Bill > S526

This bill, the Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 (BENEFIT Act of 2023), aims to strengthen the use of patient-experience data within the risk-benefit framework for the approval of new drugs. Specifically, it amends the Federal Food, Drug, and Cosmetic Act to require the consideration of patient experience data as part of the risk-benefit assessment framework in the new drug approval process. Additionally, the bill requires drug sponsors or other parties to provide a description of how the patient experience data was considered in the risk-benefit assessment.