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STAT+: Two of FDA’s top cancer regulators to depart, heightening worries about drug reviews
Deputy directors at the FDA center that oversees the regulation of cancer drugs plan to leave, adding to a flood of top talent in recent months.
Both deputy directors at the key Food and Drug Administration center that oversees the regulation of cancer drugs plan on departing the agency, sources told STAT Thursday, highlighting the drain on talent at the FDA created by layoffs, uncertainty, and shifts in policy at the agency even as it is set to lay off thousands more people.
Both Paul G. Kluetz, who joined the FDA as a medical reviewer in 2016, and Marc R. Theoret, who joined as a medical reviewer in 2009, have told colleagues of plans to leave the FDA, multiple sources familiar with the matter told STAT. The FDA’s Oncology Center of Evidence was created in 2017 by Congress as a way to speed the development of cancer treatments.
The FDA’s website says the OCE “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies” and also that the center leads a variety of research and educational programs to advance the development of cancer treatments.
