The head of the U.S. Food and Drug Administration’s drug division has resigned while under investigation, saying he was pushed out after raising concerns about plans to fast-track some new medicines. Dr. George Tidmarsh, who joined the FDA in July, stepped down on Sunday, The New York Times reported.
Tidmarsh’s departure comes days after he was placed on administrative leave as federal officials examined allegations tied to a lawsuit involving a drug company and one of its investors. The FDA confirmed that Tidmarsh’s resignation was accepted and that the leave followed “serious concerns” reported to a federal court and the inspector general.
Tidmarsh told The Times that the investigation began after he questioned the legality of a new program intended to expedite approvals for certain drugs, arguing the plan could let political aims trump science. “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,” he said. “There was insufficient legal support for what they wanted to do, and so I didn’t agree.”
A lawsuit filed last week by Kevin Tang, a major investor in Aurinia Pharmaceuticals, alleges Tidmarsh acted vindictively toward the company’s board chairman. The suit claims Tidmarsh posted negative comments online about voclosporin, Aurinia’s lupus drug, and sought payments related to a separate business deal. Tidmarsh strongly denied the claims, saying he has no interest in retaliating against Tang and that he “gave up everything” to join government service. The FDA is not named in the suit.
Tensions reportedly rose in mid-October when FDA officials met to approve the first drug under a new rapid-review program created by Health Secretary Robert F. Kennedy Jr. The program aims to speed approvals for medicines tied to government health priorities, such as addiction treatment. Tidmarsh said the program pressured staff to decide in a single day, whereas typical drug reviews span months and involve formal scientific debates.
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