Dr. George Tidmarsh, the head of the Food and Drug Administration’s drug division, said he was placed on administrative leave on Friday after he had raised concerns 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 said that he believed the inquiry was a form of retaliation and that he had offered his resignation.
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. A health department spokesman did not immediately respond to questions.
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.”
After the meeting, he said he was told that he had been placed on leave because of an investigation into a LinkedIn post he wrote — and later deleted — about drug approval standards.
Dr. Tidmarsh’s post outlined his concerns about so-called surrogate endpoints, or measures the F.D.A. sometimes uses in drug approval decisions. One such endpoint would be to determine whether a cancer drug shrunk a tumor. However, evidence of a higher certainty for the effectiveness of a cancer drug would include extending a person’s survival or measurably improving quality of life.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
The post F.D.A. Drug Unit Chief Is Placed on Leave, and Cites a ‘Toxic’ Environment appeared first on New York Times.
