FDA Drug Regulator Resigns Amid Personal Conduct Investigation, Then Reconsiders

In a surprising turn of events, George Tidmarsh, the director of the FDA's Center for Drug Evaluation and Research, has resigned from his position amid an ongoing investigation into his personal conduct. However, less than 24 hours after tendering his resignation, Tidmarsh reportedly reconsidered his decision, vowing to fight for his name and credibility.

Resignation and Reconsideration

Tidmarsh was placed on administrative leave on Friday after the agency became aware of "serious concerns about his personal conduct," according to a Health Department spokesperson. He initially resigned on Sunday morning, effective immediately. However, during a meeting of supervisors at the FDA's Office of New Drugs on Monday, it was conveyed that Tidmarsh is now on administrative leave and not resigning.

In a statement to Endpoints News, Tidmarsh said he was "second-guessing" his decision to resign. "I'm going to fight it. It's my name and credibility," he told the publication, referring to the ongoing investigation.

Investigation Origins and Industry Ties

The investigation that led to Tidmarsh's initial resignation is reportedly connected to a complaint filed by Kevin Tang, a prominent figure in the biotech industry known for acquiring and closing down struggling companies through his shell company, Concentra Biosciences.

Tidmarsh attracted Tang's attention in late September when he criticized Aurinia Pharmaceuticals' lupus nephritis drug Lupkynis in a now-deleted LinkedIn post. Tidmarsh claimed the drug had "significant toxicity" and "has not been shown to provide a direct clinical benefit for patients." Notably, Tang serves as the chair of Aurinia's board of directors.

Following Tidmarsh's post, Tang filed a complaint with the FDA, which was subsequently referred to the Office of Inspector General. Aurinia has since filed a lawsuit accusing Tidmarsh of a "longstanding personal vendetta against Kevin Tang."

FDA Leadership Turmoil

Tidmarsh's situation is the latest in a series of high-profile exits at the Department of Health and Human Services. His tenure at the FDA was reportedly rocky, with Tidmarsh describing the agency as a toxic work environment. He attributed this partly to Vinay Prasad, his counterpart at the Center for Biologics Evaluation and Research, who himself faced controversy earlier this year.

The pharmaceutical industry continues to watch closely as this situation unfolds, with potential implications for drug regulation and approval processes at the FDA.