118 S526 IS: Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 U.S. Senate 2023-02-16 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II118th CONGRESS1st SessionS. 526IN THE SENATE OF THE UNITED STATESFebruary 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 PensionsA BILLTo 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.