While personally “disappointed” about the election’s outcome, current FDA Commissioner Robert Califf, M.D., has laid out the qualities that he hopes his successor will have.
“I think ability to function as an executive is going to be a very important one,” Califf said Tuesday at the Friends of Cancer Research annual meeting. The two-time FDA chief later explained this executive function as “the ability to listen to people with disparate points of view and take in and learn in a new environment.”
Trump’s first FDA commissioner, Scott Gottlieb, M.D., fits that description, Califf noted, arguing “you just could not have found a better person for the role at that time.” Gottlieb had previously followed Califf in the role after Califf served during Obama’s administration.
“Right up with that, I would say hopefully it’ll be someone who understands that the really critical role of high-quality evidence in everything that we do, and sort of related to that, is a confidence that there is such a thing as expertise,” Califf said.
Califf’s comments come as Robert F. Kennedy Jr., a vaccine skeptic, has emerged as a top candidate to oversee healthcare policy in the incoming Trump administration. Kennedy has threatened to execute major shakeups at the FDA, suggesting that entire departments are now unneeded.
The FDA has its own expertise, but as an executive branch, it’s not immune from political intervention, Califf noted. It’d be legal for the HHS secretary to overrule decisions by the FDA, he pointed out.
“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,” Califf said.
Kennedy’s tone during the election, and the result of the voting, has created much uncertainty around the future of the FDA.
During Tuesday’s event, Califf argued that the agency is now “at peak performance” following a recent reorganization that went into effect in October. There’s no massive exodus of staff yet, but many employees are waiting to see who Trump taps to top healthcare jobs, according to Califf.
“I think we just don’t know what’s going to happen,” Califf said. “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 into key positions and how the various policies play out.”
“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, I hope, from the external regulated community, which, given the dynamics, is likely to be the most important factor,” Califf said.
As to changes he’d like to see in the biopharma industry, Califf lamented the lack of using post-marketing evidence collection to help guide clinical practice.
“What you get in that post-market phase is so dependent just on marketing, not on high-quality evidence,” Califf observed. “And I think that needs to be fixed.
It’s currently not within the FDA’s power to mandate the production of evidence to compare various drugs once they get their approvals, Califf noted. During a drug’s application, the FDA only reviews whether the benefits outweigh the risks but does not compare it to other similar treatments.
“We need a system that deals with that,” Califf said.
https://www.fiercepharma.com/pharma/respect-evidence-and-expertise-fda-commissioner-robert-califf-lays-out-hopes-his-successor
