The White House is reportedly considering an executive order to fire thousands of HHS employees. If implemented within the FDA, experts say the cuts could drive uncertainty and delay regulatory reviews.
Days before leaving office, former FDA commissioner Robert Califf told members of the media he wanted his legacy to be the workforce he was leaving behind. Three weeks later, Donald Trump is trying to tear it down.
More than 18,000 people currently work at the FDA. “We have a workforce full of highly talented people that’s been built up, and they’ll go on and do great things in the future in the multiple sectors that they’re involved in,” Califf said during a media roundtable last month. More important than specific policies, he said, is “the underlying functionality of the FDA and the people that are in it.”
But the White House is considering an executive order to fire thousands of employees at the Department of Health and Human Services (HHS), which encompasses the FDA, The Wall Street Journal reported last week. HHS Secretary nominee Robert F. Kennedy Jr. has also made his intentions clear regarding the FDA’s workforce.
“FDA’s war on public health is about to end,” RFK Jr. posted on X in October. “If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags.”
Even before Trump took office on Jan. 20, the FDA had parted with notable officials. In January, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni announced her retirement, shortly after the departure of Principal Deputy Commissioner Namandjé Bumpus. Douglas Throckmorton, deputy director for regulatory programs, and Robert Temple, CDER’s senior advisor for clinical science, have also recently retired, according to BioPharma Dive.
“The couple of leaders that we’ve lost are really important people who carry a lot of institutional knowledge and also scientific knowledge, so there’s no question those are important losses for the agency,” Califf said during the media call.
One senior leader who has stated his intent to remain at the FDA is Center for Biologics Evaluation and Research (CBER) Director Peter Marks.
“I will stay around as long as I’m considered to be welcome to stay around,” Marks said at the Jefferies London Healthcare Conference in November, Endpoints News reported. “I think it’s very important that people see that there’s constant leadership here—that we are here to work with either side of the aisle”
However, “welcome” may be the operative word. As the head of CBER, Marks has been front and center on vaccines. RFK Jr., on the other hand, has been an outspoken critic of vaccines, though he downplayed his anti-vaccine stance during his Senate confirmation hearings last week. Marks’ office did not respond to BioSpace’s request for comment.
“I know people at FDA and no one at the moment thinks they have job security,” Stuart Pape, food and drug chair at Polsinelli Law Firm and former associate chief counsel for foods at the FDA, told BioSpace. “And the higher up you are, the more likely you are in a policy position, the less job security you should feel you have.”
Encouraged to Leave
Even if an official executive order culling employees does not materialize, government workers across the board are being encouraged to leave, Pape said. “There’s no question that there’s a concerted effort to reduce the number of government employees, including at places like FDA.”
Other policy changes—including the erasure of FDA webpages focused on diversity, equity and inclusion (DEI), and a memorandum from Trump ordering federal employees back to the office full-time—could further this effort, Chad Landmon, chair of Hatch-Waxman & Biologics at Polsinelli, told BioSpace.
“Certainly, I think [the DEI issue] is going to have an impact on both retention and hiring,” he said. “The [loss of] remote work is another thing that I think may drive some folks away.”
For the biopharma industry, Pape and Landmon agreed that substantial FDA workforce cuts would create a “brain drain” that could cause confusion and delay regulatory applications.
“The uncertainty is what really concerns a lot of our clients,” Landmon said, noting that a lack of knowledge and experience within the FDA could make it more challenging to resolve issues that arise. On the other hand, if a company is advocating for a different approach, “maybe now’s a good opportunity,” he said.
In terms of the regulatory review process for new drugs, Landmon said Prescription Drug User Fee Act (PDUFA) user fees—which are up for renegotiation beginning this year—were “very successful in helping the [FDA] staff up to review applications in a timely manner.”
RFK Jr. has criticized these user fees—which account for 46% of the FDA’s budget—for giving the perception that industry drives approval decisions, Landmon said. “If they end up losing a lot of that staff, you’re going to see these review times really extend out.”
For the incoming administration, Pape indicated that efforts to deplete the FDA’s workforce could be counterproductive.
“It will make whatever agenda the secretary, presumably RFK Jr., has, and the commissioner, presumably [Marty Makary], much more difficult, because neither the secretary nor the commissioner can execute on a plan or an initiative,” he said. “You need people who know how to do those things, and you need a number of them.”
Pape added that a depleted FDA workforce “might also have the effect of ceding more control to White House staffers. There’s lots of processes and guardrails built into the way federal agencies operate . . . but those processes and guardrails only matter if the person with authority respects the guardrails and the processes, and I would suggest there’s ample evidence here that the people with authority don’t, so they can run roughshod over lots of things.”
During the January media call, Califf expressed confidence that the checks and balances between the FDA and other sectors of the U.S. government would limit the power ultimately wielded by RFK Jr and Makary. The FDA has “a lot of bosses,” including HHS, the executive branch and Congress, “which also thinks it’s your boss,” he said. “It’s interesting to me that people think the FDA could just declare this and that. It usually can’t.”
Still, Califf expressed concern about FDA’s future. In response to a question referencing RFK Jr.’s reported wish to “get rid of certain departments or entire departments within the agency, he said, “I’m worried about every part of the FDA. I don’t think you’ll find people at FDA doing work that no one cares about.”
