II
118THCONGRESS
1
STSESSION S. 2737
To require the Food and Drug Administration to determine whether to
permit the use of enriched enrollment randomized withdrawal method-
ology with respect to clinical trials.
IN THE SENATE OF THE UNITED STATES
SEPTEMBER7, 2023
Mr. M
ANCHIN(for himself and Mr. BRAUN) introduced the following bill;
which was read twice and referred to the Committee on Health, Edu-
cation, Labor, and Pensions
A BILL
To require the Food and Drug Administration to determine
whether to permit the use of enriched enrollment ran-
domized withdrawal methodology with respect to clinical
trials.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘FDA Review of Effi-4
cacy of EERW Double-Blinds of Opioids Act’’ or the 5
‘‘FREED of Opioids Act’’. 6
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•S 2737 IS
SEC. 2. CONSIDERATION OF ENRICHED ENROLLMENT RAN-1
DOMIZED WITHDRAWAL METHODOLOGY. 2
(a) I
NGENERAL.—Not later than 2 years after the 3
date of enactment of this Act, the Secretary of Health and 4
Human Services (referred to in this section as the ‘‘Sec-5
retary’’), acting through the Commissioner of Food and 6
Drugs, shall convene a meeting of the Anesthetic and An-7
algesic Drug Products Advisory Committee and the Drug 8
Safety and Risk Management Advisory Committee of the 9
Food and Drug Administration to vote on whether to per-10
mit the use of the enriched enrollment randomized with-11
drawal methodology in clinical trials of drugs, including 12
opioid drugs. In conducting such review, the Secretary 13
shall consider the report issued by the National Academy 14
of Sciences under subsection (c). 15
(b) P
RESENTATIONS.—If the Secretary allows for 16
formal presentations in support of the use of the enriched 17
enrollment randomized withdrawal methodology at the 18
meeting described in subsection (a), the Secretary shall 19
also allow for equal time at such meeting for presentations 20
that are critical of such methodology. 21
(c) NAS S
TUDY ANDREPORT.—The Secretary shall 22
seek to enter into a contract with the National Academy 23
of Sciences under which the National Academy— 24
(1) conducts a study on the effectiveness of en-25
riched enrollment randomized withdrawal method-26
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•S 2737 IS
ology in demonstrating the efficacy of opioid drugs 1
in treating chronic pain; and 2
(2) not later than 1 year after the date of en-3
actment of this Act, submits a report on such study 4
to the Secretary. 5
(d) P
OSTMARKETREVIEW.—Not later than 2 years 6
after the date of enactment of this Act, the Secretary, act-7
ing through the Commissioner of Food and Drugs, shall 8
convene 1 or more meetings of the Anesthetic and Analge-9
sic Drug Products Advisory Committee and the Drug 10
Safety and Risk Management Advisory Committee of the 11
Food and Drug Administration to review the approved la-12
beling on all opioid drugs approved using enriched enroll-13
ment randomized withdrawal methodology under section 14
505 of the Federal Food, Drug, and Cosmetic Act (21 15
U.S.C. 355) as of the date of the first such meeting, for 16
the purpose of determining whether the indications on 17
such labeling for such drugs are supported by the enriched 18
enrollment randomized withdrawal methodology. The find-19
ings from such meetings shall be made publicly available 20
on an internet website operated by the Secretary, acting 21
through the Commissioner of Food and Drugs. 22
Æ
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