An unusual alliance between conservative health reformers and historically progressive animal welfare groups is celebrating a sweeping federal overhaul that could end the default reliance on animal testing in drug development.
The Food and Drug Administration released a “direct final rule” Monday to clarify what many in the scientific community have long argued: animal testing is not required for all drugs or biological products seeking approval. The rule, scheduled for official publication Tuesday, scraps animal-specific language in federal regulations and replaces terms like “preclinical” and “in vitro” with the broader adjective “nonclinical.”
The change aligns FDA regulations with a 2022 law recognizing non-animal tests and studies “as possible ways to provide the evidence needed to begin studies in people,” according to the agency.
Acting Commissioner of Food and Drugs Kyle Diamantas framed the move as a victory for scientific flexibility. The change “gives scientists and drug developers greater flexibility to use the testing approach that best addresses their scientific question” without trying to replace “one rigid approach with another,” Diamantas said.
The FDA emphasized it’s not eliminating or prohibiting animal studies outright, nor is it changing evidentiary standards or imposing “new costs or requirements on drug developers.” Instead, the agency is removing language “that could suggest that animal testing is the only acceptable way to generate safety information for regulatory decisions in products intended for human use.”
Alongside the rule change, the FDA is launching a database for “New Approach Methodologies,” which includes “AI-powered models, human organ-on-a-chip systems, and real-world data.” The database will start with 25 examples drawn from already public FDA review materials.
Animal welfare organizations wasted no time praising the administration’s actions.
The Center for a Humane Economy and Animal Wellness Action, sibling nonprofit organizations, cheered the FDA for finally removing “archaic” language that “contradicted the plain language” of the nearly four-year-old FDA Modernization Act 2.0.
“This is a long-delayed but highly consequential move by FDA to bring drug-development regulations into the 21st century,” said Wayne Pacelle, president of both organizations.
Zaher Nahle, senior scientific advisor for the Center for a Humane Economy, called the development evidence of “the remarkable convergence taking place towards streamlining scientific discovery, regulatory policy and federal law.”
The National Institutes of Health announced its own parallel efforts Monday, unveiling “five major initiatives” to expand “human-based technologies as the future of preclinical science.” The goal: making research faster, more predictive, and more directly relevant to human health while reducing animal testing “whenever feasible.”
NIH is dedicating $88 million to 10 construction projects for biomedical infrastructure focused on new testing methodologies nationwide. The agency is also developing a “state-of-the-art laboratory” at the NIH Clinical Center to integrate “standardized human organoid models, robotics, AI, and advanced data capabilities to enable experiments on reproducible human biological systems.”
Additionally, NIH is strengthening its review grants for scientific experts on human-based research and soliciting feedback from the scientific community on how feasible it would be to track and report how many “vertebrate animals” are tested each year.
“This is tremendous progress toward a future where animals are no longer the default in biomedical research,” noted one observer.
Nicole Kleinstreuer, NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives, said the agency is taking advantage of new tools and technologies that provide “an unprecedented opportunity to advance research methodologies that more closely reflect human biology.”
Congress has continued pushing in the same direction. Lawmakers passed “3.0” legislation requiring such terminology changes, with the Senate acting last December and the House following two months ago. The chambers’ bills have not yet been reconciled.
