Goodbye message: Califf says FDA needs help in battling misinformation, has deep talent pool to mitigate departures

The US Food and Drug Administration (FDA) is "losing the battle" against misinformation and needs outside assistance to tackle this issue, outgoing Commissioner Robert Califf said in an exit interview with reporters.

Califf also expressed confidence that the agency has a strong pool of talent to fill the gaps left by the recent departures of Patrizia Cavazzoni, director of Center for Drug Evaluation and Research (CDER), and Namandjé Bumpus, the agency’s principal deputy commissioner. At press time, it was uncertain who would helm the agency in the interim between Califf’s departure and Senate action on President-Elect Donald Trump’s nomination of Marty Makary to run the agency.

Califf homed in on misinformation – one of his key priorities as commissioner – noting that while FDA has made progress, more work is needed.

"We are currently losing the battle due to the intersection of social media and cultural changes, which threatens the foundation of public health," Califf said, adding that misinformation about COVID-19 vaccines dissuaded people from the vaccines and contributed to preventable deaths. “A lot of people died who would not have died if they had gotten a free vaccine and not been misled” about vaccine safety.

He said he would be spending "a lot of my time" thinking about the issue on his drive back home in North Carolina.

“We need networks of people who are trying to figure out how to steer people to more accurate information,” he said, adding that teachers and biomedical scientists must unite to promote the truth and reach respectful agreements on facts and data.

When asked if he regretted his choice not to intervene in certain controversial approval decisions, such as the decision by Center for Biologics Evaluation and Research (CBER) Director Peter Marks’ decision to approve Sarepta Therapeutics’ gene therapy drug Elevidys despite objections from agency staff, Califf said he stands by his policy of non-intervention, and that as soon as political appointees interfere in individual decisions, this raises questions about where to draw the line.

“The minute you begin to say political appointees should intervene in individual decisions, where do you stop? I would rather have some decision that I disagree with and not set precedent, which could lead to really nefarious things if this happens.”

Califf noted that in complex disease cases, it is unavoidable that some evidence remains unclear and that opinions among staff may vary.

To avoid disagreement among center staff and directors, Califf said he has focused his efforts on getting center directors to spend more time with their staff. He believes that such interactions can help prevent conflicts. “I have been involved more than you know. I just don’t think a decision should be overruled unless the center director shows evidence of corruption or mental health problems."

To prevent disagreements, small companies should improve their demonstration of drug effectiveness in clinical development programs.

When asked whether he is concerned about the potential impact of Robert F. Kennedy, Jr.'s threats to dismantle entire departments within the agency, Califf said, “I am worried about every part of the FDA. Anyone who closely examines the FDA budget will see that it is significantly underfunded. If you run a business and look at the funding beyond the medical product center, it becomes clear that it is woefully inadequate.” Kennedy is Trump's nominee to run the US Department of Health and Human Services.

When asked what he would like to be remembered for, Califf said he wants to be remembered as a “team player.”

“Throughout my academic career, which has been most of my career, the accomplishments of the people that you trained and mentored far outshine any individual thing that you do as a leader,” Califf added. “We have a workforce full of highly talented people that’s been built up and they’ll go on and do great things in the future. To me, that is the number one thing.”

To that end, he expressed confidence that agency personnel would be more than able to take up the roles recently vacated by Cavazzoni and Bumpus.

“The couple leaders that we lost are important people who carry a lot of institutional and also scientific knowledge. There’s no question that these are important losses for the agency,” Califf said. “But one point I have just made is that we have a real deep bench, so I am not worried in the long term that this will be like a disaster that these folks have left. These folks that left had to make a personal decision based on their own careers and values.”

Earlier in the day, Califf addressed employees at final meetings, where he cited his reorganization of the food side and the organizational aspects of the inspectorate as his major accomplishments.

Goodbye message: Califf says FDA needs help in battling misinformation, has deep talent pool to mitigate departures

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