[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 965 Reported in House (RH)]

<DOC>





                                                  Union Calendar No. 33
116th CONGRESS
  1st Session
                                H. R. 965

                  [Report No. 116-55, Parts I and II]

To promote competition in the market for drugs and biological products 
 by facilitating the timely entry of lower-cost generic and biosimilar 
            versions of those drugs and biological products.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 5, 2019

Mr. Cicilline (for himself, Mr. Sensenbrenner, Mr. Nadler, Mr. Collins 
of Georgia, Mr. Welch, and Mr. McKinley) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on the Judiciary, 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

                              May 10, 2019

  Additional sponsors: Mr. Meadows, Ms. Finkenauer, Mr. Doggett, Mr. 
Cole, Mr. Gallagher, Mr. Lipinski, Mr. Rush, Ms. McCollum, Mr. Pallone, 
 Mr. Perry, Mr. Ruiz, Mrs. Dingell, Ms. Eshoo, Ms. Matsui, Mrs. Craig, 
   Mr. Tonko, Mr. Gohmert, Mr. Van Drew, Ms. Clarke of New York, Mr. 
 Courtney, Mr. Allred, Ms. Schakowsky, Mr. Crow, Mr. Gonzalez of Ohio, 
Mr. Larson of Connecticut, Mr. McAdams, Mr. Schrader, Mr. Rodney Davis 
    of Illinois, Mr. Pappas, Mr. Kennedy, Ms. Davids of Kansas, Mr. 
 Norcross, Ms. Spanberger, Mr. Quigley, Mr. Deutch, Mr. Langevin, Mr. 
Cooper, Mrs. McBath, Mr. Raskin, Ms. Mucarsel-Powell, Mr. Stanton, Mr. 
 Jordan, Ms. Wild, Mr. Cohen, Mr. Kim, Ms. Schrier, Mr. Joyce of Ohio, 
  Mr. Case, Mr. Khanna, Mr. David Scott of Georgia, Ms. Houlahan, Mr. 
Casten of Illinois, Mr. Norman, Ms. Pingree, Mr. Carbajal, Mr. Smith of 
Washington, Ms. Wexton, Mr. Cisneros, Mr. Connolly, Ms. Underwood, Ms. 
               Garcia of Texas, Ms. Meng, and Mrs. Bustos

                              May 10, 2019

  Reported from the Committee on Energy and Commerce with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

                              May 10, 2019

    Reported from the Committee on the Judiciary; committed to the 
 Committee of the Whole House on the State of the Union and ordered to 
                               be printed
    [For text of introduced bill, see copy of bill as introduced on 
                           February 5, 2019]

_______________________________________________________________________

                                 A BILL


 
To promote competition in the market for drugs and biological products 
 by facilitating the timely entry of lower-cost generic and biosimilar 
            versions of those drugs and biological products.


 


    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 ``Creating and Restoring Equal Access 
to Equivalent Samples Act of 2019'' or the ``CREATES Act of 2019''.

SEC. 2. 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. 3. 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 2, 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.''.

SEC. 4. RULE OF CONSTRUCTION.

    (a) In General.--Nothing in this Act, the amendments made by this 
Act, or in section 505-1 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355-1), shall be construed as--
            (1) prohibiting a license holder from providing an eligible 
        product developer access to a covered product in the absence of 
        an authorization under this Act; or
            (2) in any way negating the applicability of a REMS with 
        ETASU, as otherwise required under such section 505-1, with 
        respect to such covered product.
    (b) Definitions.--In this section, the terms ``covered product'', 
``eligible product developer'', ``license holder'', and ``REMS with 
ETASU'' have the meanings given such terms in section 3(a).
                                                  Union Calendar No. 33

116th CONGRESS

  1st Session

                               H. R. 965

                  [Report No. 116-55, Parts I and II]

_______________________________________________________________________

                                 A BILL

To promote competition in the market for drugs and biological products 
 by facilitating the timely entry of lower-cost generic and biosimilar 
            versions of those drugs and biological products.

_______________________________________________________________________

                              May 10, 2019

  Reported from the Committee on Energy and Commerce with an amendment

                              May 10, 2019

    Reported from the Committee on the Judiciary; committed to the 
 Committee of the Whole House on the State of the Union and ordered to 
                               be printed