Bill > HR4472

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 approval of new drugs. It amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to consider relevant patient-focused drug development data, such as data from patient preference studies, patient-reported outcomes, or patient experience data, as part of the risk-benefit assessment framework during the new drug approval process. The bill also requires the FDA to include a description of how such data and information were considered in the risk-benefit assessment.