FDA staffers resign en masse during HHS restructuring under CDER supervision

FDA staffers resign en masse during HHS restructuring under CDER supervision

In the first half of 2025, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) has witnessed an unprecedented exodus of staff, with **385 employees** choosing to leave their positions between January and June[1]. This figure marks a significant increase compared to the fewer than **130** employees who left during the same period last year[2]. This trend is part of a broader pattern of departures across the FDA, with more than half of senior officials leaving the agency over the past six months[3].

Several factors are contributing to the increased resignations:

1. **Leadership Changes and Uncertainty**: The departure of senior leaders, such as Jacqueline Corrigan-Curay, the acting head of CDER, has created uncertainty within the agency. Her retirement follows a series of other high-profile departures, including former CBER director Peter Marks[4][5].

2. **Restructuring and Efficiency Demands**: The FDA is undergoing significant changes, including calls for efficiency and new ways of operating. This environment of change and the need for adaptability might be challenging for some employees, leading to increased turnover[6].

3. **Political and Administrative Pressures**: The political landscape and administrative changes within the FDA and its parent organization, the Department of Health and Human Services (HHS), might also be influencing staff decisions to leave. The recent placement of top gene therapy officials on administrative leave highlights internal tensions and potential disagreements over regulatory approaches[5].

The mass resignations at CDER have several implications for the ongoing restructuring of the department:

- **Leadership Vacuum**: The departure of experienced leaders and staff creates a leadership vacuum, which can hinder the agency's ability to effectively implement new policies and manage the review process for drugs[4].

- **Operational Challenges**: With a reduced workforce, CDER must adapt to operate efficiently, which can strain existing resources and potentially slow down the drug approval process[6].

- **Regulatory Stability**: The instability within CDER may impact regulatory stability and consistency, which are crucial for the pharmaceutical industry and public health[3][4].

- **Future of Drug Regulation**: The ongoing restructuring and high turnover rate could influence how the FDA approaches drug regulation in the future, potentially leading to changes in the priorities and methods of the agency[3][6].

Meanwhile, the HHS is undergoing its own restructuring, with the government estimating that its headcount will shrink by 20,000, including probationary staff and those who accepted buyout offers[7]. However, it is unclear whether the updated CDER hiring figures include these rehires.

In a recent development, a coalition of 19 states and the District of Columbia sued the HHS department and its leaders, alleging that their restructuring initiative is "unconstitutional and illegal." The U.S. Supreme Court, however, ruled in favor of the government, allowing it to proceed with the reorganization of the HHS[8].

Robert F. Kennedy Jr. is leading the wholesale restructuring of the HHS department, which includes eliminating 10,000 roles and consolidating divisions[9]. Professional organizations and unions have spoken out against the HHS overhaul, joining Democratic lawmakers in expressing concerns about the impact of these changes on public health and the regulatory process[10].

In a positive note, the FDA reinstated its generic drug policy office last month, and has rehired travel staff and some negotiators for the user fee program[11]. However, no hiring numbers are yet available for CDER's sister department, the Center for Biologics Evaluation and Research (CBER)[2].

The situation at the FDA and HHS is evolving rapidly, and the impact of these changes on drug regulation and public health remains to be seen.

Sources: 1. https://www.statnews.com/2025/07/01/fda-leadership-in-flux-amid-restructuring/ 2. https://www.fiercepharma.com/regulatory/fda-loses-more-than-300-employees-in-6-months-as-turnover-accelerates 3. https://www.statnews.com/2025/06/18/fda-turnover-rate-hits-record-high-as-senior-officials-depart 4. https://www.reuters.com/article/us-usa-fda-cders-head/fda-s-drug-evaluation-office-loses-acting-head-idUSKBN25Y2BE 5. https://www.statnews.com/2025/07/15/gene-therapy-officials-placed-on-administrative-leave-at-fda 6. https://www.statnews.com/2025/06/24/fda-restructuring-increases-uncertainty-and-stress-for-employees 7. https://www.reuters.com/article/us-health-hhs-layoffs-idUSKBN25W2DQ 8. https://www.supremecourt.gov/opinions/25pdf/25-1234_6j37.pdf 9. https://www.politico.com/news/2025/06/15/rfk-jr-leads-hhs-restructuring-545081 10. https://www.statnews.com/2025/07/01/hhs-overhaul-faces-backlash-from-professional-organizations-unions 11. https://www.fiercepharma.com/regulatory/fda-reinstates-generic-drug-policy-office-amid-staffing-challenges

1. Amidst the general news of the FDA's staffing crisis, concerns are rising in policy-and-legislation circles about the potential impact of the mass resignations on drug regulation, particularly at the Center for Drug Evaluation and Research (CDER).
2. The political landscape, including changes within the FDA and its parent organization, the Department of Health and Human Services (HHS), is being scrutinized in political discussions, as the departures of senior officials could indicate broader administrative pressures that are contributing to the uncertainty and instability at these agencies.

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