[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 985 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 985

   To amend the Federal Food, Drug, and Cosmetic Act to ensure that 
 eligible product developers have competitive access to approved drugs 
  and licensed biological products, so as to enable eligible product 
  developers to develop and test new products, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 5, 2019

Mr. Welch (for himself, Mr. McKinley, and Mr. Cicilline) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to ensure that 
 eligible product developers have competitive access to approved drugs 
  and licensed biological products, so as to enable eligible product 
  developers to develop and test new products, 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.

    This Act may be cited as the ``Fair Access for Safe and Timely 
Generics Act of 2019'' or the ``FAST Generics Act of 2019''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) Reference product license or approval holders are 
        restricting competitive access to reference products by 
        sponsors seeking to develop drugs, generic drugs, and 
        biosimilars under section 505(b)(2) or 505(j) of the Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355(b)(2) and 355(j)) and 
        under section 351(k) of the Public Health Service Act (42 
        U.S.C. 262(k)). These restrictions are deterring and delaying 
        development of drugs, generic drugs, and biosimilars by 
        extending lawful patent-based monopolies beyond their lawful 
        patent life.
            (2) The enforcement provisions set forth in section 505-
        1(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355-1(f)(8)) have not been sufficient to prevent anti-
        competitive practices that interfere with access to reference 
        products which is necessary for the timely development of 
        affordable drugs, generic drugs, and biosimilars.
            (3) There is not a regulatory structure in place that is 
        sufficient to deter or remedy the anti-competitive harm that 
        results when--
                    (A) access to reference products is restricted to 
                sponsors developing drugs, generic drugs, or 
                biosimilars in accordance with section 505(b)(2) or 
                505(j) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(b)(2) or 355(j)), and section 351(k) of the 
                Public Health Service Act (42 U.S.C. 262(k)), 
                respectively; or
                    (B) license holders impede the prompt negotiation 
                and development of a single, shared system of elements 
                to assure safe use and supporting agreements under 
                section 505-1(i)(1)(B) of such Act (21 U.S.C. 355-
                1(i)(1)(B)), on commercially reasonable terms.
            (4) Requiring license holders to comply with requirements 
        for competitive access to their products, and for the 
        negotiation and development of single, shared systems of 
        elements to assure safe use under section 505-1(i)(1)(B) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-
        1(i)(1)(B)), and subjecting license holders to liability for 
        failing to do so, will not impose obligations on the courts 
        that they cannot adequately and reasonably adjudicate.

SEC. 3. COMPETITIVE ACCESS TO COVERED PRODUCTS FOR DEVELOPMENT 
              PURPOSES.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505-1 
of such Act (21 U.S.C. 355-1) the following new section:

``SEC. 505-2. COMPETITIVE ACCESS TO COVERED PRODUCTS FOR DEVELOPMENT 
              PURPOSES.

