I 

114TH CONGRESS 

2D SESSION H. R. 4976 

To require the Commissioner of Food and Drugs to seek recommendations 

from an advisory committee of the Food and Drug Administration before 

approval of certain new drugs that are opioids without abuse-deterrent 

properties, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 18, 2016 

Mr. SEAN PATRICK MALONEY of New York (for himself and Mr. LANCE) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To require the Commissioner of Food and Drugs to seek 

recommendations from an advisory committee of the 

Food and Drug Administration before approval of certain 

new drugs that are opioids without abuse-deterrent properties, 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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Opioid Review Mod5 ernization Act of 2016’’. 


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1 SEC. 2. FDA OPIOID ACTION PLAN. 

2 Chapter V of the Federal Food, Drug, and Cosmetic 

3 Act is amended by inserting after section 569 of such Act 

4 (21 U.S.C. 350bbb–8) the following: 

5 ‘‘SEC. 569–1. OPIOID ACTION PLAN. 

6 ‘‘(a) NEW DRUG APPLICATION.— 

7 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

8 prior to the approval pursuant to an application 

9 under section 505(b) of a new drug that is an opioid 

10 and does not have abuse-deterrent properties, the 

11 Secretary shall refer the application to an advisory 

12 committee of the Food and Drug Administration to 

13 seek recommendations from such advisory com14 mittee. 

15 ‘‘(2) PUBLIC HEALTH EXEMPTION.—A referral 

16 to an advisory committee under paragraph (1) is not 

17 required with respect to a new drug if the Sec18 retary— 

19 ‘‘(A) finds that such a referral is not in 

20 the interest of protecting and promoting public 

21 health; 

22 ‘‘(B) finds that such a referral is not nec23 essary based on a review of the relevant sci24 entific information; and 

25 ‘‘(C) submits a notice containing the ra26 tionale for such findings to the Committee on 


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1 Health, Education, Labor, and Pensions of the 

2 Senate and the Committee on Energy and Com3 merce of the House of Representatives. 

4 ‘‘(b) PEDIATRIC OPIOID LABELING.—The Secretary 

5 shall convene the Pediatric Advisory Committee of the 

6 Food and Drug Administration to seek recommendations 

7 from such Committee regarding a framework for the inclu8 sion of information in the labeling of drugs that are 

9 opioids relating to the use of such drugs in pediatric popu10 lations before the Secretary approves any labeling or 

11 change to labeling for any drug that is an opioid intended 

12 for use in a pediatric population. 

13 ‘‘(c) SUNSET.—The requirements of subsections (a) 

14 and (b) shall cease to be effective on October 1, 2022.’’. 

15 SEC. 3. PRESCRIBER EDUCATION. 

16 Not later than 1 year after the date of the enactment 

17 of this Act, the Secretary of Health and Human Services, 

18 acting through the Commissioner of Food and Drugs, as 

19 part of the Food and Drug Administration’s evaluation 

20 of the Extended-Release/Long-Acting Opioid Analgesics 

21 Risk Evaluation and Mitigation Strategy, and in consulta22 tion with relevant stakeholders, shall develop recommenda23 tions regarding education programs for prescribers of 

24 opioids pursuant to section 505–1 of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 355–1), including rec2 ommendations on— 

3 (1) which prescribers should participate in such 

4 programs; and 

5 (2) how often participation in such programs is 

6 necessary. 

7 SEC. 4. GUIDANCE ON EVALUATING THE ABUSE DETER8 RENCE OF GENERIC SOLID ORAL OPIOID 

9 DRUG PRODUCTS. 

10 Not later than 2 years after the end of the period 

11 for public comment on the draft guidance entitled ‘‘Gen12 eral Principals for Evaluating the Abuse Deterrence of Ge13 neric Solid Oral Opioid Drug Products’’ issued by the 

14 Center for Drug Evaluation and Research of the Food and 

15 Drug Administration in March 2016, the Commissioner 

16 of Food and Drugs shall publish in the Federal Register 

17 a final version of such guidance. 

Æ 


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