S. 3385 — Introduced in Senate

II 116th CONGRESS 2d Session S. 3385 IN THE SENATE OF THE UNITED STATES March 4, 2020Mr. 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 2020 or the BENEFIT Act of 2020. 2. Strengthening the use of patient-experience data within benefit-risk 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 relevant patient-focused drug development data, such as data from patient preference studies (benefit-risk), patient reported outcome data, or patient experience data, developed by the sponsor of an application 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.