Newly appointed Center for Drug Evaluation and Research director Richard Pazdur has filed retirement papers with the agency—three weeks after accepting the role—amid clashes with Commissioner Marty Makary over certain FDA programs.
Just three weeks after being named director of the FDA’s Center for Drug Evaluation and Research, Richard Pazdur plans to retire at the end of this month, according to multiple sources.
Pazdur has filed retirement papers with the agency, STAT News, which first broke the news, reported Tuesday morning, citing two FDA sources familiar with the matter. The longtime FDA oncology leader informed CDER leadership of his intentions at a meeting on Tuesday. While Pazdur could still retract the papers, it is unlikely that he will change his mind, according to one of the sources, The Washington Post reported.
Indeed, an FDA spokesperson confirmed Pazdur’s exit to BioSpace in an email Tuesday afternoon.
“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” they said in an email. “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.”
Pazdur’s exit “rekindles regulatory uncertainty as record FDA leadership turnover continues,” RBC Capital Markets wrote in a Tuesday afternoon note to investors. The analysts called the news “a significant, sudden and surprising turn.”
The S&P biotech index, the XBI, fell slightly Tuesday afternoon following the news. The XBI had been up 7% since Pazdur’s appointment as CDER director on Nov. 11, according to RBC.
The news comes just weeks after Pazdur reportedly initially declined the CDER role. FDA Commissioner Marty Makary subsequently spent hours at the renowned oncologist’s home attempting to assure him that he would have autonomy and independence from Center for Biologics Evaluation and Research director Vinay Prasad, Endpoints News reported on Nov. 12. Prasad had butted heads with Pazdur’s predecessor, George Tidmarsh, who resigned on Nov. 2 amid a probe into his “personal conduct” at the agency.
In all, Pazdur is the fourth individual to head CDER—arguably the FDA’s most powerful regulatory division—this year. His tenure has been tenuous from the start, however. On Nov. 21, the Post reported that Pazdur had raised concerns about the legality of the agency’s push to expedite drug approvals, arguing that it could put patients at risk. Pazdur has specifically taken issue with the new Commissioner’s National Priority Voucher program, which aims to shorten the review period from the usual 10–12 months to 1–2 months for selected therapies.
The choice of Pazdur to lead CDER was lauded by many across the biopharma industry as a stabilizing event.
“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,” Ellen Sigal, chairperson and founder of Friends of Cancer Research, told BioSpace in an interview last month.
Peter Pitts, former FDA associate commissioner for external relations, spoke to Pazdur’s reputation within the agency.
“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,” he told BioSpace last month.
The RBC analysts appeared to agree with this sentiment.
“Only weeks ago, [Pazdur’s] appointment to lead CDER, the division responsible for overseeing most drug reviews, was seen as a stabilizing force during a period of leadership transition at FDA,” they wrote Tuesday. “And as one of the most experienced and deeply respected regulators in the healthcare ecosystem, 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.”
