II 117TH CONGRESS 1ST SESSION S. 373 To strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs. IN THE SENATE OF THE UNITED STATES FEBRUARY 23, 2021 Mr. WICKER (for himself and Ms. KLOBUCHAR) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions A BILL To strengthen the use of patient-experience data within the benefit-risk framework for approval of new 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 ‘‘Better Empowerment 4 Now to Enhance Framework and Improve Treatments Act 5 of 2021’’ or the ‘‘BENEFIT Act of 2021’’. 6 VerDate Sep 11 2014 02:50 Mar 02, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S373.IS S373 kjohnson on DSK79L0C42PROD with BILLS 2 •S 373 IS SEC. 2. STRENGTHENING THE USE OF PATIENT-EXPERI- 1 ENCE DATA WITHIN BENEFIT-RISK FRAME- 2 WORK. 3 Section 569C of the Federal Food, Drug, and Cos- 4 metic Act (21 U.S.C. 360bbb–8c) is amended— 5 (1) in subsection (a)(1)— 6 (A) in subparagraph (A), by striking ‘‘; 7 and’’ and inserting a semicolon; 8 (B) in subparagraph (B), by striking the 9 period and inserting ‘‘; and’’; and 10 (C) by adding at the end the following: 11 ‘‘(C) as part of the risk-benefit assessment 12 framework in the new drug approval process de- 13 scribed in section 505(d), considering relevant 14 patient-focused drug development data, such as 15 data from patient preference studies (benefit- 16 risk), patient reported outcome data, or patient 17 experience data, developed by the sponsor of an 18 application or another party.’’; and 19 (2) in subsection (b)(1), by inserting ‘‘, includ- 20 ing a description of how such data and information 21 were considered in the risk benefit assessment de- 22 scribed in section 505(d)’’ before the period. 23 Æ VerDate Sep 11 2014 02:50 Mar 02, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\S373.IS S373 kjohnson on DSK79L0C42PROD with BILLS