The Food and Drug Administration (FDA) has announced Dr. Richard Pazdur, a distinguished 26-year veteran of the agency, as the new director of its largest unit, the Center for Drug Evaluation and Research. This appointment follows the recent ousting of the former drug director, Dr. George Tidmarsh, due to an ethics complaint.

Dr. Tidmarsh's abrupt departure occurred just over a week prior, prompted by federal ethics lawyers reviewing “serious concerns about his personal conduct.” A lawsuit filed earlier this month alleged that Tidmarsh, a former pharmaceutical executive recruited by FDA Commissioner Marty Makary, leveraged his FDA position to pursue a “longstanding personal vendetta” against the chairman of a Canadian drugmaker's board of directors. The lawsuit detailed prior business associations between the two men at several pharmaceutical companies. Tidmarsh has publicly denied any wrongdoing but has not responded to requests for comment from The Associated Press.

Dr. Pazdur, a respected cancer specialist, has held numerous roles within the FDA, most recently heading the agency's Oncology Center of Excellence. His appointment marks him as one of the few remaining senior leaders to withstand months of significant turnover within the agency, including retirements, firings, resignations, and other actions during the Trump administration that led to the departure of many long-time employees.

Pazdur's primary mandate will be to restore stability to a unit grappling with low morale, the implementation of return-to-office directives, and internal turf battles, notably with other segments of the agency like the vaccine and biologics center led by Dr. Vinay Prasad. Over the past year, the FDA’s drug center has experienced a significant loss of more than 1,000 staffers through layoffs or resignations, according to agency figures. This center is crucial for the review, safety, and quality control of both prescription and over-the-counter medicines.

In his new role, Dr. Pazdur will also oversee several new initiatives introduced by Commissioner Makary. Among these is a novel voucher program designed to expedite the review of drugs deemed a “national priority,” aiming to complete these evaluations in a rapid one to two months, a substantial reduction from the previous fastest review period of six months. As the FDA's leading cancer specialist, Pazdur previously championed efforts to accelerate approvals of experimental cancer therapies, basing decisions on early indicators such as tumor shrinkage. This approach, however, has drawn criticism from many in academia, including Dr. Prasad, who had extensively published papers scrutinizing the FDA's methods for cancer medicine approvals prior to joining the agency earlier this year.