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WASHINGTON (AP) — On Tuesday, the Food and Drug Administration announced the appointment of a seasoned cancer drug regulator as the new head of its drug center. This move comes after the previous director was dismissed following an ethics complaint.
Dr. Richard Pazdur, who has dedicated 26 years to the agency, will now lead the Center for Drug Evaluation and Research, the largest division within the FDA. With a specialized background in oncology, Pazdur has held various positions within the FDA, most recently overseeing the Oncology Center of Excellence.
The decision to appoint Pazdur comes shortly after Dr. George Tidmarsh’s sudden departure. Tidmarsh left the agency amid an investigation into “serious concerns about his personal conduct,” as reported by federal ethics attorneys. Tidmarsh, a former pharmaceutical industry executive, had been appointed by FDA Commissioner Marty Makary.
Earlier this month, a lawsuit was filed claiming that Tidmarsh exploited his role at the FDA to carry out a “longstanding personal vendetta” against a chairman of a Canadian pharmaceutical company’s board. The lawsuit highlighted a history of professional collaboration between the two men at various pharmaceutical firms.
Pazdur is among the few senior FDA leaders who have weathered a series of retirements, dismissals, and resignations instigated by the Trump administration, which resulted in the departure of many long-serving agency employees.
He’ll be tasked with bringing stability to a unit that has been riven by low morale, return-to-office orders and turf battles with other parts of the agency, including the vaccine and biologics center led by Dr. Vinay Prasad.
The FDA’s drug center has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is responsible for the review, safety and quality control of prescription and over-the-counter medicines.
Pazdur will also inherit several new initiatives announced by Makary, including a voucher program that aims to review drugs that are deemed a “national priority” in just one to two months. Previously, the FDA’s fastest drug reviews required six months.
As the FDA’s top cancer specialist, Pazdur previously oversaw efforts to expedite the approvals of experimental cancer therapies based on early measures, such as tumor shrinkage. That approach has been criticized by many in academia, including Prasad, who spent years publishing papers scrutinizing the FDA’s approach to cancer medicines before joining the agency earlier this year.
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