The nation’s top drug regulator, Richard Pazdur, has decided to retire three weeks after taking the job, according to two people familiar with his decision who spoke on the condition of anonymity to discuss personnel matters.
Pazdur privately mused last month about retiring from the Food and Drug Administration or returning to his old job at the agency as he raised concerns about the legality and pace of agency plans to expedite drug decisions, The Washington Post previously reported.
Pazdur’s retirement follows tensions with FDA Commissioner Marty Makary, who has touted multiple initiatives to boost the agency’s efficiency. Pazdur had questioned plans by Makary aimed at significantly shortening review times for drugs that are aligned with the country’s priorities. Pazdur had initially turned down the job as the top drug regulator.
A spokesman for the Department of Health and Human Services, which oversees the FDA, did not immediately return a request for comment. Pazdur did not immediately return a request for comment. STAT News first reported Pazdur’s retirement decision.
Pazdur could still change his mind and seek to reverse his planned retirement, said the two people familiar with his decision. While Pazdur submitted retirement papers intending to exit the FDA by the end of December, the process is not yet finalized. It is unlikely that Pazdur will change his mind, said one of the people.
Makary on Nov. 11 announced Pazdur would lead the agency’s Center for Drug Evaluation and Research after the previous leader, George Tidmarsh, resigned under pressure. Tidmarsh faced internal scrutiny and a lawsuit over his critique of a treatment made by a company that alleged he had a vendetta against its board chair.
Makary and Vinay Prasad, the FDA’s top vaccine regulator, extolled Pazdur at length in a Nov. 13 podcast, saying that his elevation as the FDA’s top drug regulator would bring stability and innovation to the agency. Pazdur had spent more than 25 years at FDA, including as the leader of the agency’s Oncology Center of Excellence.
“This is where Rick is a genius, right?” Makary said, praising Pazdur’s ability to expedite new drug approvals by sharing strategic guidance with pharmaceutical companies.
Wall Street analysts last month also said that Pazdur’s selection was a positive sign for FDA, which had experienced months of turbulence under President Donald Trump.
Pazdur was likely the “best choice possible for patients and industry,” Chris Meekins, a managing director at Raymond James, wrote in an investor’s note.
The retirement of Pazdur marks the latest flash point for an agency dealing with layoffs and exits of senior officials.
An HHS spokesman previously said the department “strongly disagree[s]” with the premise that FDA decisions are unpredictable.
“Regulatory requirements may evolve as new data emerge, but this reflects a rigorous, science-driven review process, not inconsistency,” Rich Danker, an HHS spokesman, wrote in an email last month.
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