In a significant leadership shakeup, the U.S. Food and Drug Administration has appointed Dr. Richard Pazdur, a seasoned cancer medicines regulator, to head its Center for Drug Evaluation and Research. This appointment comes just over a week after the abrupt departure of former director Dr. George Tidmarsh following an ethics complaint.
New Leadership Amidst Controversy
Dr. Richard Pazdur, a 26-year veteran of the FDA, will now lead the agency's largest unit responsible for reviewing prescription and over-the-counter medicines. The cancer specialist has held numerous roles within the FDA, most recently heading the Oncology Center of Excellence before this promotion to director of the entire drug evaluation center.
The leadership change follows the sudden exit of Dr. George Tidmarsh, who departed after federal ethics lawyers began reviewing what a government statement described as "serious concerns about his personal conduct." Tidmarsh, a former pharmaceutical executive and scientist, had been personally recruited to the agency by FDA Commissioner Marty Makary.
Ethics Allegations and Denials
The controversy surrounding Tidmarsh stems from a lawsuit filed earlier this month that alleged he used his FDA position to pursue a "longstanding personal vendetta" against the chairman of a Canadian drugmaker's board of directors. According to legal documents, the two men had previously worked as business associates at several pharmaceutical companies before their relationship soured.
Despite these allegations, Tidmarsh has publicly denied any wrongdoing in media interviews. Neither Tidmarsh nor his lawyer responded to requests for comment from The Associated Press regarding the recent developments.
Stabilizing a Troubled Department
Dr. Pazdur represents one of the last remaining members of the FDA's senior leadership to survive what has been months of significant turnover within the agency. The Trump administration's actions had forced numerous longtime employees out through retirements, firings, resignations, and other personnel changes.
The new director faces substantial challenges in his role, including:
- Addressing low morale among staff
- Managing return-to-office orders
- Resolving turf battles with other FDA departments
- Stemming the loss of experienced personnel
The FDA's drug center has lost more than 1,000 staffers over the past year due to layoffs or resignations, according to official agency figures. This represents a significant brain drain for an organization responsible for the review, safety, and quality control of medications used by millions of Americans.
New Initiatives and Ongoing Challenges
Pazdur will inherit several new programs announced by Commissioner Makary, including a voucher system designed to fast-track the review of drugs considered "national priority" medications. This ambitious program aims to complete drug reviews in just one to two months, compared to the FDA's previous fastest review timeline of six months.
As the FDA's top cancer specialist, Pazdur has previously overseen efforts to accelerate approvals of experimental cancer therapies based on early indicators like tumor shrinkage. However, this approach has faced criticism from academic circles, including from Dr. Vinay Prasad, who now leads the FDA's vaccine and biologics center after spending years publishing papers questioning the agency's methodology for cancer drug approvals.
The appointment of this experienced regulator signals the FDA's commitment to stabilizing its drug evaluation center while maintaining its crucial role in ensuring medication safety and efficacy for the American public.
