Patrizia Cavazzoni, key FDA official, to leave agency

Patrizia Cavazzoni, an influential Food and Drug Administration official who oversees much of the agency’s drug review work, will leave her role next week, according to an email sent to staff. 

Her departure follows announcements by several other high-ranking FDA leaders of plans to depart the regulator ahead of the coming change in presidential administration. Namandjé Bumpus, who was effectively the FDA’s second-in-command as principal deputy commissioner, left at the end of last year. Two other agency veterans, Douglas Throckmorton and Robert Temple, have also retired. 

Cavazzoni joined the FDA’s Center for Drug Evaluation and Research seven years ago and in 2021 was picked to serve at its head, replacing longtime leader Janet Woodcock. A physician by training, Cavazzoni treated and studied mood disorders at the University of Ottawa before going into the pharmaceutical industry, where she worked at Eli Lilly, Sanofi and Pfizer.

“Leaving CDER was an extremely difficult decision, but the time has come for me to be more present for my family, who have taken the backseat over the past few years due to the demands of my role and our critically important public health work,” Cavazzoni wrote in her email to staff.

While staff turnover between administrations is common, President-elect Donald Trump has signaled significant disruption could be in store for the agencies that regulate healthcare in the U.S. He has nominated Robert F. Kennedy Jr. to run the Department of Health and Human Services, which oversees the FDA, and pledged to let him “go wild” on healthcare. 

In comments on X and in interviews, Kennedy has made clear he views the FDA as in need of significant change, criticizing it as corrupt and claiming it has waged a “war on public health.” 

“If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags,” Kennedy wrote on X in October.

Trump’s nominee for FDA commissioner, the Johns Hopkins surgeon Marty Makary, is viewed as a more traditional choice, but he has also criticized the FDA, particularly for its handling of the pandemic. 

“FDA has lost the trust of Americans, and has lost sight of its primary goal as a regulator,” Trump wrote in a statement announcing his selection of Makary. 

Both Kennedy and Makary need to be confirmed by the U.S. Senate to take office. 

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