I 
114TH CONGRESS 
2D SESSION 
H. R. 5655 
To establish programs related to prevention of prescription opioid misuse, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 7, 2016 
Mr. CARTWRIGHT (for himself and Ms. NORTON) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committees on the Judiciary, Ways and Means, and Edu-
cation and the Workforce, for a period to be subsequently determined by 
the Speaker, in each case for consideration of such provisions as fall with-
in the jurisdiction of the committee concerned 
A BILL 
To establish programs related to prevention of prescription 
opioid misuse, 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 ‘‘Addiction Prevention 
and Responsible Opioid Practices Act’’. 
SEC. 2. OPIOID ACTION PLAN. 
(a) ADVISORY COMMITTEE.— 
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(1) NEW DRUG APPLICATION.—Except as pro-
vided in paragraph (4), prior to the approval of a 
new drug that is an opioid under section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), the Commissioner of Food and Drugs shall 
refer such drug to an advisory committee of the 
Food and Drug Administration to seek recommenda-
tions from such Committee. 
(2) PEDIATRIC OPIOID LABELING.—The Com-
missioner of Food and Drugs shall convene the Pedi-
atric Advisory Committee of the Food and Drug Ad-
ministration to seek recommendations from such 
Committee regarding a framework for the inclusion 
of information in the labeling of drugs that are 
opioids relating to the use of such drugs in pediatric 
populations before such Commissioner approves any 
labeling changes for drugs that are opioids intended 
for use in pediatric populations. 
(3) PUBLIC HEALTH EXEMPTION.—If the Com-
missioner of Food and Drugs finds that referring a 
new opioid drug or drugs to an advisory committee 
of the Food and Drug Administration as required 
under paragraph (1) is not in the interest of pro-
tecting and promoting public health, and has sub-
mitted a notice containing the rationale for such a 
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finding to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives, or if the matter that would be con-
sidered by such advisory committee with respect to 
any such drug or drugs concerns bioequivalence, 
sameness of active ingredient, or other criteria appli-
cable to applications submitted under section 505(j) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)), the Commissioner shall not be re-
quired to refer such drug or drugs to an advisory 
committee as required under paragraph (1). 
(4) SUNSET.—Unless Congress reauthorizes 
paragraphs (1) and (2), the requirements of such 
paragraphs shall cease to be effective on October 1, 
2022. 
(b) EDUCATION FOR PRESCRIBERS OF OPIOIDS.— 
Not later than 1 year after the date of 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 consultation 
with the Director of the Centers for Disease Control and 
Prevention, the Director of the National Institutes of 
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