I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Stop The Overuse of 

3 Petitions and Get Affordable Medicines to Enter Soon Act 

4 of 2019’’ or the ‘‘STOP GAMES Act of 2019’’. 

5 SEC. 2. DENIAL OF PETITIONS WHOSE PRIMARY PURPOSE 

6 IS TO DELAY APPROVAL OF CERTAIN APPLI7 CATIONS. 

8 (a) IN GENERAL.—Subparagraph (E) of section 

9 505(q)(1) of the Federal Food, Drug, and Cosmetic Act 

10 (21 U.S.C. 355(q)(1)) is amended to read as follows: 

11 ‘‘(E) DENIAL BASED ON INTENT TO

12 DELAY.— 

13 ‘‘(i) IN GENERAL.—If the Secretary 

14 determines that a petition or a supplement 

15 to the petition was submitted with the pri16 mary purpose of delaying the approval of 

17 an application or the petition does not on 

18 its face raise valid scientific or regulatory 

19 issues, the Secretary may deny the petition 

20 at any point based on such determination. 

21 ‘‘(ii) FACTORS.—The Secretary may 

22 issue guidance to describe the factors that 

23 will be used to determine under this sub24 paragraph whether a petition is submitted 

25 with the primary purpose of delaying the 


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1 approval of an application. Such factors 

2 shall include the following: 

3 ‘‘(I) Submission of a petition 

4 where it appears, based on the date 

5 that relevant information relied upon 

6 in the petition became known to the 

7 petitioner (or reasonably should have 

8 been known to the petitioner), that 

9 the petitioner has taken an unreason10 able length of time to submit the peti11 tion. 

12 ‘‘(II) Submission of multiple or 

13 serial petitions raising issues that rea14 sonably could have been known to the 

15 petitioner at the time of submission of 

16 the earlier petition or petitions. 

17 ‘‘(III) Submission of a petition 

18 close in time to a known, first date 

19 upon which an application under sub20 section (b)(2) or (j) of this section or 

21 under section 351(k) of the Public 

22 Health Service Act could be approved 

23 (such as submission close in time to 

24 the expiration of a blocking patent or 

25 exclusivity). 


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1 ‘‘(IV) Submission of a petition 

2 without any data or information in 

3 support of the scientific positions set 

4 forth in the petition. 

5 ‘‘(V) Submission of a petition 

6 raising the same or substantially simi7 lar issues as a prior petition to which 

8 the Food and Drug Administration 

9 has already substantively responded, 

10 particularly where the subsequent sub11 mission closely follows in time the ear12 lier response. 

13 ‘‘(VI) Submission of a petition 

14 concerning standards for approval of 

15 a drug product for which— 

16 ‘‘(aa) the Food and Drug 

17 Administration has provided an 

18 opportunity for public input 

19 (such as when the Food and 

20 Drug Administration has issued 

21 draft or final product-specific 

22 guidance applicable to the drug 

23 product); and 


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1 ‘‘(bb) the petitioner has not 

2 provided comment other than 

3 through the petition. 

4 ‘‘(VII) Submission of a petition 

5 requesting that other applicants must 

6 meet standards for testing, data, or 

7 labeling for their products that are 

8 more onerous or rigorous than the 

9 standards applicable to the applicable 

10 listed drug or the petitioner’s version 

11 of the same product. 

12 ‘‘(VIII) Other relevant consider13 ations, including the history of the pe14 titioner with the Food and Drug Ad15 ministration (such as whether the pe16 titioner has a history of submitting 

17 petitions which the Food and Drug 

18 Administration has determined were 

19 submitted with the primary purpose of 

20 delay). 

21 ‘‘(iii) REFERRAL TO FTC.—If the Sec22 retary determines that a petition has been 

23 submitted with the primary purpose of de24 laying the approval of an application, as 

25 described in clause (i), the Secretary shall 


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1 refer the matter to the Federal Trade 

2 Commission.’’. 

3 (b) DEADLINE FOR SUBMISSION OF PETITIONS.— 

4 (1) DEADLINE.—Clause (i) of section 

5 505(q)(1)(A) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 355(q)(1)(A)) is amended to 

7 read as follows: 

8 ‘‘(i) the request is in writing, is a pe9 tition submitted to the Secretary pursuant 

10 to section 10.30, 10.31, or 10.35 of title 

11 21, Code of Federal Regulations (or any 

12 successor regulations), and is submitted 

13 not later than 60 days after the informa14 tion upon which the petition is based first 

15 became known to the party on whose be16 half the petition is submitted; and’’. 

17 (2) CERTIFICATION.—Section 505(q)(1)(H) of 

18 the Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 355(q)(1)) is amended by striking ‘‘I further 

20 certify that the information upon which I have based 

21 the action requested herein first became known to 

22 the party on whose behalf this petition is submitted 

23 on or about the following date: llll.’’ and in24 serting ‘‘I further certify that the information upon 

25 which I have based the action requested herein first 


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1 became known to the party on whose behalf this pe2 tition is submitted on or about llll, which 

3 date was not more than 60 days before the date of 

4 submitting this petition.’’. 

5 (c) REPORTING TO CONGRESS.—Section 505(q)(3) of 

6 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 355(q)(3)) is amended— 

8 (1) in the matter before subparagraph (A), by 

9 striking ‘‘specifies’’; 

10 (2) in subparagraphs (A), (B), (C), and (D), by 

11 striking ‘‘the number’’ and inserting ‘‘specifies the 

12 number’’; 

13 (3) in subparagraph (C), by striking ‘‘and’’ at 

14 the end; 

15 (4) in subparagraph (D), by striking the period 

16 at the end and inserting ‘‘; and’’; and 

17 (5) by adding at the end the following: 

18 ‘‘(E)(i) lists each petition submitted during 

19 such period and, for each, identifies the peti20 tioner; 

21 ‘‘(ii) quantifies the time and resources ex22 pended on each such petition; 

23 ‘‘(iii) states the timing of the petition rel24 ative to the expiration date of the patents speci25 fied in the pending application in the certifiVerDate Sep 11 2014 03:43 May 01, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2387.IH H2387

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1 cation under subsection (b)(2)(A) or 

2 (j)(2)(A)(vii), as applicable; 

3 ‘‘(iv) quantifies the delay, if any, caused by 

4 any such petition on the approval of any appli5 cation submitted under subsection (b)(2) or (j), 

6 including a description of how any such delay is 

7 calculated and an estimate of when any delayed 

8 approval would have been granted absent the 

9 petition; and 

10 ‘‘(v) in cases in which a pending applica11 tion and a petition with respect to such pending 

12 application are disposed of on the same or near13 ly the same date, states when the Food and 

14 Drug Administration would have disposed of 

15 the pending application absent the petition.’’. 

Æ 


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