BENEFIT Act of 2021
United States117th CongressHR-4472House of Representatives
Updated: Jul 19, 2021
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.
Bill texts
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
House of Representatives
Referred to the Subcommittee on Health.
House of Representatives
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