The search continues for a new leader for the FDA’s Center for Drug Evaluation and Research after George Tidmarsh resigned on Sunday. Deputy Director Mike Davis is in the running, along with Mary Thanh Hai, currently head of the Office of New Drugs.
Richard Pazdur, director of the FDA’s Oncology Center of Excellence, turned down an offer to lead the agency’s Center for Drug Evaluation and Research.
The news, first reported by The Pink Sheet, comes after former CDER head George Tidmarsh’s sudden exit late last week.
Tidmarsh had been subject to an FDA probe over “serious concerns about his personal conduct” and was placed on administrative leave Friday, before he tendered his resignation on Sunday. On Monday, however, Tidmarsh seemed to have second thoughts about his decision to step down. “I’m going to fight it,” he told Endpoints News. “It’s my name and credibility.” Tidmarsh was appointed to the role in July and spent under four months on the job.
Meanwhile, CDER remains without a leader. Deputy Director Mike Davis has told staffers at the department that he could assume the duties of the director, though a formal selection process would still need to take place, The Pink Sheet reported. Davis met with Pazdur and FDA Commissioner Marty Makary at the Department of Health and Human Services on Nov. 3, though it remains unclear what they talked about.
Aside from Pazdur and Davis, Office of New Drugs Director Mary Thanh Hai is also being considered for CDER’s directorship post, according to the report.
Pazdur came to the FDA in 1999 to lead the agency’s Division of Oncology Drug Products, a part of CDER, and later became the director of the OCE when it was established in 2017. He stands out among the FDA’s senior officers, being one of the few who have kept their posts amid the sweeping changes enacted by Health Secretary Robert F. Kennedy, Jr.
Aside from Tidmarsh, Kennedy’s HHS also saw the exit of Peter Marks, former head of the Center for Biologics Evaluation and Research and well-known champion of vaccines and gene therapies. Marks’ successor, Vinay Prasad, was also briefly kicked from his post in late July, before being reinstated just 10 days later.
Another high-profile exit is that of Susan Monarez, former director of the CDC. Monarez was fired in late August after she allegedly declined to pre-approve recommendations from the agency’s Advisory Committee for Immunization Practices.
“I had refused to commit to approving vaccine recommendations without evidence, fire career officials without cause or resign, and I had shared my concerns with this committee,” Monarez told lawmakers in a Senate hearing in September. “I told the secretary that if he believed he could not trust me, he could fire me.”
Kennedy has denied these allegations.
