The Fda’s Top Drug Regulator Submits His Resignation To The Agency

Rick Pazdur, the FDA’s top drug regulator, told staff Tuesday he submitted his resignation to the agency, an abrupt departure weeks after he was convinced by Commissioner Marty Makary to take the post to help bring stability to an agency reeling from months of upheaval, according to four people familiar with the decision granted anonymity to discuss the move.

The decision — which comes days after top vaccine regulator Vinay Prasad said the agency would ratchet up regulatory requirements for new vaccines — is almost certain to raise new questions about Makary’s leadership of the FDA.

Pazdur in recent weeks clashed with Makary over the Commissioner’s National Priority Voucher program, according to media reports.

That program — which aims to speed final review of drugs that address health priorities, pose a transformative innovative impact, address an unmet medical need, help onshoring efforts or increase affordability — was also criticized by Pazdur’s predecessor, George Tidmarsh. FDA experts have worried the involvement of political appointees in the process of choosing which firms receive a voucher could raise questions about the program’s integrity.

STAT first reported the news of Pazdur’s decision to retire. It is unclear if the decision is final — one person familiar with the decision said the longtime cancer drug regulator has 30 days to change his decision.

“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA," an FDA spokesperson said in a statement. "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.”

The White House and Pazdur did not immediately respond to requests for comment.

John Crowley, president and CEO of the trade lobby group Biotechnology Innovation Organization, said in a statement that Pazdur's exit "raises serious concerns about the repeated turnover in key leadership" and risks U.S. biotech leadership as China seeks to compete in the sector.

"We are at a tipping point," Crowley said. "It is time to right this ship.”

Pazdur, a 26-year agency veteran, initially rebuffed efforts by Makary to convince him to assume leadership of the FDA’s Center for Drug Evaluation and Research — but ultimately agreed to take the job after being assured he would be given autonomy in the role free from political influence and the ability to rehire staff.

The FDA’s drug center historically has seen little turnover among senior leadership, but it’s had four different leaders this year. Patrizia Cavazzoni left the agency in January for a senior role at Pfizer, and Jacqueline Corrigan-Curay took over the leadership of CDER on an acting basis until her retirement in July.

Makary then brought in Tidmarsh to lead the powerful center, but he resigned from the FDA in early November after being accused of using his position to intimidate a former business partner.

The successful press by Makary to elevate Pazdur, a longtime cancer drug regulator, was intended to provide much-needed stability to Makary’s FDA.

“Great morning coffee! Few people have a track record of regulatory innovation as strong as Dr. Pazdur’s. He's a force for accelerating more cures and meaningful treatments,” Makary tweeted after Pazdur agreed to take the CDER job.

Prasad also has been the subject of controversy. Earlier this year, the White House pushed to have him removed following a campaign by MAGA influencer Laura Loomer, but Makary was able to convince White House chief of staff Susie Wiles to return Prasad to his FDA job. The White House also asked for the resignation of another Makary deputy last month — policy and research staffer Sanjula Jain-Nagpal — before reversing course.

A pharmaceutical industry lobbyist said that if Pazdur does depart, it would be a body blow to the FDA.

"It's a fucking mess over there right now. If he truly does resign I think people are going to truly start to worry about the agency,” the lobbyist said. “I think you’ll start to get some panicky sentiments from the regulatory affairs folks in the industry.”