II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘FDA Review of Effi5 cacy of EERW Double-Blinds of Opioids Act’’ or the 

6 ‘‘FREED of Opioids Act’’. 


pbinns on DSKJLVW7X2PROD with $$_JOB
2 

•S 2737 IS

1 SEC. 2. CONSIDERATION OF ENRICHED ENROLLMENT RAN2 DOMIZED WITHDRAWAL METHODOLOGY. 

3 (a) IN GENERAL.—Not later than 2 years after the 

4 date of enactment of this Act, the Secretary of Health and 

5 Human Services (referred to in this section as the ‘‘Sec6 retary’’), acting through the Commissioner of Food and 

7 Drugs, shall convene a meeting of the Anesthetic and An8 algesic Drug Products Advisory Committee and the Drug 

9 Safety and Risk Management Advisory Committee of the 

10 Food and Drug Administration to vote on whether to per11 mit the use of the enriched enrollment randomized with12 drawal methodology in clinical trials of drugs, including 

13 opioid drugs. In conducting such review, the Secretary 

14 shall consider the report issued by the National Academy 

15 of Sciences under subsection (c). 

16 (b) PRESENTATIONS.—If the Secretary allows for 

17 formal presentations in support of the use of the enriched 

18 enrollment randomized withdrawal methodology at the 

19 meeting described in subsection (a), the Secretary shall 

20 also allow for equal time at such meeting for presentations 

21 that are critical of such methodology. 

22 (c) NAS STUDY AND REPORT.—The Secretary shall 

23 seek to enter into a contract with the National Academy 

24 of Sciences under which the National Academy— 

25 (1) conducts a study on the effectiveness of en26 riched enrollment randomized withdrawal methodVerDate Sep 11 2014 22:19 Sep 07, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2737.IS S2737

pbinns on DSKJLVW7X2PROD with $$_JOB
3 

•S 2737 IS

1 ology in demonstrating the efficacy of opioid drugs 

2 in treating chronic pain; and 

3 (2) not later than 1 year after the date of en4 actment of this Act, submits a report on such study 

5 to the Secretary. 

6 (d) POSTMARKET REVIEW.—Not later than 2 years 

7 after the date of enactment of this Act, the Secretary, act8 ing through the Commissioner of Food and Drugs, shall 

9 convene 1 or more meetings of the Anesthetic and Analge10 sic Drug Products Advisory Committee and the Drug 

11 Safety and Risk Management Advisory Committee of the 

12 Food and Drug Administration to review the approved la13 beling on all opioid drugs approved using enriched enroll14 ment randomized withdrawal methodology under section 

15 505 of the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 355) as of the date of the first such meeting, for 

17 the purpose of determining whether the indications on 

18 such labeling for such drugs are supported by the enriched 

19 enrollment randomized withdrawal methodology. The find20 ings from such meetings shall be made publicly available 

21 on an internet website operated by the Secretary, acting 

22 through the Commissioner of Food and Drugs. 

Æ 


pbinns on DSKJLVW7X2PROD with $$_JOB