Richard Pazdur, the top drug regulator at the Food and Drug Administration (FDA), has opted to retire from the agency only three weeks after assuming the position, as reported by multiple media outlets. This sudden decision comes after Pazdur, an oncologist who joined the FDA in 1999, was expected to bring stability to an agency experiencing significant upheaval during the latter part of the Trump administration.
Pazdur was appointed to lead the FDA’s Center for Drug Evaluation and Research on November 11, following the departure of George Tidmarsh, who left amidst an investigation and lawsuit over allegations of abusing his position for personal vendettas. The scandal prompted a venture capital investor to liken the agency to a “clown show,” while drug industry groups criticized it as erratic and unpredictable.
The choice of Pazdur was initially welcomed by agency insiders, drug industry representatives, and patient advocacy groups, according to reports by The Washington Post. However, the optimism quickly faded. Shortly after taking office, Pazdur voiced significant concerns regarding FDA Commissioner Marty Makary’s proposed overhaul to expedite agency operations. On November 21, reports emerged that Pazdur was at odds with Makary’s plan to reduce the number of studies required for drug-related decision-making, including label changes, due to fears of legality and impact on public health. Additional concerns were raised over the transparency and potential illegality of reducing drug review times and excluding agency career scientists from certain drug review processes deemed as political priorities.