Vijay Kumar, the acting director in charge of cell and gene therapy at the Food and Drug Administration, will step down from his role after one year, according to a June 30 announcement. The decision for Kumar to vacate the position of acting director of the Office of Therapeutic Products was mutual with leadership at both the Center for Biologics Evaluation and Research and the FDA, Kumar said in an email obtained by STAT News.
Kumar took on the role in June 2025, succeeding former OTP director Nicole Verdun at the request of then-CBER director Vinay Prasad. At that time, it was suggested that Verdun's departure stemmed from disagreements with Prasad. In a memo sent to staff last year, Prasad described Kumar as “a career FDA leader who has an unwavering commitment to accelerating gene and cellular therapy for patients with rare disease.”
Kumar’s appointment surprised some observers due to his extensive medical background but limited management experience within the FDA. Leadership changes have been frequent at CBER; Prasad left his post in May following a tumultuous period marked by controversial decisions such as handling Sarepta Therapeutics’ Duchenne muscular dystrophy treatment Elevidys after patient deaths linked to its gene therapy. Acting director Katherine Szarama succeeded him but remained only three weeks before departing.
Turnover has raised concerns within the biopharma industry about stability at the agency. Both CBER and CDER are now led by acting directors—the sixth leaders for each division since January 2025—with previous ousters including Peter Marks from CBER in March 2025 and Richard Pazdur’s abrupt retirement from CDER in December.
The agency also faces criticism over transparency regarding policy initiatives like last year's Commissioner’s National Priority Voucher program rollout. Stakeholders have called for more information about such programs while urging greater independence for FDA operations.
In response to these challenges, officials say they are working to rebuild staffing levels after losing thousands of employees over the past year. The agency is reportedly seeking around 2,200 new hires to address workload issues and improve workplace culture.
