall not be 
                greater than the revenue that the license holder earned 
                on the covered product during the period--
                            (i) beginning on--
                                    (I) for a covered product that is 
                                not subject to a REMS with ETASU, the 
                                date that is 31 days after the date on 
                                which the license holder received the 
                                request; or
                                    (II) for a covered product that is 
                                subject to a REMS with ETASU, the date 
                                that is 31 days after the later of--
                                            (aa) the date on which the 
                                        license holder received the 
                                        request; or
                                            (bb) the date on which the 
                                        license holder received a copy 
                                        of the covered product 
                                        authorization issued by the 
                                        Secretary in accordance with 
                                        paragraph (2)(B); and
                            (ii) ending on the date on which the 
                        eligible product developer received sufficient 
                        quantities of the covered product.
                    (C) Avoidance of delay.--The court may issue an 
                order under subparagraph (A)(i) before conducting 
                further proceedings that may be necessary to determine 
                whether the eligible product developer is entitled to 
                an award under clause (ii) or (iii) of subparagraph 
                (A), or the amount of any such award.
    (c) Limitation of Liability.--A license holder for a covered 
product shall not be liable for any claim under Federal, State, or 
local law arising out of the failure of an eligible product developer 
to follow adequate safeguards to assure safe use of the covered product 
during development or testing activities described in this section, 
including transportation, handling, use, or disposal of the covered 
product by the eligible product developer.
    (d) No Violation of REMS.--Section 505-1 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355-1) is amended by adding at the end the 
following new subsection:
    ``(l) Provision of Samples Not a Violation of Strategy.--The 
provision of samples of a covered product to an eligible product 
developer (as those terms are defined in section 2(a) of the Creating 
and Restoring Equal Access to Equivalent Samples Act of 2019) shall not 
be considered a violation of the requirements of any risk evaluation 
and mitigation strategy that may be in place under this section for 
such drug.''.
    (e) Rule of Construction.--
            (1) Definition.--In this subsection, the term ``antitrust 
        laws''--
                    (A) has the meaning given the term in subsection 
                (a) of the first section of the Clayton Act (15 U.S.C. 
                12); and
                    (B) includes section 5 of the Federal Trade 
                Commission Act (15 U.S.C. 45) to the extent that such 
                section applies to unfair methods of competition.
            (2) Antitrust laws.--Nothing in this section shall be 
        construed to limit the operation of any provision of the 
        antitrust laws.

SEC. 102. REMS APPROVAL PROCESS FOR SUBSEQUENT FILERS.

    Section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355-1), as amended by section 101, is further amended--
            (1) in subsection (g)(4)(B)--
                    (A) in clause (i) by striking ``or'' after the 
                semicolon;
                    (B) in clause (ii) by striking the period at the 
                end and inserting ``; or''; and
                    (C) by adding at the end the following:
                            ``(iii) accommodate different, comparable 
                        aspects of the elements to assure safe use for 
                        a drug that is the subject of an application 
                        under section 505(j), and the applicable listed 
                        drug.'';
            (2) in subsection (i)(1), by striking subparagraph (C) and 
        inserting the following:
                    ``(C)(i) Elements to assure safe use, if required 
                under subsection (f) for the listed drug, which, 
                subject to clause (ii), for a drug that is the subject 
                of an application under section 505(j) may use--
                            ``(I) a single, shared system with the 
                        listed drug under subsection (f); or
                            ``(II) a different, comparable aspect of 
                        the elements to assure safe use under 
                        subsection (f).
                    ``(ii) The Secretary may require a drug that is the 
                subject of an application under section 505(j) and the 
                listed drug to use a single, shared system under 
                subsection (f), if the Secretary determines that no 
                different, comparable aspect of the elements to assure 
                safe use could satisfy the requirements of subsection 
                (f).'';
            (3) in subsection (i), by adding at the end the following:
            ``(3) Shared rems.--If the Secretary approves, in 
        accordance with paragraph (1)(C)(i)(II), a different, 
        comparable aspect of the elements to assure safe use under 
        subsection (f) for a drug that is the subject of an abbreviated 
        new drug application under section 505(j), the Secretary may 
        require that such different comparable aspect of the elements 
        to assure safe use can be used with respect to any other drug 
        that is the subject of an application under section 505(j) or 
        505(b) that references the same listed drug.''; and
            (4) by adding at the end the following:
    ``(m) Separate REMS.--When used in this section, the terms 
`different, comparable aspect of the elements to assure safe use' or 
`different, comparable approved risk evaluation and mitigation 
strategies' means a risk evaluation and mitigation strategy for a drug 
that is the subject of an application under section 505(j) that uses 
different methods or operational means than the strategy required under 
subsection (a) for the applicable listed drug, or other application 
under section 505(j) with the same such listed drug, but achieves the 
same level of safety as such strategy.''.

