Richard Pazdur, who was appointed director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) just three weeks ago, is set to retire at the end of December, according to several sources.
STAT News first reported that Pazdur had filed retirement papers with the FDA, citing two agency sources familiar with the matter. He informed CDER leadership of his decision during a meeting on Tuesday. Although there remains a possibility that he could withdraw his retirement papers, one source told The Washington Post this is unlikely.
An FDA spokesperson confirmed Pazdur’s departure in an email to BioSpace: “We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” they said. “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.”
RBC Capital Markets analysts commented on Pazdur’s exit in a note to investors, stating it “rekindles regulatory uncertainty as record FDA leadership turnover continues.” They described the move as “a significant, sudden and surprising turn.” Following news of his retirement, the S&P biotech index XBI fell slightly Tuesday afternoon after having risen 7% since Pazdur took over as CDER director on November 11.
Pazdur's appointment came after initial hesitation about accepting the role. According to Endpoints News on November 12, FDA Commissioner Marty Makary visited Pazdur at home in an effort to assure him autonomy and independence from Vinay Prasad, director of the Center for Biologics Evaluation and Research. Prasad had previously clashed with George Tidmarsh—Pazdur’s predecessor—who resigned earlier in November amid an investigation into his personal conduct.
This year alone has seen four different leaders at CDER. Since taking office, Pazdur expressed concerns about efforts within the agency to speed up drug approvals—a process he suggested might risk patient safety. In particular, he questioned the legality of Commissioner Makary's National Priority Voucher program designed to reduce review times for certain therapies from 10–12 months down to just 1–2 months.
Despite these issues, many in biopharma viewed Pazdur’s selection as a stabilizing factor for CDER leadership during a turbulent period. Ellen Sigal, chairperson and founder of Friends of Cancer Research, told BioSpace last month: “I think the fact that [FDA] have put him in this job is a good signal that they’re very serious about getting back on the track.”
Peter Pitts, former FDA associate commissioner for external relations, also highlighted Pazdur’s longstanding reputation: “The beauty of Rick Pazdur is that he’s not walking into CDER as an unknown. He’s been there a long time. People have a great deal of respect for him,” Pitts told BioSpace last month.
RBC analysts added: “Only weeks ago, [Pazdur’s] appointment to lead CDER...was seen as a stabilizing force during a period of leadership transition at FDA...Dr. Pazdur’s potential departure raises concerns over the future direction of the division and the FDA’s ability to maintain its current pace of progress.”
