FDA’s Top Gene Therapy Regulator and Her Deputy Forced Out

The Food and Drug Administration forced out Nicole Verdun, who was in charge of reviews of cell and gene therapies, and her deputy Rachael Anatol.

They were put on administrative leave and escorted out.

Verdun worked closely with Peter Marks, who was in charge of the Center for Biologics Evaluation and Research. They were defining new paths to bring gene therapies to market, especially for rare diseases. Marks was forced out in March due to his role in regulation of Covid-19 vaccines.

Dr. Scott Gottlieb, senior fellow at the nonpartisan American Enterprise Institute think tank, commented in social media:

“Along with loss of other senior FDA staff, this is a significant setback for cell gene therapy. The advent of these advances was one of Pres Trump’s first term triumphs, along with his efforts to expand access to them. The field now faces a harder future.”

 Gottlieb said the ousted FDA leaders possess “deep subject matter expertise” and “knew how to make the pathway for these cell and gene therapies more viable.”

“They have been doing hard work to pave the way for safe and effective advances to reach patients who could benefit from them.”

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