FDA Gene and Cell Therapy Review Chief Vijay Kumar to Step Down as Acting Director
Vijay Kumar, Acting Director of the Office of Gene and Cell Therapy Review at the FDA's Center for Biologics Evaluation and Research (CBER), will step down, with CBER Acting Director Karim Mikhail temporarily taking over the position to ensure regulatory continuity. Kumar will remain at the FDA. This change occurs during a period of high-level personnel instability at the FDA, following the resignation of Commissioner Marty Makary, the departure of CBER Director Vinay Prasad, and the dismissal of CDER Director Tracy Beth Høeg. Kumar's office reviewed experimental therapies from companies such as Uniqure, Regenxbio, and Atara Biotherapeutics, and his departure may impact the direction of rare disease drug review policies.
At a Glance
- Another senior drug review official at the U.S. Food and Drug Administration (FDA) is about to step down. According to an agency spokesperson confirmed on Tuesday (June 30), Vijay Kumar, acting director of the Office of Gene and Cell Therapy Review under the Center for Biologics Evaluation and Research (CBER), plans to leave that position.
- CBER Acting Director Karim Mikhail will also serve as acting director of the Office of Therapeutic Products to ensure absolute continuity in regulatory work. The FDA will seek a permanent candidate for the position both within and outside the agency. Kumar himself will remain at the FDA, having previously been promoted from chief medical officer to acting director.
- Kumar's decision to step down comes amid FDA personnel turmoil. Previously, Commissioner Marty Makary resigned, CBER Director Vinay Prasad also departed, and Center for Drug Evaluation and Research (CDER) Director Tracy Beth Høeg was removed. Currently, several senior positions at the agency are held by interim appointees, and it is unclear when permanent appointments will be made.
In-Depth Analysis
During Vinay Prasad's tenure as CBER director, the review of cell and gene therapies and vaccines received particular attention, as he had questioned the evidence supporting the approval of these therapies.
The "therapeutic products" division that Kumar oversaw is precisely the core department reviewing these cutting-edge therapies. The division has been at the center of controversies over the review of experimental products from companies such as Uniqure, Regenxbio, and Atara Biotherapeutics.
With the FDA reversing several negative decisions, there are signs that the post-Makary FDA may be more favorable to pharmaceutical companies—especially in the rare disease field. Previously, the FDA had shown greater flexibility in this area due to the limited number of patients that can be recruited for rare disease clinical trials.
Kumar's departure was first reported by Stat News. He assumed the position after former director Nicole Verdun and her deputy Rachael Anatol left, an event that itself occurred following the resignation of the widely respected former CBER director Peter Marks.
Emily Hilliard, senior press secretary at the U.S. Department of Health and Human Services (HHS), said in a statement that Kumar's appointment was an "interim acting arrangement" and expressed that "we look forward to his continued service and expertise within the agency."
Hilliard also stated: "The FDA remains fully committed to maintaining rigorous review timelines and will soon post announcements for the permanent director position both within and outside the agency."