FDA gene therapy office head Kumar steps down
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- Vijay Kumar, acting director of the FDA's Office of Therapeutic Products, is stepping down from the role that reviews cell and gene therapies, according to an internal email obtained by STAT.
- Kumar wrote that 'the time has come for me to move on,' and said he and Center and Agency leadership mutually decided not to renew his detail.
- CBER Director Vinay Prasad elevated Kumar to director of the Office of Therapeutic Products a little over a year ago after pushing out former director Nicole Verdun.
- Before his promotion, Kumar served as a lead physician in the same cell and gene therapy review office.
- Kumar's exit is the latest move in a broader leadership shake-up at the FDA and what STAT describes as a particularly rocky year of turnover at CBER, the center that houses the gene therapy office.
Why it matters: The departure leaves the FDA's cell and gene therapy review office without a permanent director for the second time in roughly a year — CBER Director Vinay Prasad pushed out Nicole Verdun before elevating Kumar, who is now also leaving. CBER has weathered what STAT describes as a particularly rocky year of turnover at the center overseeing biologics reviews.
