HHS, NIH and FDA steps aim to cut unnecessary animal testing, invest in human-based methods

HHS Secretary Kennedy told the press event that the department is taking steps to reduce unnecessary animal testing and to accelerate the adoption of human-based research methods. He said the FDA issued a direct final rule implementing the FDA Modernization Act to broaden non-clinical terminology and allow validated non-animal approaches where appropriate.

"When validated human-based methods can give us better information about human biology, researchers should be able to use them," Kennedy said, adding that NIH will invest more than $88 million in biomedical research infrastructure, support new approach methodology awards and create a new NIH clinical-center laboratory combining standardized human organoids, robotics and AI. Kennedy also cited expected reductions in animal use, saying CDC plans to reduce its laboratory animal colony from approximately 1,400 in 2025 to fewer than 600 in fiscal year 2027 and that FDA changes are expected to spare hundreds of non-human primates and more than a million horseshoe crabs annually.

Kennedy emphasized the change does not ban animal testing but removes unnecessary regulatory barriers when validated alternatives exist and pledged additional investments and validation activities across NIH and ARPA-H.