FDA names longtime cancer scientist Pazdur to lead drug center

The Food and Drug Administration on Tuesday appointed veteran cancer medicine regulator Dr. Richard Pazdur to lead its drug division following the abrupt departure of his predecessor amid ethics concerns.

Pazdur, who brings 26 years of experience at the agency, will serve as director of the Center for Drug Evaluation and Research (CDER), the FDA’s largest operational unit. Prior to this appointment, he headed the agency’s Oncology Center of Excellence, establishing himself as a key figure in the regulation of cancer treatments in the United States.

The leadership change comes just over a week after Dr. George Tidmarsh was forced to leave the position following the emergence of what government officials described as “serious concerns about his personal conduct.” Tidmarsh, who had been recruited to the agency by FDA Commissioner Marty Makary, had previously worked as a pharmaceutical executive and scientist.

At the center of Tidmarsh’s departure is a lawsuit filed earlier this month that alleged he used his FDA position to pursue a “longstanding personal vendetta” against the board chairman of a Canadian pharmaceutical company. According to court documents, the two men had previously been business associates at several drug companies. Tidmarsh has publicly denied any wrongdoing in media statements but did not respond to requests for comment from The Associated Press.

Pazdur’s appointment represents a rare instance of continuity within the FDA’s senior leadership, which has experienced significant turnover in recent months through retirements, firings, and resignations amid broader Trump administration actions that have pushed many career employees out of the agency.

The new drug center director faces numerous challenges in his role. CDER has been plagued by declining morale, controversial return-to-office mandates, and internal conflicts with other FDA divisions, particularly the vaccine and biologics center now led by Dr. Vinay Prasad. Adding to these difficulties, the drug center has lost over 1,000 staff members in the past year through layoffs and resignations, according to agency data.

CDER holds critical responsibilities for American healthcare, overseeing the review, safety monitoring, and quality control of both prescription medications and over-the-counter products. The division’s work impacts virtually every American who takes medication.

Pazdur will also be responsible for implementing several new initiatives announced by Commissioner Makary, including an ambitious voucher program designed to review drugs deemed a “national priority” in just one to two months—significantly faster than the agency’s previous expedited review timeline of six months. This acceleration of drug reviews has raised both hopes for faster patient access to new treatments and concerns about maintaining thorough safety assessments.

During his FDA tenure, Pazdur has been known for his work to accelerate approvals of experimental cancer therapies based on early indicators such as tumor shrinkage, rather than waiting for more definitive survival data. This approach has drawn criticism from some academic researchers, including Prasad himself, who before joining the FDA earlier this year published numerous papers questioning the agency’s approach to cancer drug approvals.

Industry analysts note that Pazdur’s appointment may signal an attempt to stabilize the drug center with experienced leadership while navigating the complex regulatory, political, and scientific challenges facing the agency. Pharmaceutical companies will be watching closely to see how his leadership affects the pace and standards of drug approvals moving forward.

The transition comes at a critical moment for the FDA as it balances pressure to accelerate innovative treatments to market while maintaining its core mission of ensuring drug safety and efficacy for the American public.