Richard Pazdur had spent 26 years at the FDA before stepping down last year due to disagreements with Commissioner Marty Makary about lowering the number of clinical trials required for a new drug application, Pazdur told the media.
Richard Pazdur, former top drug regulator at the FDA, resigned from his post as the head of the FDA’s Center for Drug Evalation and Research after he was reportedly pressured to support the agency’s move to reduce the number of clinical trials required for a drug application.
“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,” Pazdur told The Wall Street Journal in an interview on Friday. The FDA in December said that drug applications would now only require one clinical trial for an approval, instead of the usual two.
Under the leadership of Commissioner Marty Makary, “this wall between the commissioner’s office and the review staff has been breached” Pazdur continued in his interview with the publication. While previous FDA heads have refrained from getting involved with drug reviews, things have now changed under Makary, Pazdur said. “We have an unclear future of what the FDA will be.”
In a statement to WSJ, a spokesperson for the Department of Health and Human Services (HHS) said that Pazdur was indecisive about the changes in trial requirements, and that the FDA “needed urgent reform.”
Makary “leads the agency with a profound sense of urgency in delivering cures to the American people,” the HHS spokesperson continued. Regulatory verdicts under Makary have “represented the recommendation of each primary review team of career scientists,” the spokesperson insisted.
Before leaving the agency last December, Pazdur had spent 26 years with the FDA, ultimately becoming the inaugural head of the Oncology Center of Excellence when it was established in 2017. Then last November, Makary named Pazdur as director of the Center for Drugs Evaluation and Research (CDER) after the division’s previous leader, George Tidmarsh, stepped down amid controversy over his personal conduct.
Despite the disagreement on trial requirements that ultimately pushed Pazdur out, Makary apparently spent considerable time courting Pazdur, according to a November 2025 report from Endpoints News. To convince the oncologist to take the CDER reins, Makary assured him that he would enjoy autonomy and independence at his new post. An HHS spokesperson at the time confirmed to BioSpace that there was a “series of discussions that ultimately led to Dr. Pazdur’s acceptance.”
Pazdur was the fourth CDER director in 2025, pointing to the high degree of turnover and staffing difficulties at the agency. He was replaced by Makary’s former aide, Tracy Beth Høeg, a known vaccine critic whose research supported Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad’s erroneous claims about the number of children who have died from COVID-19 immunizations.
