With just a few months to go before he likely steps down, President Biden’s FDA Commissioner Rob Califf weighed in on how the agency might be affected by the incoming administration.
Califf, while not mentioning President-elect Donald Trump by name, or his healthcare lead, Robert F. Kennedy Jr., made pointed remarks on Tuesday about the risk to the agency’s authority and its workforce.
And he directly addressed several of Kennedy’s recent comments about the FDA. Trump has promised to let Kennedy “go wild” on healthcare and pharma policy, and Kennedy has said he will push drastic changes, overhaul or shrink some FDA and NIH divisions, and has threatened staff with investigations.
Addressing hiring concerns and the potential for an exodus of staff when the Trump administration takes over, Califf said, “We’re hiring pretty well and not having trouble getting very talented people. And I think we just don’t know what’s going to happen now.”
Kennedy has repeatedly raised doubts about vaccine safety and called for new data reviews, part of a theme of skepticism he’s expressed.
“Not having experts, I think historically, in every society, has been a case for demise of that society,” Califf said at the Friends of Cancer Research’s annual meeting in Washington.
Depending on who gets appointed as leaders of the various health agencies, Califf acknowledged that the Trump administration has stressed the need for change and, “in times of changing chaos, there’s also opportunity.”
As far as who might replace him in the coming months, Califf said, “Hopefully it’ll be someone who understands the really critical role of high-quality evidence in everything we do,” and “that there is such a thing as expertise.”
He also made clear that although the FDA has historically relied on its nonpartisan physicians to review the clinical data for medical product approval decisions, and very few approval decisions ever reach the level of center director or commissioner, “it is very clear that there is a hierarchy” within the executive branch.
“It’s totally within the law for the president or the HHS secretary to overrule the entire FDA. And so that could happen,” Califf said. “Did it happen to me? No, but also want to say, I think the view that there’s a sharp line between political and scientific, we got to speak truthfully about this. It’s not a sharp line in many cases.”
He also warned against tinkering too much with the agency’s operations, saying it’s “sort of at peak performance right now.”
https://endpts.com/fda-commissioner-warns-of-risk-to-agency-under-rfk-jr-influence/
