[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6294 Introduced in House (IH)]

<DOC>






115th CONGRESS
  2d Session
                                H. R. 6294

  To amend the Federal Food, Drug, and Cosmetic Act to encourage the 
 development of priority antimicrobial products through the award of a 
   transferable exclusivity extension period, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 28, 2018

  Mr. Shimkus (for himself and Mr. Cardenas) 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 encourage the 
 development of priority antimicrobial products through the award of a 
   transferable exclusivity extension period, 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 ``Re-Valuing Anti-Microbial Products 
Act of 2018'' or the ``REVAMP Act''.

SEC. 2. EXCLUSIVITY TO ENCOURAGE DEVELOPMENT OF NOVEL THERAPIES 
              TARGETING SERIOUS MICROBIAL INFECTIONS.

    Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360aa et seq.) is amended by inserting after section 
529A the following:

``SEC. 530. EXCLUSIVITY TO ENCOURAGE DEVELOPMENT OF NOVEL THERAPIES 
              TARGETING SERIOUS MICROBIAL INFECTIONS.

    ``(a) In General.--If the Secretary approves an application 
pursuant to section 505(c) of this Act or section 351(a) of the Public 
Health Service Act for a drug that has been designated as a priority 
antimicrobial product under subsection (k), the Secretary shall award 
to the holder of the application a 12-month exclusivity extension 
period described in subsection (c) for the sole purpose of conveying 
such extension, in whole or in portions, to other sponsors or holders 
to be applied with respect to one or more other drugs--
            ``(1) for which an application is submitted under section 
        505(b)(1);
            ``(2) for which at approval, new chemical entity 
        exclusivity is granted under subsection (c)(3)(E)(ii) and 
        (j)(5)(F)(ii) of section 505; and
            ``(3) that is designated as a fast track product under 
        section 506(b).
    ``(b) Notice to Secretary.--Upon making a conveyance under 
subsection (a), the holder of the approved application for the priority 
antimicrobial product involved shall submit a notice to the Secretary 
including--
            ``(1) the name of the priority antimicrobial product;
            ``(2) the name of the recipient drug; and
            ``(3) the duration of the conveyed exclusivity extension 
        period.
    ``(c) Effect of Conveyance.--
            ``(1) Extension of other applicable exclusivity periods.--
        Immediately upon the Secretary's receipt of a notice under 
        subsection (b), with respect to the recipient drug, the 
        following exclusivity periods (as applicable) are each extended 
        by the conveyed exclusivity extension period:
                    ``(A) The 4-year, 5-year, 48-month, and 7\1/2\-year 
                periods described in subsections (c)(3)(E)(ii) and 
                (j)(5)(F)(ii) of section 505.
                    ``(B) The 3-year periods described in clauses (iii) 
                and (iv) of subsection (c)(3)(E) and clauses (iii) and 
                (iv) of subsection (j)(5)(F) of section 505.
                    ``(C) The 7-year period described in section 527.
            ``(2) Drugs subject to listed patents.--Immediately upon 
        the Secretary's receipt of a notice under subsection (b), the 
        period during which an approval of an application may not be 
        made effective by operation of subsection (c)(3) or (j)(5)(B) 
        of section 505, as applicable, in the case of a recipient drug 
        that is the subject of--
                    ``(A) a listed patent for which a certification has 
                been submitted under subsection (b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II) of section 505;
                    ``(B) a listed patent for which a certification has 
                been submitted under subsection (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505; or
                    ``(C) a listed patent for which a certification has 
                been submitted under subsection (b)(2)(A)(iv) or 
                (j)(2)(A)(vii)(IV) of section 505 if in the patent 
                infringement litigation resulting from the 
                certification the court determines that the patent is 
                valid and would be infringed,
        shall be extended after the date the listed patent expires 
        (including any patent extensions) for a period equal to the 
        conveyed exclusivity extension period.
    ``(d) Timing of Conveyance and Notice.--The conveyance of an 
exclusivity extension period pursuant to subsection (a) and the 
provision of notice under subsection (b) shall be made no later than--
            ``(1) in the case of a priority antimicrobial product that 
        is a drug, the last day of the ninth year of the 5-year period 
        described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), as 
        extended, as applicable, under section 505E; and
            ``(2) in the case of a priority antimicrobial product that 
        is a biological product, the last day of the eleventh year of 
        the exclusivity period described in section 351(k)(7)(A) of the 
        Public Health Service Act applicable with respect to such 
        product.
    ``(e) Permitted Transactions.--Except as provided in this section, 
the holder of a conveyed exclusivity extension period may sell, 
exchange, convey, or hold for use, such period.
    ``(f) Exception.--A period referred to in paragraph (1) or (2) of 
subsection (c) shall not be extended under such subsection if the 
conveyance of an exclusivity extension period pursuant to subsection 
(a) or the provision of notice under subsection (b) is made later than 
4 years prior to the expiration of such period.
    ``(g) Limitations.--
            ``(1) Number of awards.--The Secretary may make not more 
        than 10 awards under subsection (a).
            ``(2) Award for prior approved application.--A drug is not 
        eligible for designation under this section as a priority 
        antimicrobial product if an application for approval or 
        licensure of such drug was approved under section 505(b) or 
        licensed under section 351(a) of the Public Health Service Act 
        before January 1, 2018.
            ``(3) Drugs intended for cosmetic purpose.--A drug is not 
        eligible for designation under this section as a priority 
        antimicrobial product if the drug is intended to promote hair 
        growth or for any other cosmetic purpose.
