Congress and the Food and Drug Administration (FDA) have made considerable progress in driving forward policies and procedures to ensure the patient perspective is considered by FDA reviewers evaluating candidate drugs and other medical products. While much progress has been made, some significant gaps remain.
Ahead of rare disease week, Senators Wicker (R-MS) and Klobuchar (D-MN) and Reps. Matsui (D-CA) and Wenstrup (R-OH) have introduced the bipartisan Better Empowerment Now to Enhance Framework and Improve Treatments, or BENEFIT Act (S.526/H.R. 1092), to address those gaps.
This bill is an amended version from the 117th Congress’ BENEFIT act based on technical feedback from the FDA. It would ensure that patient experience, patient focused drug development (PFDD) and related data – including information developed by a product sponsor or a third party such as a patient advocacy organization or academic institution – be considered as part of the risk-benefit assessment.