What CDER Director Patrizia Cavazzoni’s retirement means for FDA

Life Sciences | By Alexander Gaffney, MS, RAC, Jason Wermers, MS

Jan. 10, 2025

PATRIZIA CAVAZZONI, the country’s top drug regulator, announced today that she will retire from her position as director of the FDA’s Center for Drug Evaluation and Research (CDER) on Jan. 18, 2025. The announcement’s timing, just before a new presidential administration takes over, removes another senior FDA leader and contributes to the unclear picture of the agency’s actions moving forward.

  • A quick background on Cavazzoni: Cavazzoni joined the FDA in 2018 as CDER’s deputy director for operations and briefly served as the agency’s acting principal deputy commissioner in 2019 before AMY ABERNETHY was appointed to that position. Cavazzoni previously held executive positions at Pfizer, Sanofi and Eli Lilly. When Cavazzoni was named the permanent director of CDER in 2021, it marked a sea change for the center. JANET WOODCOCK had led the center almost continuously since 1994; the position only opened up because Woodcock left her position to help with the Covid-19 response, then becoming acting FDA commissioner in January 2021 when early in his administration, President JOE BIDEN replaced Trump-appointed FDA Commissioner STEPHEN HAHN. As compared to Woodcock, Cavazzoni kept a much lower profile externally. Still, she managed to push through some major changes within CDER during her tenure, including standing up several efforts related to rare diseases like CDER’s Advancing Rare disease Cures (ARC) program and overseeing a reorganization of the Office of Pharmaceutical Quality.
  • As CDER’s director, Cavazzoni was the nation’s top regulator of drugs, to include innovative, generic and nonprescription drug products. Her departure leaves an opening for a major and influential role at the agency that will need to be filled both on an acting basis and permanently. While the FDA has not yet confirmed who will be acting leader, the likely candidate is JACQUELINE CORRIGAN-CURAY, CDER’s principal deputy center director and the former director of CDER’s Office of Medical Policy.
  • But long-term, the next director of CDER is more likely to be selected by the next FDA commissioner, to whom the director reports. Current FDA Commissioner ROBERT CALIFF is expected to resign his position on Jan. 20, 2025, when President-elect DONALD TRUMP is sworn into office. Since Cavazzoni is set to retire on Jan. 18, Califf is unlikely to have enough time to search for a successor.
  • That could allow MARTY MAKARY, President-elect Trump’s intended nominee to serve as FDA Commissioner, a rare opportunity to quickly affect how FDA regulates. With roughly $2.2 billion in annual budget authority – more than any other FDA center – CDER is arguably the most influential of the agency’s centers, with oversight of the majority of the pharmaceutical sector (aside from biologics and vaccines, which are regulated by the Center for Biologics Evaluation and Research, or CBER).
  • If Makary selects the next leader from the FDA’s own ranks, he will have plenty of good options. CDER is relatively fortunate to have a strong bench of experienced senior leaders, including Corrigan-Curay, PETER STEIN, the longtime director of the Office of New Drugs, MICHAEL KOPCHA, the director of the Office of Pharmaceutical Quality, IILUN MURPHY, the director of the Office of Generic Drugs, and others.
  • Cavazzoni’s retirement comes amidst a wave of other departures from the agency – a trend unlikely to relent any time soon. Prior to Cavazzoni’s announcement, FDA Principal Deputy Commissioner NAMANDJÉ BUMPUS left FDA and CDER Deputy Center Director for Regulatory Programs DOUGLAS THROCKMORTON announced his imminent retirement. Other FDA executives, including Commissioner Califf, are expected to resign on Jan. 20, 2025, when Trump is sworn in as President.
  • Cavazzoni is also the latest to turn over as center leader. JEFF SHUREN, most recently director of FDA’s Center for Devices and Radiological Health, stepped down in 2024, and SUSAN MAYNE stepped down as director of the Center for Food Safety and Applied Nutrition after the office was absorbed as part of FDA’s recent reorganization. That leaves CBER Director PETER MARKS as the longest-tenured center director since the leaders of FDA’s tobacco and veterinary centers both took over within the last three years. (If you’re counting FDA centers of excellence in this calculation, then RICK PAZDUR, director of FDA’s Oncology Center of Excellence, has been leading that center since 2017).
  • Potential PDUFA impact: The Prescription Drug User Fee program was last reauthorized in 2022, and negotiations between FDA and industry regarding the program are set to commence this summer. The PDUFA program provides significant funding for CDER – $1.61 billion compared to the $719 million in appropriated funding the FDA received from Congress – and any changes in the program could have significant impacts on the life sciences industry. The new Director of CDER could potentially heavily influence the negotiations over PDUFA this summer.
  • Potential controversy: The Center is also charged with regulating products like the abortion drug mifepristone. Cavazzoni’s departure could be seized upon by advocates of tighter controls of drugs used in abortion procedures as an opportunity to influence and advance the regulation of these (and other) products. While top health leaders like the HHS Secretary could also exert the same influence, the Director of CDER has both more influence on regulatory decisions and less public oversight.
  • The next CDER director will face a challenging environment, marked by HHS leadership that will likely not be supportive of FDA’s approach to regulation, a new FDA commissioner, likely budget cuts from Congress and the White House (including some spurred by the Department of Government Efficiency), in-office requirements that could make it difficult to recruit or retain staff, the potential for intense political pressure on CDER staff, and the potential rollback of civil service protections that currently protect some policy staff.
  • The next CDER director may well come into conflict with ROBERT F. KENNEDY JR., should Trump’s intended nominee be appointed to the role of secretary of the Department of Health and Human Services (HHS). After Trump named Kennedy as his choice to lead HHS, even before Trump won the presidential election, Kennedy posted a statement on the social media platform X that sparked alarm at FDA: “FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma. 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.” CDER is the regulator of several of those products, including psychedelics, peptides, chelating compounds, ivermectin, hydroxychloroquine, and – in certain contexts – nutraceuticals and vitamins.

