News update
WASHINGTON (AP) — The Food and Drug Administration on Tuesday named a longtime regulator of cancer medicines to lead the agency’s drug center, replacing the former drug director who was recently ousted after an ethics complaint.
Dr. Richard Pazdur, a 26-year veteran of the agency, will become director of the Center for Drug Evaluation and Research, the FDA’s largest unit. A cancer specialist, Pazdur has previously served in numerous FDA roles, most recently leading the agency’s Oncology Center of Excellence.
Pazdur’s appointment comes just over a week after Dr. George Tidmarsh abruptly departed the agency after federal ethics lawyers began reviewing “serious concerns about his personal conduct,” according to a government statement. Tidmarsh, a former pharmaceutical executive and scientist, had been recruited to the agency by FDA Commissioner Marty Makary.
A lawsuit filed early this month alleged that Tidmarsh used his position at the FDA to pursue a “longstanding personal vendetta” against the chairman of a Canadian drugmaker’s board of directors. The two men had previously worked as business associates at several pharmaceutical companies, according to the lawsuit.
Tidmarsh has denied any wrongdoing in media interviews. He did not respond to requests for comment sent by The Associated Press to him and his lawyer.
Pazdur is one of the last remaining members of the FDA’s senior leadership to survive months of retirements, firings, resignations, and other actions by the Trump administration that forced longtime employees out of the agency.
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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