FACA Reform
From January 2024 to July 2024, the Federation of American Scientists interviewed 30 current and former FDA Advisory Committee (AdComm) members to learn about the Advisory Committee experience and identify existing challenges and opportunities to help inform actionable policy solutions. The goal of this project was to create a vision for how the FDA and other federal agencies can better engage external scientific experts and the public to address critical challenges facing public health. Discussions included topics such as how the FDA can better leverage Advisory Committee membership through expanding the role of the chair, overall committee composition, implementing mandatory training programs, streamlining the conflict of interest process, and more.
Based on these discussions, we were able to source potential policy recommendations that may assist with enhancing the FDA’s ability to obtain valuable advice for evidence-based decision-making. The results of these discussions are presented in case studies detailing the recurring themes that emerged and policy recommendations for improvement.
These recommendations can catapult the Advisory Committee structure into one that continues providing the government with the best advice.
Improving public awareness of FDA Advisory Committees would improve public trust and deter misinformation related to the approval of medical products.
The absence of consistent voting privileges for patient representatives on Advisory Committees hinders representatives from providing an voice on behalf of the community they represent.
Internal disagreements present a growing concern about FDA leadership overruling the expert opinions of scientific staff and proceeding with official approvals, thus undermining staff expertise, decreasing agency morale, and potentially diminishing public trust.