Ensuring Timely Access to Generics Act of 2019

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Ensuring Timely Ac- 4 cess to Generics Act of 2019’’. 5 SEC. 2. CITIZEN PETITIONS. 6 Section 505(q)(1) of the Federal Food, Drug, and 7 Cosmetic Act (21 U.S.C. 355(q)(1)) is amended— 8 (1) in subparagraph (E)— 9 VerDate Sep 11 2014 02:00 Apr 19, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1169.IS S1169 pamtmann on DSKBFK8HB2PROD with BILLS 2 •S 1169 IS (A) by striking ‘‘If the Secretary’’ and in- 1 serting the following: 2 ‘‘(i) IN GENERAL.—If the Secretary’’; 3 (B) by striking the second sentence and in- 4 serting the following: 5 ‘‘(ii) FACTORS.—In determining 6 whether a petition was submitted with the 7 primary purpose of delaying the approval 8 of an application, the Secretary shall con- 9 sider— 10 ‘‘(I) whether it appears, based on 11 the date that relevant information re- 12 lied upon in the petition became 13 known to the petitioner (or reasonably 14 should have been known to the peti- 15 tioner), as certified by the petitioner 16 in accordance with subparagraph (H), 17 that the petitioner has taken an un- 18 reasonable length of time to submit 19 the petition; 20 ‘‘(II) whether the petitioner has 21 submitted multiple or serial petitions 22 raising issues that reasonably could 23 have been known to the petitioner at 24 VerDate Sep 11 2014 02:00 Apr 19, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1169.IS S1169 pamtmann on DSKBFK8HB2PROD with BILLS 3 •S 1169 IS the time of submission of the earlier 1 petition or petitions; 2 ‘‘(III) whether the petition was 3 submitted close in time to a known, 4 first date upon which an application 5 under subsection (b)(2) of this section 6 or section 351(k) of the Public Health 7 Service Act could be approved; 8 ‘‘(IV) whether the petition was 9 submitted without any data or infor- 10 mation in support of the scientific po- 11 sitions set forth in the petition; 12 ‘‘(V) whether the petition raises 13 the same or substantially similar 14 issues as a prior petition to which the 15 Secretary has responded substantively 16 already, particularly if the subsequent 17 submission follows the earlier response 18 closely in time; 19 ‘‘(VI) whether the petition con- 20 cerns standards for approval of a drug 21 for which the Secretary has provided 22 an opportunity for public input, such 23 as draft or final product-specific guid- 24 ance applicable to the drug, and the 25 VerDate Sep 11 2014 02:00 Apr 19, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1169.IS S1169 pamtmann on DSKBFK8HB2PROD with BILLS 4 •S 1169 IS petitioner has not provided comment 1 other than through the petition; 2 ‘‘(VII) whether the petition re- 3 quests that other applicants meet 4 standards for testing, data, or labeling 5 for a drug that are more onerous or 6 rigorous than the standards applicable 7 to, as applicable, the listed drug, ref- 8 erence product, or petitioner’s version 9 of the same drug; 10 ‘‘(VIII) the history of the peti- 11 tioner with the Food and Drug Ad- 12 ministration, such as whether the pe- 13 titioner has a history of submitting 14 petitions that the Secretary has deter- 15 mined were submitted with the pri- 16 mary purpose of delay; and 17 ‘‘(IX) other relevant consider- 18 ations, as the Secretary may describe 19 in guidance.’’; and 20 (C) by adding at the end the following: 21 ‘‘(iii) PUBLIC AVAILABILITY.—The 22 Secretary shall publish on the internet 23 website of the Food and Drug Administra- 24 tion a list of any petitions that the Sec- 25 VerDate Sep 11 2014 02:00 Apr 19, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1169.IS S1169 pamtmann on DSKBFK8HB2PROD with BILLS 5 •S 1169 IS retary determines were submitted for the 1 primary purpose of delaying the approval 2 of an application. 3 ‘‘(iv) REFERRAL TO THE FEDERAL 4 TRADE COMMISSION.—The Secretary shall 5 establish procedures for referring to the 6 Federal Trade Commission any petition or 7 supplement to a petition that the Secretary 8 determines was submitted with the primary 9 purpose of delaying approval of an applica- 10 tion. Such procedures shall include notifi- 11 cation to the petitioner and an opportunity 12 for the petitioner to respond to the Sec- 13 retary prior to referral to the Federal 14 Trade Commission.’’; and 15 (2) by adding at the end the following: 16 ‘‘(J) TIMELINE FOR SUBMITTING PETI- 17 TIONS.—The Secretary may establish a time pe- 18 riod after the relevant information relied upon 19 in a petition became known to the petitioner (or 20 reasonably should have been known to a peti- 21 tioner), as certified by the petitioner in accord- 22 ance with subparagraph (H), and any petition 23 VerDate Sep 11 2014 02:00 Apr 19, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1169.IS S1169 pamtmann on DSKBFK8HB2PROD with BILLS 6 •S 1169 IS that is submitted after such time period has 1 passed shall be summarily denied.’’. 2 Æ VerDate Sep 11 2014 02:00 Apr 19, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S1169.IS S1169 pamtmann on DSKBFK8HB2PROD with BILLS