Bill > S3385

This bill, known as the Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act of 2020, aims to strengthen the use of patient-experience data within the benefit-risk framework for the approval of new drugs. Specifically, the bill amends the Federal Food, Drug, and Cosmetic Act to require the consideration of relevant patient-focused drug development data, such as patient preference studies, patient-reported outcomes, and patient experience data, as part of the risk-benefit assessment framework in the new drug approval process. The bill also requires the inclusion of a description of how such data and information were considered in the risk-benefit assessment.