FDA Advisory Panels: Activity Levels Normalize After 2023 Surge
Normalization of Activity Levels:
After a significant increase in advisory committee meetings (adcomms) in 2023, with 29 meetings held, the FDA has seen a return to 2022 levels in 2024, with only 2 meetings scheduled through March3.
Reform Efforts:
The FDA is planning systemic changes to the advisory committee process, led by Acting Chief Scientist Dr. Namandjé Bumpus, aiming to improve flexibility and earlier engagement in the drug development process3.
Virtual Meeting Conduct:
The FDA has redefined "face-to-face" meetings to include both in-person and virtual meetings with audio and visual communication, allowing for hybrid meetings and more flexibility in meeting formats3.
Shift in Focus:
There is a move towards more discussion and less voting in adcomms, with an emphasis on gathering information that informs decision-making rather than relying on voting outcomes3.
Increased Patient Engagement:
The FDA is working to increase patient engagement and give patients a more significant role in advisory committee discussions, reflecting a broader commitment to patient-centered drug development3.
Advisory Committee Vacancies:
The FDA reported an increase in advisory committee vacancies from 14% in FY 2022 to 21% in FY 2023, indicating ongoing challenges in filling these critical roles1.
Applications and Qualifications:
In FY 2023, the FDA received 234 applications for advisory committee positions, with 169 nominees (72%) identified as qualified and willing to serve1.
Sources:
1. https://www.fda.gov/media/178303/download
3. https://proedcomblog.com/2024/02/13/adcoms-they-are-a-changin/