In an interview today at the Friends of Cancer Research annual meeting, Califf said he was personally disappointed by the election results but wouldn’t engage in hypotheticals about potential changes to the U.S. Department of Health and Human Services and its agencies, including the FDA, CDC and NIH.
“From the FDA perspective, we have got all engines on go right now. We’ve done a massive reorganization, we’ve got very significant plans. There’s a meeting going on today that I just left going over hiring. We’re hiring pretty well, not having trouble getting very talented people. I think we just don’t know what’s going to happen now. It’s not correct of me to make any specific comments about what exactly will happen, but I do think it’s pretty clear that the gist of this administration from everything that’s been said is to change a lot of things, and how it gets changed depends on who gets appointed to key positions and how the various policies play out — and also, I think as FDA is concerned, how the broader regulated industries see things and play into this.”
“In times of change and chaos, there’s also opportunity,” he continued. “I will just comment, there’s a lot of things that I bet almost everyone in leadership positions in the health agencies would have liked to have changed but couldn’t because of the gridlock of various interests that made it difficult to change things.”
Calliff said he believes the FDA is at “peak performance right now — and we’ll see what happens as the new team comes in.”
He defended FDA personnel working on nutrition after attacks by Trump surrogate Robert F. Kennedy Jr.
“I’ve gotten to know them very well,” Califf said. “They are really hard-working people. And they’re limited in what they can change by the laws that Congress passes.”
“I want to stand by the people who work at FDA,” he later continued. “They’re good people, they’re hard-working and they want what’s best for the American public. I have no question about that.”
Asked whether FDA employees are eying the exits, Califf said “people are waiting to see.”
“From things that have been said, the change could happen internally or from external decisions made by the administration,” he said. “I just think we have to wait and see and have some faith that hard-working, high-quality people are still going to be in place and have support from — I hope — the external regulated community, which given the dynamics is likely to be the most important factor. I don’t think there’s a lot the people inside the FDA can say, and what I’ve seen already is they’re putting their heads down and doing the work.”
While Califf hasn’t officially announced his departure from the FDA, he said today that “this is not the first time I’ve ridden out of town after an election.”
Given support from Republicans for his previous confirmations as FDA commissioner, Cardiff offered traits he hopes the agency’s next leader will have: “Executive function, a commitment to using evidence to make decisions and believing there is such a thing as expertise.”
“I’m not saying experts are always right,” he said. ” … But not having experts, I think historically in every society, has been a cause for demise of that society.”
He warned that politics and science are not separate, saying that the law allows the president or HHS secretary to make decisions counter to the will of FDA personnel, including its commissioner.
“In more than 99.95% of FDA decisions about individual products, those decisions 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. But it’s totally within the law for the president or the HHS secretary to overrule the entire FDA. So that could happen. Did it happen to me? No.”
“But I also want to say that I think the view that there’s a sharp line between political and scientific, we’ve got to speak truthfully about that,” he continued. “It’s not a sharp line in many cases. I feel like for individual product decisions where you have high quality evidence, where the criteria is survive, feel or function — the standard criteria for medical products — there is no role for politics there. If a drug enables to live longer and the benefit-risk equation is positive, by law the FDA should approve it. But there are so many aspects of this that are integrated in various ways with politics and there’s just no way around it. … To argue that there’s no integration of politics and science is a mistake, and we’re going to need to talk bluntly about this.”
Medical Design & Outsourcing: AdvaMed congratulates Trump, but big questions remain for medtech regulation, import taxes and payments
