II 

114TH CONGRESS 

1ST SESSION S. 954 

To establish procedures regarding the approval of opioid drugs by the Food 

and Drug Administration. 

IN THE SENATE OF THE UNITED STATES 

APRIL 15, 2015 

Mr. MANCHIN (for himself, Mr. VITTER, Mrs. CAPITO, and Mr. KAINE) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To establish procedures regarding the approval of opioid 

drugs by the Food and Drug Administration. 

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 ‘‘FDA Accountability 

5 for Public Safety Act’’. 

6 SEC. 2. APPROVAL OF OPIOID DRUGS. 

7 (a) IN GENERAL.—Notwithstanding any other provi8 sion of law, the Commissioner of Food and Drugs (re9 ferred to in this Act as ‘‘the Commissioner’’) shall ensure 

10 that, with respect to each application for an opioid drug 


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•S 954 IS

1 submitted under section 505 of the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 355)— 

3 (1) an advisory committee of the Center for 

4 Drug Evaluation and Research of the Food and 

5 Drug Administration evaluates the application and 

6 issues a recommendation regarding approval of such 

7 drug prior to a final decision to approve such drug; 

8 and 

9 (2) if a final decision to approve such drug is 

10 inconsistent with the recommendation under para11 graph (1), such final decision shall be made by the 

12 Commissioner and shall not be delegated. 

13 (b) REPORTS TO CONGRESS.—If the advisory com14 mittee recommends under subsection (a)(1) that the Com15 missioner not approve an opioid drug under section 505 

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

17 355), and the Commissioner approves that drug under 

18 subsection (a)(2), the Commissioner shall— 

19 (1) submit a report to the Committee on 

20 Health, Education, Labor, and Pensions of the Sen21 ate and the Committee on Energy and Commerce of 

22 the House of Representatives, and to any member of 

23 Congress that requests the report, that includes— 

24 (A) medical and scientific evidence regard25 ing patient safety that clearly supports the 


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1 Commissioner’s decision to approve the opioid 

2 drug against the recommendation of the advi3 sory committee; and 

4 (B) a disclosure of any potential conflicts 

5 of interest that may exist regarding any official 

6 of the Food and Drug Administration who was 

7 involved in the decision to approve the drug 

8 prior to the Commissioner’s final decision under 

9 subsection (a)(2); and 

10 (2) at the request of the Committee on Health, 

11 Education, Labor, and Pensions of the Senate or the 

12 Committee on Energy and Commerce of the House 

13 of Representatives, testify before that committee re14 garding the Commissioner’s decision to approve the 

15 opioid drug against the recommendation of the advi16 sory committee. 

17 (c) PROHIBITION ON MARKETING.—A drug described 

18 in subsection (b) shall not be introduced or delivered for 

19 introduction into interstate commerce until the report de20 scribed in subsection (b)(1) has been submitted to Con21 gress. 

Æ 


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