            ``(4) Conveyance date.--The holder of an exclusivity 
        extension period awarded under or conveyed pursuant to 
        subsection (a) may not convey such period to be applied with 
        respect to a drug unless such drug is or will be first approved 
        under section 505(c) on or after January 1, 2023.
    ``(h) Contribution Upon Conveyance.--As a condition on the award of 
an exclusivity extension period to the holder of a drug pursuant to 
subsection (a), the Secretary shall require the holder, upon any 
conveyance of the period pursuant to such subsection, in whole or in 
portions, to make a monetary contribution to the Foundation for the 
National Institutes of Health that--
            ``(1) is in an amount that is equal to 5 percent of the 
        total value of the consideration received by the holder as a 
        result of the conveyance; and
            ``(2) is designated to be used by the Foundation to conduct 
        or support early-stage research on the development of products 
        to treat or prevent a disease attributable to a multi-drug 
        resistant bacterial or fungal pathogen.
    ``(i) Relation to Pediatric Exclusivity.--Any extension of a period 
under subsection (c) shall be in addition to any extension of the 
period under section 505A of this Act, and any reference to a period in 
subsection (c) is deemed to be a reference to the period as extended 
under such section 505A, if applicable.
    ``(j) Critical Need Antimicrobial Priorities.--
            ``(1) Committee on developing critical need 
        antimicrobials.--Not later than 60 days after the date of 
        enactment of the Re-Valuing Anti-Microbial Products Act of 
        2018, the Secretary shall establish a Committee on Developing 
        Critical Need Antimicrobials.
            ``(2) Membership.--The members of the Committee shall 
        include--
                    ``(A) one representative of the Food and Drug 
                Administration;
                    ``(B) one representative of the Centers for Disease 
                Control and Prevention;
                    ``(C) one representative of the Biomedical Advanced 
                Research and Development Authority; and
                    ``(D) five representatives of the community of 
                other stakeholders with research, commercialization, 
                clinical, public health, and economic expertise in the 
                field of antimicrobial resistance, which 
                representatives shall include at least one physician 
                with experience treating infections caused by multidrug 
                resistant organisms.
            ``(3) Duties.--The Committee shall--
                    ``(A) not later than 60 days after all of the 
                initial members of the Committee have been appointed, 
                develop and publish on the website of the Office of the 
                Assistant Secretary for Preparedness and Response a 
                proposed list of critical need antimicrobial priorities 
                consisting of specific multi-drug resistant bacterial 
                or fungal pathogens, which list shall be developed 
                taking into consideration--
                            ``(i) specific prevention or treatment of 
                        bacterial or fungal infections for which there 
                        is an unmet medical need; and
                            ``(ii) susceptibility to specific 
                        microorganisms and treatment need for multi-
                        drug resistant pathogens;
                    ``(B) perform other activities, as determined 
                necessary by the Secretary, to support the designation 
                of priority antimicrobial products under subsection (k) 
                and the review and disposition of applications for 
                priority antimicrobial products under subsection (a); 
                and
                    ``(C) develop recommendations to the Secretary and 
                the Congress regarding other incentives needed to 
                ensure a robust and renewable pipeline of antimicrobial 
                drugs, with priority given to antimicrobial drugs that 
                are first in class, possess a novel mechanism of 
                action, or treat a vulnerable population such as 
                children.
            ``(4) Finalization and updating of list of critical need 
        antimicrobials priorities.--Upon receipt from the Committee of 
        the initial proposed list of critical need antimicrobial 
        priorities or proposed updates to such list, the Secretary 
        shall--
                    ``(A) provide a period of public notice and comment 
                on the proposal, including by publishing the proposed 
                list on the Internet;
                    ``(B) hold public meetings to elicit input from 
                stakeholders on the proposal; and
                    ``(C) not later than 180 days after the Secretary's 
                receipt of the proposal, publish a final version of the 
                list.
            ``(5) Subsequent updates.--The Secretary, in coordination 
        with the Committee, shall revise, and publish in accordance 
        with paragraph (4), the list of critical need antimicrobial 
        priorities within 30 days of approval of a product designated 
        under subsection (k) or if the Secretary determines it is 
        necessary, but in any case no later than every 2 years.
            ``(6) Restriction on removal from list.--No critical need 
        antimicrobial priority may be removed from the list of critical 
        need antimicrobial priorities until after submission of the 
        report required by subsection (n)(1).
    ``(k) Designation of Priority Antimicrobial Products.--
            ``(1) Request.--The manufacturer or sponsor of a drug may 
        request that the Secretary designate a drug as a priority 
        antimicrobial product at any time before or after submission of 
        an application for approval or licensure of such drug under 
        section 505(b) of this Act or section 351(a) of the Public 
        Health Service Act, as applicable.
            ``(2) Designation.--Not later than 60 days after the 
        submission of a request under paragraph (1), the Secretary, in 
        coordination with the Committee, shall--
                    ``(A)(i) approve the request if the drug subject to 
                the request is intended to treat or prevent a disease 
