BENEFIT Act of 2021

Bill: 117-s-373
Sponsor: full_name: Sen. Wicker, Roger F. [R-MS]
Introduced: 2021-02-23
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Health information and medical records

Product development and innovation
Latest action: action_date: 2021-02-23
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2021-02-23
action_desc: Introduced in Senate
text: <p><b>Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 or the BENEFIT Act of 2021</b></p> <p>This bill requires the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs.</p> <p>After a new drug application has been approved, the FDA's public statement about how it used patient experience data shall include a description of how such data was considered in the risk-benefit assessment framework. </p>

tv_txt: II 117th CONGRESS 1st Session S. 373 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, 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 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.