FDA's Top Drug Regulator Resigns       11/03 06:14

   

   WASHINGTON (AP) -- The head of the Food and Drug Administration's drug 
center abruptly resigned Sunday after federal officials began reviewing 
"serious concerns about his personal conduct," according to a government 
spokesperson.

   Dr. George Tidmarsh, who was named to the FDA post in July, was placed on 
leave Friday after officials in the Department of Health and Human Services' 
Office of General Counsel were notified of the issues, HHS press secretary 
Emily Hilliard said in an email. 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 said.

   The departure came the same day that a drugmaker connected to one of 
Tidmarsh's former business associates filed a lawsuit alleging that he made 
"false and defamatory statements," during his time at the FDA.

   The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used 
his FDA position to pursue a "longstanding personal vendetta" against the chair 
of the company's board of directors, Kevin Tang.

   Tang previously served as a board member of several drugmakers where 
Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved 
in his ouster from those leadership positions, according to the lawsuit.

   Messages placed to Tidmarsh and his lawyer were not immediately returned 
late Sunday.

   Tidmarsh founded and led a series of pharmaceutical companies over several 
decades working in California's pharmaceutical and biotech industries. Before 
joining the FDA, he also served as an adjunct professor at Stanford University. 
He was recruited to join the agency over the summer after meeting with FDA 
Commissioner Marty Makary.

   Tidmarsh's ouster is the latest in a string of haphazard leadership changes 
at the agency, which has been rocked for months by firings, departures and 
controversial decisions on vaccines, fluoride and other products.

   Dr. Vinay Prasad, who oversees FDA's vaccine and biologics center, resigned 
in July after coming under fire from conservative activists close to President 
Donald Trump, only to rejoin the agency two weeks later at the behest of Health 
Secretary Robert F. Kennedy Jr.

   The FDA's drug center, which Tidmarsh oversaw, has lost more than 1,000 
staffers over the past year to layoffs or resignations, according to agency 
figures. The center is the largest division of the FDA and is responsible for 
the review, safety and quality control of prescription and over-the-counter 
medicines.

   In September, Tidmarsh drew public attention for a highly unusual post on 
LinkedIn stating that one of Aurinia Pharmaceutical's products, a kidney drug, 
had "not been shown to provide a direct clinical benefit for patients." It's 
very unusual for an FDA regulator to single out individual companies and 
products in public comments online.

   According to the company's lawsuit, Aurinia's stock dropped 20% shortly 
after the post, wiping out more than $350 million in shareholder value.

   Tidmarsh later deleted the LinkedIn post and said he had posted it in his 
personal capacity, not as an FDA official.

   Aurinia's lawsuit also alleges, among other things, that Tidmarsh used his 
post at FDA to target a type of thyroid drug made by another company, American 
Laboratories, where Tang also 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," according to the company.