Bold shift in FDA leadership amid ongoing turmoil: Top drug regulator resigns after just three weeks on the job.
Richard Pazdur, the FDA’s leading figure in charge of the Center for Drug Evaluation and Research, has announced his retirement just three weeks after taking the helm. Pazdur, an oncologist with a long tenure at the agency since 1999, was widely viewed as a stabilizing presence during a period of upheaval that intensified during the final days of the previous administration. He assumed leadership of the CDER on November 11, following the departure of George Tidmarsh, who left amid an investigation and a lawsuit accusing him of using his position to exact petty revenge against a former business partner. The surrounding scandal prompted some observers to label the FDA a “clown show,” while industry groups described the agency as erratic and unpredictable.
Inside sources, including drug industry insiders and patient advocacy groups, had welcomed Pazdur’s appointment as a hopeful sign of steadiness, according to reporting by The Washington Post.
However, the trajectory quickly soured. Within days of taking the role, Pazdur voiced serious concerns about the legality and public health implications of plans proposed by FDA Commissioner Marty Makary to overhaul and accelerate agency operations. Reports from November 21 indicated that Pazdur disagreed with plans to reduce the number of studies required to support drug-related decisions, such as label changes. He warned that accelerating drug review timelines without adequate transparency could be unlawful. Pazdur also challenged Makary’s efforts to limit the involvement of agency career scientists in certain drug-review activities that were framed as political priorities.
