FDA Gene Therapy Official Ousted: Internal Conflict
- The Food and Drug Administration (FDA) is facing scrutiny after the chief regulator of cell and gene therapies was removed from their role.The ouster followed a dispute regarding...
- Nicole Verdun, the regulator in question, had scheduled an advisory committee meeting to assess a therapy developed by Capricor Therapeutics.Though,Vinay Prasad,director of the FDA's Center for Biologics evaluation...
- Simultaneously,sources indicate that there had been ongoing tensions related to Verdun's management style.
The FDA is under fire. Chief regulator Nicole Verdun has been removed from her role, sparking intense debate around the review process for a Duchenne muscular dystrophy cell therapy.This decision,triggered by internal conflicts over a treatment developed by Capricor Therapeutics,raises serious questions about the FDA’s handling of cell and gene therapies. The FDA Director, Vinay Prasad, canceled an advisory commitee meeting, making the situation more complex. Could tensions in management style drive this decision? News Directory 3 is watching closely as future investigations may reveal deeper details.Discover what’s next as the FDA faces increased scrutiny.
FDA Regulator Ousted After Duchenne Muscular Dystrophy Disagreement
Updated June 20,2025
The Food and Drug Administration (FDA) is facing scrutiny after the chief regulator of cell and gene therapies was removed from their role.The ouster followed a dispute regarding the review process for a cell therapy targeting Duchenne muscular dystrophy, raising questions about the agency’s decision-making.
Nicole Verdun, the regulator in question, had scheduled an advisory committee meeting to assess a therapy developed by Capricor Therapeutics.Though,Vinay Prasad,director of the FDA’s Center for Biologics evaluation and Research,reportedly canceled the meeting. Prasad was allegedly skeptical about the treatment’s potential, leading to the unilateral decision, according to sources familiar with the situation.
Simultaneously,sources indicate that there had been ongoing tensions related to Verdun’s management style. These tensions add complexity to the situation, making it difficult to pinpoint the exact reason for her being placed on leave.
What’s next
The FDA’s handling of cell and gene therapies,especially concerning Duchenne muscular dystrophy,will likely face increased scrutiny.Further investigations may reveal more details about the circumstances surrounding Verdun’s departure and the future of the Capricor Therapeutics treatment.