To contact the authors of this item, please email Alexander Gaffney ( agaffney@agencyiq.com) and Jason Wermers ( jwermers@agencyiq.com).

To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com).

 

Key Document

Text of emailed announcement by PATRIZIA CAVAZZONI to CDER staff (Friday, Jan. 10, 2025)

Dear CDER Colleagues:

I am writing to let you know that after much consideration, I have decided to retire from FDA, and my last day will be January 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.

When I joined CDER seven years ago as deputy director for operations, I was new to government, and I had the great fortune of learning from the best. After I was entrusted with leading CDER four and a half years ago, during the early and darkest days of the pandemic, I was in awe of how we all pulled together to battle the virus and save lives. What we did as a team was nothing short of heroic. Even more astounding, while responding to the biggest public health emergency in the past 100 years, we continued to grow as a Center. We made enormous strides in innumerable areas across every single office and program.

While I could spend a lot of time enumerating our achievements, I want to highlight our biggest success: our people and our culture. As I leave CDER, I can say with confidence that the Center is at its strongest. We have hired and retained record numbers of the best scientists and professionals. We have built a cohort of world-class managers and executives who are solidly at the helm of our organization and will continue to lead CDER. And most important of all, we created a culture that fosters respect for one another, inclusion, accountability, and diversity of thought and life experience. Our culture is what makes us strong and resilient, and it’s the foundation of what we have accomplished and will accomplish in the future.

I would like to thank each of you for everything that you do every single day, over countless hours, days and nights, to serve the American people and to achieve our public health mission. And I would be remiss if I didn’t call out the exceptional group of leaders that comprise the CDER Executive Committee, with whom I have worked hand in hand to make us what I consider the premier drug regulatory organization in the world. I have the utmost trust in this leadership team.

I will always view my time at CDER as the most important contribution I will have made toward making the world a better place. And I will cherish my time as CDER’s Center Director. It has been the greatest honor and privilege of my professional life. While I am leaving my position at CDER, my commitment and support for all of you and your mission will continue after my departure, and I will continue to do my utmost to support and advocate for CDER and FDA.

Please do not hesitate to reach out via e-mail or come by my office over the next week to catch up or say hello.

All the best,

Patrizia

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