S 526
Benefit act of 2023
Benefit Act of 2023
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- Passed Senate
- Passed House
- To President
- Became Law
Bill overview
This bill, the Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act), aims to improve how the Food and Drug Administration (FDA) evaluates the risks and benefits of new drugs. It requires the FDA to actively consider patient experience data when reviewing new drug applications and to publicly disclose how this data was used in the risk-benefit assessment process. Furthermore, the bill mandates that the FDA include a description of the patient experience data considered in its public statements about drug approvals. This will provide greater transparency and potentially lead to more patient-centered drug approvals.
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Primary sponsor
Cosponsors
Mike Braun
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