Trump administration moves to end animal testing requirements for drug safety research

The U.S. Department of Health and Human Services and the FDA launch a coordinated effort to transition away from animal testing in biomedical research. On September 21, 2026, the FDA issues a direct final rule allowing non-animal methods, such as human organoids and AI, to verify drug safety. Backed by HHS Secretary Robert F. Kennedy Jr., the initiative includes over $95 million in NIH funding and a database of alternative testing methods, aiming to modernize drug development while maintaining safety standards.

FDA nonclinical testing rule

• ▪The U.S. Food and Drug Administration's September 21, 2026 rule removes regulatory language suggesting animal testing is the only acceptable way to generate safety information for human drugs.
• ▪The U.S. Food and Drug Administration issued a direct final rule on September 21, 2026, clarifying that non-animal methods can be used to test the safety of human drugs and biological products.
• ▪The U.S. Food and Drug Administration's September 21, 2026 rule replaces terms like "animal tests" and "animal studies" with "nonclinical tests" and "nonclinical studies" in its regulations.
• ▪The U.S. Food and Drug Administration's September 21, 2026 rule does not eliminate animal studies, change evidentiary standards, or impose new costs on drug developers.

New Approach Methodologies adoption

• ▪The U.S. Food and Drug Administration launched a database on September 21, 2026, featuring 25 use-case examples of New Approach Methodologies drawn from public review materials.
• ▪The Advanced Research Projects Agency for Health is investing in artificial intelligence and computational modeling to predict whether medicines will be safe for humans.
• ▪The Centers for Disease Control and Prevention is using non-animal methods in more than a dozen studies to improve public-health threat response capabilities.

HHS animal testing reduction initiatives

• ▪U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. and Agriculture Secretary Brooke Rollins head a new task force to fight animal cruelty.
• ▪The U.S. Department of Health and Human Services announced a series of agency-wide actions on September 21, 2026, to reduce unnecessary laboratory testing on animals.
• ▪Since February 2025, the U.S. Department of Health and Human Services has launched more than 20 initiatives to expand human-based technologies and reduce animal models.

Laboratory animal population statistics

• ▪By 2025, the number of reported research animals in U.S. facilities fell to 751,355, and those in pain-involved procedures fell to 231,003.
• ▪U.S. research facilities reported 851,423 animals in 2021, with nearly 292,000 used in procedures classified as involving pain, according to Department of Agriculture data.

Research animal retirement programs

• ▪The National Institutes of Health announced over $88 million in biomedical infrastructure funding and over $7 million in awards to encourage alternatives to animal testing.
• ▪The National Institutes of Health is allowing grant funding to be used to retire or rehome former research-lab animals after closing its last beagle-testing lab.

Debatable claims

• ▪The U.S. government should phase out animal testing in biomedical research
• ▪Non-animal testing methods are sufficient to ensure human drug safety