Former FDA cancer drug chief under consideration to return

Richard Pazdur, the former director of the FDA’s Oncology Center of Excellence and recently appointed head of the Center for Drug Evaluation and Research (CDER), is reportedly considering a return to his previous role in light of recent leadership instability at the agency. Pazdur’s abrupt decision to resign from the CDER director position in December 2025, just weeks after taking office, has left the FDA in a state of uncertainty, with no clear internal successor available to lead the agency’s largest product center.

Pazdur’s departure followed reports of disagreements with FDA Commissioner Martin Makary over the agency’s new Commissioner’s National Priority Voucher program, which offers expedited reviews for drugs aligned with national health priorities. Lawmakers and industry stakeholders have raised concerns about regulatory bias and inconsistent timelines. Pazdur had reportedly sought assurances that his leadership of CDER would remain free from political interference, a promise that may have unraveled during his brief tenure.

With the FDA now facing its fifth CDER director search in less than a year, industry observers are watching closely to see whether Pazdur will return to his former role as oncology chief. His extensive experience and reputation for regulatory innovation have made him a trusted figure in the biopharma sector, particularly in oncology drug development. The Biotechnology Innovation Organization (BIO) has emphasized importance of retaining experienced leadership at the FDA to maintain U.S. competitiveness in global biotech innovation.

Pazdur’s potential return could bring stability to an agency struggling with internal investigations, leadership turnover, and external scrutiny. However, the path forward remains unclear, with no immediate resolution to the leadership vacuum or the broader concerns about regulatory consistency and scientific integrity.