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.
Late on Sunday, a pharmaceutical company lodged explosive claims against Dr. Tidmarsh in a lawsuit claiming that the regulator had acted vengefully against its board chairman and investor, Kevin C. Tang, who had previously asked Dr. Tidmarsh to leave several companies. The lawsuit claimed that Dr. Tidmarsh attempted to extort him. Dr. Tidmarsh denied the allegations, saying he had no interest in revenge against Mr. Tang, a San Diego investor.
Dr. Tidmarsh said he was told Friday that the leave was related to a complaint lodged by Mr. Tang, a major investor in Aurinia Pharmaceuticals, a Canada-based 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 the drug as having little benefit and “significant toxicity.”
In the interview, Dr. Tidmarsh also described a “toxic environment” that he attributed to Dr. Vinay Prasad, the F.D.A.’s chief medical and scientific officer, who also oversees vaccines and gene therapies. Dr. Prasad had frustrated scientists within the agency for overriding some staff decisions on drugs and also on Covid vaccines.
