S. 526 — Introduced in Senate

II 118th CONGRESS 1st Session S. 526 IN THE SENATE OF THE UNITED STATES February 16, 2023Mr. Wicker (for himself and Ms. Klobuchar) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs. 1. Short title This Act may be cited as the Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 or the BENEFIT Act of 2023. 2. Strengthening the use of patient-experience data within risk-benefit framework Section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c) is amended— (1) in subsection (a)(1)— (A) in subparagraph (A), by striking ; and and inserting a semicolon; (B) in subparagraph (B), by striking the period and inserting ; and; and (C) by adding at the end the following: (C) as part of the risk-benefit assessment framework in the new drug approval process described in section 505(d), considering patient experience data submitted by the medical product sponsor or another party. ; and (2) in subsection (b)(1), by inserting , including a description of how such data and information were considered in the risk-benefit assessment described in section 505(d) before the period at the end.