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United States · Bill · S

S. 373 (117th)

BENEFIT Act of 2021

referredUnited States· United States Congress· EN

Introduced

23 February 2021

Last action

Status

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

Subjects

Discovery layer

Source updated

5 December 2025

Summary

Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 or the BENEFIT Act of 2021 This bill requires the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies and patient-reported outcome data, in the risk-benefit assessment framework used in the process for approving new drugs. After a new drug application has been approved, the FDA's public statement about how it used patient experience data shall include a description of how such data was considered in the risk-benefit assessment framework.

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3 official files

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