FDA's CDER Faces Unprecedented Staff Exodus Amid HHS Restructuring

The pharmaceutical industry is grappling with significant upheaval as the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) experiences a mass exodus of employees. This development comes in the wake of a controversial 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 resigned from CDER in the first six months of 2025. This figure represents a nearly threefold increase compared to the same period last year when just under 130 staff members departed. The situation is further exacerbated by a dramatic slowdown in hiring, with only 18 new employees joining CDER during this period, in stark contrast to the nearly 250 new hires in the first half of 2024.

HHS Restructuring and Legal Challenges

The staff exodus at CDER is occurring against the backdrop of a larger restructuring effort within HHS. Announced in late March, this initiative aims to eliminate approximately 10,000 roles across the agency, with the FDA set to lose around 3,500 positions. The restructuring has faced significant legal and political opposition:

• A coalition of 19 states and the District of Columbia sued HHS, alleging the restructuring to be "unconstitutional and illegal."
• Rhode Island Judge Melissa DuBose ruled in favor of 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, suspending an injunction from a California judge and allowing the reorganization to proceed.

Broader Impact and Controversy

The HHS overhaul has had far-reaching consequences beyond CDER:

• On July 14, HHS officially began layoffs, with terminated employees receiving notification emails.
• The government estimates that HHS' headcount will shrink by 20,000, including probationary staff let go in February and those who accepted buyout offers.
• Secretary Kennedy admitted that more than 2,000 employees had been mistakenly laid off, leading to some reinstatements, including travel staff, user fee program negotiators, and the generic drug policy office.

As the pharmaceutical industry grapples with these unprecedented changes, concerns mount about the long-term implications for drug evaluation and approval processes. The ongoing staff shortage at CDER, coupled with the broader restructuring of HHS, may significantly impact the pace and quality of drug reviews, potentially affecting patient access to new treatments.