                attributable to a multi-drug resistant bacterial or 
                fungal pathogen that is listed as a critical need 
                antimicrobial priority pursuant to subsection (j); or
                    ``(ii) disapprove the request if the drug subject 
                to the request is not intended to treat or prevent such 
                a disease; and
                    ``(B) notify the requestor of such action and, for 
                any disapproval, include in such notification an 
                explanation of the reason for the disapproval.
            ``(3) Limitation.--A designation under paragraph (2) shall 
        not be withdrawn for any reason, including modifications to the 
        list of critical need antimicrobial priorities, unless the 
        Secretary finds that the request for such designation contained 
        an untrue statement of material fact.
    ``(l) Antimicrobial Susceptibility Testing Devices.--As a condition 
on designation of a priority antimicrobial product pursuant to 
subsection (k), the sponsor of such product shall--
            ``(1) make such product available to antimicrobial 
        susceptibility test device manufacturers as early in the 
        development process as possible; and
            ``(2) submit a plan for such availability to the Secretary.
    ``(m) Appropriate Use.--As a condition on designation of a priority 
antimicrobial product pursuant to subsection (k), the sponsor of such 
product shall agree to--
            ``(1) identify, track, and make publicly available 
        antimicrobial resistance occurrence data and trends for such 
        product;
            ``(2) develop, through the sponsor's chief compliance 
        officer, the sponsor's chief medical officer, or another 
        appropriate designee, written guidelines and procedures to 
        ensure appropriate use of such product, including appropriate--
                    ``(A) promotional practices;
                    ``(B) education to encourage appropriate use;
                    ``(C) surveillance and monitoring; and
                    ``(D) stewardship;
            ``(3) develop education and communications strategies for 
        educating health care professionals about such product and its 
        appropriate use; and
            ``(4) submit to the Food and Drug Administration, beginning 
        at 24 months after the date of approval pursuant to section 
        505(c) of this Act or section 351(a) of the Public Health 
        Service Act of an application for such product, and every two 
        years thereafter so long as such product is marketed in the 
        United States, an assessment of the sponsor's stewardship 
        activities relating to such product.
    ``(n) Studies.--
            ``(1) Joint study by hhs and gao.--
                    ``(A) In general.--Beginning 5 years after the date 
                of enactment of the Re-Valuing Anti-Microbial Products 
                Act of 2018 or on the date that the Secretary awards 
                the fifth exclusivity extension period under this 
                section, whichever is earlier, the Director of the 
                Centers for Disease Control and Prevention and 
                Comptroller General of the United States shall conduct 
                a study of the effectiveness of the program under this 
                section for the development of priority antimicrobial 
                products.
                    ``(B) Contents of the study.--In conducting the 
                study under subparagraph (A), the Director of the 
                Centers for Disease Control and Prevention and 
                Comptroller General shall examine--
                            ``(i) the indications and usage for each 
                        drug for which an exclusivity extension period 
                        was awarded under subsection (a);
                            ``(ii) the development of resistance to 
                        each drug for which an exclusivity extension 
                        period was awarded under subsection (a);
                            ``(iii) the private and societal value of 
                        each drug for which an exclusivity extension 
                        period was awarded under subsection (a); and
                            ``(iv) the impact on patients and public 
                        and private markets of the recipient drug with 
                        respect to which a conveyed exclusivity 
                        extension period was used.
                    ``(C) Report.--Not later than 1 year after the date 
                by which the study under subparagraph (A) is required 
                to begin under subparagraph (A), the Director of the 
                Centers for Disease Control and Prevention and 
                Comptroller General shall submit to the Congress a 
                report containing the results of the study.
            ``(2) Study by gao.--Not later than the date that is 5 
        years after the date of the first award under subsection (a), 
        the Comptroller General of the United States shall--
                    ``(A) complete a study on the actual and projected 
                impacts of the program under this section on Federal 
                expenditures; and
                    ``(B) submit a report on the results of such study 
                to the Congress.
    ``(o) Report on Reauthorization.--Not later than 180 days after the 
Secretary awards the ninth exclusivity extension period under this 
section, the Committee shall submit a report to the Secretary and the 
Congress containing recommendations on the reauthorization of this 
section, including recommendations on increasing the number of awards 
allowed by subsection (g)(1).
    ``(p) Definitions.--In this section:
            ``(1) The term `biological product' has the meaning given 
        to such term in section 351(i) of the Public Health Service 
        Act.
            ``(2) The term `Committee' means the Committee on 
        Developing Critical Need Antimicrobials established under 
        subsection (j).
            ``(3) The term `conveyed exclusivity extension period' 
        means an exclusivity extension period conveyed pursuant to 
        subsection (a).
            ``(4) The term `priority antimicrobial product' means a 
        product that is designated under subsection (k).
            ``(5) The term `recipient drug' means a drug approved under 
        section 505 receiving a conveyed exclusivity extension 
        period.''.
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