Report: Richard Pazdur Out as Director of CDER

Report: Richard Pazdur Out as Director of CDER


FDA is once again on the lookout for a new director for The Center for Drug Evaluation and Research (CDER), as recently appointed director Dr. Richard Pazdur has filed for retirement.

The decision comes as a surprise as both FDA commissioner Dr. Marty Makary and chief of biologics Dr. Vinay Prasad were supportive of Dr. Pazdur’s appointment as director of CDER. Dr. Pazdur has 26 years of experience within the FDA and was the founding director of the agency’s Oncology Center of Excellence.1

When Dr. Pazdur was appointed, Makary said, “Dr. Pazdur is a true regulatory innovator who will help guide our broader agenda to modernize the agency and streamline the approval process, He has a track record of success and is an impressive forward-thinking scientist.”

With his retirement, Dr.Pazdur leaves two top level positions vaccant at the agency in both the drug division and the oncology center.

Despite the positive recognition he received during his appointment as director, a report from CNN states that Dr. Pazdur’s decision stems from growing frustration with Dr. Makary and Dr Prasad.

Those close to Dr. Pazdur claim he “balked” at what he labeled as political interference within his division of overlooking prescription drugs, over-the-counter medicines, and commonly used products.1

Along with Dr. Pazdur’s growing frustrations with Dr. Makary and Dr. Prasad, another factor in his decision to retire, according to a report from CNN, is his reservations about the Commissioners National Priority Voucher Program (CNPV).

The CNPV was first announced back in June of this year and is a new initiative at the agency promoting novel treatments that FDA believes can benefit the health interests of Americans, such as medications that meet a large unmet need, and or reduce downstream health care utilization.

“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” an agency spokesperson said Tuesday. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.”

Dr. Pazdur’s decision comes just weeks after being appointed as the head of CDER earlier in November this year.His appointment followed former director of CDER George Tidmarsh being placed on leave, which ultimately led to Tidmarsh’s decision to step down from the position.

According to ABC News, Tidmarsh’s decision came from what he described as a “toxic environment” at the agency, while various conflicting reports surfaced as to the reason Tidmarsh was out, Tidmarsh himself claims that he was initially placed on leave following his criticism of Dr. Prasad.



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