II 

116TH CONGRESS 

1ST SESSION S. 1169 

To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen 

petitions. 

IN THE SENATE OF THE UNITED STATES 

APRIL 11, 2019 

Mr. GARDNER (for himself, Mrs. SHAHEEN, Mr. CASSIDY, and Mr. BENNET) 

introduced the following bill; which was read twice and referred to the 

Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to citizen petitions. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ensuring Timely Ac5 cess to Generics Act of 2019’’. 

6 SEC. 2. CITIZEN PETITIONS. 

7 Section 505(q)(1) of the Federal Food, Drug, and 

8 Cosmetic Act (21 U.S.C. 355(q)(1)) is amended— 

9 (1) in subparagraph (E)— 


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1 (A) by striking ‘‘If the Secretary’’ and in2 serting the following: 

3 ‘‘(i) IN GENERAL.—If the Secretary’’; 

4 (B) by striking the second sentence and in5 serting the following: 

6 ‘‘(ii) FACTORS.—In determining 

7 whether a petition was submitted with the 

8 primary purpose of delaying the approval 

9 of an application, the Secretary shall con10 sider— 

11 ‘‘(I) whether it appears, based on 

12 the date that relevant information re13 lied upon in the petition became 

14 known to the petitioner (or reasonably 

15 should have been known to the peti16 tioner), as certified by the petitioner 

17 in accordance with subparagraph (H), 

18 that the petitioner has taken an un19 reasonable length of time to submit 

20 the petition; 

21 ‘‘(II) whether the petitioner has 

22 submitted multiple or serial petitions 

23 raising issues that reasonably could 

24 have been known to the petitioner at 


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1 the time of submission of the earlier 

2 petition or petitions; 

3 ‘‘(III) whether the petition was 

4 submitted close in time to a known, 

5 first date upon which an application 

6 under subsection (b)(2) of this section 

7 or section 351(k) of the Public Health 

8 Service Act could be approved; 

9 ‘‘(IV) whether the petition was 

10 submitted without any data or infor11 mation in support of the scientific po12 sitions set forth in the petition; 

13 ‘‘(V) whether the petition raises 

14 the same or substantially similar 

15 issues as a prior petition to which the 

16 Secretary has responded substantively 

17 already, particularly if the subsequent 

18 submission follows the earlier response 

19 closely in time; 

20 ‘‘(VI) whether the petition con21 cerns standards for approval of a drug 

22 for which the Secretary has provided 

23 an opportunity for public input, such 

24 as draft or final product-specific guid25 ance applicable to the drug, and the 


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1 petitioner has not provided comment 

2 other than through the petition; 

3 ‘‘(VII) whether the petition re4 quests that other applicants meet 

5 standards for testing, data, or labeling 

6 for a drug that are more onerous or 

7 rigorous than the standards applicable 

8 to, as applicable, the listed drug, ref9 erence product, or petitioner’s version 

10 of the same drug; 

11 ‘‘(VIII) the history of the peti12 tioner with the Food and Drug Ad13 ministration, such as whether the pe14 titioner has a history of submitting 

15 petitions that the Secretary has deter16 mined were submitted with the pri17 mary purpose of delay; and 

18 ‘‘(IX) other relevant consider19 ations, as the Secretary may describe 

20 in guidance.’’; and 

21 (C) by adding at the end the following: 

22 ‘‘(iii) PUBLIC AVAILABILITY.—The 

23 Secretary shall publish on the internet 

24 website of the Food and Drug Administra25 tion a list of any petitions that the SecVerDate Sep 11 2014 02:00 Apr 19, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1169.IS S1169

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1 retary determines were submitted for the 

2 primary purpose of delaying the approval 

3 of an application. 

4 ‘‘(iv) REFERRAL TO THE FEDERAL

5 TRADE COMMISSION.—The Secretary shall 

6 establish procedures for referring to the 

7 Federal Trade Commission any petition or 

8 supplement to a petition that the Secretary 

9 determines was submitted with the primary 

10 purpose of delaying approval of an applica11 tion. Such procedures shall include notifi12 cation to the petitioner and an opportunity 

13 for the petitioner to respond to the Sec14 retary prior to referral to the Federal 

15 Trade Commission.’’; and 

16 (2) by adding at the end the following: 

17 ‘‘(J) TIMELINE FOR SUBMITTING PETI18 TIONS.—The Secretary may establish a time pe19 riod after the relevant information relied upon 

20 in a petition became known to the petitioner (or 

21 reasonably should have been known to a peti22 tioner), as certified by the petitioner in accord23 ance with subparagraph (H), and any petition 


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1 that is submitted after such time period has 

2 passed shall be summarily denied.’’. 

Æ 


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