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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3557 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
                                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

                           December 19, 2023

 Mr. Murphy (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 considers the public health effects of such opioid 
                                 drugs.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. REVIEW OF OPIOID DRUGS AND ACTIONS.

    Not later than one year after the date of enactment of this Act, 
the Secretary of Health and Human Services (referred to in this section 
as the ``Secretary'') shall publish on the website of the Food and Drug 
Administration (referred to in this section as the ``FDA'') a report 
that outlines a plan for completing a review of opioid analgesic drugs 
that are approved under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) that considers the public health effects 
of such opioid drugs as part of the benefit-risk assessment, and that 
addresses the activities of the FDA that relate to increasing the 
development of non-addictive medical products intended to treat pain or 
addiction. Such report shall include--
            (1) an opportunity for public input concerning the 
        regulation by the FDA of opioid analgesic drugs, including 
        scientific evidence that relates to conditions of use, safety, 
        or benefit-risk assessment (including consideration of the 
        public health effects) of such opioid drugs;
            (2) an update on the actions taken by the FDA to review the 
        effectiveness, safety, benefit-risk profile (which may include 
        public health effects), and use of approved opioid analgesic 
        drugs;
            (3) a timeline for an assessment of the potential need, as 
        appropriate, for labeling changes, revised or additional 
        postmarketing requirements, enforcement actions, or withdrawals 
        for opioid analgesic drugs;
            (4) an overview of the steps that the FDA has taken to 
        support the development and approval of non-addictive medical 
        products intended to treat pain or addiction, and actions 
        planned to further support the development and approval of such 
        products; and
            (5) an overview of the consideration by the FDA of clinical 
        trial methodologies for analgesic drugs, including the enriched 
        enrollment randomized withdrawal methodology, and the benefits 
        and drawbacks associated with different trial methodologies for 
        such drugs, incorporating any public input received under 
        paragraph (1).
                                 <all>
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