      TITLE II--INCREASING ACCESS TO DRUGS AND BIOSIMILAR PRODUCTS

SEC. 201. EXPEDITED DEVELOPMENT AND PRIORITY REVIEW FOR GENERIC COMPLEX 
              DRUG PRODUCTS.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the 
following:

``SEC. 524B. EXPEDITED DEVELOPMENT AND PRIORITY REVIEW FOR GENERIC 
              COMPLEX DRUG PRODUCTS.

    ``(a) Establishment of Program.--The Secretary shall establish a 
program to expedite the development of, and provide priority review 
under section 505(j) for, generic complex drug products.
    ``(b) Request for Designation.--A sponsor of a generic complex drug 
product may request that the Secretary designate such product for 
expedited development and priority review under this section.
    ``(c) Designation Process.--
            ``(1) In general.--Not later than 60 calendar days after 
        the receipt of a request under subsection (c), the Secretary 
        shall determine whether the product that is the subject of the 
        request meets the criteria under subsection (e) to be 
        considered a generic complex drug product. If the Secretary 
        determines that the product meets the criteria, the Secretary 
        shall designate the product for expedited development and 
        priority review.
            ``(2) Review.--Review of a request under subsection (b) 
        shall be undertaken by a team that is composed of experienced 
        staff and senior managers of the Food and Drug Administration.
            ``(3) Withdrawal.--The Secretary may not withdraw a 
        designation granted under this section on the basis of the 
        criteria under subsection (e) no longer applying because of the 
        subsequent clearance or approval of any other product.
    ``(d) Expedited Development and Priority Review Guidance.--
            ``(1) Content.--Not later than December 31, 2021, the 
        Secretary shall issue guidance on the implementation of this 
        section. Such guidance shall--
                    ``(A) set forth the process by which a person may 
                seek a designation under subsection (c);
                    ``(B) provide a template for requests under 
                subsection (b);
                    ``(C) identify the criteria the Secretary will use 
                in evaluating a request for designation under this 
                section; and
                    ``(D) identify the criteria and processes the 
                Secretary will use to expedite the development and 
                review of products designated under this section.
            ``(2) Process.--Prior to finalizing the guidance under 
        paragraph (1), the Secretary shall seek public comment on a 
        draft version of that guidance.
    ``(e) Generic Complex Drug Product Defined.--In this section, the 
term `generic complex drug product' means a product that represents a 
complex therapy that consists of or includes a drug for approval under 
section 505(j) and that--
            ``(1)(A) contains complex active ingredients (such as 
        peptides, polymeric compounds, complex mixtures of active 
        ingredients, and naturally sourced ingredients);
            ``(B) is composed of complex formulations (such as 
        liposomes or colloids);
            ``(C) requires a complex route of delivery (such as locally 
        acting drugs such as dermatological products and complex 
        ophthalmological products and otic dosage forms that are 
        formulated as suspensions, emulsions, or gels); or
            ``(D) involves a complex dosage form (such as transdermals, 
        metered dose inhalers, or extended release injectables);
            ``(2) presents as a complex drug-device combination product 
        (such as auto injectors or metered dose inhalers); or
            ``(3) is a product that would benefit from early scientific 
        engagement due to complexity or uncertainty concerning the 
        approval pathway under section 505(j).''.

SEC. 202. INCREASING PHARMACEUTICAL OPTIONS TO TREAT AN UNMET MEDICAL 
              NEED.

    Subsection (b) of section 506 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356) is amended by adding at the end the 
following:
            ``(4) Unmet medical need.--For purposes of paragraph (1), a 
        drug shall be deemed to address an unmet medical need for a 
        disease or condition if fewer than 3 available drugs exist for 
        the treatment of such disease or condition.''.

