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) in-
troduced the following bill; which was referred to the Committee on En-
ergy 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 prop-
erties, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Opioid Review Mod-
ernization Act of 2016’’. 
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SEC. 2. FDA OPIOID ACTION PLAN. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 569 of such Act 
(21 U.S.C. 350bbb–8) the following: 
‘‘SEC. 569–1. OPIOID ACTION PLAN. 
‘‘(a) NEW DRUG APPLICATION.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
prior to the approval pursuant to an application 
under section 505(b) of a new drug that is an opioid 
and does not have abuse-deterrent properties, the 
Secretary shall refer the application to an advisory 
committee of the Food and Drug Administration to 
seek recommendations from such advisory com-
mittee. 
‘‘(2) PUBLIC HEALTH EXEMPTION.—A referral 
to an advisory committee under paragraph (1) is not 
required with respect to a new drug if the Sec-
retary— 
‘‘(A) finds that such a referral is not in 
the interest of protecting and promoting public 
health; 
‘‘(B) finds that such a referral is not nec-
essary based on a review of the relevant sci-
entific information; and 
‘‘(C) submits a notice containing the ra-
tionale for such findings to the Committee on 
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Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives. 
‘‘(b) PEDIATRIC OPIOID LABELING.—The Secretary 
shall convene the Pediatric Advisory Committee of the 
Food and Drug Administration to seek recommendations 
from such Committee regarding a framework for the inclu-
sion of information in the labeling of drugs that are 
opioids relating to the use of such drugs in pediatric popu-
lations before the Secretary approves any labeling or 
change to labeling for any drug that is an opioid intended 
for use in a pediatric population. 
‘‘(c) SUNSET.—The requirements of subsections (a) 
and (b) shall cease to be effective on October 1, 2022.’’. 
SEC. 3. PRESCRIBER EDUCATION. 
Not later than 1 year after the date of the enactment 
of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, as 
part of the Food and Drug Administration’s evaluation 
of the Extended-Release/Long-Acting Opioid Analgesics 
Risk Evaluation and Mitigation Strategy, and in consulta-
tion with relevant stakeholders, shall develop recommenda-
tions regarding education programs for prescribers of 
opioids pursuant to section 505–1 of the Federal Food, 
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Drug, and Cosmetic Act (21 U.S.C. 355–1), including rec-
ommendations on— 
(1) which prescribers should participate in such 
programs; and 
(2) how often participation in such programs is 
necessary. 
SEC. 4. GUIDANCE ON EVALUATING THE ABUSE DETER-
RENCE OF GENERIC SOLID ORAL OPIOID 
DRUG PRODUCTS. 
Not later than 2 years after the end of the period 
for public comment on the draft guidance entitled ‘‘Gen-
eral Principals for Evaluating the Abuse Deterrence of Ge-
neric Solid Oral Opioid Drug Products’’ issued by the 
Center for Drug Evaluation and Research of the Food and 
Drug Administration in March 2016, the Commissioner 
of Food and Drugs shall publish in the Federal Register 
a final version of such guidance. 
Æ 
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