115 S1052 IS: Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2017 U.S. Senate 2017-05-04 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.

II 115th CONGRESS1st Session S. 1052 IN THE SENATE OF THE UNITED STATES May 4, 2017 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 2017 or the BENEFIT Act of 2017.

2.

Strengthening the use 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.