Acting director Vijay Kumar calls his exit a mutual non renewal, a year after his predecessor Nicole Verdun was pushed out under Vinay Prasad, who runs the FDA center that houses the gene therapy office.
The FDA's gene therapy office is about to lose its second director in roughly 14 months. Vijay Kumar, who has run the Office of Therapeutic Products on an acting basis since mid-2025, told STAT he would step down, framing the move as "a mutual non-renewal of my detail with Center and Agency leadership" after "careful reflection."
The Office of Therapeutic Products is the FDA's small review shop for cell and gene therapies, a class of treatments that includes gene-editing medicines, engineered cell therapies for cancer, and a growing pipeline of one-time genetic fixes for rare diseases. Its director is one of the most consequential regulators a sponsor encounters on the way to market, because every cell and gene therapy submission in the United States eventually passes through the office's reviewers.
Kumar's exit follows a familiar pattern. A little over a year ago, then-director Nicole Verdun was pushed out of the same role under Vinay Prasad, the FDA official who runs the broader biologics center that houses the gene therapy office. Prasad elevated Kumar, who had been a lead physician inside the office, into the acting directorship. Now Kumar is leaving too, leaving the office once again without a permanent leader at the top.
In his remarks to STAT, Kumar did not describe any dispute or directive from leadership. He said only that "after careful reflection, I decided the time has come for me to move on." That phrasing leaves the door open on whether the move was voluntary, pressured, or some negotiated blend, a question that matters because the previous transition at the office was, by STAT's prior reporting, not mutual.
The wider FDA picture makes this vacancy harder to read as a routine personnel note. The agency has been working through a turbulent year of turnover, with trade press reporting a leadership overhaul following the reported departure of Commissioner Marty Makary, a pattern law firms have tracked as a practical matter for drug sponsors. Each change at the top of a review office reshapes the practical signals sponsors use to plan their submissions.
For cell and gene therapy developers, the effect is concentrated. The Office of Therapeutic Products is small by FDA standards, and its reviewers handle an entire therapy class whose pipeline has grown sharply over the past several years, a fact Kumar himself highlighted in a PharmaBoardroom interview during his tenure. With a second vacancy at the top, sponsors now face the practical question of who will own the office's priorities during a stretch when several cell and gene therapy decisions are working through the FDA.
What to watch next: whether Prasad names a permanent successor or rotates another acting director in, how Kumar's exit is characterized in any subsequent FDA communication, and whether the broader leadership churn at the agency stabilizes or accelerates. STAT reported the Kumar departure first; the FDA had not, as of the article's publication, named a successor.