Key Takeaways
- Industry support for the FDA’s work and staff will be important to the agency's prospects under the incoming Trump Administration, Commissioner Robert Califf said.
- Califf said the FDA’s next leader must have good executive functioning capability, a commitment to using evidence to make decisions, and a belief in expertise.
- Although almost all medical product decisions are made by career staff, the line between politics and science is fuzzier than most realize when it comes to policymaking, he said.
How the US Food and Drug Administration fares during President-elect Donald Trump’s second term will depend, in part, on industry’s support for the agency and its staff, Commissioner Robert Califf told the Friends of Cancer Research annual meeting on 12 November.
Califf’s second term as commissioner will end when Trump takes office in January.
“This not the first time I’ve ridden out of town after an election,” he joked.
Califf said the incoming administration clearly is intent on changing a lot of things, but “how it gets changed depends on who gets appointed to the key positions and how the various policies play out.”
“How the broader regulated industries see things and play into this” will have an impact, he said.
The incoming Trump Administration could bring the biopharma industry some relief from Medicare drug price negotiations, but also could create more uncertainty by upending drug and biologic approvals norms.
Changes Ahead Despite ‘Peak Performance’
Califf said he was personally disappointed in the election results and is concerned about the uncertainty and potential upheaval facing the agency in the coming months.
“Obviously I’m biased, but I feel like the FDA is sort of at peak performance right now, and we’ll just see what happens as a new team comes in,” he said.
“We’ve sort of got all engines on go right now,” Califf added. “We’ve done a massive reorganization. We’ve got very significant plans.”
“We’re hiring pretty well and not having trouble getting very talented people,” he said. “And I think we just don’t know what’s going to happen.”
“I just think we have to wait and see and have some faith that hard-working, high-quality people are going to still be in place and will have support, I hope, from the external regulated community which, given the dynamics, is likely to be the most important factor.”
FDA’s Robert Califf
When moderator Ramsey Baghdadi, co-founder of Prevision Policy, asked Califf if he expects a mass exodus of staff, the commissioner said FDA employees are taking a cautious approach.
“I just think we have to wait and see and have some faith that hard-working, high-quality people are going to still be in place and will have support, I hope, from the external regulated community which, given the dynamics, is likely to be the most important factor,” Califf said.
Belief In Expertise
Califf summarized the three qualities he thinks the FDA’s next leader will need to succeed: executive function, a commitment to using evidence to make decisions, and “believing that there is such a thing as expertise.”
Executive function is the ability to listen to people with disparate points of view, learn in a new environment and make executive decisions, he said.
“Hopefully, it’ll be someone who understands the really critical role of high-quality evidence in everything that we do,” Califf said. “And sort of related to that is the confidence that there is such a thing as expertise.”
“I feel like a lot of what’s in question right now in our society is, should we make decisions based on how we feel at any given moment in time, versus analyzing things and coming up with an opinion, particularly as it relates to issues that affect our long-term outcome,” he added. “And the role of experts in that is really being questioned right now in a major way.”
Califf acknowledged that experts are not always right, “but not having experts, I think historically in every society, has been a case for demise of that society.”
Political Interference
Califf also addressed concerns about political interference in the FDA’s scientific decisions.
Almost all FDA decisions about individual products are made by career civil servants, he said.
“The commissioner actually has no role in that unless there’s an internal dissent and an appeal, or in some cases an external appeal that makes it all the way up to the commissioner level,” he said.
However, “it’s totally within the law for the president or the HHS secretary to overrule the entire FDA,” he said. “Did it happen to me? No.”
Califf said the line between political and scientific decisions is fuzzier than many people think.
“For individual product decisions where you have high-quality evidence, where the criteria is based on survive, feel or function, the sort of standard criteria for medical products, there is no role for politics there,” he said. “If a drug enables people to live longer and the benefit-risk equation is positive, by law the FDA should approve it. But there’s so many other aspects of this that are integrated in various ways with politics, and there’s just no way around it.”
For example, he noted the role of the Office of Management and Budget’s Office of Information and Regulatory Affairs in scrutinizing FDA regulations before release.
“That’s a political arm of the White House,” Califf said of OIRA. “So to argue that there’s no integration of politics and science I think is a mistake, and we’re going to need to talk bluntly about this … as we go through the next phase. There’s a lot at stake for the cancer community and the industry.”
The RFK Factor
Califf declined to specifically respond to comments by Trump ally Robert F. Kennedy Jr., who could receive a public health-related role in the new administration.
Kennedy is a long-time skeptic of mainstream medicine, including vaccines. He is interested in reducing chronic disease, including by using alternative treatments, and has been quoted as saying entire departments at the FDA, such as staff working on nutrition issues, should be eliminated.
“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,” Califf said.
However, he defended the FDA nutrition issues staff as “really hard-working people, and they’re limited in what they can change by the laws that Congress passes.”
Califf said he has spent the majority of his second term as commissioner working on food issues.
“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 that are not getting better,” he said. “And there is work that needs to be done.”
