Vijay Kumar, acting director of CBER’s Office of Therapeutic Products, will leave his role at a tumultuous time for the FDA.
The FDA’s acting director in charge of cell and gene therapy, Vijay Kumar, will step down from his role at the agency one year after entering the position.
The move marks another instance of leadership churn at the FDA that has characterized the past year and a half. Kumar’s decision to vacate the role of acting director of the Office of Therapeutic Products (OTP) was mutual with the Center for Biologics Evaluation and Research (CBER) and FDA leadership, Kumar said in an email obtained by STAT News.
Kumar stepped into the position in June 2025, replacing former OTP director Nicole Verdun at the behest of former CBER director Vinay Prasad. It was suggested at the time that Verdun was ousted due to disagreements with Prasad.
Prasad in a memo sent to staff last year called Kumar, who was previously a lead physician at the OTP a “career FDA leader who has an unwavering commitment to accelerating gene and cellular therapy for patients with rare disease.”
Kumar was considered a surprise pick to lead the OTP with his experience reflecting an exceptional career in medicine but little FDA management experience, according to Citeline at the time of his appointment.
Prasad himself left CBER in May following a tumultuous incumbency that included a temporary departure in July 2025 and controversial decisions, including the market status of Sarepta Therapeutics’ Duchenne muscular dystrophy treatment Elevidys after the deaths of two non-ambulatory patients linked to the gene therapy. He was succeeded by acting director Katherine Szarama, who had served as Prasad’s deputy, but she lasted just three weeks before also hitting the exit.
Turnover at the FDA has been a cause for concern in the biopharma industry, with many pointing to ousters like those of former CBER director Peter Marks in March 2025 and the abrupt retirement of CDER director Richard Pazdur in December as signals of a regulator in turmoil. Both divisions are on their sixth directors since President Donald Trump took office in January 2025, and both currently chiefs are serving in an acting capacity.
The agency has also come under fire for a lack of transparency around policy moves, including the introduction and roll-out of the Commissioner’s National Priority Voucher program last year that has stakeholders requesting more information from leadership.
Now, the agency is attempting to steer the ship in another direction, actively seeking to fill its ranks after losing thousands of staffers over the last year. Officials have said the agency is looking to hire about 2,200 for its workforce in an effort to shore up an uneven workload, as well as heighten culture and morale.
