The FDA is standing by for changes within the agency after Donald Trump’s victory in the 2024 presidential election, agency Commissioner Robert Califf said Tuesday.

“Change can happen internally or externally,” Califf said. “We have to wait and see and have some faith that hard-working, high-quality people are going to still be in place and we’ll have support.”

“What I’ve seen already is that they’re putting their heads down and doing their work,” Califf added about staff at the FDA.

The remarks from the Food and Drug Administration’s leader came at the annual meeting for Friends of Cancer Research, a nonprofit cancer research think tank and advocacy organization. Ramsey Baghdadi, founder of Prevision Policy, moderated the keynote discussion on the commissioner’s reaction to the election and priorities for his remaining time at the agency.

“Personally, I’m disappointed in the election,” Califf said. “We sort of got all engines on the go right now. We’ve done a massive reorganization. We’ve got very significant plans.”

“I think we just don’t know what’s going to happen,” he added.
Califf said he’s “committed through Jan. 20,” in response to a question after the keynote.

Mass Exodus?

The agency has been under the spotlight after Trump promised to allow vaccine skeptic Robert F. Kennedy Jr. to “go wild” on health care. He signaled that he would allow Kennedy to have a role at a health agency under his administration, which could include the FDA.

Kennedy has made remarks signaling major changes to the agency if he were to take a leading role, including comments he shared in October on X, formerly known as Twitter.

“FDA’s war on public health is about to end,” he wrote Oct. 25. “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.”

In comments made after the election during a Nov. 6 interview with MSNBC, Kennedy warned that “entire departments” in the FDA “have to go.”

When asked about his reaction to the FDA potentially facing a “mass exodus” if Kennedy were to clear departments within the agency, Califf said it’s “best not to respond to those kinds of things, because getting into a back and forth about hypotheticals is not productive for anyone.”

“I want to stand by the people who work at FDA,” he said. “They’re good people, they’re hard working, and they want what’s best for the American public. I have no question.”

He also noted the “hierarchy” within the agency if there were to be massive changes or any political interference to agency decisions.

“The tradition in 99.95% of FDA decisions about individual products is that those decisions are made by career civil servants,” he said. “The commissioner actually has no role in that unless there was an internal dissent and appeal, or in some cases, an external appeal that makes it all the way up to the commissioner.”

The qualities of the next FDA commissioner should include the ability to function as an executive, such as listening to “people with disparate points of view and take in and learn in a new environment,” Califf said.

“Hopefully it’ll be someone who understands the really critical role of high quality evidence in everything that we do.”

Focus on Food, Tobacco

Califf said he plans to prioritize food policy and tobacco regulation in his remaining days at the agency, while medical products would require more technical changes.

“Food and tobacco,” Califf said. “That’s what’s causing the chronic and serious crisis we’re having right now for life expectancy.”

He mentioned how finalizing the agency’s rule to ban menthol cigarettes has been an issue, but also noted the importance of possibly putting out a rule for a “nicotine standard.”

As for food, he noted issues around labeling for food packages and updating the term “healthy.”

“How could it be that you can’t get the label in front of the package?” he said. “That just sounds crazy to me, but it’s an ordeal.”

— With assistance from Jeannie Baumann.

To contact the reporter on this story: Nyah Phengsitthy in Washington at nphengsitthy@bloombergindustry.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bloombergindustry.com; Karl Hardy at khardy@bloomberglaw.com