Federal

BENEFIT Act of 2023

Source: Congress.gov · 343 words in original text

What This Bill Does

This bill changes how the federal government approves new drugs by requiring patient-experience data (information about how patients actually experience a drug) to be considered in the approval process. The bill modifies existing drug approval rules to make sure patient experiences are part of the benefit-risk assessment (the comparison of whether a drug helps more than it harms).

Who It Affects

Medical product sponsors (companies developing new drugs), the federal agency that approves drugs, and patients seeking access to new medications.

Key Provisions

• Patient-experience data must be considered as part of the risk-benefit assessment when approving new drugs (Sec. 2) • Medical product sponsors or other parties can submit patient-experience data for drug approval review (Sec. 2) • Federal approval documents must explain how patient-experience data was considered in the risk-benefit assessment (Sec. 2)

What Changes

The federal government must now formally include patient-experience data in its drug approval process and must explain in writing how it used that data when making approval decisions.

Important Definitions

None defined in bill text.

II 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, Edu- cation, 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Better Empowerment 4 Now to Enhance Framework and Improve Treatments Act 5 of 2023’’ or the ‘‘BENEFIT Act of 2023’’. 6 VerDate Sep 11 2014 04:36 Mar 07, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 kjohnson on DSK79L0C42PROD with BILLS 2 •S 526 IS SEC. 2. STRENGTHENING THE USE OF PATIENT-EXPERI- 1 ENCE DATA WITHIN RISK-BENEFIT FRAME- 2 WORK. 3 Section 569C of the Federal Food, Drug, and Cos- 4 metic Act (21 U.S.C. 360bbb–8c) is amended— 5 (1) in subsection (a)(1)— 6 (A) in subparagraph (A), by striking ‘‘; 7 and’’ and inserting a semicolon; 8 (B) in subparagraph (B), by striking the 9 period and inserting ‘‘; and’’; and 10 (C) by adding at the end the following: 11 ‘‘(C) as part of the risk-benefit assessment 12 framework in the new drug approval process de- 13 scribed in section 505(d), considering patient 14 experience data submitted by the medical prod- 15 uct sponsor or another party.’’; and 16 (2) in subsection (b)(1), by inserting ‘‘, includ- 17 ing a description of how such data and information 18 were considered in the risk-benefit assessment de- 19 scribed in section 505(d)’’ before the period at the 20 end. 21 Æ VerDate Sep 11 2014 04:36 Mar 07, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\S526.IS S526 kjohnson on DSK79L0C42PROD with BILLS

Important: This plain English summary was generated by AI and is provided for informational purposes only. It is not legal advice. Always consult the official bill text on Congress.gov or a qualified attorney for legal matters.