Jacqueline Corrigan-Curay, the FDA's acting director of the Center for Drug Evaluation and Research (CDER), announced her retirement from the agency in July, marking another significant departure from the FDA's senior leadership ranks during a period of substantial organizational change.
In an internal email sent Monday to CDER staff, Corrigan-Curay described her decision as "incredibly challenging" after "considerable reflection." She emphasized her deep appreciation for the agency's collective achievements and the unique opportunities it provides to advance public health.
"This decision has been incredibly challenging, as I deeply value our collective achievements and recognize that no other place offers the same opportunities to advance public health alongside such smart, talented, and supportive colleagues," Corrigan-Curay stated in her farewell message.
Leadership Transition at Critical Time
Corrigan-Curay assumed the acting director role after Patrizia Cavazzoni departed the FDA in January, shortly before the Trump administration took office. A physician and lawyer, Corrigan-Curay joined the FDA in October 2016 as CDER's director for the Office of Medical Policy, where she led the development and implementation of medical policy programs and strategic initiatives.
She was promoted to principal deputy center director in July 2021, positioning her to oversee the agency's drug review processes during a period of significant regulatory evolution.
Widespread FDA Exodus
The departure represents part of a broader leadership overhaul at the FDA under President Donald Trump and FDA Commissioner Martin Makary. The agency has experienced substantial turnover, with several long-time officials leaving since January, including Peter Marks, former director of the Center for Biologics Research and Evaluation; Jim Jones, head of the Human Foods Program; and Michael Rogers, former associate commissioner of inspections and investigations.
The workforce changes extend beyond voluntary departures. April layoffs across the Department of Health and Human Services, which oversees the FDA, combined with other Trump administration moves to force out staff, have left the FDA with approximately 20% fewer employees than previously, though no official accounting of job cuts has been provided.
Regulatory Changes Under New Leadership
The leadership transition occurs as Makary implements significant changes to U.S. medical regulation. Recent initiatives include setting stricter approval standards for COVID-19 vaccines, ordering rapid adoption of new artificial intelligence tools, and rolling out programs to expedite review of drugs supporting U.S. national interests. The FDA has also begun phasing out requirements for animal toxicology testing.
Impact on Operations
Despite the substantial workforce reduction, FDA leaders maintain that drug review timelines remain unaffected. At a Senate hearing last month, Makary testified that the "trains are running on time." However, some pharmaceutical companies have reported unexpected delays in agency decision-making, with at least one company being told that "resource constraints" were the reason for delays.
Succession Planning
It remains unclear who will replace Corrigan-Curay as CDER's leader. According to reports, Commissioner Makary is considering naming former pharmaceutical executive Karim Mikhail, recently hired as a senior adviser, to the position.
Corrigan-Curay expressed confidence in CDER's resilience despite the leadership changes. "CDER's strength isn't defined by any single individual," she noted, adding that she will "leave knowing CDER is in capable hands."
The retiring official acknowledged the difficulty of her decision, particularly given the support from CDER staff during "recent challenging times." She plans to remain at the FDA for several more weeks to ensure a smooth transition.
