Dr. George Tidmarsh, the head of the Food and Drug Administration’s drug division, resigned on Sunday amid an investigation into criticism he aired publicly about a drug tied to a former business associate.
Dr. Tidmarsh said he believed the review was opened in retaliation to concerns he raised last week about the legal basis of a new program for the rapid approval of some new drugs.
Dr. Tidmarsh, a drug industry veteran who joined the agency in July, said in an interview Sunday that he believed the new program injected politics into the drug review program, superseding decisions based on science.
He was placed on leave Friday pending the outcome of an investigation by the inspector general for the Department of Health and Human Services. On Sunday, he offered his resignation and Emily Hilliard, an F.D.A. spokeswoman, said it had been accepted. But on Sunday evening, Dr. Tidmarsh maintained that he was still on administrative leave.
Dr. Tidmarsh said he was told Friday that the leave was related to a complaint lodged by Kevin C. Tang, a major investor in a company that makes the drug voclosporin, a treatment for a type of lupus affecting the kidneys. The complaint involved a post that Dr. Tidmarsh wrote on LinkedIn in September that criticized that drug as having “significant toxicity.” The company’s stock dropped 16 percent.
Mr. Tang had been the board chairman of a different company that Dr. Tidmarsh ran as chief executive before leaving “to pursue other interests” in 2019.
In the post that Dr. Tidmarsh later deleted, he also publicly criticized some aspects of the agency’s decision-making.
Ms. Hilliard said on Sunday evening that Dr. Tidmarsh was placed on leave “after the office of the general counsel and the office of the inspector general were notified of serious concerns about his personal conduct.”
Dr. Tidmarsh also said that he did not want to work in a “toxic environment” that he attributed to Dr. Vinay Prasad, the agency’s chief medical and scientific officer, who also oversees vaccines and gene therapies. Dr. Prasad was ousted from the agency in July but brought back.
The tumult at the F.D.A. is just the latest in a series of ousters, firings and high-profile disagreements under the nation’s health secretary, Robert F. Kennedy Jr. Several of his top staff members were pushed out or resigned in recent months.
The most high-profile so far was the firing of Susan Monarez after she had served only a month as director of the Centers for Disease Control and Prevention. She told senators that she was fired after she had refused to sign off on recommendations from Mr. Kennedy’s vaccine advisory panel, which he has filled with mainly vaccine skeptics.
Dr. Tidmarsh said his concerns stemmed from the F.D.A.’s announcement in mid-October that it would approve a slate of drugs in record time. The program was meant to convey quick authorizations to drugs that reflected the administration’s priorities, which included addressing unmet medical needs or supporting lower pricing. Candidates for the program included a drug meant to help people break their addiction to vaping and another meant to help children who were born deaf.
“The effort was going to basically change the entire paradigm of the legal underpinnings of drug approvals that have for decades supported the actions on the safety and effectiveness of drugs,” Dr. Tidmarsh said. “There was insufficient legal support for what they wanted to do, and so I didn’t agree.”
Dr. Tidmarsh said the issue came to a head last week when officials met to make the agency’s first official approval decision. The process typically takes months, and involves extensive review and formal opportunities for dissent among agency scientists. But it was expected to be completed in a day.
“I didn’t know the legal underpinnings so all I did is say ‘I don’t think this is a decision,’” he said. “‘I see this as practice run,’ because no one had given anything about the process, the legality of it.”
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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