George Tidmarsh, MD, PhD, director of the FDA’s Center for Drug Evaluation and Research, resigned Nov. 2 after being placed on administrative leave, The New York Times reported Nov. 2.
Dr. Tidmarsh told the Times he was placed on leave Oct. 31 pending an investigation by HHS’ Office of Inspector General. He believed the move was retaliatory, stemming from his voicing concerns about the legal basis for the FDA’s new National Priority Voucher program. The initiative aims to accelerate the approval process of certain new drug applications. The FDA announced the first nine medications selected for the program in mid-October.
“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,” Dr. Tidmarsh told the Times. “There was insufficient legal support for what they wanted to do, and so I didn’t agree.”
After voicing his concerns during a meeting about the agency’s first approval decision, Dr. Tidmarsh was told he was placed on leave because of an investigation into a now-deleted LinkedIn post he authored regarding “surrogate endpoints” — measures sometimes used by the FDA in drug approval decisions.
An HHS spokesperson told The Wall Street Journal that the Office of the General Counsel and the Office of the Inspector General were informed of “serious concerns about his personal conduct,” the Journal reported Nov. 2.
“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” the spokesperson said.
The same day he resigned, Dr. Tidmarsh was named in a lawsuit filed by Canadian drugmaker Aurinia Pharmaceuticals. The company alleges he defamed its FDA-approved kidney drug, voclosporin, by stating in a September LinkedIn post that the medication had “not been shown to provide a direct clinical benefit for patients.”
According to the lawsuit, the post caused Aurinia’s stock to drop 20% within hours, erasing more than $350 million in market value. Aurinia alleges defamation and injurious falsehood and is seeking damages and punitive compensation. It also accuses him of “soliciting a bribe and tanking its stock with false statements as part of a revenge campaign against a former colleague,” according to the Journal.
