STAT+: FDA’s top gene therapy regulator is leaving his role

STAT PlusExclusive FDA’s top gene therapy regulator is leaving his role Vijay Kumar took over after Vinay Prasad tried to fire Nicole Verdun Manage alerts for this article Email this article Share this article By Lizzy LawrenceJune 29, 2026 FDA Reporter Lizzy Lawrence[email protected]Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53. WASHINGTON — Vijay Kumar, acting director of the office that reviews cell and gene therapies at the Food and Drug Administration, is stepping down from his role, according to an email obtained by STAT. “After careful reflection, I decided the time has come for me to move on,” Kumar wrote. “I discussed with Center and Agency leadership; we mutually decided not to renew my detail.”Advertisement Kumar’s departure follows a broader leadership shake-up inside the agency and a particularly rocky year of turnover in the Center for Biologics Evaluation and Research where the cell and gene therapy office is housed. CBER Director Vinay Prasad promoted Kumar to director of the Office of Therapeutic Products after pushing former director Nicole Verdun out of the role a little over a year ago. Before that, Kumar was a lead physician in the office. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In biotechnology, FDA, Pharmaceuticals, Policy, STAT+ Submit a correction requestReprints Lizzy Lawrence FDA Reporter Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53. Newsletter Your morning rundown of the science, politics, and money driving biotech today Recommended Biotech June 30, 2026 STAT Plus: AI company Anthropic announces it will begin developing drugs of its own Biotech June 30, 2026 STAT Plus: Anthropic releases Claude Science, a product aimed at researchers, the pharma industry Advertisement The Readout June 30, 2026 STAT Plus: Investors double down on Bain-backed startup Health Tech Newsletter June 30, 2026 STAT Plus: FDA digital leader hints at coming AI policy updates Biotech June 30, 2026 STAT Plus: Abivax seeks to ease safety concerns with new data, boosting shares Subscriber Picks