FREED of Opioids Act

II 117TH CONGRESS 1ST SESSION S. 1634 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 MAY 13, 2021 Mr. MANCHIN (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 VerDate Sep 11 2014 05:26 May 27, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1634.IS S1634 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1634 IS SEC. 2. CONSIDERATION OF ENRICHED ENROLLMENT RAN- 1 DOMIZED WITHDRAWAL METHODOLOGY. 2 (a) IN GENERAL.—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) PRESENTATIONS.—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 STUDY AND REPORT.—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 VerDate Sep 11 2014 05:26 May 27, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1634.IS S1634 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1634 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 Æ VerDate Sep 11 2014 05:26 May 27, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S1634.IS S1634 kjohnson on DSK79L0C42PROD with BILLS