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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2387 Introduced in House (IH)]

<DOC>

116th CONGRESS
  1st Session
                                H. R. 2387

 To amend subsection (q) of section 505 of the Federal Food, Drug, and 
Cosmetic Act to clarify the process for denying certain petitions whose 
 primary purpose is to delay the approval of an application submitted 
   under subsection (b)(2) or (j) of such section 505, and for other 
                               purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             April 29, 2019

     Mr. Levin of Michigan (for himself and Mr. Rooney of Florida) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
 To amend subsection (q) of section 505 of the Federal Food, Drug, and 
Cosmetic Act to clarify the process for denying certain petitions whose 
 primary purpose is to delay the approval of an application submitted 
   under subsection (b)(2) or (j) of such section 505, 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 ``Stop The Overuse of Petitions and 
Get Affordable Medicines to Enter Soon Act of 2019'' or the ``STOP 
GAMES Act of 2019''.

SEC. 2. DENIAL OF PETITIONS WHOSE PRIMARY PURPOSE IS TO DELAY APPROVAL 
              OF CERTAIN APPLICATIONS.

    (a) In General.--Subparagraph (E) of section 505(q)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)) is amended 
to read as follows:
                    ``(E) Denial based on intent to delay.--
                            ``(i) In general.--If the Secretary 
                        determines that a petition or a supplement to 
                        the petition was submitted with the primary 
                        purpose of delaying the approval of an 
                        application or the petition does not on its 
                        face raise valid scientific or regulatory 
                        issues, the Secretary may deny the petition at 
                        any point based on such determination.
                            ``(ii) Factors.--The Secretary may issue 
                        guidance to describe the factors that will be 
                        used to determine under this subparagraph 
                        whether a petition is submitted with the 
                        primary purpose of delaying the approval of an 
                        application. Such factors shall include the 
                        following:
                                    ``(I) Submission of a petition 
                                where it appears, based on the date 
                                that relevant information relied upon 
                                in the petition became known to the 
                                petitioner (or reasonably should have 
                                been known to the petitioner), that the 
                                petitioner has taken an unreasonable 
                                length of time to submit the petition.
                                    ``(II) Submission of multiple or 
                                serial petitions raising issues that 
                                reasonably could have been known to the 
                                petitioner at the time of submission of 
                                the earlier petition or petitions.
                                    ``(III) Submission of a petition 
                                close in time to a known, first date 
                                upon which an application under 
                                subsection (b)(2) or (j) of this 
                                section or under section 351(k) of the 
                                Public Health Service Act could be 
                                approved (such as submission close in 
                                time to the expiration of a blocking 
                                patent or exclusivity).
                                    ``(IV) Submission of a petition 
                                without any data or information in 
                                support of the scientific positions set 
                                forth in the petition.
                                    ``(V) Submission of a petition 
                                raising the same or substantially 
                                similar issues as a prior petition to 
                                which the Food and Drug Administration 
                                has already substantively responded, 
                                particularly where the subsequent 
                                submission closely follows in time the 
                                earlier response.
                                    ``(VI) Submission of a petition 
                                concerning standards for approval of a 
                                drug product for which--
                                            ``(aa) the Food and Drug 
                                        Administration has provided an 
                                        opportunity for public input 
                                        (such as when the Food and Drug 
                                        Administration has issued draft 
                                        or final product-specific 
                                        guidance applicable to the drug 
                                        product); and
                                            ``(bb) the petitioner has 
                                        not provided comment other than 
                                        through the petition.
                                    ``(VII) Submission of a petition 
                                requesting that other applicants must 
                                meet standards for testing, data, or 
                                labeling for their products that are 
                                more onerous or rigorous than the 
                                standards applicable to the applicable 
                                listed drug or the petitioner's version 
                                of the same product.
                                    ``(VIII) Other relevant 
                                considerations, including the history 
                                of the petitioner with the Food and 
                                Drug Administration (such as whether 
                                the petitioner has a history of 
                                submitting petitions which the Food and 
                                Drug Administration has determined were 
                                submitted with the primary purpose of 
                                delay).
                            ``(iii) Referral to ftc.--If the Secretary 
                        determines that a petition has been submitted 
                        with the primary purpose of delaying the 
                        approval of an application, as described in 
                        clause (i), the Secretary shall refer the 
                        matter to the Federal Trade Commission.''.
    (b) Deadline for Submission of Petitions.--
            (1) Deadline.--Clause (i) of section 505(q)(1)(A) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)(A)) 
        is amended to read as follows:
                            ``(i) the request is in writing, is a 
                        petition submitted to the Secretary pursuant to 
                        section 10.30, 10.31, or 10.35 of title 21, 
                        Code of Federal Regulations (or any successor 
                        regulations), and is submitted not later than 
                        60 days after the information upon which the 
                        petition is based first became known to the 
                        party on whose behalf the petition is 
                        submitted; and''.
            (2) Certification.--Section 505(q)(1)(H) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1)) is amended 
        by striking ``I further certify that the information upon which 
        I have based the action requested herein first became known to 
        the party on whose behalf this petition is submitted on or 
        about the following date: ____.'' and inserting ``I further 
        certify that the information upon which I have based the action 
        requested herein first became known to the party on whose 
        behalf this petition is submitted on or about ____, which date 
        was not more than 60 days before the date of submitting this 
        petition.''.
    (c) Reporting to Congress.--Section 505(q)(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(q)(3)) is amended--
            (1) in the matter before subparagraph (A), by striking 
        ``specifies'';
            (2) in subparagraphs (A), (B), (C), and (D), by striking 
        ``the number'' and inserting ``specifies the number'';
            (3) in subparagraph (C), by striking ``and'' at the end;
            (4) in subparagraph (D), by striking the period at the end 
        and inserting ``; and''; and
            (5) by adding at the end the following:
                    ``(E)(i) lists each petition submitted during such 
                period and, for each, identifies the petitioner;
                    ``(ii) quantifies the time and resources expended 
                on each such petition;
                    ``(iii) states the timing of the petition relative 
                to the expiration date of the patents specified in the 
                pending application in the certification under 
                subsection (b)(2)(A) or (j)(2)(A)(vii), as applicable;
                    ``(iv) quantifies the delay, if any, caused by any 
                such petition on the approval of any application 
                submitted under subsection (b)(2) or (j), including a 
                description of how any such delay is calculated and an 
                estimate of when any delayed approval would have been 
                granted absent the petition; and
                    ``(v) in cases in which a pending application and a 
                petition with respect to such pending application are 
                disposed of on the same or nearly the same date, states 
                when the Food and Drug Administration would have 
                disposed of the pending application absent the 
                petition.''.
                                 <all>
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