II
118THCONGRESS
1
STSESSION S. 3557
To require the Secretary of Health and Human Services to prepare a report
that outlines a plan for completing a review of approved opioid analgesic
drugs that considers the public health effects of such opioid drugs.
IN THE SENATE OF THE UNITED STATES
DECEMBER19, 2023
Mr. M
URPHY(for himself and Mr. BRAUN) introduced the following bill; which
was read twice and referred to the Committee on Health, Education,
Labor, and Pensions
A BILL
To require the Secretary of Health and Human Services
to prepare a report that outlines a plan for completing
a review of approved opioid analgesic drugs that con-
siders the public health effects of such opioid drugs.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. REVIEW OF OPIOID DRUGS AND ACTIONS. 3
Not later than one year after the date of enactment 4
of this Act, the Secretary of Health and Human Services 5
(referred to in this section as the ‘‘Secretary’’) shall pub-6
lish on the website of the Food and Drug Administration 7
(referred to in this section as the ‘‘FDA’’) a report that 8
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•S 3557 IS
outlines a plan for completing a review of opioid analgesic 1
drugs that are approved under section 505 of the Federal 2
Food, Drug, and Cosmetic Act (21 U.S.C. 355) that con-3
siders the public health effects of such opioid drugs as part 4
of the benefit-risk assessment, and that addresses the ac-5
tivities of the FDA that relate to increasing the develop-6
ment of non-addictive medical products intended to treat 7
pain or addiction. Such report shall include— 8
(1) an opportunity for public input concerning 9
the regulation by the FDA of opioid analgesic drugs, 10
including scientific evidence that relates to condi-11
tions of use, safety, or benefit-risk assessment (in-12
cluding consideration of the public health effects) of 13
such opioid drugs; 14
(2) an update on the actions taken by the FDA 15
to review the effectiveness, safety, benefit-risk profile 16
(which may include public health effects), and use of 17
approved opioid analgesic drugs; 18
(3) a timeline for an assessment of the potential 19
need, as appropriate, for labeling changes, revised or 20
additional postmarketing requirements, enforcement 21
actions, or withdrawals for opioid analgesic drugs; 22
(4) an overview of the steps that the FDA has 23
taken to support the development and approval of 24
non-addictive medical products intended to treat 25
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•S 3557 IS
pain or addiction, and actions planned to further 1
support the development and approval of such prod-2
ucts; and 3
(5) an overview of the consideration by the 4
FDA of clinical trial methodologies for analgesic 5
drugs, including the enriched enrollment randomized 6
withdrawal methodology, and the benefits and draw-7
backs associated with different trial methodologies 8
for such drugs, incorporating any public input re-9
ceived under paragraph (1). 10
Æ
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