The head of the Food and Drug Administration’s drug heart abruptly resigned Sunday after federal officials started reviewing “serious concerns about his personal conduct,” based on a authorities spokesperson.
Dr. George Tidmarsh, who was named to the FDA publish in July, was positioned on go away Friday after officials within the Department of Health and Human Services’ Office of General Counsel have been notified of the problems, HHS press secretary Emily Hilliard mentioned in an e-mail. Tidmarsh then resigned Sunday morning.
“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard mentioned.
The departure got here the identical day {that a} drugmaker related to one in all Tidmarsh’s former enterprise associates filed a lawsuit alleging that he made “false and defamatory statements,” throughout his time on the FDA.
The lawsuit, introduced by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA place to pursue a “longstanding personal vendetta” towards the chair of the corporate’s board of administrators, Kevin Tang.
Tang beforehand served as a board member of a number of drugmakers the place Tidmarsh was an government, together with La Jolla Pharmaceutical, and was concerned in his ouster from these management positions, based on the lawsuit.
Messages positioned to Tidmarsh and his lawyer weren’t instantly returned late Sunday.
Tidmarsh based and led a collection of pharmaceutical corporations over a number of many years working in California’s pharmaceutical and biotech industries. Before becoming a member of the FDA, he additionally served as an adjunct professor at Stanford University. He was recruited to affix the company over the summer time after assembly with FDA Commissioner Marty Makary.
Tidmarsh’s ouster is the most recent in a string of haphazard management modifications on the company, which has been rocked for months by firings, departures and controversial selections on vaccines, fluoride and other products.
Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics heart, resigned in July after coming below fireplace from conservative activists near President Donald Trump, solely to rejoin the company two weeks later on the behest of Health Secretary Robert F. Kennedy Jr.
The FDA’s drug heart, which Tidmarsh oversaw, has misplaced greater than 1,000 staffers over the previous yr to layoffs or resignations, based on company figures. The heart is the most important division of the FDA and is answerable for the assessment, security and high quality management of prescription and over-the-counter medicines.
In September, Tidmarsh drew public consideration for a extremely uncommon publish on LinkedIn stating that one in all Aurinia Pharmaceutical’s merchandise, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very uncommon for an FDA regulator to single out particular person corporations and merchandise in public feedback on-line.
According to the corporate’s lawsuit, Aurinia’s inventory dropped 20% shortly after the publish, wiping out greater than $350 million in shareholder worth.
Tidmarsh later deleted the LinkedIn publish and mentioned he had posted it in his private capability, not as an FDA official.
Aurinia’s lawsuit additionally alleges, amongst different issues, that Tidmarsh used his publish at FDA to focus on a sort of thyroid drug made by one other firm, American Laboratories, the place Tang additionally serves as board chair.
The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” based on the corporate.