Top FDA Drug Regulator Resigns Amid Misconduct Allegations

The Food and Drug Administration is facing further turmoil as George Tidmarsh, head of the Center for Drug Evaluation and Research, resigned yesterday following allegations of misconduct, adding to concerns about the agency’s stability under recent leadership changes.

Aurinia Pharmaceuticals filed a lawsuit Sunday claiming Tidmarsh made “false and defamatory statements” about its drug, voclosporin – used to treat lupus nephritis – in a now-deleted LinkedIn post, alleging the medication had “not been shown to provide a direct clinical benefit for patients.” The suit alleges the comments caused Aurinia’s stock to plummet by 20 percent and that Tidmarsh engaged in a six-year campaign to retaliate against the company’s board chairman, Kevin Tang, even attempting to “extort” him, according to The New York Times. Tidmarsh has denied the allegations.

This resignation follows previous criticism of Tidmarsh’s leadership, including a move away from expert review of new drugs, with Tidmarsh stating the FDA wanted to focus its time on “the big questions.” The FDA has experienced significant upheaval in recent months, with numerous staff departures and concerns about declining morale; this instability could potentially impact the agency’s ability to efficiently approve and monitor critical medications. Internal communications reportedly reveal FDA staffers are “disturbed by the turmoil and increasingly motivated to leave,” according to sources.

Prior to his resignation, Tidmarsh was placed on administrative leave after the FDA’s general counsel and inspector general were notified of “serious concerns about his personal conduct.” This latest development comes amidst broader changes within the Department of Health and Human Services, including recent staff reductions and the dismissal of members of the Centers for Disease Control and Prevention’s vaccine advisory committee – you can learn more about the CDC’s role in public health here. An FDA spokesperson stated the agency is reviewing the matter.