WASHINGTON (AP) — The Food and Drug Administration on Tuesday named a longtime cancer drug regulator to lead the agency's pharmaceutical center, replacing a former drug director who was recently fired 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 division. A cancer specialist, Pazdur previously held numerous positions at the FDA, most recently leading the Oncology Center of Excellence.
Pazdur's appointment comes just over a week after Dr. George Tidmarsh abruptly left 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, was recruited to the agency by FDA Commissioner Marty Macari.
The lawsuit, filed earlier this month, alleged that Tidmarsh used his position at the FDA to pursue a “long-standing personal vendetta” against the chairman of the Canadian drugmaker's board of directors. According to the lawsuit, the two men previously worked as business partners at several pharmaceutical companies.
In media interviews, Tidmarsh denied any wrongdoing. 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 top leadership, surviving months of retirements, layoffs, resignations and other actions by the Trump administration that forced longtime employees to leave the agency.
He will be tasked with bringing stability to a unit riven by low morale, return-to-office orders and turf battles with other parts of the agency, including the Vaccines and Biologics Center headed by Dr. Vinay Prasad.
The FDA's pharmaceutical center has lost more than 1,000 employees due to layoffs or layoffs over the past year, according to the agency. The center is responsible for the testing, safety and quality control of prescription and over-the-counter drugs.
Pazdur will also inherit several new initiatives announced by Makari, including a voucher program that aims to test drugs considered a “national priority” in just one to two months. Previously, the FDA's fastest drug reviews took six months.
As the FDA's top cancer specialist, Pazdur previously oversaw efforts to speed approval of experimental cancer treatments that rely on early interventions 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 drugs before joining the agency earlier this year.
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