BENEFIT Act of 2023

This bill requires drug manufacturers to include patient experience data in the U.S. Food and Drug Administration's risk-benefit assessments for new drug approvals. It amends the Federal Food, Drug, and Cosmetic Act to mandate that sponsors submit and describe how patient experience data was considered during the review process. The law directly affects pharmaceutical companies seeking new drug approvals and the FDA during its evaluation. The key provision adds specific language to the approval framework, making patient experience data a formal part of the assessment.