Handbrake turn at FDA as Vinay Prasad returns to CBER

Vinay Prasad has returned to lead the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research, resuming responsibility for oversight of vaccines, gene therapies and blood products. His reinstatement comes just over a week after stepping down from the role, which he first assumed in May.

Dr Prasad’s first tenure at the biologics division unfolded under significant political pressure. His resignation in July followed calls from the White House for him to step down, alongside public criticism from right-wing activist Laura Loomer over his regulatory record.

Regulatory and political backdrop