Political Quotes

“I ask unanimous consent that the bill be considered read a third time and passed and the motion to reconsider be considered made and laid upon the table. The PRESIDING OFFICER. Without objection, it is so ordered. The bill (S. 1052) was ordered to be engrossed for a third reading, was read the third time, and passed, as follows: S. 1052 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 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''. SEC. 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).…”