FDA’s Drug Chief Quits Amid Probe, Lawsuit — and a Very Public Feud

AP, the New York Times, ABC News contributed to this report.

The Food and Drug Administration’s top drug regulator, Dr. George Tidmarsh, abruptly resigned Sunday, two days after he was placed on leave while federal officials reviewed what they called “serious concerns” about his personal conduct. The move capped a chaotic weekend that also saw a drugmaker sue him, accusing the recently appointed official of using his post to settle old scores.

An HHS spokesperson said the Office of the General Counsel was alerted to the issues late last week; Tidmarsh was put on leave Friday and resigned Sunday morning.

“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” press secretary Emily Hilliard said.

Tidmarsh, a biotech veteran who joined the FDA in July after founding several pharma startups and teaching as an adjunct at Stanford, insists he’s being targeted for speaking up. He told reporters he objected to a new fast-track approval process he believes injects politics into drug decisions and centralizes power inside the agency. He described the FDA environment as “toxic” and said the program would short-circuit the debate and documentation that typically underpins approvals.

As the internal probe revved up, Aurinia Pharmaceuticals filed a federal lawsuit in Maryland accusing Tidmarsh of making “false and defamatory” statements about its lupus kidney drug and waging a “longstanding personal vendetta” against board chair Kevin Tang, a former colleague who had once pushed Tidmarsh out of company roles. The suit points to a September LinkedIn post in which Tidmarsh said the therapy hadn’t shown direct clinical benefit; Aurinia says the post helped knock its stock down 20% and erase more than $350 million in value. Tidmarsh later deleted the post, saying he’d written it in a personal capacity, not as an FDA official. He has denied any attempt at retaliation or extortion and says his actions on other products — like a thyroid drug tied to a company where Tang is also chair — were about longstanding regulatory concerns, not personal grudges.

The upheaval lands at an already fraught moment for the agency. The FDA’s drug center, which Tidmarsh ran, is down more than a thousand staff in the past year amid departures and layoffs. Leadership has been whipsawed by high-profile exits and reversals, including the brief July resignation — and quick return — of senior official Dr. Vinay Prasad after political blowback. Controversies over vaccines, fluoride, and accelerated review policies have further rattled morale.

In that swirl, Tidmarsh’s tenure was always going to be scrutinized. It became combustible once a private industry dispute spilled into public posts and the courts, and a clash over how fast to move on certain drugs collided with questions about ethics and influence. By Sunday night, the FDA had accepted his resignation. The lawsuit will now play out without him in office, while HHS attorneys and inspectors finish their own review.