Richard Pazdur, who recently resigned as the head of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), has said he was pressured to endorse a reduction in clinical trial requirements for drug approvals.
In an interview with The Wall Street Journal, Pazdur described being presented with a press release containing a quotation attributed to him and asked to approve it without his input. “All of a sudden, I was given a press release with a quotation by myself written in it, and asked to just agree to it,” he told the publication. This occurred after the FDA announced in December that only one clinical trial would be needed for drug approval instead of two.
Pazdur expressed concerns about changes at the agency under Commissioner Marty Makary. He said, “this wall between the commissioner’s office and the review staff has been breached.” According to Pazdur, previous commissioners avoided involvement in specific drug reviews, but this practice changed under Makary’s leadership. “We have an unclear future of what the FDA will be,” he added.
A spokesperson from the Department of Health and Human Services (HHS) responded in a statement to The Wall Street Journal that Pazdur was indecisive about changing trial requirements and emphasized that urgent reform was necessary at the FDA. The spokesperson stated Makary “leads the agency with a profound sense of urgency in delivering cures to the American people” and insisted that regulatory decisions reflected recommendations from primary review teams comprised of career scientists.
Pazdur had spent 26 years at the FDA before stepping down last December. He became CDER director after George Tidmarsh left amid controversy over personal conduct issues. Prior to that role, Pazdur served as inaugural head of the Oncology Center of Excellence when it launched in 2017.
Makary reportedly invested significant effort persuading Pazdur to accept leadership at CDER following Tidmarsh’s departure, assuring him autonomy in his new position. A spokesperson confirmed there were several discussions leading up to Pazdur's acceptance.
During 2025, four different individuals held the CDER director position—a sign of ongoing turnover and staffing challenges within the agency. After Pazdur's exit, Tracy Beth Høeg—formerly an aide to Makary—was named as his successor; Høeg is known for her critical views on vaccines and research cited by other officials questioning COVID-19 vaccine safety for children.
