II 

116TH CONGRESS 

1ST SESSION S. 418 

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

and Drug Administration. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 7, 2019 

Mr. MANCHIN (for himself, Mrs. CAPITO, and Mr. KING) 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 AGAINST THE RECOMMENDATION OF 

7 THE FDA ADVISORY COMMITTEE ON OPIOID 

8 DRUGS. 

9 (a) IN GENERAL.—Any approval of an application or 

10 supplement to an application under section 505(b) of the 


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•S 418 IS

1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) 

2 for a drug that is an opioid against the recommendation 

3 of the advisory committee pursuant to section 106 of the 

4 Comprehensive Drug and Recovery Act of 2016 (Public 

5 Law 114–198) shall be made by the Commissioner of 

6 Food and Drugs (referred to in this section as the ‘‘Com7 missioner’’) and shall not be delegated. 

8 (b) REPORTS TO CONGRESS.—If the Commissioner 

9 approves a drug as described in subsection (a), the Com10 missioner shall— 

11 (1) submit a report to the Committee on 

12 Health, Education, Labor, and Pensions of the Sen13 ate and the Committee on Energy and Commerce of 

14 the House of Representatives, and to any member of 

15 Congress that requests the report, that includes— 

16 (A) medical and scientific evidence regard17 ing patient safety that clearly supports the 

18 Commissioner’s decision to approve the opioid 

19 drug against the recommendation of the advi20 sory committee; and 

21 (B) a disclosure of any potential conflicts 

22 of interest that may exist regarding any official 

23 of the Food and Drug Administration who was 

24 involved in the decision to approve the drug 


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•S 418 IS

1 prior to the Commissioner’s final decision under 

2 subsection (a); and 

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

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

5 Committee on Energy and Commerce of the House 

6 of Representatives, testify before that committee re7 garding the Commissioner’s decision to approve the 

8 opioid drug against the recommendation of the advi9 sory committee. 

10 (c) PROHIBITION ON MARKETING.—A drug approved 

11 as described in subsection (a) shall not be introduced or 

12 delivered for introduction into interstate commerce until 

13 the report described in subsection (b)(1) has been sub14 mitted to Congress. 

15 (d) SCOPE OF ADVISORY COMMITTEE REVIEW.—Sec16 tion 106(a)(1)(A) of the Comprehensive Addiction and Re17 covery Act of 2016 (Public Law 114–198) is amended— 

18 (1) by inserting ‘‘, or supplement to an applica19 tion,’’ after ‘‘application’’ each place such term ap20 pears; and 

21 (2) by striking ‘‘of a new’’ and inserting ‘‘for’’. 

Æ 


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