Top Drug Chief Resigns Amid Misconduct Probe, Lawsuit
CDER director George Tidmarsh has stepped down after being placed on administrative leave amid an internal ethics investigation and a defamation lawsuit tied to a public post criticizing a company’s drug. Tidmarsh’s abrupt exit — just four months after his appointment to lead the agency’s drug center — comes after reports that HHS’ Office of Inspector General was alerted to “serious concerns” about his personal conduct.
Tidmarsh’s departure coincided with a lawsuit from Aurinia Pharmaceuticals, a drugmaker connected to one of Tidmarsh’s former business associates, alleging that he made “false and defamatory statements” and used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang. Tidmarsh and Tang previously worked together at La Jolla Pharmaceuticals. Tidmarsh left La Jolla in 2019, at which time a company press release had Tang noting that Tidmarsh resigned to “pursue other interests.”
The controversy appears to center on a late September social media post by Tidmarsh that questioned the use of surrogate endpoints and publicly attacked Aurinia’s Lupkynis (voclosporin), which was approved in 2021 for treating lupus nephritis. In an unprecedented and now-deleted LinkedIn post, Tidmarsh claimed that voclosporin has “significant toxicity” and has not been shown to have a clinical benefit for patients. A subsequent, and now-deleted, post by Tidmarsh noted that his earlier post reflected his own views and did not represent FDA’s opinions. The post allegedly prompted a sharp selloff in Aurinia’s shares and a $350 million loss in market value.
“CDER will be evaluating surrogate endpoints used for FDA approval,” Tidmarsh said in the post. “While there is no doubt that the use of such endpoints has benefited patients by bringing valuable treatments to patients sooner, there have been notable failures in confirmatory trials, such as those for exon skipping therapies in DMD [Duchenne muscular dystrophy]. And for some diseases such as lupus nephritis, companies have not run trials to demonstrate a benefit on hard clinical endpoints like progression to end-stage renal disease. So we have approved drugs with significant toxicity like voclosporin that has not been shown to provide a direct clinical benefit for patients. We will be taking a close look at the use of surrogate endpoints to see where we can further accelerate promising drugs faster while requiring companies to perform the trials necessary to confirm actual clinical benefit.”
In an interesting twist, Tidmarsh told ABC News over the weekend that he believes the agency’s initial action to place him on administrative leave was less about the Tang and the Lupus drug post and more about internal retaliation after he raised concerns about a new expedited drug‑approval process (Commissioner’s National Priority Voucher pilot program) and for his speaking out against CBER director Vinay Prasad.
Tidmarsh said he raised concerns about the voucher program’s legality, which uses a tumor board-style review process to fast-track approvals. He told ABC News the new approval process, as designed, would be “different than the entire history of decades of the FDA… It circumvents rigorous scientific debate and puts Vinay Prasad in charge of every drug approval.” About FDA in general, Tidmarsh further said: “It’s toxic, it’s bad, it’s bad for the American people. Anybody with a right mind would get out of a situation like that."
ABC News said an HHS spokesperson did not respond to a direct question about Tidmarsh’s claims of retaliation. “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” the spokesperson wrote in addressing his administrative leave action.
FDA commissioner Marty Makary brought Tidmarsh on board in July to fill the CDER head vacancy left by former Center director Patrizia Cavazzoni, who departed the agency in the early days of the Trump administration. At the time, Makary said his “appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency.” Now, his short tenure is ending under a cloud of scrutiny. FDA has not announced who will serve as acting CDER director, though agency officials say continuity of operations would not be affected.
Tidmarsh has over 30 years of experience in the biotechnology industry, including the clinical development of six FDA-approved drugs, according to his bio. He previously served as the founder and chief executive officer of Horizon Pharma, where he led the development of Duexis, which was approved for treating rheumatoid arthritis. In 2022, Horizon was sold to Amgen for $28B, his bio says. He also founded Threshold Pharmaceuticals, Inc. and held senior positions at Coulter Pharmaceutical, Inc. (acquired by GlaxoSmithKline) and SEQUUS Pharmaceuticals, Inc. (acquired by Johnson & Johnson). While at Coulter and SEQUUS, Tidmarsh led the clinical development of Bexxar and Doxil, two FDA-approved anti-cancer agents.
The resignation adds to a turbulent stretch for FDA’s drug office, which has seen senior staff departures and ongoing restructuring under FDA commissioner Marty Makary. Industry observers say the Tidmarsh episode highlights renewed concerns about conflicts of interest and the boundary between personal expression and official authority.