Top FDA Drug Regulator Departing After Weeks in Position

(The Epoch Times)—One of the Food and Drug Administration’s top officials is departing the agency, a spokesperson confirmed on Dec. 2.

Dr. Richard Pazdur will be retiring, an FDA spokesperson told The Epoch Times in an email.

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“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 did not respond to requests for comment by publication time.

FDA Commissioner Dr. Marty Makary named Pazdur as director of the agency’s Center for Drug Evaluation and Research (CDER) in November.

Pazdur started working for the FDA in 1999, as director of the CDER’s Division of Oncology Drug Products, after about a decade at the MD Anderson Cancer Center. He had most recently been in charge of regulating cancer drugs as head of the FDA Oncology Center of Excellence.

“I’m honored to lead CDER at a time when the FDA is achieving long-sought regulatory reforms,” Pazdur said in a statement when his appointment was announced. “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.”

The CDER has nearly 5,000 employees, making it one of the FDA’s largest divisions.

Dr. George Tidmarsh, a Stanford University professor and longtime executive for pharmaceutical companies, headed CDER from July through early November.

Tidmarsh, whom Makary said he selected, resigned on Nov. 2 after he was placed on leave following officials’ learning about personal conduct concerns, a spokesperson for the Department of Health and Human Services, the FDA’s parent agency, told The Epoch Times in an email.

She said that Health Secretary Robert F. Kennedy Jr. “expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency.”

Tidmarsh, who has not returned requests for comment, was sued in November by Aurinia Pharmaceuticals over allegations that he illegally targeted the company, including by issuing a public statement describing one of its FDA-approved products as having “significant toxicity” and not having any clinical benefit.

Dr. Vinay Prasad, who heads the FDA’s Center for Biologics Evaluation and Research, exited the FDA in July, several months after he was appointed. He rejoined the agency in August at the FDA’s request.