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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2665 Introduced in Senate (IS)]

<DOC>

115th CONGRESS
  2d Session
                                S. 2665

   To require guidance on how the Food and Drug Administration will 
consider claims of opioid sparing and on the conditions under which the 
Food and Drug Administration will consider misuse and abuse of drugs in 
                making certain determinations of safety.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 12, 2018

Mr. Young (for himself and Mr. Donnelly) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
   To require guidance on how the Food and Drug Administration will 
consider claims of opioid sparing and on the conditions under which the 
Food and Drug Administration will consider misuse and abuse of drugs in 
                making certain determinations of safety.

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

SECTION 1. OPIOID SPARING CLAIMS AND INDICATIONS.

    (a) Opioid Sparing.--
            (1) Draft guidance.--Not later than 1 year after the date 
        of enactment of this Act, the Secretary, acting through the 
        Commissioner of Food and Drugs, shall issue draft guidance to 
        clarify how the Food and Drug Administration will assess 
        evidence to support claims of opioid sparing for non-opioid or 
        other non-addictive medical products intended to treat pain. 
        Such guidance shall include--
                    (A) data collection methodologies, including the 
                use of innovative clinical trial designs (consistent 
                with section 3021 of the 21st Century Cures Act (Public 
                Law 114-255)), and real world evidence (as defined in 
                section 505F(b) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 355g(b))), as appropriate, to support 
                product labeling;
                    (B) ethical implications of exposure to controlled 
                substances in clinical trials to support opioid sparing 
                claims and considerations on methods to reduce harm;
                    (C) endpoints, including primary, secondary, and 
                surrogate endpoints, to evaluate the reduction in 
                opioid use;
                    (D) best practices for communication between 
                sponsors and the agency on the development of such data 
                collection methods, including the initiation of data 
                collection; and
                    (E) the appropriate format to submit such data 
                results to the Secretary.
            (2) Final guidance.--Not later than 6 months after the 
        close of the period for public comment on the draft guidance 
        under paragraph (1), the Secretary shall finalize such 
        guidance.
    (b) Risk of Abuse and Misuse.--
            (1) Draft guidance.--Not later than 1 year after the date 
        of enactment of this Act, the Secretary, acting through the 
        Commissioner of Food and Drugs, shall issue draft guidance to 
        clarify the circumstances under which the Food and Drug 
        Administration considers misuse and abuse of drugs in making 
        determinations of safety under paragraphs (2) and (4) of 
        subsection (d) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) and in finding that a drug is 
        unsafe under paragraph (1) or (2) of subsection (e) of such 
        section.
            (2) Final guidance.--Not later than 6 months after the 
        close of the period for public comment on the draft guidance 
        under paragraph (1), the Secretary shall finalize such 
        guidance.
    (c) Definitions.--In this section--
            (1) the term ``medical product'' means a drug (as that term 
        is defined by section 201(g)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as 
        that term is defined by section 351(i) of this Act (42 U.S.C. 
        262(i))), or device (as that term is defined by section 201(h) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        321(h))); and
            (2) the term ``opioid sparing'' means reducing the use of 
        opioids or other controlled substances.
                                 <all>
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