FDA drug chief quits amid lawsuit and internal tensions

George Tidmarsh has resigned as director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) after being placed on administrative leave late last week. The move came hours before Aurinia Pharmaceuticals (Nasdaq: AUPH) filed a lawsuit against him, claiming that comments he made about its lupus nephritis drug Lupkynis (voclosporin) caused the company’s stock to tumble.

The Canadian biotech alleges that Dr Tidmarsh’s LinkedIn post, criticizing Lupkynis as unsafe and lacking clinical benefit, wiped more than $350 million from its market value. The suit, filed in Maryland federal court on Sunday, seeks both compensatory and punitive damages. A spokesperson for the Department of Health and Human Services confirmed that Dr Tidmarsh stepped down Sunday morning, noting that he had been placed on leave two days earlier amid “serious concerns” about his conduct.

A department spokeswoman said Health Secretary Robert F Kennedy Jr expects “the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency.” The HHS Office of the General Counsel and Office of the Inspector General have both been informed of the matter.