Vijay Kumar, the acting head of the FDA office that oversees new gene therapies, is stepping down from his role after a year in the job.
As Kumar’s tenure atop the Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) wraps up, “we look forward to his continued service and expertise within the agency,” Emily Hilliard, senior press secretary for the Department of Health and Human Services, told Fierce in a statement.
Acting CBER Director Karim Mikhail “will assume direct oversight of OTP” during the leadership transition, Hilliard added.
“The agency remains fully committed to maintaining our rigorous review timelines and will soon advertise the permanent director position both internally and externally,” she said.
Kumar’s departure was first reported by STAT News.
After serving at CBER for more than five years, Kumar was promoted to acting head of OTP by former CBER Director Vinay Prasad, M.D., who himself departed the FDA at the end of April after a controversial tenure that saw many applications for rare disease medicines shot down.
Under Mikhail, many of these decisions are starting to be reversed.
Prasad was followed out the door not long after by his boss, FDA Commissioner Marty Makary, M.D. Acting FDA leader Kyle Diamantas has since cleared out the agency’s leadership ranks of many Makary appointees, including Mikhail’s predecessor Katherine Szarama, Ph.D., and Tracy Beth Høeg, M.D., Ph.D., acting head of the Center for Drug Evaluation and Research.