[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 373 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                 S. 373

  To strengthen the use of patient-experience data within the benefit-
               risk framework for approval of new drugs.


_______________________________________________________________________


                   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.

    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 2021'' or the ``BENEFIT Act of 
2021''.

SEC. 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.
                                 <all>