FDA's Tidmarsh Resigns Amid Personal Conduct Investigation and Industry Fallout

George Tidmarsh, director of the FDA's Center for Drug Evaluation and Research (CDER), has resigned following an investigation into his personal conduct. The sudden departure marks another high-profile exit from the Department of Health and Human Services and adds to the ongoing turmoil within key regulatory bodies.

Investigation and Resignation

Tidmarsh, who was appointed to his position in July, tendered his resignation on Sunday morning after being placed on administrative leave just two days prior. The Health Department spokesperson revealed that "serious concerns" about Tidmarsh's personal conduct prompted the agency to initiate an investigation.

The probe appears to be linked to a complaint filed by Kevin Tang, a prominent biopharma investor known for acquiring struggling biotech companies through his shell company, Concentra Biosciences. Tang's affiliated company, Aurinia Pharmaceuticals, filed a lawsuit against Tidmarsh on the same day as his resignation, accusing the former regulator of harboring a "longstanding personal vendetta" against Tang.

Controversy Surrounding Lupkynis

The conflict between Tidmarsh and Tang stems from a now-deleted LinkedIn post in which Tidmarsh criticized Aurinia's lupus nephritis drug, Lupkynis. The former CDER director claimed that the drug, which received FDA approval in 2021 based on surrogate endpoints, had "significant toxicity" and lacked demonstrated direct clinical benefit for patients.

Tidmarsh's comments reignited debates surrounding the use of surrogate endpoints in drug approvals, particularly for complex diseases like lupus nephritis. Aurinia had previously submitted data from an extension study, leading to a label update for Lupkynis that reflected improved long-term efficacy.

Broader Implications for the FDA

Tidmarsh's resignation is the latest in a series of high-profile departures from key health agencies. Earlier this year, CDC Director Susan Monarez was dismissed after just 28 days in office, allegedly due to her refusal to pre-approve vaccine recommendations. The FDA has also seen the exits of Peter Marks and Nicole Verdun, former director of the Office of Therapeutic Products.

These departures, coupled with the recent controversy surrounding Vinay Prasad at the Center for Biologics Evaluation and Research, have raised questions about the stability and working environment within crucial regulatory bodies. Tidmarsh himself reportedly described the FDA as a "toxic work environment" during his brief tenure.

As the pharmaceutical industry grapples with these leadership changes, stakeholders are closely watching for potential impacts on drug evaluation processes, approval timelines, and overall regulatory strategy. The Department of Health and Human Services has emphasized its commitment to maintaining high ethical standards and transparency in the wake of these events.