HR 4472
Benefit act of 2021
Benefit Act of 2021
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- Passed House
- Passed Senate
- To President
- Became Law
Bill overview
This bill, the BENEFIT Act of 2021, aims to improve how the Food and Drug Administration (FDA) evaluates the benefits and risks of new drugs. It requires the FDA to actively consider patient-reported data, such as patient preference studies and patient experience data, when deciding whether to approve a new medication. The FDA will also be required to publicly explain how this patient data was used in the drug’s risk-benefit assessment after approval. Ultimately, the goal is to ensure that new drug approvals better reflect the actual experiences of patients.
Sponsors
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Primary sponsor
Cosponsors
Brad R. Wenstrup
Brian Higgins
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