Rick Pazdur, director of the FDA’s Oncology Center of Excellence, has publicly called for fundamental restructuring of the agency, citing years of internal organizational disruption and intensifying global competition. Speaking at the American Society of Clinical Oncology annual meeting in Chicago, Pazdur emphasized that the FDA should not simply restore previous operational models. “We’ve had a lot of destruction here, and it doesn’t mean that we have to just go back and say, well, let’s rebuild it as it was,” he stated. The comments represent a rare public acknowledgment from senior FDA leadership regarding organizational challenges. Pazdur, who brings over three decades of experience in oncology drug approvals, positioned the agency’s current upheaval as an opportunity for meaningful reform rather than restoration. International regulatory competition, particularly from China and emerging Asian regulatory powers, is driving the urgency for restructuring efforts.
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