IB 

Union Calendar No. 431 

114TH CONGRESS 

2D SESSION H. R. 4976 

[Report No. 114–557] 

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 

MAY 10, 2016 

Committed to the Committee of the Whole House on the State of the Union 

and ordered to be printed 


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•HR 4976 RH

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. 


SSpencer on DSK4SPTVN1PROD with BILLS
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•HR 4976 RH

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’’. 

6 SEC. 2. FDA OPIOID ACTION PLAN. 

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

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

9 (21 U.S.C. 350bbb–8) the following: 

10 ‘‘SEC. 569–1. OPIOID ACTION PLAN. 

11 ‘‘(a) NEW DRUG APPLICATION.— 

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

13 prior to the approval pursuant to an application 

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

15 and does not have abuse-deterrent properties, the 

16 Secretary shall refer the application to an advisory 

17 committee of the Food and Drug Administration to 

18 seek recommendations from such advisory com19 mittee. 

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

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

22 required with respect to a new drug if the Sec23 retary— 


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•HR 4976 RH

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

2 the interest of protecting and promoting public 

3 health; 

4 ‘‘(B) finds that such a referral is not nec5 essary based on a review of the relevant sci6 entific information; and 

7 ‘‘(C) submits a notice containing the ra8 tionale for such findings to the Committee on 

9 Health, Education, Labor, and Pensions of the 

10 Senate and the Committee on Energy and Com11 merce of the House of Representatives. 

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

13 shall convene the Pediatric Advisory Committee of the 

14 Food and Drug Administration to seek recommendations 

15 from such Committee regarding a framework for the inclu16 sion of information in the labeling of drugs that are 

17 opioids relating to the use of such drugs in pediatric popu18 lations before the Secretary approves any labeling or 

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

20 for use in a pediatric population. 

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

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

23 SEC. 3. PRESCRIBER EDUCATION. 

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

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


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•HR 4976 RH

1 acting through the Commissioner of Food and Drugs, as 

2 part of the Food and Drug Administration’s evaluation 

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

4 Risk Evaluation and Mitigation Strategy, and in consulta5 tion with relevant stakeholders, shall develop recommenda6 tions regarding education programs for prescribers of 

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

8 Drug, and Cosmetic Act (21 U.S.C. 355–1), including rec9 ommendations on— 

10 (1) which prescribers should participate in such 

11 programs; and 

12 (2) how often participation in such programs is 

13 necessary. 

14 SEC. 4. GUIDANCE ON EVALUATING THE ABUSE DETER15 RENCE OF GENERIC SOLID ORAL OPIOID 

16 DRUG PRODUCTS. 

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

18 for public comment on the draft guidance entitled ‘‘Gen19 eral Principals for Evaluating the Abuse Deterrence of Ge20 neric Solid Oral Opioid Drug Products’’ issued by the 

21 Center for Drug Evaluation and Research of the Food and 

22 Drug Administration in March 2016, the Commissioner 

23 of Food and Drugs shall publish in the Federal Register 

24 a final version of such guidance. 


SSpencer on DSK4SPTVN1PROD with BILLS
Union Calendar No. 431 

114TH CONGRESS 

2D SESSION H. R. 4976 

[Report No. 114–557] 

A BILL 

To require the Commissioner of Food and Drugs to 

for other purposes. opioids without abuse-deterrent properties, and fore approval of certain new drugs that are mittee of the Food and Drug Administration beseek recommendations from an advisory comMAY 10, 2016 

Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 


SSpencer on DSK4SPTVN1PROD with BILLS