Bold disruption at the FDA continues: Retirement shocks the agency just three weeks after taking the helm.
Richard Pazdur, the FDA’s top drug regulator and a long-time oncologist who has been with the agency since 1999, is stepping away after a remarkably brief tenure of three weeks in the leading position. Reports from several outlets confirm the move.
Pazdur assumed leadership of the FDA’s Center for Drug Evaluation and Research on November 11, following the departure of former chief George Tidmarsh. Tidmarsh left amid an investigation and a lawsuit alleging misuse of his authority to exact petty retaliation against a former business associate. The surrounding scandal drew sharp commentary from venture capitalists and industry observers, with some labeling the FDA a “clown show” during the upheaval, and others describing the agency as erratic and unpredictable.
Within the industry, Pazdur’s appointment had been hailed as a hopeful sign by insiders, pharmaceutical stakeholders, and patient advocacy groups, according to coverage from The Washington Post.
Yet the optimism quickly gave way to tension. Within days of assuming the role, Pazdur voiced serious concerns about the legality and public health implications of FDA Commissioner Marty Makary’s proposed reforms to speed operations. On November 21, The Washington Post reported that Pazdur opposed Makary’s initiative to trim the number of required studies for drug-related decisions, including label changes. He also warned that cutting review times without robust transparency could verge on illegality. Moreover, Pazdur pushed back against Makary’s plan to remove career agency scientists from certain drug-review activities that align with political priorities, stressing the importance of scientific independence in decision-making.
