IIB 

114TH CONGRESS 

2D SESSION H. R. 4976 

IN THE SENATE OF THE UNITED STATES 

MAY 12, 2016 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Opioid Review Mod3 ernization Act of 2016’’. 

4 SEC. 2. FDA OPIOID ACTION PLAN. 

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

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

7 (21 U.S.C. 350bbb–8) the following: 

8 ‘‘SEC. 569–1. OPIOID ACTION PLAN. 

9 ‘‘(a) NEW DRUG APPLICATION.— 

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

11 prior to the approval pursuant to an application 

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

13 and does not have abuse-deterrent properties, the 

14 Secretary shall refer the application to an advisory 

15 committee of the Food and Drug Administration to 

16 seek recommendations from such advisory com17 mittee. 

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

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

20 required with respect to a new drug if the Sec21 retary— 

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

23 the interest of protecting and promoting public 

24 health; 


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1 ‘‘(B) finds that such a referral is not nec2 essary based on a review of the relevant sci3 entific information; and 

4 ‘‘(C) submits a notice containing the ra5 tionale for such findings to the Committee on 

6 Health, Education, Labor, and Pensions of the 

7 Senate and the Committee on Energy and Com8 merce of the House of Representatives. 

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

10 shall convene the Pediatric Advisory Committee of the 

11 Food and Drug Administration to seek recommendations 

12 from such Committee regarding a framework for the inclu13 sion of information in the labeling of drugs that are 

14 opioids relating to the use of such drugs in pediatric popu15 lations before the Secretary approves any labeling or 

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

17 for use in a pediatric population. 

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

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

20 SEC. 3. PRESCRIBER EDUCATION. 

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

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

23 acting through the Commissioner of Food and Drugs, as 

24 part of the Food and Drug Administration’s evaluation 

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


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1 Risk Evaluation and Mitigation Strategy, and in consulta2 tion with relevant stakeholders, shall develop recommenda3 tions regarding education programs for prescribers of 

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

5 Drug, and Cosmetic Act (21 U.S.C. 355–1), including rec6 ommendations on— 

7 (1) which prescribers should participate in such 

8 programs; and 

9 (2) how often participation in such programs is 

10 necessary. 

11 SEC. 4. GUIDANCE ON EVALUATING THE ABUSE DETER12 RENCE OF GENERIC SOLID ORAL OPIOID 

13 DRUG PRODUCTS. 

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

15 for public comment on the draft guidance entitled ‘‘Gen16 eral Principals for Evaluating the Abuse Deterrence of Ge17 neric Solid Oral Opioid Drug Products’’ issued by the 

18 Center for Drug Evaluation and Research of the Food and 

19 Drug Administration in March 2016, the Commissioner 


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1 of Food and Drugs shall publish in the Federal Register 

2 a final version of such guidance. 

Passed the House of Representatives May 11, 2016. 

Attest: KAREN L. HAAS, 

Clerk. 


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