The Trump administration has missed its September 2 deadline to finalize new federal rules restricting gain-of-function (GOF) research, more than eight weeks past the due date established by executive order.
The delay has prompted concern among biosafety experts and reopened debate within the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) over the handling of high-risk biological research.
The May 2025 executive order required a multi-agency task force to develop updated policies governing the creation and manipulation of pandemic-level pathogens.
The initiative was intended to prevent research similar to pre-COVID experiments funded by NIH at the Wuhan Institute of Virology.
“The atom has been split in biology with COVID, but nobody seems to be talking about it with urgency,” said Sean Kaufman, CEO and founding partner of Safer Behaviors, a biosafety consulting firm.
The policy dispute has placed HHS Secretary Robert F. Kennedy Jr., a longtime critic of NIH funding for Wuhan research, at odds with NIH Director Jay Bhattacharya.
Bhattacharya has faced criticism from both inside and outside the agency for mixed public statements on the GOF issue and for retaining officials linked to Anthony Fauci’s former research oversight network.
Hellbound and Down 