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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2737 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
                                S. 2737

  To require the Food and Drug Administration to determine whether to 
permit the use of enriched enrollment randomized withdrawal methodology 
                    with respect to clinical trials.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           September 7, 2023

Mr. Manchin (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 Food and Drug Administration to determine whether to 
permit the use of enriched enrollment randomized withdrawal methodology 
                    with respect to clinical trials.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Review of Efficacy of EERW 
Double-Blinds of Opioids Act'' or the ``FREED of Opioids Act''.

SEC. 2. CONSIDERATION OF ENRICHED ENROLLMENT RANDOMIZED WITHDRAWAL 
              METHODOLOGY.

    (a) In General.--Not later than 2 years after the date of enactment 
of this Act, the Secretary of Health and Human Services (referred to in 
this section as the ``Secretary''), acting through the Commissioner of 
Food and Drugs, shall convene a meeting of the Anesthetic and Analgesic 
Drug Products Advisory Committee and the Drug Safety and Risk 
Management Advisory Committee of the Food and Drug Administration to 
vote on whether to permit the use of the enriched enrollment randomized 
withdrawal methodology in clinical trials of drugs, including opioid 
drugs. In conducting such review, the Secretary shall consider the 
report issued by the National Academy of Sciences under subsection (c).
    (b) Presentations.--If the Secretary allows for formal 
presentations in support of the use of the enriched enrollment 
randomized withdrawal methodology at the meeting described in 
subsection (a), the Secretary shall also allow for equal time at such 
meeting for presentations that are critical of such methodology.
    (c) NAS Study and Report.--The Secretary shall seek to enter into a 
contract with the National Academy of Sciences under which the National 
Academy--
            (1) conducts a study on the effectiveness of enriched 
        enrollment randomized withdrawal methodology in demonstrating 
        the efficacy of opioid drugs in treating chronic pain; and
            (2) not later than 1 year after the date of enactment of 
        this Act, submits a report on such study to the Secretary.
    (d) Postmarket Review.--Not later than 2 years after the date of 
enactment of this Act, the Secretary, acting through the Commissioner 
of Food and Drugs, shall convene 1 or more meetings of the Anesthetic 
and Analgesic Drug Products Advisory Committee and the Drug Safety and 
Risk Management Advisory Committee of the Food and Drug Administration 
to review the approved labeling on all opioid drugs approved using 
enriched enrollment randomized withdrawal methodology under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) as of the 
date of the first such meeting, for the purpose of determining whether 
the indications on such labeling for such drugs are supported by the 
enriched enrollment randomized withdrawal methodology. The findings 
from such meetings shall be made publicly available on an internet 
website operated by the Secretary, acting through the Commissioner of 
Food and Drugs.
                                 <all>
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