In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer meetings than usual and agreed with its advisors only 57% of the time, Jefferies reported.
The FDA went against the recommendation of its advisory committees on 3 of 7 occasions in 2025, Jefferies reported in a note to investors on Saturday—a considerable departure from recent years.
Those three decisions—an approval for UroGen Pharma’s Zusduri after a negative adcomm vote, a rejection for Seikagaku Corporation’s SI-6603 after a positive adcomm and a closely-watched approval for GSK’s Blenrep after a negative adcomm vote—represent 43% of all 2025 adcomms, according to Jefferies, compared with a 16% discordance rate between 2020 and 2024.
That there were only seven advisory committee meetings—and that all seven occurred earlier in the year—could also be a bellwether of things to come at the FDA in terms of how decisions on new drugs and indication expansions are made. There were an average of 12 adcomms between 2021 and 2024, but only five in the COVID-19-impacted 2020.
Adcomms were an early target of Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary when they took office early in 2025. On April 17, Makary announced that the FDA would limit pharmaceutical company employees from serving as members on its independent advisory committees in a move he said would help “restore impeccable integrity” to the drug review process and minimize or eliminate “potential conflicts of interest at the agency.”
This followed remarks made by Kennedy during a tour of the FDA campus where he blasted the agency and its staff, accusing them of being a “sock puppet” to the pharma industry.
Then, in September, then-Center for Drug Evaluation and Research director George Tidmarsh said he was considering a move to “abandon” the use of advisory committee meetings for specific drugs, according to reporting by KFF Health News. “I don’t think they’re needed,” Tidmarsh said at a meeting of healthcare product developers and to an advocacy group, according to KFF, adding that the reviews are redundant and require “a tremendous amount of work for the company and for the FDA.”
While Tidmarsh appeared to walk those comments back in an interview with Endpoints News—and resigned from his post in early November amid a probe into his “personal conduct” at the agency—Jefferies in its Jan. 3 report flagged “an absence of new AdComs” since its August 2025 update. The analysts said this largely reflects “FDA’s decision in Sep 2025 to phase out AdComs for individual drug applications, which were viewed as time-consuming.”
One adcomm meeting that did go ahead last year, an Oncologic Drugs Advisory Committee (ODAC) session that convened in May to discuss four separate drug applications—was apparently thrown into “absolute chaos” in part by a hiring freeze preventing the recruitment of temporary members with expertise pertaining to the specific indications, according to an agency insider who spoke with BioSpace. When it came to advisory committee meetings, the source said in May, the FDA was operating with a “fake it till you make it” mentality.
Apart from an apparent late-year pause in advisory committee meetings, the FDA experimented with another feedback format last year: expert panels. The agency held two such panels this summer, one focused on the use of selective serotonin reuptake inhibitor (SSRIs) during pregnancy, the other on menopause and hormone replacement therapy. The panels drew criticism from medical experts and FDA watchers for being one-sided.
Diana Zuckerman, president of the nonprofit National Center for Health Research, was struck by the lack of nuance presented during these panels. “It seemed they didn’t want any real difference of opinion,” she told BioSpace in September.
