FDA's Center for Drug Evaluation and Research Faces Mass Exodus Amid HHS Restructuring

The pharmaceutical industry is grappling with significant upheaval as the U.S. Food and Drug Administration (FDA) experiences a dramatic surge in resignations from its Center for Drug Evaluation and Research (CDER). This development comes against the backdrop of a sweeping overhaul of the Department of Health and Human Services (HHS) initiated by Secretary Robert F. Kennedy Jr.

CDER Staffing Crisis

In a startling revelation, recent FDA hiring data shows that 385 employees departed from CDER in the first six months of 2025. This figure represents a nearly threefold increase compared to the same period last year when approximately 130 staff members left the center. The exodus is further exacerbated by a sharp decline in new hires, with only 18 employees joining CDER during this period, in stark contrast to the nearly 250 new staff recruited in the first half of 2024.

The staffing crisis at CDER is unfolding amidst a broader restructuring of HHS, which aims to eliminate approximately 10,000 roles across the agency. The FDA itself is slated to lose around 3,500 positions as part of this initiative.

Legal Challenges and Government Response

The HHS restructuring has faced significant legal opposition. A coalition of 19 states and the District of Columbia sued the department, alleging that the reorganization was "unconstitutional and illegal." In a notable ruling, Rhode Island Judge Melissa DuBose sided with the plaintiffs, stating that "the executive branch does not have the authority to order, organize, or implement wholesale changes to the structure and function of the agencies created by Congress."

Despite these challenges, the U.S. Supreme Court recently ruled in favor of the government, lifting an injunction from a California judge and allowing the reorganization to proceed. Following this decision, HHS officially began layoffs on July 14, 2025, with affected employees receiving termination notices via email.

Implications and Industry Reaction

The mass exodus from CDER raises concerns about the FDA's ability to maintain its regulatory oversight and drug approval processes. Professional organizations, unions, and Democratic lawmakers have voiced strong opposition to the HHS overhaul, citing potential risks to public health and drug safety.

The pharmaceutical industry is closely monitoring these developments, as changes in FDA staffing and structure could significantly impact drug evaluation timelines and regulatory processes. As the situation continues to evolve, stakeholders across the healthcare sector are bracing for potential disruptions in the drug development and approval landscape.