117 HR 4472 IH: Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 U.S. House of Representatives 2021-07-16 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.

I 117th CONGRESS1st Session H. R. 4472 IN THE HOUSE OF REPRESENTATIVES July 16, 2021 Ms. Matsui (for herself and Mr. Wenstrup) introduced the following bill; which was referred to the Committee on Energy and Commerce 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 2021 or the BENEFIT Act of 2021.

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.