What's Happening?
In 2025, the FDA deviated from its advisory committees' recommendations on three out of seven occasions, marking a significant shift from previous years. This change, reported by Jefferies, indicates a 43%
discordance rate, a notable increase from the 16% rate between 2020 and 2024. The FDA held fewer advisory committee meetings, with only seven occurring in 2025, compared to an average of 12 in prior years. Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary have been critical of the advisory committees, leading to a reduction in their use. Makary announced measures to limit pharmaceutical company employees from serving on these committees to enhance integrity and reduce conflicts of interest. Additionally, the FDA experimented with expert panels, which faced criticism for lacking diverse opinions.
Why It's Important?
The FDA's decision to reduce reliance on advisory committees and its increased rate of discordance with these committees' recommendations could have significant implications for the drug approval process. This shift may affect the transparency and perceived integrity of the FDA's decision-making, potentially impacting public trust. The reduction in advisory committee meetings and the introduction of expert panels may streamline the approval process but could also lead to concerns about the thoroughness and impartiality of drug evaluations. Stakeholders, including pharmaceutical companies and healthcare providers, may need to adjust their strategies in response to these changes.
What's Next?
The FDA's approach to advisory committees and drug approvals is likely to continue evolving. The agency may further refine its use of expert panels and explore alternative methods for gathering input on drug applications. Stakeholders will be closely monitoring these developments, as they could influence future drug pricing, availability, and innovation. The FDA's actions may also prompt legislative or regulatory responses aimed at ensuring a balanced and transparent drug approval process.
