Updated
Updated · STAT · Jun 29
FDA Gene Therapy Chief Vijay Kumar Steps Down After 1 Year Amid Leadership Shake-up
Updated
Updated · STAT · Jun 29

FDA Gene Therapy Chief Vijay Kumar Steps Down After 1 Year Amid Leadership Shake-up

3 articles · Updated · STAT · Jun 29

Summary

  • Vijay Kumar, the acting head of the FDA office reviewing cell and gene therapies, said he will leave after agency leadership mutually decided not to renew his detail.
  • Kumar wrote that he chose to move on after "careful reflection," framing the exit as a personal decision reached with center and agency leaders.
  • The departure adds to a turbulent year inside the Center for Biologics Evaluation and Research, where turnover has already hit the cell and gene therapy office.
  • Vinay Prasad had elevated Kumar to lead the Office of Therapeutic Products a little over 1 year after pushing out former director Nicole Verdun, underscoring the broader FDA leadership reshuffle.

Insights

As another top director departs, is the FDA's ability to regulate revolutionary medicines on the verge of collapse?
With FDA leadership in constant flux, will the approval of life-saving gene therapies be dangerously delayed?