EFFECTIVE Act

II 118TH CONGRESS 1ST SESSION S. 607 To allow the Secretary of Health and Human Services to deny approval of a new drug application for an opioid analgesic drug on the basis of such drug not being clinically superior to other commercially available drugs. IN THE SENATE OF THE UNITED STATES MARCH 1, 2023 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 allow the Secretary of Health and Human Services to deny approval of a new drug application for an opioid analgesic drug on the basis of such drug not being clini- cally superior to other commercially available drugs. 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 ‘‘Ensuring the FDA 4 Fully Examines Clinical Trial Impact and Vitalness before 5 Endorsement Act’’ or the ‘‘EFFECTIVE Act’’. 6 VerDate Sep 11 2014 05:17 Mar 11, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S607.IS S607 kjohnson on DSK79L0C42PROD with BILLS 2 •S 607 IS SEC. 2. REQUIREMENT FOR APPROVAL OF NEW OPIOID AN- 1 ALGESICS. 2 Section 505(c) of the Federal Food, Drug, and Cos- 3 metic Act (21 U.S.C. 355(c)) is amended by adding at 4 the end the following: 5 ‘‘(6) Notwithstanding any other provision of this sec- 6 tion, the Secretary may deny approval of an application 7 submitted under subsection (b) for an opioid analgesic 8 drug if the Secretary determines that such drug does not 9 provide a significant advantage, in terms of greater safety 10 or effectiveness, compared to an appropriate comparator 11 drug, as determined by the Secretary.’’. 12 Æ VerDate Sep 11 2014 05:17 Mar 11, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\S607.IS S607 kjohnson on DSK79L0C42PROD with BILLS