SEC. 203. PREEMPTION OF STATE BARRIERS TO THE SUBSTITUTION OF 
              BIOSIMILAR PRODUCTS.

    No State, or any political subdivision thereof, may prohibit a 
pharmacy or pharmacist from dispensing, in place of a biological 
reference product, any product that, pursuant to section 351(k) of the 
Public Health Service Act (42 U.S.C. 262(k)), has been determined by 
the Secretary of Health and Human Services to be interchangeable with 
the reference product in accordance with subsections (a) and (k)(4) of 
such Act (42 U.S.C. 262(a), (k)(4)).

SEC. 204. EXPEDITED PROCESS FOR BIOLOGICAL PRODUCTS AUTHORIZED FOR 
              MARKETING IN EUROPEAN UNION.

    Section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) 
is amended by adding at the end the following new paragraph:
            ``(4) Products authorized for marketing in european 
        union.--In considering whether to license a biological product 
        under this subsection or subsection (k), the Secretary may 
        expedite the licensing process if the biological product has 
        been authorized for marketing by the European Medicines Agency 
        and such authorization remains in effect.''.

          TITLE III--PRESCRIPTION DRUG PRICING AND COMPETITION

SEC. 301. MEDICARE DRUG COVERAGE.

    Notwithstanding any other provision of law, the Secretary of Health 
and Human Services may alter payments for prescription drugs, including 
biologicals, provided through the Medicare part B program by paying at 
rates that, based on the average sales price plus 6 percent in the year 
of implementation of this Act, grow at the consumer price index (CPI 
Prescription Drugs).

SEC. 302. FEE TRANSPARENCY BETWEEN PHARMACIES AND PBMS.