    ``(a) Definitions.--In this section:
            ``(1) Covered product.--The term `covered product'--
                    ``(A) means--
                            ``(i) any drug approved under section 505 
                        or biological product licensed under section 
                        351 of the Public Health Service Act;
                            ``(ii) any combination thereof; or
                            ``(iii) when reasonably necessary to 
                        demonstrate sameness, biosimilarity, or 
                        interchangeability for purposes of this 
                        section, section 505, or section 351 of the 
                        Public Health Service Act (as applicable), any 
                        product, including any device, that is marketed 
                        or intended for use with such drug or 
                        biological product; and
                    ``(B) excludes any drug or biological product which 
                the Secretary has determined to be currently in 
                shortage and that appears on the drug shortage list in 
                effect under section 506E, unless the shortage will not 
                be promptly resolved--
                            ``(i) as demonstrated by the fact that the 
                        drug or biological product has been in shortage 
                        for more than 6 months; or
                            ``(ii) as otherwise determined by the 
                        Secretary.
            ``(2) Eligible product developer.--The term `eligible 
        product developer' means a person that seeks to develop a 
        product for approval pursuant to an application under section 
        505(b)(2) or 505(j) or for licensing pursuant to an application 
        under section 351(k) of the Public Health Service Act.
            ``(3) License holder.--The term `license holder' means the 
        holder of an application approved under section 505(b) or 
        section 505(j) of this Act or under section 351 of the Public 
        Health Service Act for a covered product (including the 
        holder's agents, wholesalers, distributors, assigns, corporate 
        affiliates, and contractors).
            ``(4) REMS.--The term `REMS' means a risk evaluation and 
        mitigation strategy under section 505-1.
            ``(5) REMS product.--The term `REMS product' means a 
        covered product that--
                    ``(A) is subject to a risk evaluation and 
                mitigation strategy under section 505-1; or
                    ``(B) is deemed under section 909(b) of the Food 
                and Drug Administration Amendments Act of 2007 to have 
                in effect an approved risk evaluation and mitigation 
                strategy under section 505-1.
            ``(6) REMS impacting product distribution.--The term `REMS 
        impacting product distribution' means a REMS that contains 
        elements to assure safe use that impact the distribution of the 
        product subject to the REMS.
    ``(b) Competitive Access to Covered Products as a Condition on 
Approval or Licensing.--As a condition of approval or licensure, or 
continuation or renewal of approval or licensure, of a covered product 
under section 505 of this Act or section 351 of the Public Health 
Service Act, respectively, the Secretary shall require that the covered 
product's license holder not construe or apply any condition or 
restriction relating to the sale, resale, or distribution of the 
covered product, including any condition or restriction adopted, 
imposed, or enforced as an aspect of a risk evaluation and mitigation 
strategy, in a way that restricts or has the effect of restricting the 
supply of such covered product to an eligible product developer for 
development or testing purposes.
    ``(c) Competitive Access for Development Purposes to Products With 
REMS Impacting Product Distribution.--With respect to a product subject 
to a REMS impacting product distribution, no aspect of such a REMS 
shall be construed or applied by the REMS product's license holder in a 
way that prohibits or restricts the supply, at commercially reasonable, 
market-based prices, of such REMS product from the REMS product's 
license holder to an eligible product developer with an applicable 
individual covered product authorization obtained pursuant to 
subsection (e) for development and testing purposes.
    ``(d) Single, Shared System of Elements To Assure Safe Use.--Where 
an eligible product developer seeks approval of an application under 
505(j) referencing a REMS product whose REMS includes elements to 
assure safe use--
            ``(1) no license holder shall take any step that impedes--
                    ``(A) the prompt development on commercially 
                reasonable terms of a single, shared system of elements 
                to assure safe use under section 505-1; or
                    ``(B) the prompt entry on commercially reasonable 
                terms of an eligible product developer into a 
                previously approved system of elements to assure safe 
                use; and
            ``(2) license holders shall negotiate in good faith towards 
        the prompt development of (or entry into) a single, shared 
        system of elements to assure safe use under section 505-1(i) on 
        commercially reasonable terms.
    ``(e) Procedures for Obtaining Access to Covered Products.--
            ``(1) Competitive access to products not subject to rems 
        impacting product distribution.--Notwithstanding any other 
        provision of law, a license holder that receives a request from 
        an eligible product developer or its agent for sufficient 
        supplies of a covered product (that is not subject to a REMS 
        impacting product distribution) to conduct testing necessary to 
        support an application under section 505(b)(2) or 505(j) or 
        under section 351(k) of the Public Health Service Act (or 
        otherwise meet the requirements for approval of such an 
        application) shall provide to the eligible product developer or 
        its agent the quantity requested within 30 days of receipt of 
        the request at a nondiscriminatory, commercially reasonable, 
        market-based price for which such covered product has been 
        previously sold by the license holder to third parties in the 
        open market.
            ``(2) Competitive access to products subject to rems 
        impacting product distribution: individual covered product 
        authorization.--Any eligible product developer may seek an 
        authorization to obtain an individual covered product subject 
        to a REMS impacting product distribution for development and 
        testing purposes by making a written request to the Secretary. 
        Within 120 days of receiving such a request, the Secretary 
        shall, by written notice, issue such authorization for purposes 
        of--
                    ``(A) 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
                    ``(B) development and testing that involves human 
                clinical trials if the eligible product developer has--
