Key Takeaways
- The FDA is not publicly scheduling new advisory committee meetings due to limits on public communications, sources said.
- Stakeholders said the lack of meetings could lead to approval delays or less-informed decisions.
- Otsuka and UroGen previously have said they expect advisory committee meetings for products currently under review.
The US Food and Drug Administration is not scheduling new advisory committee meetings due to ongoing limits on agency communications, four sources told the Pink Sheet.
Cancelling or postponing meetings could delay approval actions and make settling review team disagreements more challenging, and potentially lead to lower-quality decisions.
The FDA must publish advisory committee announcements in the Federal Register at least 15 calendar days before a meeting date, though the agency usually announces meetings two or three months in advance.
The FDA has interpreted the Health and Human Services Department’s restrictions on external communication to limit its ability to issue Federal Register notices, meaning some planned advisory meetings that were not publicly noticed have been postponed or cancelled, said Jim DiBiasi, cofounder of 3D Communications, a consulting firm that prepares sponsors for advisory committees.
DiBiasi said he has been told by people in close contact with the FDA that more normal communications are starting to resume, which soon should facilitate the usual meeting scheduling practices.
The FDA typically holds an advisory committee four to six weeks before a user fee goal date, but dates can vary.
The agency’s public advisory committee calendar currently lists a postponed 20 February meeting of its General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The FDA previously postponed a 5 February meeting on postmarket requirements for extended-release/long-acting opioids and cancelled a 24 February meeting for Novartis' Fabhalta for an ultra-rare kidney disease.
No other future meetings are publicly listed.
The Pink Sheet is aware of two products with upcoming user fee deadlines whose sponsors said they expected an advisory committee.
On 10 January, Otsuka Pharmaceutical announced the 8 February user fee goal date for Rexulti (brexpiprazole) in post-traumatic stress disorder would be delayed because the FDA planned an advisory committee meeting, likely in the first half of 2025.
UroGen’s UGN-102 (mitomycin intravesical solution) for non-muscle invasive bladder cancer has a 13 June user fee goal date.
The agency’s freeze on external communications was supposed to lift at the beginning of February, but staff remain confused about the public interactions that are allowed. The FDA did not respond to a request for comment.
Delayed, Less-Informed Approval Decisions Possible
Advisory committees are typically an important event late in the drug review process. The FDA does not have to call a committee meeting as part of an application review, but often will, particularly with new molecular entities, or if the benefit-risk analysis does not support a clear decision.
DiBiasi said advisory committees promote transparency “and are one of the most scientifically valuable and cost-efficient parts of the drug and device review process.”
“In just one day the FDA gets scientific advice from the best and brightest experts in healthcare,” he said. “We are concerned that weakening that process has the potential to ultimately jeopardize public health by having products approved without a positive benefit-risk profile or keeping products from the market that do, and no one wants that.”
Reshma Ramachandran, co-director of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency and chair of the FDA Task Force for Doctors for America, said the delay or loss of these meetings is concerning.
“In the best-case scenario,” FDA can reschedule the meetings without impacting the timeline for approval decisions and patient access to a beneficial treatment or needed safety information, she told the Pink Sheet.
In the worst-case scenario, Ramachandran worries about the possibility for poor FDA decision-making.
“I’m worried that in those instances where there is disagreement among FDA reviewers about a particular candidate product, that instead of calling an expert advisory committee to deliberate and provide the agency with recommendations around a regulatory action, that instead FDA, in a rush to fulfill PDUFA timelines, will rush to make a decision,” she said.
“This could mean approving a drug or device with significant uncertainty or not taking a safety action around a medical product despite concerns,” Ramachandran added.
A lack of advisory committee meetings is not good for patients or providers “because those public meetings provide important information about risks and benefits, as well as what is known about the products and what isn’t known or isn’t proven,” said Diana Zuckerman, president of the National Center for Health Research.
Zuckerman also worried about FDA staff making difficult decisions at a time when federal workers “are concerned that anything they do or say could get them fired.”
“That can result in FDA staff not being candid about their views, and that could result in timid decisions and risky or ineffective products,” she said.
Ramachandran said the FDA should consider making an exception for scheduling advisory committees for now, citing both HHS Secretary nominee Robert F. Kennedy Jr. and FDA Commissioner nominee Martin Makary’s commitments to transparency and calls for more advisory committee meetings.
“The real issue here is it’s interfering,” said Robert Steinbrook, director of Public Citizen’s Health Research Group. “We want the FDA to do its job and protect the public health and serve patients and other constituencies, and it just interferes with the agency’s ability to do its basic function.”
Harvard University Medical School’s Aaron Kesselheim, who has served on advisory committees, said he fears the administration’s next step may be to arrange advisory panel membership “in ways that are designed to get a specific, predetermined outcome,” and sideline independent scientists and voices that disagree.
This “will lead to reduced confidence in the government and in the products that the FDA approves, to the detriment of the public health,” said Kesselheim, professor of medicine and director of the Harvard Program on Regulation, Therapeutics and Law.
Preparations Continue, ACIP Meetings Remain Scheduled
DiBiasi said his clients continue preparing for advisory committee meetings as usual.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which plays a key role in vaccine coverage and availability, still has a 26-28 February meeting listed on its website. The meeting’s agenda includes votes on meningococcal, chikungunya, influenza and RSV vaccines. Other vaccines will be discussed, including COVID vaccines.
ACIP also has two other planned meetings listed for June and October 2025.