FDA and NIH announce more initiatives to reduce animal testing in drug development
The agencies released new industry guidance and research grants
March 18, 2026
Excerpts:
WASHINGTON — The Department of Health and Human Services on Wednesday announced several initiatives to try to reduce reliance on animal testing in drug development.
The Food and Drug Administration released draft guidance meant to help drug companies explore new ways to assess the safety and efficacy of their products without using animals. And the National Institutes of Health said it has offered more than $150 million to institutions working on new research methods that better simulate human biology.
HHS has made reducing animal testing a priority over the past year. In April 2025, the FDA announced it would phase out the animal testing requirement for monoclonal antibodies. A few months later, the NIH said it would no longer fund research projects that rely solely on animal testing.
Researchers have historically tested their products in animals before moving onto human clinical trials, but recent studies have shown that the majority of drugs that work on animals are ultimately not proven to work on humans. This can lead to increased research costs, and unnecessary cruelty towards animals, activists say.
Scientists have slowly started transitioning towards other types of preclinical tests, testing products with artificial intelligence or lab-grown cell structures intended to mimic certain organs. But HHS wants to jumpstart the process.
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Biomedical research group Americans for Medical Progress said the FDA and NIH should not discount animal testing in cases where such research is necessary.
“A balanced approach that integrates new tools without prematurely sidelining established models will be critical to maintaining both scientific rigor and patient safety,” said Naomi Charalambakis, director of communications and science policy at AMP.
Lizzy Lawrence, FDA Reporter, STAT
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