The FDA’s Office of Therapeutic Products (OTP), the agency’s cell and gene therapy division, has suffered a significant blow with the sudden placement of director Nicole Verdun and her deputy Rachael Anatol on administrative leave. The move comes amid reports of power consolidation within the FDA.
Verdun, who was appointed to lead OTP in 2023, had been seen as a stabilizing force following the departure of former Center for Biologics Evaluation and Research (CBER) Director Peter Marks in late March. Industry professionals have expressed shock at Verdun’s sudden exit, citing her expertise and commitment to modernizing the FDA’s regulatory approach to cell and gene therapy.
Verdun had disagreed with Marks on several occasions, including over Sarepta’s gene therapy for Duchenne muscular dystrophy, which has been linked to patient deaths. Current CBER Director Vinay Prasad had also expressed disagreement with Marks’ decision-making process, but Verdun was seen as an ally of the current administration.
The placement of Verdun and Anatol on leave has raised concerns about power consolidation within the FDA. Industry observers believe that this move is part of a broader effort to control interactions with industry and consolidate power under the new leadership.
Verdun’s departure has also led to questions about the role of her deputy, Anatol, who had worked closely with Verdun to modernize the FDA’s regulatory approach to cell and gene therapy. The exact reasons for their placement on administrative leave remain unclear, but the move has sparked speculation about the motivations behind it.
As the FDA navigates this period of change, industry experts are urging the new leadership to prioritize transparency and communication with stakeholders. “It is rare that you can blame a single person for a regulatory failure,” said Vinay Prasad, in a statement after Verdun’s departure.
Source: https://www.biospace.com/fda/nicole-verduns-exits-fda-as-cber-director-vinay-prasad-consolidates-power