Mere weeks after being named the nation’s top drug regulator, Richard Pazdur, M.D., is taking steps to retire as head of the FDA’s Center for Drug Evaluation and Research (CDER), an FDA spokesperson confirmed to Fierce Biotech.
“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” the spokesperson 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.”
Pazdur has filed papers to retire at the end of this month and informed FDA colleagues of his decision at a Tuesday meeting, according to a report from Stat News.
Pazdur’s planned departure would send yet another shockwave through CDER, which he was chosen to lead on Nov. 11 after former director George Tidmarsh, M.D., Ph.D., was ousted. Tidmarsh resigned under pressure in early November amid an internal investigation into alleged misuse of his regulatory authority to act on a personal vendetta.
Pazdur, who has led the FDA's Oncology Center of Excellence since its 2017 inception, appeared reluctant to take on the role of CDER chief. He reportedly turned down the job offer initially, according to several reports. But FDA Commissioner Marty Makary, M.D., and other senior officials insisted that he take the role, according to The Washington Post.
Pazdur’s appointment was generally praised and seen as a stabilizing move for an agency that has endured extensive layoffs, leadership upheaval and review delays during President Donald Trump’s second term.
He is a 26-year veteran of the FDA who has profoundly shaped the agency’s approach to cancer drug development. Under Pazdur’s oncology leadership, the FDA has placed greater emphasis on overall survival as a critical endpoint and implemented tighter control over accelerated approvals for cancer drugs.
After reports of Pazdur's planned retirement broke Tuesday, John Crowley, president and CEO of the Biotechnology Innovation Organization, said in a statement that the “departure raises serious concerns about the repeated turnover in key leadership occurring at the FDA.”
“We need organizational strength and stability at the agency,” Crowley added. “This constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.”
It's time to “right this ship,” Crowley said, describing the current situation as a “tipping point.”
Editor's note: This story was updated at 2:20 p.m. ET on Dec. 2 with a statement from the FDA and at 8:40 a.m. ET on Dec. 3 with a statement from BIO CEO John Crowley.