The U.S. Food and Drug Administration (FDA) deviated from the recommendations of its advisory committees in three out of seven cases in 2025, according to a note to investors from Jefferies. This marks a significant change compared to previous years, as the discordance rate between FDA decisions and advisory committee votes was only 16% from 2020 to 2024, while it reached 43% in 2025.
Among the notable decisions were the approval of UroGen Pharma’s Zusduri despite a negative advisory committee vote, the rejection of Seikagaku Corporation’s SI-6603 after a positive recommendation, and the approval of GSK’s Blenrep following another negative vote. These actions represented nearly half of all advisory committee meetings held that year.
In addition to diverging more often from its advisory panels’ advice, the FDA convened fewer such meetings overall—just seven in 2025, all held earlier in the year. This is down from an average of twelve per year between 2021 and 2024. The reduction may signal a shift in how new drug applications and indication expansions are evaluated by the agency.
Advisory committees came under early scrutiny by Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary when they assumed their roles at the beginning of 2025. On April 17, Makary announced that pharmaceutical company employees would be limited from serving on independent advisory committees—a step he said would “restore impeccable integrity” to drug reviews and minimize or eliminate “potential conflicts of interest at the agency.”
Kennedy also criticized the agency during a visit to its campus, calling it a “sock puppet” for the pharmaceutical industry.
Later in September, then-director of the Center for Drug Evaluation and Research George Tidmarsh suggested moving away from using advisory committee meetings for specific drugs. According to KFF Health News reporting, Tidmarsh told healthcare product developers and an advocacy group: “I don’t think they’re needed,” arguing that such reviews are redundant and create excessive work for both companies and FDA staff.
Although Tidmarsh later moderated his comments in an interview with Endpoints News, he resigned his position in November amid an investigation into his personal conduct at the agency. Jefferies analysts noted in their January report that there had been no new advisory committee meetings since August 2025—a development attributed to what they described as "FDA’s decision in Sep 2025 to phase out AdComs for individual drug applications," citing concerns over time consumption.
One meeting that did proceed—the May session of the Oncologic Drugs Advisory Committee (ODAC), which reviewed four drug applications—was reportedly hampered by staffing shortages due to a hiring freeze. An FDA insider told BioSpace that without temporary members with relevant expertise available, operations resembled a “fake it till you make it” approach.
The FDA also tried alternative feedback mechanisms last year by organizing two expert panels: one addressing selective serotonin reuptake inhibitor (SSRI) use during pregnancy and another focusing on menopause and hormone replacement therapy. Both drew criticism for presenting only one perspective.
Diana Zuckerman, president of the National Center for Health Research, commented on these panels: “It seemed they didn’t want any real difference of opinion,” she told BioSpace in September.
