Additional Coverage:
- FDA’s drug regulator put on leave, considering resigning, citing ‘toxic’ environment (abcnews.go.com)
Top FDA Drug Regulator on Leave Amid “Toxic” Environment Claims
Washington D.C. – Dr. George Tidmarsh, the Food and Drug Administration’s (FDA) leading drug regulator, has been placed on administrative leave and is reportedly considering resignation, citing a “toxic” atmosphere within the agency.
Tidmarsh, who heads the FDA’s Center for Drug Evaluation and Research, was put on leave Friday following “serious concerns about his personal conduct,” according to Emily Hilliard, a spokeswoman for the Department of Health and Human Services (HHS). These concerns were brought to the attention of the Office of the General Counsel and the Office of the Inspector General.
A report by STAT News, a publication specializing in health, science, and medicine, indicated Sunday that Tidmarsh is accused of leveraging his regulatory authority to cause financial harm to a former business associate.
In an interview with ABC News on Sunday night, Tidmarsh denied these allegations. He countered that the administrative leave was a retaliatory measure for his outspoken criticism of Vinay Prasad, the FDA’s chief medical and scientific officer.
Tidmarsh claims he raised concerns about a new regulatory process at the FDA designed to accelerate the review of certain drugs. He specifically questioned the legality of a “tumor board-style review process” intended to fast-track approvals for “companies aligned with critical U.S. national health priorities,” as described by the FDA.
He told ABC News that this new arrangement would be a significant departure from “decades of the FDA’s entire history.” Tidmarsh stated, “It circumvents rigorous scientific debate and puts Vinay Prasad in charge of every drug approval.”
Hilliard, the HHS spokeswoman, did not comment on Tidmarsh’s claims of retaliation. She did, however, emphasize, “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency.”
While Hilliard stated that Tidmarsh had resigned on Sunday, Tidmarsh informed ABC News that he is still deliberating his resignation. He expressed his strong disapproval of the current environment at the FDA, alleging, “I would resign from a place as toxic as the current environment.
It’s toxic, it’s bad, it’s bad for the American people. Anybody with a right mind would get out of a situation like that.”