Senior leadership turnover at the U.S. Food and Drug Administration (FDA) has intensified following the recent retirement of Richard Pazdur, just three weeks after he began as director of the Center for Drug Evaluation and Research (CDER). This development leaves only three veterans from last year’s senior ranks still in place.
The past year has seen significant upheaval within the FDA, starting with Peter Marks stepping down as director of the Center for Biologics Evaluation and Research (CBER). The wave of departures comes amid broader industry uncertainty driven by drug pricing reforms, tariffs, and ongoing capital shortages.
John Crowley, president of the Biotechnology Innovation Organization (BIO), responded to Pazdur’s exit with concern. “Dr. Pazdur’s departure raises serious concerns about the repeated turnover in key leadership occurring at the FDA,” Crowley said. “This constant turmoil is undermining America’s leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.”
Peter Marks had been a respected regulator who initially pledged to work with the incoming administration despite staff reductions and ideological differences. However, reports indicate that Marks refused to give editing access to the Vaccines Adverse Event Reporting System (VAERS) to Health Secretary Robert F. Kennedy Jr.’s team due to concerns about data integrity. As a result, Marks was reportedly given an ultimatum to resign or be fired.
In his resignation letter, Marks wrote: “It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”
Since April 2025, more than half of FDA’s senior leadership roles have turned over—a rate considered unprecedented even during changes in presidential administrations.
Some departures have drawn little attention; Yashika Rahaman left her post quietly after a 17-year career at the agency. Others have been highly publicized: George Tidmarsh resigned as CDER director amid an investigation into his conduct; Vinay Prasad returned briefly after leaving earlier in connection with another controversy.
Pazdur’s retirement marks his exit from both CDER and his previous position leading the Oncology Center of Excellence—an office he founded in 2017—citing concerns about FDA operations.
Analysts from RBC Capital Markets noted: “[It] rekindles regulatory uncertainty as record FDA leadership turnover continues,” calling it “a significant, sudden and surprising turn.”
There is also speculation regarding Commissioner Marty Makary’s future at FDA. Reports suggest that Health Secretary Kennedy may limit Makary's role or appoint someone else to lead daily operations while retaining him as a figurehead.
RBC analysts observed: “Given Dr. Pazdur’s departure, and the multiple high-ranking officials that have left, even if temporarily, in our view it would not be unreasonable should Dr. Makary’s tenure be on shaky ground.”
Many former FDA leaders have since moved into positions at major pharmaceutical companies such as Eli Lilly, Pfizer, and Iovance—a trend highlighted by industry observers who note that losses for the agency often translate into gains for private sector firms.
Crowley summarized current industry sentiment: “We are at a tipping point,” he wrote. “It is time to right this ship.”
