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Stat+ — FDA commissioner suggests RFK Jr. and Trump might compromise an agency ‘at peak performance’

Stat+ — FDA commissioner suggests RFK Jr. and Trump might compromise an agency ‘at peak performance’

WASHINGTON — Food and Drug Administration Commissioner Robert Califf said he’s unsure about the future of the agency under the incoming Trump administration and “disappointed” about the election’s outcome.

“I think we just don’t know what’s going to happen,” Califf said at a conference hosted by the nonprofit Friends of Cancer Research on Tuesday. “The gist of this administration, from everything that’s been said, is that they want to change a lot of things, and how it gets changed depends on who gets appointed into key positions.”

The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s hostility to civil servants, Califf said. Trump has said he plans to give Kennedy, leader of the “Make America Healthy Again” movement, power over health care policy in his administration.

“I’m biased, but I feel like the FDA is at peak performance right now and we’ll just see what happens as the new team comes in,” Califf said. He was nominated by President Joe Biden to run the agency and confirmed in February 2022, and previously served as FDA commissioner in the Obama administration.

Kennedy told MSNBC last week that he plans to get rid of “corporate corruption” inside the FDA, floating the idea of purging entire departments. What Kennedy will actually be able to do depends on who ultimately leads the agency, as well as how much FDA-regulated industries successfully lobby against more disruptive ideas.

Most FDA regulatory decisions are made by rank-and-file employees, but Califf noted that it’s completely legal for the commissioner, president, or secretary of health and human services to overrule the entire agency. He said that although FDA decisions are meant to be rooted in science, they have always been subject to political pressure.

“The view that there’s a sharp line between the political and scientific, we’ve got to speak truthfully about this,” Califf said. “It’s not a sharp line in many cases.”

In late October, RFK Jr. wrote on X: “FDA’s war on public health is about to end.”

“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,” he continued.

RFK Jr. has expressed particular skepticism of FDA employees in the food and nutrition departments. The agency has been slow to regulate potentially harmful additives in food, as well as ultra-processed foods. MAHA’s central tenet is to end chronic disease, and Kennedy wants to leverage the public health agencies to do that. It’s a mission that Califf said he can get behind as well.

“I don’t think you have to be too smart to say we have a chronic disease crisis going on in this country that starts in childhood with terrible diets,” Califf said. “There is work that needs to be done.”

“I want to stand by the people who work at FDA,” Califf said. “They’re good people, they’re hardworking and they want what’s best for the American public.”

When asked whether FDA employees may choose to leave the government given the potential for chaos, Califf said workers are waiting to see who Trump nominates to lead the public health agencies. All kinds of names are floating around for FDA commissioner, with MAHA leaders even launching a website to crowdsource potential options.

Califf called Trump’s first FDA commissioner, Scott Gottlieb, an effective leader. He’s said he’s hopeful the agency will snag someone similar, particularly with pressure from the drug and other industries.

“We have to have some faith that hard-working, high-quality people are going to still be in place and have support from the external regulated community,” Califf said.

Califf did not address RFK Jr.’s history of vaccine skepticism or his ability to potentially slow down vaccination efforts.

Califf did discuss drug pricing, noting that while he’s a fan of the FDA’s accelerated approval process, he’s not sure whether drugs approved through that program should command such high prices. FDA does not have the authority to set or negotiate prices for prescription drugs.

He said his top remaining priorities as commissioner are to propose nicotine level standards, to put nutrition labels on the front of food packaging, and to publish a rule pushing certain foods to be labeled as “healthy.”

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

FDA commissioner suggests RFK Jr. and Trump might compromise an agency ‘at peak performance’