    (a) Prohibiting Medicare PDP Sponsors and MA-PD Organizations From 
Retroactively Reducing Payment on Clean Claims Submitted by 
Pharmacies.--
            (1) In general.--Section 1860D-12(b)(4)(A) of the Social 
        Security Act (42 U.S.C. 1395w-112(b)(4)(A)) is amended by 
        adding at the end the following new clause:
                            ``(iv) Prohibiting retroactive reductions 
                        in payments on clean claims.--Each contract 
                        entered into with a PDP sponsor under this part 
                        with respect to a prescription drug plan 
                        offered by such sponsor shall provide that 
                        after the date of receipt of a clean claim 
                        submitted by a pharmacy, the PDP sponsor (or an 
                        agent of the PDP sponsor) may not retroactively 
                        reduce payment on such claim directly or 
                        indirectly through aggregated effective rate or 
                        otherwise except in the case such claim is 
                        found to not be a clean claim (such as in the 
                        case of a claim lacking required substantiating 
                        documentation) during the course of a routine 
                        audit as permitted pursuant to written 
                        agreement between the PDP sponsor (or such an 
                        agent) and such pharmacy. The previous sentence 
                        shall not prohibit any retroactive increase in 
                        payment to a pharmacy pursuant to a written 
                        agreement between a PDP sponsor (or an agent of 
                        such sponsor) and such pharmacy.''.
            (2) Effective date.--The amendment made by subsection (a) 
        shall apply with respect to contracts entered into on or after 
        January 1, 2021.
    (b) Elimination of DIR Fees.--
            (1) Pharmacy benefits manager standards under the medicare 
        program for prescription drug plans and ma-pd plans.--
                    (A) In general.--Section 1860D-12(b) of the Social 
                Security Act (42 U.S.C. 1395w-112(b)) is amended by 
                adding at the end the following new paragraph:
            ``(7) Pharmacy benefits manager transparency 
        requirements.--Each contract entered into with a PDP sponsor 
        under this part with respect to a prescription drug plan 
        offered by such sponsor or with an MA organization offering an 
        MA-PD plan under part C shall provide that the sponsor or 
        organization, respectively, may not enter into a contract with 
        any pharmacy benefits manager (referred to in this paragraph as 
        a `PBM') to manage the prescription drug coverage provided 
        under such plan, or to control the costs of the prescription 
        drug coverage under such plan, unless the PBM adheres to the 
        following criteria when handling personally identifiable 
        utilization and claims data or other sensitive patient data:
                    ``(A) The PBM may not transmit any personally 
                identifiable utilization, protected health information, 
                or claims data, with respect to a plan enrollee, to a 
                pharmacy owned by a PBM if the plan enrollee has not 
                voluntarily elected in writing or via secure electronic 
                means to fill that particular prescription at the PBM-
                owned pharmacy.
                    ``(B) The PBM may not require that a plan enrollee 
                use a retail pharmacy, mail order pharmacy, specialty 
                pharmacy, or other pharmacy entity providing pharmacy 
                services in which the PBM has an ownership interest or 
                that has an ownership interest in the PBM, or provide 
                an incentive to a plan enrollee to encourage the 
                enrollee to use a retail pharmacy, mail order pharmacy, 
                specialty pharmacy, or other pharmacy entity providing 
                pharmacy services in which the PBM has an ownership 
                interest or that has an ownership interest in the PBM, 
                if the incentive is applicable only to such 
                pharmacies.''.
                    (B) Regular update of prescription drug pricing 
                standard.--Paragraph (6) of section 1860D-12(b) of the 
                Social Security Act (42 U.S.C. 1395w-112(b)) is amended 
                to read as follows:
            ``(6) Regular update of prescription drug pricing 
        standard.--
                    ``(A) In general.--If the PDP sponsor of a 
                prescription drug plan (or MA organization offering an 
                MA-PD plan) uses a standard for reimbursement (as 
                described in subparagraph (B)) of pharmacies based on 
                the cost of a drug, each contract entered into with 
                such sponsor under this part (or organization under 
                part C) with respect to the plan shall provide that the 
                sponsor (or organization) shall--
                            ``(i) update such standard not less 
                        frequently than once every 7 days, beginning 
                        with an initial update on January 1 of each 
                        year, to accurately reflect the market price of 
                        acquiring the drug;
                            ``(ii) disclose to applicable pharmacies 
                        and the contracting entities of such pharmacies 
                        the sources used for making any such update 
                        immediately without requirement of request;
                            ``(iii) if the source for such a standard 
                        for reimbursement is not publicly available, 
                        disclose to the applicable pharmacies and the 
                        respective contracting entities of such 
                        pharmacies all individual drug prices to be so 
                        updated in advance of the use of such prices 
