The FDA’s influential director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., will soon retire from the agency.
The seven-year FDA veteran communicated the decision in an internal communication viewed by Fierce Pharma. Her last day will be Jan. 18.
“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 to colleagues.
Cavazzoni became CDER director in 2021 following a long tenure at the department by FDA legend Janet Woodcock. After a career in industry, Cavazzoni joined the FDA in 2018, initially serving as deputy director of operations for CDER.
Cavazzoni’s departure comes merely weeks after the FDA’s principal deputy commissioner, Namandjé Bumpus, Ph.D., left her post in December 2024 after a short term.
The CDER director role is viewed as one of the three most influential positions held by public servants on the drugs side of the FDA, alongside the leaders of the Center for Biologics Evaluation and Research (CBER) and the Oncology Center of Excellence (OCE).
Under Cavazzoni’s leadership, CDER approved 55 new drugs in 2023, including cancer therapies managed by OCE. These include an accelerated approval for Eisai and Biogen’s Alzheimer’s disease drug Leqembi. In 2024, the number was 50 new drugs.
“As I leave CDER, I can say with confidence that the Center is at its strongest,” Cavazzoni wrote in the email, pointing to the talent and culture the center has developed.
But whether those talented staffers will stick around has come under question after President-elect Donald Trump’s pick for health secretary, Robert F. Kennedy Jr., threatened a massive overhaul of the FDA. Although staff turnover is typical during administration transitions, RFK Jr.’s stance appeared to increase the risk of involuntary severances for FDA staffers.
In mid-November, outgoing FDA Commissioner Robert Califf, M.D., said there hadn't been a mass exodus, as many staffers were taking a wait-and-see approach at the time.
“I think we just don’t know what’s going to happen,” Califf said at the Friends of Cancer Research annual meeting. “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 added.
Califf is slated to be replaced as commissioner by Johns Hopkins surgeon Martin Makary, M.D., if confirmed by the Senate. Although Makary has also criticized some of the FDA’s policies, he is viewed as a less controversial figure than RFK Jr.