Senior FDA Drug Regulator Steps Down Shortly After Appointment
Dr. Richard Pazdur, a veteran with over two decades of experience, departs, reportedly citing political tensions and policy disagreement.
The U.S. Food and Drug Administration (FDA) is once again searching for a leader for its Center for Drug Evaluation and Research (CDER) following the unexpected retirement filing by Dr. Richard Pazdur. The veteran regulator’s decision to step down comes just weeks after he was named to the top post at CDER.
Dr. Pazdur has a distinguished 26-year tenure within the agency, which includes serving as the founding director of the FDA’s Oncology Center of Excellence. His recent appointment was publicly supported by FDA Commissioner Dr. Marty Makary and Chief of Biologics Dr. Vinay Prasad, with Commissioner Makary previously commending Dr. Pazdur as a “forward-thinking scientist” and “regulatory innovator.”
However, reports indicate that the departure may be linked to internal disagreements. A news report suggests that Dr. Pazdur’s decision resulted from increasing dissatisfaction with Drs. Makary and Prasad. Sources close to the situation claim that he objected to what he perceived as political interference within the division responsible for overseeing prescription drugs and other common products.
Additionally, the same report cited his reservations regarding the Commissioners National Priority Voucher Program (CNPV), a recently announced initiative designed to accelerate treatments for significant public health needs.
Dr. Pazdur’s retirement creates two vacancies at the highest levels of the agency: the directorship of the drug division and the head of the Oncology Center.
In an official statement, an FDA representative acknowledged Dr. Pazdur’s departure, stating that the agency respects his choice and honors his 26 years of service. The statement highlighted his contribution as the founding director of the Oncology Center of Excellence, noting that his legacy of cross-center regulatory innovation advanced patient care.
This latest development continues a pattern of high-level staff turnover. Dr. Pazdur’s appointment followed the removal of the previous CDER director, George Tidmarsh, who subsequently resigned. Mr. Tidmarsh reportedly attributed his departure to a challenging environment at the agency, following criticism he levied against Dr. Prasad. Dr. Prasad himself briefly left the FDA before returning to lead the Center for Biologics Evaluation and Research (CBER).
Source: https://www.pharmexec.com/view/report-richard-pazdur-out-director-cder
