As the FDA gears up for a jam-packed Oncologic Drugs Advisory Committee (ODAC) meeting next week, internal sources are raising concerns about the agency’s preparedness. According to an FDA insider who spoke with BioSpace on condition of anonymity, staffing challenges stemming from recent workforce reductions have left the agency relying on undertrained volunteers to support critical planning and conflict-of-interest (COI) functions.
In recent months, significant staffing cuts have hit the FDA hard, including within the Division of Advisory Committee and Consultant Management—the team responsible for ensuring COI compliance. According to the insider, key responsibilities are now being handled by volunteers who have received just “30 minutes of training.”
The insider described the agency’s current approach to advisory committee planning as “fake it till you make it,” emphasizing the strain placed on an already overwhelmed system.
This staffing strain comes at a time of heightened scrutiny for the FDA. Last month, Health and Human Services Secretary Robert F. Kennedy Jr. criticized the agency during a campus tour, accusing staff of acting as a “sock puppet” for the pharmaceutical industry. Around the same time, FDA Commissioner Marty Makary began taking steps to address conflict-of-interest concerns by barring pharma representatives from serving on certain advisory committees.
Given that, the recent layoffs in the division charged with COI oversight appear particularly incongruous.
Despite the internal upheaval, ODAC is scheduled to review four major drug applications during its meetings on May 20 and 21. On the first day, the committee will consider supplemental biologics license applications for Roche’s Columvi (for diffuse large B-cell lymphoma) and Johnson & Johnson’s Darzalex Faspro (for high-risk smoldering multiple myeloma). The second day will focus on UroGen Pharma’s UGN-102 (mitomycin) for non-muscle invasive bladder cancer and Pfizer’s Talzenna for metastatic castration-resistant prostate cancer.
Planning for this “juggernaut” of a meeting has been underway since December 2024, according to the insider, who noted that the process has been made even more difficult by a hiring freeze imposed by the new administration. This freeze has impacted the recruitment of temporary voting members—experts typically brought in to address specific clinical indications. As a result, only those deemed “mission critical” have been cleared to participate.
“It’s been absolute chaos in the agency trying to figure out who can do what,” the insider said.
Publicly, however, sponsors and committee members have not expressed concerns. “Our team hasn’t observed any changes in our communications with the FDA,” a UroGen spokesperson told BioSpace. Daniel Spratt, an ODAC member and radiation oncologist at Case Western Reserve University, also said he was “unaware of any challenges” related to the upcoming meeting.
Roche and Pfizer declined to comment in detail. Roche stated it would not speculate on potential changes to FDA processes, while Pfizer noted it does not discuss ongoing regulatory interactions.
Nevertheless, the FDA insider—who claims to have reviewed the meeting roster—warned that the sponsors and participants should brace for “reduced expertise” during next week’s sessions.
Adcomms in Flux
Adcomms, in general, have been in a state of flux since Kennedy took the helm at HHS earlier this year. On Feb. 26, shortly after being confirmed as HHS Secretary, Kennedy canceled a VRBPAC meeting that was to take place March 13. The advisers had planned to select strains for inclusion in the upcoming 2025-2026 flu season. A separate subcommittee meeting was also canceled, Offit told Reuters at the time. Meanwhile, Kennedy postponed a meeting of the Centers for Disease Control and Prevention’s vaccine advisers who on Feb. 27 were scheduled to update immunization recommendations for a host of infectious diseases, including COVID-19. That meeting finally came together last month.
Meanwhile, the VRBPAC is set to convene on May 22 to decide on the formulation for COVID-19 vaccines to be used in the upcoming 2025-2026 season. This meeting has also faced challenges. A federal register notice announcing the adcomm was posted on May 8—one day short of the customary 15-day public notice. “FDA regrets that it was unable to publish this notice 15 days prior to the [meeting] due to technical issues,” according to the notice. But the agency opted to move forward with the meeting, given “the time-sensitive need for input and public discussion” on the subject at hand.
When asked by BioSpace how the planning for this meeting is progressing, longstanding committee member Paul Offit said in an email that he hasn’t “heard about anything unusual.”
