As the FDA prepares for a busy Oncologic Drugs Advisory Committee next week, an agency insider told BioSpace that volunteers with little training are scrambling to secure the required expertise after workforce cuts decimated the adcomm planning office.
When it comes to advisory committee meetings—such as that of next week’s Oncologic Drugs Advisory Committee—the FDA is operating with a “fake it till you make it,” mentality, an agency insider told BioSpace.
The massive workforce cuts that have hit the FDA in the past three months have not spared the agency’s Division of Advisory Committee and Consultant Management—which includes staff responsible for conflict of interest (COI) screening. According to the FDA insider, who spoke with BioSpace on the condition of anonymity, these roles are currently being filled by volunteers with “30 minutes of training.”
The FDA is often criticized for the so-called “revolving door” through which individuals move from regulatory roles to the biopharma industry and vice versa. Last month, during a tour of the FDA’s campus, Health and Human Services Secretary Robert F. Kennedy Jr. blasted the agency’s staff, accusing them of being a “sock puppet” for the pharma industry. Also in April, Commissioner Marty Makary took a first step toward addressing one alleged COI, banning pharmaceutical representatives from serving as members on some of the agency’s advisory committees. So, it may seem discordant that HHS would lay off a division whose main purpose is to prevent conflicts of interest from occurring on adcomms.
Next week, the Oncologic Drugs Advisory Committee will meet to discuss four drug applications. On May 20, the ODAC will consider supplemental biologics license applications for Roche’s (Genentech’s) Columvi in diffuse large B cell lymphoma and Johnson & Johnson’s Darzalex Faspro in high-risk smoldering multiple myeloma.
The following day, the committee will discuss a new drug application for UroGen Pharma’s for UGN-102 (mitomycin) intravesical solution for non-muscle invasive bladder cancer and a supplemental new drug application for Pfizer’s Talzenn in metastatic castration-resistant prostate cancer.
Such a “juggernaut” of a meeting takes months of planning, the FDA insider said. This one has been in the works since December 2024.
One challenge, they said, has been navigating a hiring freeze implemented by the new administration that affected temporary voting members. Each of the FDA’s adcomms—including the ODAC and the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which also meets next week—has a roster of standing members. ODAC’s current webpage lists six vacancies. However, adcomms will also typically recruit temporary members with expertise pertaining to a specific indication. In the current hiring situation, these individuals must be “mission critical,” according to the FDA insider; if they did not participate, “it’d be tough to have this meeting go forward.”
Amid pressure to make it work, it has been “absolute chaos in the agency trying to figure out who can do what,” the source said.
Sponsors and ODAC members, however, told BioSpace they had not noticed anything out of the ordinary regarding next week’s meeting. “Our team hasn’t observed any changes in our communications with the FDA,” a UroGen spokesperson said in an email. And Daniel Spratt, a radiation oncologist at Case Western Reserve University and ODAC member, told BioSpace in an email that he is “unaware of any challenges” with the upcoming meeting.
A Roche representative, meanwhile, declined to “speculate on potential changes to FDA processes or how job cuts at federal health agencies may impact regulatory applications,” while a Pfizer spokesperson responded to BioSpace’s inquiries by saying the company does not comment on ongoing conversations with regulatory agencies.
But the FDA insider, who claims to have reviewed the meeting roster, said that Roche, J&J, Pfizer and UroGen—along with other attendees—should expect “reduced expertise,” for 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.”
