Califf looks back on his time as FDA commissioner

In the interview, Califf said that his confirmation as FDA commissioner in February 2022, which was the second time he had been confirmed to the post, was "a pretty low time."

"As the waves came through on Covid, the constant realization that people were dying who didn't need to, if they just took the vaccine, was really wearing," he said.

On Califf's first day as commissioner, Abbott announced a recall of infant formula. Addressing the resulting shortage became Califf's top priority.

"That was coupled with a full realization that the structure of the food side of the FDA was wrong," Califf said. "We had very good people who just couldn't get done what they needed to get done because of the way the thing was structured."

As a result, FDA collapsed its food division into a single organizational structure, a move that Califf said was possibly his proudest accomplishment in his time at the agency.

According to Califf, much of the way he has approached running FDA comes down to the philosophy of setting policy and staying out of the way, even though he acknowledges that certain regulators at FDA can have substantial leeway.

Critics interpreted a series of controversial drug approvals during his time as commissioner as "lowering the bar on what should be required to approve a new medicine."

But "I shouldn't be involved in the interpretation of an individual case unless there's an appeal that comes up the chain from the civil servants at the level of the center were somehow displaying malfeasance or loss of intellectual capacity or sanity," Califf said. "If a political appointee starts doing that, where does it stop? It doesn't mean I agree with all the decisions. But I don't think that's the role of political appointees."  "You can criticize the decisions that civil servants make," Califf said. "But I can't think of a better system than requiring that companies produce the evidence and people without a financial conflict of interest make the decisions without political interference. Seems to me like the right way to do it."

"I'm a political appointee, and the election didn't go as I hoped it would, and given the statements that have been made by various people who are in contention for key posts, I have a lot of reason to be concerned," Califf said.

Califf said he wouldn't directly comment on any individual person and added that he'll be "guarded" until after the transition to the new administration. However, Califf expressed concerns about the incoming Trump administration, saying that "brain drain" in the government is a legitimate concern, including at FDA.

"It's already happening. I mean, we're seeing an increase in early retirements and loss of good people. So I'm worried about it," Califf said. "A lot of people are sticking it out, and I've encouraged them to do so. And you know, sometimes you get surprised by how well things work that you thought might not work so well. So it's worth it, given the mission."

Califf also said that reforming the food industry — a topic that's been a large component of Kennedy's "Make America Healthy Again" movement — is something that's been important to him as a cardiologist for years, adding that funding for nutrition research is "pathetic."

"I think much of the criticism of FDA is really, in my view, just pointing out that we have a food system in the United States where the easiest thing for people to do is to eat unhealthy food, and we have an advertising machine of the food companies which reinforces that, and we have very little ability to counteract that from the point of view of FDA," Califf said.