Lizzy Lawrence, STAT News, March 9, 2026
WASHINGTON — On Thursday, the Trump administration organized a private press conference so that a senior Food and Drug Administration official could anonymously criticize an experimental Huntington’s disease treatment made by the company UniQure.
In the past, when faced with a controversial regulatory matter, the agency would often organize public gatherings with an independent panel of advisors, known in industry parlance as an advisory committee meeting, or adcomm. Patients, doctors, and other interested parties were given an opportunity to comment. They gained a transparent look inside the scientific dialogue between company leaders and regulators, who would present their own analysis of applications for medical product approvals.
UniQure announced last fall that a clinical trial showed its treatment dramatically slowed the progression of Huntington’s disease. The company seemed confident it could apply for approval. Then, the FDA said it wasn’t convinced.
Under previous administrations, this dispute might have been hashed out in one of these adcomm meetings. Instead, the FDA has approached the conversation via anonymous or vague barbs in the press. Asked about this tactic on the Thursday call, the FDA official bashed the advisory committee process.
“Advisory committees are costly,” the official said. “Advisory committees are slow.” Later, he said the expert panelists “do not do their homework.” Some may be motivated by their own conflicts of interest, he noted.
The official’s remarks exemplify the FDA’s shift away from these meetings under the Trump administration. STAT spoke with more than 10 industry leaders, patients, and academic experts about their thoughts on the dwindling number of advisory committees. Many were concerned that the FDA — which under Commissioner Marty Makary has promised “radical transparency” via initiatives like releasing the agency’s rejection letters — is actively shunning a process that allows agency leaders, drug developers, patients, and physicians to speak their minds in public.
“The fact that you are sharing information with the press without standing behind it either suggests that you know you should not be talking to the press or that you don’t really stand behind your opinion,” Holly Fernandez Lynch, a bioethics and law professor at the University of Pennsylvania, said of the UniQure situation. “Why are we debating this in the court of public opinion? The stakes are too high.”
She said that in her opinion, holding an adcomm would be the best approach.
The shift away from advisory committee meetings has coincided with a slide into regulatory uncertainty. The agency has seen tremendous turnover over the past year and political leaders have become unprecedentedly involved in scientific decisions.
These two dynamics make it even more critical to hold public meetings that allow stakeholders to weigh in, argued former top drug regulator Richard Pazdur. Pazdur left the FDA in December after observing that the historic firewall between politics and science had been breached.
“The major thing is transparency,” Pazdur said. “We need that, especially when there is this potential for political influence.”
The decline
The agency held 14 advisory committee meetings in 2025, down from 38 in 2024 and 29 in 2023. The number of advisory committee meetings related to drugs decreased by 72% last year, according to an analysis run by Genevieve Kanter, a public policy professor at the University of Southern California.
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These meetings have faced scrutiny in the past. Robert Califf, the FDA commissioner under former President Biden, pushed to reduce the number of votes at the end of meetings. Pazdur, who worked at the FDA for 26 years, told STAT the agency should simplify briefing documents and require more robust disclosures from speakers.
While some staff felt the agency sometimes held unnecessary meetings, for example to provide political cover rather than engage in scientific discussion, the move to hold far fewer meetings has been shocking.
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HHS spokesperson Andrew Nixon said the agency received feedback from industry leaders that such meetings are costly and time-consuming. But several companies have publicly requested advisory committee meetings, and at least three have said that the FDA told them to prepare for a meeting, only to retract that guidance later.
The rare disease patient community has been particularly worried about the turn away from advisory committees, as the agency under new leadership has reversed its previous flexibility and delivered a series of surprising drug rejections.
“It puts these discussions out in the public,” said Jamie Sullivan, head of policy at the EveryLife Foundation. “It provides information on the FDA’s approach. The guidance that gives to the community, and to other developers, is also really important.“
Diana Zuckerman, who leads the nonprofit think tank the National Center for Health Research, said advisory committees held under this FDA may not be as useful. If the agency has already made up its mind and fills committees with people who think similarly, why go through the rigamarole?
“If they’re going to have advisory committee meetings, and they’ve already decided what they’re going to do, then what’s the point?” Zuckerman said.
Further, if the FDA lacks the staff to identify high-quality, non-conflicted experts, the quality of the discussion may suffer. Three agency officials told STAT that new members for advisory committees now have to be approved by the White House. Historically, this process was handled by career staff.
The change suggests that political officials could more easily fill the panels with ideologically aligned experts, similar to how health secretary and vaccine skeptic Robert F. Kennedy Jr. remade the Centers for Disease Control and Prevention’s vaccine advisory committee.
“The public should demand that the political structure of the executive branch is not involved with selection of advisory committee members,” Pazdur said. “They should not be chosen on the basis of ideology.”
Makary and other leaders have held a number of other public meetings, called expert panels, on topics of interest to the administration and to Makary personally. Unlike traditional advisory committees, it’s unclear how the agency selects panelists and screens them for conflicts of interest. Many of these meetings have been filled with people who share similar views.
“What we really need is meetings with a diversity of opinions,” said Zuckerman. She noted that the lack of advisory meetings is “a symptom of a bigger problem, but we don’t want them to fix it by having meetings that are meaningless.”
Shifting leadership, shifting views
The move away from advisory committees began with the cancellation last February of a meeting to discuss flu shots. In April, HHS fired most of the staff familiar with organizing and running these meetings. Then, other previously scheduled meetings were canceled.
Nicole Verdun, former top cell and gene therapy regulator, scheduled a meeting in June to discuss a Duchenne muscular dystrophy drug from Capricor Therapeutics. Top biologics regulator Vinay Prasad, who is leaving the agency in April, canceled the meeting, and later fired Verdun. The FDA rejected Capricor’s drug in July.
Sydnexis, a company developing a treatment for myopia, told STAT that the agency said in July to prepare for an advisory committee meeting in September. In August, after the company said it had already spent millions on consultants, mock meetings, and other preparations, the agency said a meeting was no longer necessary. The FDA rejected Sydnexis’ drug in October, saying that its efficacy data was not “clinically meaningful.”
“That was a huge drain on the company, and a drain on our resources,” said Patrick Johnson, president of Sydnexis. “But perhaps most importantly, we have a disease here that’s affecting 27 million kids in the U.S. The FDA expressed a concern about the need to get some external advice, and then they pulled back from that.”
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The shifting guidance is partially due to changes in leadership. The Center for Drug Evaluation and Research had five different directors in 2025. Six officials told STAT that the first two directors, Patrizia Cavazzoni and Jacqueline Corrigan-Curay, were supportive of advisory committees.
George Tidmarsh, who left FDA in October, was against them. Pazdur, who replaced him and spent less than a month in the role, was pro. Tracy Beth Høeg, who stepped into the role after Pazdur, is skeptical, agency officials told STAT.
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“In some cases, members have had financial conflicts of interest, including waivers for ongoing relationships with affected companies, raising significant concerns about impartiality,” Nixon said.
Fernandez Lynch said she supports the FDA trying to speak more candidly about its decisions, which seemed to be the purpose of Thursday’s press call. But doing so under a cloak of anonymity, rather than in a public forum with relevant stakeholders, will make the public more confused about the science, she said.
“Either come out fully and say, these are the reasons with my name behind them, or be quiet,” she said. “This middle ground does not help us actually get closer to the truth.”
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