Better Empowerment Now to Enhance Framework and Improve Treatments Act of 2023 or the BENEFIT Act of 2023
This bill requires the Food and Drug Administration (FDA) to consider relevant patient experience data in the risk-benefit assessment framework used in the process for approving new drugs.
After a new drug application has been approved, the FDA's public statement about how it used patient experience data shall include a description of how such data was considered in the risk-benefit assessment framework.