Dive Brief:
- The Food and Drug Administration is losing another top drug reviewer in Vijay Kumar, who intends to step down as acting director of the office of gene and cell therapy reviews in the Center for Biologics Evaluation and Research, a spokesperson said Tuesday.
- Acting CBER Director Karim Mikhail will serve as the acting director of the Office of Therapeutic Products “to ensure absolute regulatory continuity” while the FDA seeks candidates for the role within and outside the agency, the spokesperson said. Kumar will remain with the FDA, having been elevated to the acting director role from his position as lead physician.
- Kumar’s decision comes amid personnel turbulence at the FDA, following the resignation of former Commissioner Marty Makary and CBER Director Vinay Prasad, along with the firing of Tracy Beth Høeg as director of the Center for Drug Evaluation and Research. Multiple top-level positions at the agency are staffed by officials in time-limited acting roles, without a clear indication when they will be filled permanently.
Dive Insight:
Reviews of cell and gene therapies as well as vaccines were under a particular spotlight during Prasad’s tenure, challenging the evidence that has been used to support their approvals.
Kumar’s division overseeing “therapeutic products” was responsible for the review of these more cutting-edge therapies, which have been front and center in the controversies over the review of experimental products from Uniqure, Regenxbio and Atara Biotherapeutics.
With the FDA reversing course on several negative decisions, there are signs that the post-Makary era will be more amicable to drugmakers — particularly those working in rare diseases, where the agency previously had been more flexible because of the small numbers of available patients to enroll in clinical trials.
Kumar’s decision was first reported by Stat. He was appointed to the role after the departure of previous director Nicole Verdun and deputy Rachael Anatol, an event that itself followed the resignation of the widely respected CBER director Peter Marks.
In a statement, HHS senior press secretary Emily Hilliard called Kumar’s tenure a “temporary acting detail” and added, “We look forward to his continued service and expertise within the agency.”
“The agency remains fully committed to maintaining our rigorous review timelines and will soon advertise the permanent Director position both internally and externally,” Hilliard said.
