In the five weeks since Donald Trump returned as U.S. president, the FDA, NIH and CDC have been thrown into disarray, with meetings regarding vaccines and rare diseases canceled or indefinitely postponed—all without a clear reason why.
FDA, NIH and CDC staff must feel like they’re holding their collective breath, as meeting after meeting is canceled or postponed without explanation—or at least none to which those of us in the media are privy—and staff are let go, only for some to be rehired.
The postponement of the first 2025 meeting of the CDC’s vaccine advisory board and subsequent cancelation of a meeting of the FDA’s vaccine advisory panel were perhaps unsurprising given the well-known vaccine skepticism of recently confirmed Department of Health and Human Services Secretary Robert F. Kennedy Jr.
“There’s so much disruption going on at the FDA, the CDC and the NIH,” Stanley Perlman, a member of the FDA’s vaccine advisory panel told Reuters on Wednesday. He told the publication of another FDA subcommittee meeting that had been planned for next month but has now also been canceled, noting “I don’t know what the basis for [that] is.”
Vaccines are not the only space being affected. Last Friday, FDA and NIH revealed that their joint Rare Disease Day event, which was to take place Feb. 27 and Feb. 28 in Bethesda, Maryland, was also being postponed. The two-day meeting, which was to also be streamed online, is intended to raise awareness among policymakers and the public about rare diseases and their impact on patients’ lives.
Notably, this is the first time in recent history that Rare Disease Day will not be observed by the federal government. Even during the COVID-19 pandemic, the FDA and NIH held the event virtually, according to Rare Disease Advisor. No reason was given for this year’s postponement, and neither the FDA nor NIH provided further detail in response to BioSpace’s requests.
Members of the rare disease advocacy community were floored by the decision. Amy Case, chief medical officer of the Pulmonary Fibrosis Foundation told Rare Disease Advisor that she was “really disappointed.”
“Unfortunately, we’ve observed a lot of chaos as the new administration has implemented policy changes, as well as changes in the ability to communicate and plan meetings,” she told the publication. “This has been very disruptive to everybody in medical research and those who take care of patients.”
Meanwhile, Terry Jo Bichell, CEO of CombinedBrain who has a son with Angelman syndrome, called the postponement and absence of an explanation a “disaster,” Rare Disease Advisor reported.
It’s yet another example of the lack of transparency that has pervaded HHS since Trump took office on Jan. 20. Interestingly, when I reached out to several rare disease advocacy organizations for comment on the postponed rare disease programming, I received mostly crickets or declines to comment—even from groups who are frequently quoted in BioSpace articles. To me, this speaks to the culture of fear being cultivated both within HHS and the larger biopharma industry it regulates.
Workforce Cuts Unexplained
Another move that has been shrouded in secrecy is the massive cuts being made to the federal workforce. Earlier this month, Jeremy Levin, CEO of Ovid Therapeutics, called for clarity regarding the rationale behind the recent FDA layoffs.
“The extent and the rapidity of the actions taken has been remarkable, and that has perhaps led to, in many cases, the concern that there is no understanding of exactly why they’re being done,” Levin told me. Whatever the plan, he said, it is imperative that it be communicated effectively.
This sentiment has been espoused by current and former FDA leaders over the past couple of years. In a fireside chat at last year’s American Society of Gene & Cell Therapy conference, Center for Biologics Evaluation and Research (CBER) Director Peter Marks emphasized that one of the mottos his division follows is to be “transparent about what we’re doing.”
And in a December 2023 statement, former FDA Commissioner Robert Califf stressed the importance of clinical trial transparency, touting the creation of the ClinicalTrials.gov website—which the FDA monitors—in 2000, as “a major step forward.”
I’ll bet vaccine developers already planning for the 2025–2026 flu season were eagerly anticipating similar transparency and guidance from the FDA’s Vaccine and Related Biological Products Advisory Committee. Unfortunately, they will now have to wait. Likewise, GSK and Moderna, whose recently approved meningococcal and COVID-19 shots were to be discussed at the now-canceled CDC Vaccine Advisory Board, will also be forced to await potential news about rescheduling.
Coincidentally, BioSpace discovered yet another example of the FDA’s lack of transparency when reporting on the agency’s recently released guidance document regarding weight loss drugs. Hoping to compare and contrast the new guidance with previous guidance released in 2007, we went searching for the earlier document online, only to find that it was no longer readily available. An FDA spokesperson confirmed its disappearance and said the document could not be shared, though they did suggest that a Freedom of Information Act request could potentially turn it up if we wanted to go down that path.
As a journalist—and just as a human being—I am a stickler for transparency. I am a bundle of nerves without it, so I can only imagine how HHS staffers are feeling right now. An FDA staffer, who spoke on the condition of anonymity, told me that rumors of additional cuts were swirling. Another source expressed concern about whether a grant they had been working on for a year would still exist when they finally submitted it.
It is clearly a tenuous time at the agency. As Levin told me, the new administration may well have a plan, he said, “It’s simply that we can’t, as yet, see what the plan is.”