                        for the reimbursement of claims;
                            ``(iv) establish a process to appeal, 
                        investigate, and resolve disputes regarding 
                        individual drug prices that are less than the 
                        pharmacy acquisition price for such drug, which 
                        must be adjudicated within 7 days of the 
                        pharmacy filing its appeal; and
                            ``(v) provide all such pricing data in an 
                        .xml spreadsheet format or a comparable easily 
                        accessible and complete spreadsheet format.
                    ``(B) Prescription drug pricing standard defined.--
                For purposes of subparagraph (A), a standard for 
                reimbursement of a pharmacy is any methodology or 
                formula for varying the pricing of a drug or drugs 
                during the term of the pharmacy reimbursement contract 
                that is based on the cost of the drug involved, 
                including drug pricing references and amounts that are 
                based upon average wholesale price, wholesale average 
                cost, average manufacturer price, average sales price, 
                maximum allowable cost (MAC), or other costs, whether 
                publicly available or not.''.
                    (C) Effective date.--The amendments made by this 
                section shall apply to plan years beginning on or after 
                January 1, 2020.
            (2) Regular update of prescription drug pricing standard 
        under tricare retail pharmacy program.--Section 1074g(d) of 
        title 10, United States Code, is amended by adding at the end 
        the following new paragraph:
    ``(3) To the extent practicable, with respect to the TRICARE retail 
pharmacy program described in subsection (a)(2)(E)(ii), the Secretary 
shall ensure that a contract entered into with a TRICARE managed care 
support contractor includes requirements described in section 1860D-
12(b)(6) of the Social Security Act (42 U.S.C. 1395w-112(b)(6)) to 
ensure the provision of information regarding the pricing standard for 
prescription drugs.''.
            (3) Prescription drug transparency in the federal employees 
        health benefits program.--
                    (A) In general.--Section 8902 of title 5, United 
                States Code, is amended by adding at the end the 
                following new subsections:
    ``(p) A contract may not be made or a plan approved under this 
chapter under which a carrier has an agreement with a pharmacy benefits 
manager (in this subsection referred to as a `PBM') to manage 
prescription drug coverage or to control the costs of the prescription 
drug coverage unless the carrier and PBM adhere to the following 
criteria:
            ``(1) The PBM may not transmit any personally identifiable 
        utilization, protected health information, or claims data with 
        respect to an individual enrolled under such contract or plan 
        to a pharmacy owned by the PBM if the individual has not 
        voluntarily elected in writing or via secure electronic means 
        to fill that particular prescription at such a pharmacy.
            ``(2) The PBM may not require that an individual enrolled 
        under such contract or plan use a retail pharmacy, mail order 
        pharmacy, specialty pharmacy, or other pharmacy entity 
        providing pharmacy services in which the PBM has an ownership 
        interest or that has an ownership interest in the PBM or 
        provide an incentive to a plan enrollee to encourage the 
        enrollee to use a retail pharmacy, mail order pharmacy, 
        specialty pharmacy, or other pharmacy entity providing pharmacy 
        services in which the PBM has an ownership interest or that has 
        an ownership interest in the PBM, if the incentive is 
        applicable only to such pharmacies.
    ``(q)(1) If a contract made or plan approved under this chapter 
provides for a standard for reimbursement (as described in paragraph 
(2)) with respect to a prescription drug plan, such contract or plan 
shall provide that the applicable carrier--
            ``(A) update such standard not less frequently than once 
        every 7 days, beginning with an initial update on January 1 of 
        each year, to accurately reflect the market price of acquiring 
        the drug;
            ``(B) disclose to applicable pharmacies and the contracting 
        entities of such pharmacies the sources used for making any 
        such update immediately without requirement of request;
            ``(C) if the source for such a standard for reimbursement 
        is not publicly available, disclose to the applicable 
        pharmacies and contracting entities of such pharmacies all 
        individual drug prices to be so updated in advance of the use 
        of such prices for the reimbursement of claims;
            ``(D) establish a process to appeal, investigate, and 
        resolve disputes regarding individual drug prices that are less 
        than the pharmacy acquisition price for such drug, which must 
        be adjudicated within 7 days of the pharmacy filing its appeal; 
        and
            ``(E) provide all such pricing data in an .xml spreadsheet 
        format or a comparable easily accessible and complete 
        spreadsheet format.
    ``(2) For purposes of paragraph (1), a standard for reimbursement 
of a pharmacy is any methodology or formula for varying the pricing of 
a drug or drugs during the term of the pharmacy reimbursement contract 
that is based on the cost of the drug involved, including drug pricing 
references and amounts that are based upon average wholesale price, 
wholesale average cost, average manufacturer price, average sales 
price, maximum allowable cost, or other costs, whether publicly 
available or not.''.
                    (B) Application.--The amendment made by 
                subparagraph (A) shall apply to any contract entered 
                into under section 8902 of title 5, United States Code, 
                on or after the date of enactment of this section.

