Nov 3 (Reuters) - The director of the U.S. Food and Drug Administration's Center for
Drug Evaluation and Research, George Tidmarsh, resigned on Sunday amid serious concerns about
his personal conduct, a Department of Health and Human Services spokesperson told Reuters on
Monday.
He was placed on administrative leave on Friday after the Office of the General Counsel
and the Office of the Inspector General were notified of the concerns, the spokesperson said.
Tidmarsh was appointed in July to oversee one of the FDA's largest and most important
divisions, which regulates over-the-counter and prescription drugs.
"Secretary Kennedy expects the highest ethical standards from all individuals serving under
his leadership and remains committed to full transparency," the HHS said.
In an interview with the New York Times on Sunday, Tidmarsh said he was placed on
administrative leave after raising concerns about the legal basis of a new program for the rapid
approval of some drugs.
He is also facing a lawsuit from Canadian drugmaker Aurinia Pharmaceuticals ( AUPH )
that accuses him of soliciting a bribe and damaging the company's stock with false statements as
part of a revenge campaign against a former colleague, the Wall Street Journal reported on
Sunday.
In September Tidmarsh questioned the safety and clinical benefit of Aurinia's lupus
drug, Lupkynis, in a LinkedIn post that was later deleted. Aurinia said the drug is safe and
effective, citing data from two major trials and the FDA's full approval in 2021.
The departure comes as U.S. health agencies undergo significant leadership changes under
Health Secretary Robert F. Kennedy Jr.
Longtime vaccine official Peter Marks was ousted earlier this year, followed by gene-therapy
head Nicole Verdun.