FDA Leadership Exodus Continues as Acting CDER Head Announces Retirement
In a significant development that underscores the ongoing leadership turmoil at the U.S. Food and Drug Administration (FDA), Jacqueline Corrigan-Curay, M.D., the acting director of the Center for Drug Evaluation and Research (CDER), has announced her retirement from the agency effective July 2025. This latest departure adds to a growing list of high-profile exits that have reshaped the FDA's upper echelons in recent months.
Wave of Departures Rocks FDA
Corrigan-Curay's impending exit comes on the heels of several other significant leadership changes at the FDA. Just days prior, Nicole Verdun, M.D., director of the FDA's cell and gene therapy office, and her deputy Rachael Anatol, Ph.D., were reportedly placed on administrative leave. This move followed the forced departure of Peter Marks, M.D., Ph.D., the former director of the Center for Biologics Evaluation and Research (CBER), in March.
The leadership turnover extends beyond these recent events. Patrizia Cavazzoni, M.D., the former CDER director, stepped down shortly before the start of President Donald Trump's second term. Other notable departures include Hilary Marston, M.D., the FDA's former chief medical officer, and Celia Witten, M.D., Ph.D., the former CBER Deputy Director.
Impact on FDA Operations and Drug Review Process
The exodus of senior officials has raised concerns about the FDA's ability to maintain its regulatory functions effectively. While FDA Commissioner Marty Makary, M.D., has assured that drug review timelines are not being impacted, some pharmaceutical companies have reported unexpected delays in agency decision-making. In one instance, a company was informed that "resource constraints" were the reason for a delay.
The turnover comes amid significant changes to U.S. medical regulation under the leadership of Makary and Health and Human Services Secretary Robert F. Kennedy Jr. New initiatives include stricter approval standards for COVID-19 vaccines, the adoption of artificial intelligence tools, and a program to expedite review of drugs supporting U.S. national interests. Additionally, the agency has begun phasing out requirements for animal toxicology tests in drug development.
Industry Reaction and Future Outlook
The biopharma industry has expressed concern over the leadership changes, particularly in the field of cell and gene therapies. The Alliance for Regenerative Medicine stated it was "deeply disappointed" by the removal of Verdun and Anatol from their positions. These departures have created uncertainty for cell and gene therapy developers at a time when the field faces significant challenges.
As the FDA navigates this period of transition, questions remain about who will fill key leadership roles and how these changes will impact the agency's regulatory approach in the long term. The pharmaceutical industry and healthcare stakeholders will be closely watching for signals of policy shifts and their potential effects on drug development and approval processes.
References
- Acting CDER Head Becomes Latest in String of FDA Leaders to Leave Agency
Jacqueline Corrigan-Curay, who stepped into the role as the agency’s top drug regular in January, is departing in July, according to an email sent to agency staff.
- Top drug official at FDA reportedly set to exit next month
Jacqueline Corrigan-Curay, who serves as acting head of the powerful CDER office, will leave after nearly a decade at the agency.
- FDA's acting CDER head Jacqueline Corrigan-Curay heads for the exit amid period of heavy turnover: reports
Only a few days after reports emerged that the director of the FDA's cell and gene therapy office had been abruptly put on administrative leave, a new departure shows an intense period of leadership turnover at the agency isn't over.
- FDA's acting CDER head Jacqueline Corrigan-Curay heads for the exit amid period of heavy turnover: reports
Only a few days after reports emerged that the director of the FDA's cell and gene therapy office had been abruptly put on administrative leave, a new departure shows an intense period of leadership turnover at the agency isn't over.
Explore Further
What is the background and professional experience of Jacqueline Corrigan-Curay, M.D., and how might her retirement impact FDA's operations?
What specific challenges are cell and gene therapy developers facing amidst the leadership changes at the FDA?
What are the potential reasons behind the FDA's current wave of high-profile personnel changes?
Have there been similar patterns of leadership turnover in other regulatory agencies within the healthcare field?
In what ways might the recent leadership changes at the FDA affect the agency's regulatory approach to drug approval processes?