FDA’s top drug officer set to exit, weeks into new role ...Middle East

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By Sarah Owermohle, Adam Cancryn, Ben Tinker, Meg Tirrell, CNN

(CNN) — The US Food and Drug Administration’s longtime oncology chief has filed to retire from the agency just weeks after he was tapped to lead the FDA’s drug division, according to four people familiar with his decision.

Dr. Richard Pazdur was named director of the Center for Drug Evaluation and Research on November 11, taking leadership of the FDA’s largest division after its former director, Dr. George Tidmarsh, abruptly resigned.

FDA Commissioner Dr. Marty Makary said in a statement at the time that that Pazdur is a “a true regulatory innovator” and “an impressive forward-thinking scientist.”

Pazdur’s decision was first reported by Stat News.

His exit comes amid frustration with Makary and the chief of the biologics division, Dr. Vinay Prasad, according to three people familiar.

Those people said Pazdur had balked at what he saw as political interference in his division, which oversees most prescription drugs, over-the-counter medicines and commonly used products such as sunscreen and toothpaste.

A spokesperson for the US Department of Health and Human Services did not immediately respond to a request for comment.

Pazdur first arrived at the FDA in 1999 from the University of Texas MD Anderson Cancer Center in Houston, to lead its Division of Oncology Drug Products.

In 2017, he became founding director of the Oncology Center of Excellence, tasked with advancing innovations in cancer treatments. He has transformed how the agency regulates cancer drugs, helping forge faster pathways to get them to market.

Pazdur’s retirement — slated for the end of this month — would mean vacancies at both the top of the drug division and the oncology center.

His appointment to lead CDER was seen as a move toward stability for an agency rocked with chaos among its top personnel.

Pazdur was “an optimal fit,” wrote Brian Abrahams, who closely follows the FDA as a biotechnology analyst for Wall Street firm RBC Capital Markets, in a research note the day he was appointed. Abrahams called Pazdur “arguably the most qualified candidate in the entire healthcare ecosystem for this role.”

Stocks of biotechnology companies, including makers of cancer drugs, dropped Tuesday morning after the news of Pazdur’s looming departure.

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