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.
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Although the 120-day deadline passed several weeks ago, a government shutdown over budget disputes delayed work on the final policy by roughly a month.
The administration has not provided a revised completion timeline.
Bhattacharya, speaking at the White House signing ceremony for the executive order in May, said the policy would “make it go away forever.”
However, in an August podcast he appeared to temper that stance, saying the new regulations would involve “a calculation” because GOF work is “sometimes really important.”
Emails described to the Daily Caller News Foundation by two former federal officials show that two NIH staffers who helped draft the 2017 pre-pandemic GOF policy—under which federal funds flowed to Wuhan—are also involved in writing the Trump-era version.
Those earlier rules, which critics said were overly permissive, limited oversight to a small number of projects and allowed internal review panels to operate in secret.
Some policy analysts have also raised questions about the scope of the May order, noting that it delegates significant authority to agency heads and allows for only a five-year research funding ban for violations—half the maximum debarment period typically applied by HHS.
🚨 BREAKING: In a jaw-dropping development, DNI Tulsi Gabbard has confirmed an official probe into Anthony Fauci for perjury and his role in funding gain-of-function research at the Wuhan Institute of Virology, as part of efforts to uncover the origins of COVID-19. pic.twitter.com/jGjH6GyELe
— MAGA ARMY (@MAGAARMY_) October 30, 2025
A spokesperson for HHS referred all questions to the White House.
The delay also coincides with several high-level staffing changes. Gerald Parker, who led the executive order’s drafting as head of the White House Office of Pandemic Preparedness and Response Policy, stepped down over the summer for personal reasons.
The OSTP has since brought in Anna Puglisi, a former U.S. counterintelligence official with expertise on Chinese technology and biosecurity issues.
Puglisi’s views on GOF remain unclear; in a 2023 interview with Nature, she said regulators must weigh “the true risk for both not regulating it and over-regulating.”
Puglisi did not respond to requests for comment.
Following an August DCNF report alleging that one of Bhattacharya’s advisors had supported GOF research and opposed President Trump, the NIH dismissed two advisors.
The status of the advisor who backed GOF work remains unclear.
Lyric Jorgenson, the NIH associate director for science policy and the agency’s lead on drafting the GOF framework, previously oversaw the Biden-Harris administration’s GOF policy—criticized by Bhattacharya last year as inadequate.
Meanwhile, HHS recently dissolved a biosecurity office within the Administration for Strategic Preparedness and Response, consolidating more authority under NIH’s science policy division.
Bhattacharya has continued to defend his appointment of virologist Jeffrey Taubenberger to lead the National Institute of Allergy and Infectious Diseases.
Taubenberger, a longtime advocate for GOF research, is advising on the current policy and is expected to play a key role in its implementation.
🎙️ On the latest episode of The Director’s Desk, I sat down with Dr. Jeffery Taubenberger, Acting Director of @NIAIDNews, to discuss the groundbreaking research that @NIH supports that is shaping the fight against infectious, immunologic, and allergic diseases.
Watch our… pic.twitter.com/xDq6RAyxsq
— Jay Bhattacharya, MD, PhD (@NIHDirector_Jay) August 12, 2025
The debate over GOF oversight dates back to 2016, when the Obama administration attempted to impose stricter external review standards on federally funded pathogen research.
According to a former NIH official, the agency resisted that plan and advanced its own framework, which preserved decision-making power within HHS.
Emails released in 2025 through Freedom of Information Act requests show that NIH officials were aware as early as 2016 that coronavirus-related GOF research would take place in Wuhan but conducted no national security review beyond a “letter of support” from University of North Carolina researcher Ralph Baric.
As a result, NIH approved experiments that later became central to global scrutiny following the COVID-19 pandemic, which has been linked to more than 7 million deaths worldwide.
Biosafety experts including Alina Chan, coauthor of Viral: The Search for the Origin of COVID-19, and MIT biologist Kevin Esvelt have urged the administration to ensure independent oversight rather than allowing NIH to self-regulate.
“The new policy must implement some form of independent oversight so that catastrophic research is not self-regulated,” Chan told the DCNF.
The White House has not said when the delayed GOF policy will be finalized. Until it is, federal agencies remain under the 2017 framework that critics say failed to prevent risky pandemic-related research abroad.
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