In a surprise move, the FDA has named the longtime leader of its oncology department, Richard Pazdur, M.D., as the new director of the Center for Drug Evaluation and Research, which oversees most prescription drugs.
The U.S. Department of Health and Human Services announced the appointment Nov. 11, with FDA Commissioner Marty Makary, M.D., calling Pazdur a “renowned regulatory innovator.”
Pazdur takes over from George Tidmarsh, M.D., Ph.D., who resigned from the agency about a week ago amid an internal investigation into alleged misuse of his regulatory authority to act on a personal vendetta.
Pazdur, a 26-year veteran of the FDA, is a tall figure at the agency who has had a profound influence on cancer drug development and reviews. He was the founding director of the FDA’s Oncology Center of Excellence, which was established in 2017. He’s one of only two center leaders to have remained in service at the FDA after the agency’s significant leadership shakeup under the Trump administration.
He’ll continue to serve as director of the Oncology Center of Excellence for the time being, but the HHS announcement suggests a search is on for Pazdur's successor.
During Pazdur’s long reign, the FDA’s oncology office has rolled out many programs designed to expedite, streamline or guide the biopharma industry’s development—and the FDA’s reviews—of cancer therapies. These include Project Orbis, which allows for the concurrent submission and review of oncology products among multiple international regulators. One project however, Project Equity, an initiative to promote diversity in cancer studies, was shelved amid a broader rollback of diversity programs in the federal government under the Trump administration.
Under Pazdur’s leadership, the FDA has placed greater emphasis on overall survival as a critical endpoint to assess both the efficacy and safety of cancer drugs. The agency is also implementing tighter control over accelerated approvals for cancer drugs, requiring that confirmatory trials be underway as a condition for these nods.
There have some controversies during Pazdur's FDA tenure. These include the high-profile rejection of Innovent Biologics’ PD-1 inhibitor Tyvyt, which was then partnered with Eli Lilly, because of the applicants' China-only clinical data. More recently, Pazdur was reportedly behind the FDA’s surprise complete response letter to Replimune’s oncolytic virus candidate in melanoma.
Before Tuesday’s announcement, Pazdur reportedly turned down the CDER offer. But Makary and other senior officials insisted that he take the role, The Washington Post reported, citing two people familiar with the situation.
“I’m honored to lead CDER at a time when the FDA is achieving long-sought regulatory reforms,” Pazdur said in a Nov. 11 announcement. “I look forward to working closely with Dr. Makary and the medical experts he’s assembled to help our country reach its peak in drug development.”
Makary’s appointment of Pazdur could indicate a desire to bring stability and reliability to the FDA's operations, desperately sought by the industry, after a tumultuous few months at the agency.
“At a time when the agency faces both extraordinary opportunity and complexity, Rick’s steady leadership and commitment to scientific integrity make him exactly the right person to lead CDER,” Ellen Sigal, chair and founder of Friends of Cancer Research, said in a statement Tuesday.
Pazdur is stepping up after Tidmarsh resigned from the FDA earlier this month. Tidmarsh hit the exit just days after the FDA launched a probe over a complaint against Tidmarsh by the ex-CDER chief’s former business associate Kevin Tang.
Tidmarsh was only appointed to the post of the FDA’s top drug regulator in July, joining the agency after a lengthy tenure in biotech and academia. He took over from acting CDER director Jacqueline Corrigan-Curay, M.D., who was filling in on an interim basis since the center’s longtime leader Patrizia Cavazzoni, M.D., stepped down at the beginning of the year.
For his part, Tidmarsh told The New York Times last week that he believed the FDA targeted him for raising concerns over its new national priority review voucher program.
Upon taking on the CDER director role, Pazdur will soon face the unenviable job of having to decide the fate of Sarepta Therapeutics’ two Duchenne muscular atrophy drugs Vyondys 53 and Amondys 45, which have just failed in a confirmatory trial.
Accelerated approvals of the Sarepta drugs previously landed former CDER director Janet Woodcock, M.D., in hot water, an action that some still consider a blot on her long FDA career.
Editor's Note: The story was updated with a statement from Friends of Cancer Research.
Fraiser Kansteiner contributed to the reporting.