[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 526 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                 S. 526

  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 16, 2023

  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 2023'' or the ``BENEFIT Act of 
2023''.

SEC. 2. STRENGTHENING THE USE OF PATIENT-EXPERIENCE DATA WITHIN RISK-
              BENEFIT 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 patient experience data 
                submitted by the medical product sponsor 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 at the end.
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