                            ``(i) submitted a protocol for testing that 
                        includes protections that will provide an 
                        assurance of safety comparable to the assurance 
                        of safety provided by any distribution 
                        restrictions governing the approval or 
                        licensure of the covered product; or
                            ``(ii) otherwise satisfied the Secretary 
                        that such protections will be provided.
            ``(3)(A) Process for obtaining product pursuant to an 
        authorization.--
                    ``(i) An eligible product developer shall be 
                entitled to obtain, from the license holder of a 
                covered product subject to a REMS impacting 
                distribution, sufficient quantities of the covered 
                product for purposes of development and testing 
                necessary to support an application under section 
                505(b)(2) or 505(j) or under section 351(k) of the 
                Public Health Service Act, or otherwise meet the 
                requirements for approval of such application, if the 
                eligible product developer has obtained an applicable 
                authorization under paragraph (2).
                    ``(ii) Each license holder shall publicly designate 
                at least one wholesaler or specialty distributor to 
                receive and fulfill requests for covered products 
                submitted pursuant to paragraph (1) or clause (i) of 
                this paragraph.
                    ``(iii) An eligible product developer shall 
                initiate its acquisition of a covered product under 
                clause (i) by providing or having its agent provide a 
                written request for specific quantities of such covered 
                product to the license holder.
            ``(B) Request contents and response.--A request under 
        subparagraph (A)(iii) shall include a statement regarding the 
        quantity of covered product sought for development or testing 
        purposes, and state that the eligible product developer has an 
        authorization under paragraph (2) to obtain the specific 
        covered product. Within 30 days of receiving such a request, 
        the wholesaler or specialty distributor shall provide the 
        requested quantity of the covered product at a 
        nondiscriminatory, commercially reasonable, market-based price 
        for which such covered product has been previously sold by the 
        license holder to third parties in the open market.
            ``(C) Disclosure of information by wholesalers and 
        specialty distributors.--In the event that a request is made to 
        a wholesaler or specialty distributor under this paragraph, the 
        wholesaler or specialty distributor shall not disclose to the 
        license holder of the covered product involved the identity of 
        the eligible product developer, but may disclose to such 
        license holder--
                    ``(i) the fact that a request has been made;
                    ``(ii) the dates on which the request was made and 
                fulfilled;
                    ``(iii) the commercial terms on which the request 
                was fulfilled; and
                    ``(iv) the quantity of the covered product 
                furnished by the wholesaler or specialty distributor in 
                compliance with the request.
            ``(D) Imminent hazard.--At any time, the Secretary may 
        prohibit, limit, or otherwise suspend a transfer of a covered 
        product to an eligible product developer if the Secretary 
        determines that the transfer of such product to the eligible 
        product developer would present an imminent hazard to the 
        public health. In such cases, the Secretary shall specify the 
        basis for the determination, including the specific information 
        available to the Secretary which served as the basis for such 
        determination, and confirm such determination in writing.
    ``(f) Enforcement.--
            ``(1) Remedies.--An eligible product developer that is 
        aggrieved by a violation of subsection (b), (c), (d), (e)(1) or 
        (e)(3) by a license holder may sue such license holder in a 
        court of competent jurisdiction for injunctive relief and 
        treble damages (including costs and interest of the kind 
        described in section 4(a) of the Clayton Act (15 U.S.C. 
        15(a))).
            ``(2) Rule of construction.--
                    ``(A) Preservation of antitrust laws.--Nothing in 
                this Act, or the amendments made by this Act, shall be 
                construed to modify, supersede, or impair the operation 
                of the antitrust laws.
                    ``(B) Definition.--For purposes of paragraph (1), 
                the term `antitrust laws' shall have the meaning given 
                such term in subsection (a) of the 1st section of the 
                Clayton Act (15 U.S.C. 12), except that such term shall 
                include section 5 of the Federal Trade Commission Act 
                (15 U.S.C. 45) to the extent that such subsection 
                applies to unfair methods of competition.
    ``(g) Limitation of Liability.--The holder of an approved 
application or license for a covered product shall not be liable for 
any claim arising out of an eligible product developer's failure to 
follow adequate safeguards to assure safe use of the covered product 
during development or testing activities conducted under this 
section.''.
    (b) Waiver of Single, Shared System Requirement.--Section 505-
1(i)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-
1(i)(1)(C)) is amended--
            (1) in clause (i), by striking ``or'' at the end;
            (2) in clause (ii), by striking the period at the end and 
        inserting ``; or''; and
            (3) by inserting after clause (ii) the following:
                            ``(iii) the applicant for an abbreviated 
                        new drug application certifies that it 
                        attempted in good faith to create or negotiate 
                        entry into a single, shared system, but was 
                        unable to finalize commercially reasonable 
                        terms with the holder of the listed drug within 
                        120 days, and such certification includes a 
                        description of the efforts made by the 
                        applicant for the abbreviated new drug 
                        application to create or negotiate entry into a 
                        single, shared system.''.
    (c) Effective Date.--This section and the amendments made by this 
section shall take effect upon enactment, and shall apply to all 
approved applications or licenses for a covered product (as defined in 
section 505-2(a) of the Federal Food, Drug, and Cosmetic Act, as added 
by this section) regardless of whether those applications or licenses 
were approved before, on, or after the date of enactment of this Act.
                                 <all>