The top drug regulator at the Food and Drug Administration (FDA) resigned Sunday, according to officials, after being accused of using his position of authority to publicly denigrate a treatment tied to a former business associate.
Dr. George Tidmarsh, a drug industry veteran who joined the administration in July, was placed on administrative leave Friday after officials in the Department of Health and Human Services (HHS) Office of General Counsel and Office of the Inspector General “were notified of serious concerns about his personal conduct,” HHS spokesperson Emily Hilliard confirmed in an email.
Tidmarsh resigned Sunday morning, effective immediately.
“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said, referring to HHS Secretary Robert F. Kennedy Jr.
The company in question, Aurinia Pharmaceuticals, on Sunday filed an explosive lawsuit accusing Tidmarsh of making false and defamatory statements about the company and the drug it developed because of a “long-standing personal vendetta” against its board chair Kevin Tang.
FDA was not named in the suit. The developments around Tidmarsh were first reported Sunday by Stat.
The lawsuit, filed in federal court in Maryland, claims Tidmarsh has targeted multiple companies affiliated with Tang and his investment company Tang Capital.
The complaint concerned a post that Tidmarsh wrote on LinkedIn in September that criticized the drug as having little benefit for patients and “significant toxicity.” The post was deleted, and Tidmarsh later clarified that his post reflected his own personal views, and not those of the agency. Aurinia then issued a statement defending the drug.
Tidmarsh’s statements caused Aurinia’s share price to plummet more than 20 percent, but it has since increased.
The lawsuit accused Tidmarsh of attempting to extort and solicit a bribe from Tang in exchange for Tidmarsh using his power to reverse or otherwise mitigate an FDA action against the company and its drug voclosporin, a treatment for a type of lupus affecting the kidneys.
According to the lawsuit, Tidmarsh’s “vendetta” against Tang began in 2019, when Tang ousted him from his position as president and CEO of La Jolla Pharmaceutical and other companies for which Tang served as board chair.
Tidmarsh left the company “to pursue other interests,” according to a statement at the time. The lawsuit says Tang asked him to resign.
Shortly after Tidmarsh joined FDA, the lawsuit claims he “pushed [the agency] to effectively remove” from the market the top-selling product made by American Laboratories, one of the companies Tang forced him to resign from.
Days after the FDA announced its action, the lawsuit alleges, Tidmarsh’s personal lawyer emailed Tang and requested that American Laboratories extend an existing services agreement with a Tidmarsh-associated entity “for another 10 years.”
In an interview with The New York Times, Tidmarsh said there was a “toxic environment” at the FDA and alleged he was being retaliated against for his concerns about a new program to expedite priority drug approval decisions championed by FDA Commissioner Marty Makary. Tidmarsh indicated he was worried about politics overriding science.
The program is meant to expedite reviews of products that have a significant potential to address the administration’s priorities. The criteria for the new program are much broader than other priority review vouchers, and include meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability.
Tidmarsh told the Times he did not “send anything” to Tang and denied his focus on American Laboratories was associated with Tang.
Tidmarsh’s resignation is the latest in a string of high-profile resignations, ousters and retirements of top officials under Kennedy’s leadership.
Kennedy in March pushed out FDA’s top vaccine regulator, Peter Marks. Susan Monarez was fired after serving as director for the Centers for Disease Control and Prevention for just a month.
FDA has also been rocked by controversial decisions on high-profile issues like vaccines and fluoride.
