[Congressional Record (Bound Edition), Volume 163 (2017), Part 9]
[Senate]
[Pages 12576-12577]
[From the U.S. Government Publishing Office, www.gpo.gov]




BETTER EMPOWERMENT NOW TO ENHANCE FRAMEWORK AND IMPROVE TREATMENTS ACT 
                                OF 2017

  Mr. ALEXANDER. Mr. President, I ask unanimous consent that the 
Committee on Health, Education, Labor, and Pensions be discharged from 
further consideration of S. 1052 and the Senate proceed to its 
immediate consideration.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 1052) to strengthen the use of patient-
     experience data within the benefit-risk framework for 
     approval of new drugs.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. ALEXANDER. Mr. President, 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

[[Page 12577]]

     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.

  The PRESIDING OFFICER. The Senator from Wisconsin.

                          ____________________