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The director of CDER is one of the most powerful officials at the FDA besides Commissioner Marty Makary. The center oversees the review of almost all new drug applications — outside of vaccines and gene and cell therapies — and regulates everything from over-the-counter pills to sunscreen.
As head of the oncology unit, Pazdur was a thoughtful leader who helped speed drug approvals but wasn’t afraid to seek the withdrawal of medicines that later failed to live up to their potential, RBC Capital Markets analyst Brian Abrahams wrote in a note to clients. His appointment is a sign that Makary values “stable leadership” and should mean that further vacancies will be filled by equally capable officials, he said.
Pazdur is “arguably the most qualified candidate in the entire healthcare ecosystem for this role,” Abrahams wrote. “We also see a low likelihood of controversies or negative headlines that in recent months may have spooked some healthcare investors.”
That’s important because the FDA has been rocked by turmoil since the beginning of the second Trump administration. Key officials have resigned amid mass layoffs and reports of a toxic environment, especially in the biologics division. Vinay Prasad, a longtime critic of the FDA, was tapped to lead the Center for Biologics Evaluation and Research in May, quit in July and took the job on again in August.
At the same time, industry watchers say the agency has become more unpredictable in terms of regulatory reviews, moving the goalposts and surprising companies who believed their applications were on track. In the latest example, UniQure last week said the FDA had abruptly shifted its position on the outlook for an experimental gene therapy for Huntington’s disease.
The messy review process has drawn the ire of the Wall Street Journal editorial page and left company executives frazzled. Pazdur’s appointment “should reduce most lingering regulatory uncertainties,” Abrahams wrote. Pazdur will likely be received warmly by industry and “offer a steady hand at a time when there has been a notable uptick in review delays,” he added.
