FDA's top drug regulator resigns after federal officials probe 'serious concerns'
Share and Follow


WASHINGTON (AP) — The director of the FDA’s drug division unexpectedly stepped down on Sunday, following the initiation of a federal review into “serious concerns about his personal conduct,” as reported by a government representative.

Dr. George Tidmarsh, who assumed the FDA role in July, was placed on administrative leave on Friday. This action occurred after officials from the Department of Health and Human Services’ Office of General Counsel were informed about the issues, according to HHS press secretary Emily Hilliard via email. Tidmarsh subsequently submitted his resignation on Sunday morning.

“Secretary Kennedy demands the utmost ethical behavior from all personnel under his leadership and is dedicated to ensuring complete transparency,” Hilliard stated.

The resignation coincided with a lawsuit filed by a pharmaceutical company linked to a former business partner of Tidmarsh. This suit accuses him of making “false and defamatory statements” during his tenure at the FDA.

Aurinia Pharmaceuticals, the company behind the legal action, claims that Tidmarsh exploited his FDA position to carry out a “longstanding personal vendetta” against Kevin Tang, the chair of the company’s board of directors.

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.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Share and Follow
You May Also Like
Usha Vance is PREGNANT: Second Lady reveals gender of fourth baby

Usha Vance Announces Pregnancy and Reveals Gender of Fourth Child

Usha Vance has joyfully announced that she is expecting a baby boy.…
Mandarin High alum Carson Beck plays for national championship with University of Miami

Mandarin High’s Carson Beck Shines as University of Miami Battles for National Championship Glory

In 2018, Carson Beck clinched a championship title with Mandarin High School,…
Families sue TikTok over deaths of their children after apparent 'choking challenge'

Heartbreaking Lawsuits Filed Against TikTok: Families Demand Justice After Tragic ‘Choking Challenge’ Deaths

In Wilmington, Delaware, six families have taken legal action against TikTok, alleging…
California hit by FOURTEEN earthquakes in less than 24 hours

California Shaken by Unprecedented Surge: 14 Earthquakes Rock the State in Under 24 Hours

Southern California has experienced its fourteenth earthquake within a 24-hour span, and…
Minneapolis software engineers mistaken for ICE agents while eating lunch harassed by anti-ICE crowd

Minneapolis Software Engineers Mistaken for ICE Agents Face Harassment from Anti-ICE Protesters During Lunch Break

A group of software engineers in Minneapolis faced a barrage of insults…
Meghan's Series With Love, Meghan 'won't be returning to Netflix'

Meghan Markle’s ‘With Love, Meghan’ Series Not Renewed by Netflix

Meghan Markle’s much-publicized Netflix series is reportedly not set to return for…
Dolly Parton releases new music to celebrate 80th birthday

Dolly Parton Debuts New Music Collection in Honor of Her 80th Birthday Celebration

Dolly Parton is ringing in her 80th birthday with a musical treat…
FILE - Jazz Watts, a resident of Sapelo Island, wears a hat that reads

Georgia Island Descendants Battle for Heritage: Voters Decide Fate of Historic Slave Ancestral Homes

Residents of a coastal Georgia county are heading to the polls on…