Robert Califf, commissioner of the US Food and Drug Administration (FDA), said he is “disappointed” in the outcome of the presidential election and warned of potential changes coming to the agency under a second Trump administration.

Califf delivered these remarks during the Friends of Cancer Research (FOCR) annual meeting in Washington, DC on Tuesday, where he was asked to discuss the election’s impact on FDA amid comments by President-elect Donald Trump and Robert Kennedy Jr., who is said to be advising the incoming president on key health agency appointments.

“I think we just don’t know what will happen now, but I do think that it is pretty clear that the gist of this administration, from everything that’s been said, is that they want to change a lot of things, and how it gets changed depends on who gets appointed into key positions,” Califf said. (RELATED: This Week at FDA: A second Trump term, RFK Jr., and what’s to come, Regulatory Focus 8 November 2024; Experts say RFK Jr. could play big role in Trump 2.0, FDA leadership to face scrutiny, Regulatory Focus 11 November 2024)

Califf bemoaned the occurrence of political pressure on the agency, stressing that FDA decisions should be based on science, not politics. “There are so many aspects of this that are related to politics and there is no way around it,” he said. “To me there is a not a sharp line” dividing science and politics. Califf was one of seven former FDA commissioners who penned an opinion piece in The Washington Post in September 2020, calling on the Trump administration to end its political interference with FDA, following reports of the White House attempting to influence the authorization of the first COVID-19 vaccines.

The FDA commissioner also offered praise for the agency in its current form. “I feel like FDA is at peak performance right now. We will just see what happens,” he said, adding that he stands by the agency’s “hardworking” staff.

Califf is unlikely to be asked to stay on as FDA commissioner and is expected to offer his resignation on 20 January 2025, when Trump’s second term officially begins.

When asked to respond to Kennedy’s recent comment that there are “entire departments – like the nutrition department at FDA – that have to go,” Califf declined to answer in detail. “It is best not to respond to these things because getting into a back and forth about this is hypothetical and is not productive to anyone.”

To be successful, Califf said the next FDA commissioner should have the ability to “function as an executive,” noting that former FDA commissioner Scott Gottlieb possessed this trait. He said that “this is not the first time I have ridden out of town following an election. With Scott Gottlieb you could not have found a better person for that role at that time.” Gottlieb, who served as Trump’s first FDA commissioner from 2017 to 2019, was eventually succeeded by Stephen Hahn, who faced months of pressure by the Trump administration to authorize the first COVID-19 vaccines.

Califf also said it is also important to take “disparate points of view” into account before making decisions and to understand the role of high-quality evidence in decision making. Another important trait is to rely on the experts before making decisions.

When asked to comment on his views on whether center directors should overrule staff on approval decisions, Califf said “in an ideal world we would never have to overrule staff.” Yet he admitted that things have changed since he served on FDA’s Cardio-Renal Advisory Panel where the FDA used to speak with one voice before making decisions.

“In the good old days…there was one FDA opinion. Now everyone can express their opinion, this leads to a lot more give and take between the center director and the staff.”

In his remaining weeks as commissioner, Califf said his priorities are to continue to act on food and tobacco reform.

In his parting remarks, Califf urged the audience to focus on developing approaches to pragmatic clinical trials (PCTs). Califf endorsed this approach in a June article he co-wrote with other FDA officials.

https://www.raps.org/news-and-articles/news-articles/2024/11/califf-%E2%80%98disappointed-about-election,-warns-of-chan