SEC. 303. SUNSET OF LIMIT ON MAXIMUM REBATE AMOUNT FOR SINGLE SOURCE 
              DRUGS AND INNOVATOR MULTIPLE SOURCE DRUGS.

    Section 1927(c)(2)(D) of the Social Security Act (42 U.S.C. 1396r-
8(c)(2)(D)) is amended by inserting after ``December 31, 2009,'' the 
following: ``and before December 31, 2024,''.

SEC. 304. REGULATION OF MANUFACTURER-SPONSORED COPAY CONTRIBUTIONS.

    Notwithstanding any other provision of law, the Secretary of Health 
and Human Services may establish a mechanism prohibiting drug 
manufacturers from contributing financially to patient copays, and 
establish a system of penalizing such behavior.

                TITLE IV--PATENT DISCLOSURE REQUIREMENTS

SEC. 401. PATENT DISCLOSURE AND TRANSPARENCY REQUIREMENTS.

    (a) In General.--
            (1) In general.--Section 351 of the Public Health Service 
        Act (42 U.S.C. 262) is amended by adding at the end the 
        following:
    ``(o) Additional Requirements With Respect to Patents.--
            ``(1) Publication of information.--
                    ``(A) In general.--Within 1 year of the date of 
                enactment of the Biologic Patent Transparency Act, the 
                Secretary shall publish and make available to the 
                public a single, easily searchable list that includes--
                            ``(i) the proper and proprietary name of 
                        each biological product licensed or deemed to 
                        be licensed under subsection (a) or (k);
                            ``(ii) the date of approval and application 
                        number for each such biological product;
                            ``(iii) the marketing status, dosage form, 
                        route of administration, strength, and, if 
                        applicable, reference product, for each such 
                        biological product;
                            ``(iv) the licensure status for each such 
                        biological product, including whether the 
                        license at the time of listing is approved, 
                        withdrawn, or revoked;
                            ``(v) for each such biological product that 
                        is a reference product for which an exclusivity 
                        period applies, and for which the Secretary has 
                        determined the dates of such exclusivity 
                        period, under subsection (k)(7)(A) or 
                        subsection (k)(7)(B) of this section or under 
                        section 527 of the Federal Food, Drug, and 
                        Cosmetic Act, including any extension of such 
                        exclusivity period in accordance with 
                        subsection (m) of this section, the date on 
                        which such exclusivity period expires;
                            ``(vi) any determination of biosimilarity 
                        or interchangeability for each such biological 
                        product; and
                            ``(vii) information regarding approved 
                        indications for each such biological product, 
                        in such manner as the Secretary determines 
                        appropriate.
                    ``(B) Updates.--Every 30 days after the publication 
                of the first list under subparagraph (A), the Secretary 
                shall revise the list to include--
                            ``(i)(I) each biological product licensed 
                        under subsection (a) or (k) during the 30-day 
                        period; and
                            ``(II) with respect to each biological 
                        product described in subclause (I), the 
                        information described in clauses (i) through 
                        (vii) of subparagraph (A); and
                            ``(ii) any updates to information 
                        previously published in accordance with 
                        subparagraph (A).''.
            (2) Public listing of patent information.--
                    (A) In general.--The Secretary of Health and Human 
                Services shall include in the recommendations 
                transmitted to Congress under section 744I(f) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
                53(f)) recommendations with respect to the collection 
                and publication of patent information in the list 
                described in section 351(o) of the Public Health 
                Service Act (42 U.S.C. 262), as added by paragraph (1).
                    (B) Development.--In developing recommendations 
                under subparagraph (A), the Secretary of Health and 
                Human Services may consult with the Federal Trade 
                Commission, the Director of the United States Patent 
                and Trademark Office, and the Federal Trade Commission, 
                in addition to the entities listed in section 
                744I(f)(1) of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 379j-53(f)(1)).
    (b) Rule of Construction.--Nothing in this section, including the 
amendment made by this section, shall be construed to require or allow 
the Secretary of Health and Human Services to delay the review or 
approval of a biologic license application under section 351 of the 
Public Health Service Act (42 U.S.C. 262).

SEC. 402. ANTITRUST EXEMPTION FOR HEALTH INSURANCE ISSUERS TO NEGOTIATE 
              WHOLESALE ACQUISITION PRICES OF PRESCRIPTION DRUGS 
              PURCHASED FROM DRUG MANUFACTURERS.

