US FDA Drug Chief Resigns Amid Ethics Concerns and Lawsuit
The chief of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, George Tidmarsh, has resigned amid significant ethical concerns. This announcement was made by a spokesperson for the Department of Health and Human Services (HHS) on Monday.
Background on the Resignation
Tidmarsh, who took on the role in July, oversaw critical operations for regulating both over-the-counter and prescription medications. His resignation followed his placement on administrative leave last Friday, an action taken after the Office of the General Counsel and the Office of the Inspector General were alerted to issues regarding his conduct.
Ethical Standards and Transparency
- The HHS highlighted the commitment to high ethical standards under Secretary Robert F. Kennedy Jr.
- Transparency remains a priority for the health department in light of the situation.
In an interview with the New York Times, Tidmarsh stated that his leave was a result of his concerns over the legal foundation of a new program aimed at expediting drug approvals.
Legal Challenges and Controversies
Tidmarsh is currently facing a lawsuit from Canadian drug company Aurinia Pharmaceuticals. The lawsuit accuses him of soliciting a bribe and making false statements that adversely affected the company’s stock as part of a vendetta against a former colleague. This lawsuit was reported by the Wall Street Journal.
Concerns Over Drug Safety
In September, Tidmarsh expressed doubts about the safety and effectiveness of Aurinia’s drug, Lupkynis, through a LinkedIn post that has since been removed. Aurinia has defended the drug, stating it is both safe and effective, supported by data from two major clinical trials and receiving FDA approval in 2021.
Reshuffling in U.S. Health Agencies
Tidmarsh’s resignation comes amid a broader shake-up within U.S. health agencies under Secretary Kennedy. Earlier this year, Peter Marks, a prominent vaccine official, was dismissed, followed by the removal of Nicole Verdun, who led gene therapy efforts.
The departure of George Tidmarsh raises questions about leadership integrity within crucial health sectors and the implications of ongoing ethical scrutiny.
