BENEFIT Act of 2023

The BENEFIT Act of 2023 amends the Federal Food, Drug, and Cosmetic Act to require drug sponsors to include patient experience data in the risk-benefit assessment for new drug approvals under Section 505(d). This directly affects pharmaceutical companies seeking FDA approval for new drugs and the FDA itself, which must now consider this data during evaluations. The key provision adds a specific requirement for sponsors to submit patient experience data as part of the approval framework and to describe how this data influenced the risk-benefit assessment. The bill does not change drug safety standards but expands the data considered during the review process. This is a procedural change to the FDA’s evaluation criteria, not a new drug benefit.