The Department of Health and Human Services has seen significant turnover in its highest-level agency leaders, with the Centers for Disease Control and Prevention (CDC) having six different leaders in the past 18 months and two major review units at the Food and Drug Administration (FDA) each having five directors since January 2025. The information was reported on May 7.
This high rate of leadership change is notable because it affects three critical divisions: the CDC, the FDA’s Center for Biologics Evaluation and Research (CBER), and its Center for Drug Evaluation and Research (CDER). With all three currently led by acting officials, further changes are expected.
The most recent departure was CBER head Vinay Prasad, who left after a planned one-year leave from his university post. His exit was described as positive for biotech companies working in rare diseases. However, industry uncertainty remains as Katherine Szarama has stepped into an acting role but is reportedly not being considered for a permanent appointment. Prasad’s tenure included regulatory controversies and an investigation into workplace issues at CBER.
Leadership instability also continues at CDER. George Tidmarsh resigned after just over three months due to a probe into his conduct following public criticism of a drug therapy online. Richard Pazdur then briefly took over before retiring suddenly amid policy disagreements. Tracy Beth Høeg now serves as acting director without news of a permanent replacement.
The CDC has faced similar instability since Susan Monarez's short-lived directorship ended in controversy last summer. Interim leaders have included Jim O’Neill and currently NIH Director Jay Bhattacharya, while Erica Schwartz awaits congressional confirmation to take over permanently.
“Dr. Pazdur’s departure raises serious concerns about the repeated turnover in key leadership occurring at the FDA,” BIO President John Crowley said at the time. “This constant turmoil is undermining America’s leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.”
With several agencies lacking stable leadership, observers question whether trust can be restored or if these agencies will see continued upheaval.
