George Tidmarsh, head of the Food and Drug Administration’s (FDA) drug center, resigned Sunday following allegations that he misused his regulatory power to financially harm a former business associate.
STAT News, in its report, said FDA Commissioner Marty Makary placed Tidmarsh on administrative leave after opening an investigation into his conduct in recent days based on a complaint filed against Tidmarsh by Kevin Tang, a San Diego-based health care investor and business owner.
One of Tang’s affiliated companies, Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH), filed a lawsuit against Tidmarsh on Sunday, accusing him of a “longstanding personal vendetta against Kevin Tang.”
Also Read: Biogen, UCB Take A Leap In Lupus With Promising Phase 3 Results
In an email to AP News, HHS press secretary Emily Hilliard said that Tidmarsh was placed on leave on Friday after the agency’s Office of General Counsel was alerted to the claims. Aurinia alleged he made “false and defamatory statements” while serving at the FDA.
Tidmarsh Denies Wrongdoing
In an interview with STAT, Tidmarsh said he was placed on leave from his role as director of the FDA’s Center for Drug Evaluation and Research (CDER). He learned of Tang’s complaint on Friday from Makary but discovered he’d been put on leave only after losing access to his agency email on Saturday. Tidmarsh denies any wrongdoing.
In September, Tidmarsh criticized a method of evaluating drugs that was used to approve Aurinia Pharmaceuticals’ flagship lupus drug, Lupkynis (voclosporin), which was approved in 2021.
For the three and six months ended June 30, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $66.6 million and $126.5 million, up 21% and 23%, respectively, from $55.0 million and $103.1 million, respectively, for the same periods of 2024.
Public Remarks and Backlash
Tidmarsh said on LinkedIn that voclosporin has “significant toxicity” and has not been proven to benefit patients. He later deleted that post and, in a subsequent post, clarified that those were his personal views and not of the FDA.
Aurinia responded and said it stands behind the favorable benefit/risk profile of Lupkynis.
Citing the lawsuit, the Wall Street Journal said that after the criticism, Aurinia’s stock dropped around 20% in a few hours, wiping out more than $350 million of market value.
Price Action: AUPH stock was trading lower by 0.53% to $13.10 premarket at last check Monday.
Read Next:
Image by Tada Images via Shutterstock
