George Tidmarsh has resigned from the US Food and Drug Administration (FDA), becoming the latest in a long line of high-profile leadership changes at US regulatory bodies in healthcare.
Formerly the agency’s head drug regulator, Tidmarsh was placed on administrative leave on 31 October after concerns about his conduct, according to the US Department of Health & Human Services (HHS).
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The agency initiated an investigation into the now former director of the Center for Drug Evaluation and Research (CDER) after a complaint by healthcare investor Kevin Tang. Just two days later, Tidmarsh resigned from his post.
In an emailed statement, an HHS spokesperson told Pharmaceutical Technology said: “HHS placed Dr Tidmarsh on administrative leave after the Office of the General Counsel and the Office of the Inspector General were notified of serious concerns about his personal conduct. On Sunday, George Tidmarsh resigned effective immediately.”
Tang’s ire centres around Aurinia Pharmaceuticals, a company that developed the lupus nephritis drug Lupkynis (voclosporin). Tidmarsh had singled Lupkynis out, using the drug to catalyse reforms on surrogate endpoint-based approvals.
In a now-deleted LinkedIn post, Tidmarsh said that Lupkynis had “significant toxicity” and “has not been shown to provide a direct clinical benefit for patients”. Tang, who has bought three biotechs this year, is the chair of Aurinia’s board of directors.
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By GlobalDataTang filed a complaint with the FDA, which the agency referred to the Office of Inspector General, according to STAT News. Aurinia filed a lawsuit on 2 November – the same day Tidmarsh resigned – accusing Tidmarsh of a “longstanding personal vendetta against Kevin Tang”.
The HHS spokesperson added: “[HHS Secretary Robert F Kennedy Jr] expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency.”
In a surprise turn after a tumultuous past few days, Tidmarsh is now reportedly second-guessing his decision to resign, as per Endpoints News.
Whatever the outcome, his exit is the latest in a string of high-profile position changes at US healthcare regulatory bodies this year.
Agency leadership shuffles in 2025
Peter Marks resigned as the FDA’s Center for Biologics Evaluation and Research (CBER) in March 2025, a role he held from 2016. Marks stated that US Health Secretary Robert F Kennedy (RFK) Jr favoured “misinformation and lies”.
After this, FDA’s cell and gene therapy office director Nicole Verdun was placed on administrative leave in June. Both Marks and Verdun were well-respected regulators by industry and academic experts, according to William Blair analysts.
Another prominent axing came in the form of Centers for Disease Control and Prevention (CDC) director Susan Monarez, who was fired just 28 days into her post. Lawyers representing Dr Monarez have said her sacking was illegal, and alleged she was targeted by Kennedy because she refused “to rubber-stamp unscientific, reckless directives”. At least three senior CDC leaders resigned from the agency in support of Monarez. RFK Jr has stated that the shakeups were necessary to maintain the CDC’s gold standard status.
Even those aligned with RFK Jr have found themselves on the chopping block. On 29 July, Vinay Prasad stepped down from his role as head of CBER. It has since emerged that his exit was amid a slew of social media attacks against him from controversial conservative activists. In a U-turn that caught many in the industry off guard, Prasad reassumed his role at the agency in August.
At the time, investment bank Jefferies said in a research note: “The FDA leadership turmoil amid the Prasad saga raises the question: how politically versus scientifically driven is the agency today?”