    (a) Exemption.--It shall not be a violation of the antitrust laws 
for one or more health insurance issuers or their designated agents to 
jointly negotiate wholesale acquisition prices of a prescription drug 
with a manufacturer of a prescription drug with regards to the 
reimbursement policies of the insurers of the manufacturer's drugs so 
long as no single wholesale acquisition price is jointly determined 
between the insurance issuers or their designated agents.
    (b) Definitions.--For purposes of this section:
            (1) Antitrust laws.--The term ``antitrust laws'' has the 
        meaning given it in subsection (a) of the 1st section of the 
        Clayton Act (15 U.S.C. 12(a)), except that such term includes 
        section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to 
        the extent such section 5 applies to unfair methods of 
        competition.
            (2) Health insurance issuer.--The term ``health insurance 
        issuer'' has the meaning given that term in section 2791(b) of 
        the Public Health Service Act (42 U.S.C. 300gg-91(b)).
            (3) Health maintenance organization.--The term ``health 
        maintenance organization'' means--
                    (A) a federally qualified health maintenance 
                organization (as defined in section 300e(a) of title 42 
                of the Code of Federal Regulations),
                    (B) an organization recognized under State law as a 
                health maintenance organization, or
                    (C) a similar organization regulated under State 
                law for solvency in the same manner and to the same 
                extent as such a health maintenance organization.
            (4) Manufacturer.--The term ``manufacturer'' means anyone 
        who is engaged in manufacturing, preparing, propagating, 
        compounding, processing, packaging, repackaging, or labeling of 
        a prescription drug.
            (5) Prescription drug.--The term ``prescription drug'' 
        means a drug for human use subject to section 503(b)(1) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)).
    (c) Effective Date.--This section shall take effect on the date of 
the enactment of this Act but shall not apply with respect to conduct 
that occurs before such date.

SEC. 403. FAIR TREATMENT OF MEDICARE PART B BILLING CODES FOR THE 
              PRESCRIBING OF BIOSIMILARS.

    Section 1847A of the Social Security Act (42 U.S.C. 1395w-3a) is 
amended by adding at the end the following new subsection:
    ``(h) Use of Certain Codes.--Notwithstanding any previous provision 
of this section, for purposes of payment of biological biosimilar 
product the Secretary of Health and Human Services shall assign a 
uniform Common Procedure System code to describe all such products that 
share a common reference product.''.

                   TITLE V--FIXING GLOBAL FREELOADING

SEC. 501. CHIEF PHARMACEUTICAL NEGOTIATOR IN THE OFFICE OF THE UNITED 
              STATES TRADE REPRESENTATIVE.

    (a) In General.--Section 141 of the Trade Act of 1974 (19 U.S.C. 
2171) is amended--
            (1) in subsection (b)(2)--
                    (A) by striking ``and one Chief Innovation and 
                Intellectual Property Negotiator'' and inserting ``one 
                Chief Innovation and Intellectual Property Negotiator, 
                and one Chief Pharmaceutical Negotiator'';
                    (B) by striking ``or the Chief Innovation and 
                Intellectual Property Negotiator'' and inserting ``the 
                Chief Innovation and Intellectual Property Negotiator, 
                or the Chief Pharmaceutical Negotiator''; and
                    (C) by striking ``and the Chief Innovation and 
                Intellectual Property Negotiator'' and inserting ``the 
                Chief Innovation and Intellectual Property Negotiator, 
                and the Chief Pharmaceutical Negotiator''; and
            (2) in subsection (c), by adding at the end the following 
        new paragraph:
            ``(7) The principal function of the Chief Pharmaceutical 
        Negotiator shall be to conduct trade negotiations and to 
        enforce trade agreements relating to United States 
        pharmaceutical products and services. The Chief Pharmaceutical 
        Negotiator shall be a vigorous advocate on behalf of United 
        States pharmaceutical interests, including patients and United 
        States pharmaceutical workers. The Chief Pharmaceutical 
        Negotiator shall perform such other functions as the United 
        States Trade Representative may direct.''.
    (b) Compensation.--Section 5314 of title 5, United States Code is 
amended by striking ``Chief Innovation and Intellectual Property 
Negotiator, Office of the United States Trade Representative.'' and 
inserting the following:
    ``Chief Innovation and Intellectual Property Negotiator, Office of 
the United States Trade Representative.
    ``Chief Pharmaceutical Negotiator, Office of the United States 
Trade Representative.''.
    (c) Report Required.--Not later than one year after the appointment 
of the first Chief Pharmaceutical Negotiator pursuant to paragraph (2) 
of section 141(b) of the Trade Act of 1974, as amended by subsection 
(a), and annually thereafter, the United States Trade Representative 
shall submit to the Committee on Finance of the Senate and the 
Committee on Ways and Means of the House of Representatives a report 
describing in detail--
            (1) enforcement actions taken by the Trade Representative 
        during the one-year period preceding the submission of the 
        report to ensure the protection of United States pharmaceutical 
        products and services; and
            (2) other actions taken by the Trade Representative to 
        advance United States pharmaceutical products and services.
                                 <all>