FDA ouster of top gene therapy official reveals internal tensions

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

The ouster of the Food and Drug Administration’s chief regulator of cell and gene therapies earlier this week came immediately after a disagreement with her boss over the review of a cell therapy for Duchenne muscular dystrophy, STAT has learned. 

The regulator, Nicole Verdun, had scheduled an advisory committee meeting to review the therapy developed by Capricor Therapeutics. But Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, was skeptical of the treatment and decided unilaterally to cancel the meeting, according to a person familiar with the matter.  

At the same time, there had been long-simmering tensions over Verdun’s management style, according to others familiar with the matter, raising further questions about the precise reason she was placed on leave. 

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