Bill > S373

This bill, the Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2021 (BENEFIT Act of 2021), aims to strengthen the use of patient-experience data within the benefit-risk framework for the approval of new drugs by the FDA. Specifically, it requires the FDA to consider patient-focused drug development data, such as patient preference studies, patient-reported outcomes, and patient experience data, as part of the risk-benefit assessment during the new drug approval process. The bill also mandates that the FDA include a description of how such patient data was considered in the risk-benefit assessment when approving new drugs.