More FDA drama: Top drug regulator calls it quits after 3 weeks

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Richard Pazdur, the Food and Drug Administration’s top drug regulator, has decided to retire from the agency just three weeks after taking the leading post, according to multiple media outlets.

Pazdur, an oncologist who has worked at the FDA since 1999, was seen as a stabilizing force for an agency that was mired in turmoil during the second Trump administration. He assumed the role of leading the FDA’s Center for Drug Evaluation and Research on November 11, after the previous leader, George Tidmarsh, left the agency amid an investigation and lawsuit alleging that he used his position to take revenge on a former business partner. In light of the scandal, one venture capital investor called the agency a “clown show”. Meanwhile, drug industry groups slammed the FDA as unregulated and unpredictable.

Pazdur’s selection was seen as a positive sign by agency insiders, drug industry representatives and patient advocacy groups, The Washington Post reported.

But things quickly turned sour. Just days into the job, Pazdur expressed deep concerns about the legality and public health risks of FDA Commissioner Marty Macri’s plan to overhaul and accelerate agency operations. On November 21, the Post reported that Pazdur disagreed with Macri’s plans to reduce the number of studies required to make drug-related decisions, such as label changes. Pazdur was also concerned that Macri’s plan to reduce drug review times was not transparent enough and might be illegal. Pazdur also pushed back Makri’s plan to exclude the agency’s career scientists from some drug review processes deemed political priorities.



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