STAT+: FDA and NIH announce more initiatives to reduce animal testing in drug development

FDA and NIH move to cut animal testing from drug development — with $150M and new guidance

The Department of Health and Human Services on Wednesday announced its most concrete steps yet toward reducing the pharmaceutical industry's reliance on animal testing, releasing new industry guidance and committing more than $150 million in research grants aimed at replacing traditional animal studies with methods that better reflect human biology.

The FDA released guidance designed to help drug companies explore non-animal approaches to assessing safety and efficacy — the latest implementation of the agency's "Roadmap to Reducing Animal Testing in Preclinical Safety Studies" first announced in April 2025. The NIH said it has directed more than $150 million in grants to institutions developing new approach methodologies (NAMs) — a category that includes organ-on-a-chip systems, AI-driven in silico models, and advanced in vitro assays.

The effort builds on a series of regulatory and legislative steps over the past year. In April 2025, the FDA said it would begin phasing out animal testing requirements for monoclonal antibodies. In December 2025, the agency issued a draft guidance offering ways to reduce the use of nonhuman primates in mAb toxicity studies after the initial three-month testing period. Separately, the FDA Modernization Act 3.0 — approved by the Senate in December 2025 — is currently awaiting House action and would require the FDA to update its regulations so they no longer default to animal tests, replacing those references with nonclinical methods.

Not everyone sees NAMs as a straight replacement for animal studies. Matthew R. Bailey, president of the National Association for Biomedical Research, told Healio that new approach methodologies and animal studies should be considered part of a continuum rather than competitors. "These NAMs currently cannot replace a full living system in preclinical research and testing for new drugs and biologics," he said. "They are most effective when used in combination with in vivo research and testing methods."

Dr. Lena Smirnova, an assistant professor at Johns Hopkins University, called the FDA's April 2025 announcement "a clear signal that the agency wants human-relevant evidence to increasingly replace or reduce certain traditional animal studies." She said FDA Modernization Act 3.0 adds a critical regulatory alignment piece by requiring the agency to update its regulations so they no longer read as if animal tests are the default legal requirement.

For biological drugs in particular, the scientific case for change has been building. Sarfaraz K. Niazi, an adjunct professor at the University of Illinois and founder of the biosimilar company Adello Biologics, noted that more than 90 percent of drugs that appear safe and effective in animal models ultimately fail in human trials. "This decision is not simply about ethics, speed or cost," he said. "It is about scientific relevance."

The shift has also attracted investment in new infrastructure. The NIH established the Office of Research Innovation, Validation, and Application (ORIVA) in 2025 to coordinate development and scaling of non-animal approaches across its portfolio. The agency also said it will no longer fund research projects that rely solely on animal testing.

The $150 million in NIH grants represents the largest single funding commitment to NAMs research to date. Which institutions received the grants and what specific methods they are developing were not immediately disclosed.