Newly appointed drugs chief set to leave FDA, STAT News reports

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Dec 2 (Reuters) – The U.S. Food and Drug Administration’s newly appointed head of the drug evaluation department, Richard Pazdur, is set to exit the health agency weeks after taking the job, STAT News reported on Tuesday, citing sources familiar with the matter.

Pazdur, the agency’s veteran oncology chief, took over the role on November 11, replacing George Tidmarsh after he resigned amid serious concerns about his personal conduct.

The latest high-profile departure comes as U.S. Health Secretary Robert F. Kennedy Jr. makes stark changes at the agency. Longtime FDA vaccine chief Peter Marks was ousted in April and replaced by Vinay Prasad, an ally of FDA Commissioner Marty Makary.

Days after taking over the new role, Pazdur had questioned a new fast-approval path created by Makary, warning it could pose a risk to public health and be illegal, according to a Washington Post report.

Pazdur informed leaders at the FDA’s drug center of his intention to leave the agency at a meeting on Tuesday, STAT reported, adding that he could still retract the papers, citing sources.

The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment. The STAT story said that the FDA had confirmed the move.

Pazdur joined the FDA in 1999 and was named director of the Office of Oncology Drug Products in 2005.

He has been credited with speeding the review process for dozens of cancer drugs and is known as much for his advocacy, driven in part by the death of his wife from ovarian cancer, as for his regulatory expertise.

(Reporting by Christy Santhosh in Bengaluru; Editing by Krishna Chandra Eluri, Maju Samuel and Shinjini Ganguli)