Five years after passage of the FDA Modernization Act 2.0, FDA updating its regulations to remove Depression-era animal testing mandate
WASHINGTON, D.C. — The Center for a Humane Economy and Animal Wellness Action today applauds the U.S. Food and Drug Administration for issuing a new rule to strip out archaic language requiring animal testing that contradicted the plain language of the FDA Modernization Act 2.0. Federal drug-screening regulations recognize modern technologies as viable alternatives, including human cell-based systems, organs-on-chips, organoids, sophisticated computer models and other advanced technologies.
FDA said its new rule “removes language that could suggest that animal testing is the only acceptable way to generate safety information for regulatory decisions” involving human drugs and biological products.
The direct final rule replaces terms such as “animal tests” and “animal studies” with the broader terms “nonclinical tests” and “nonclinical studies” throughout key FDA regulations, bringing them into closer alignment with the FDA Modernization Act 2.0, enacted by Congress in 2022. Rulemaking is an important step towards implementing laws at a federal agency like FDA.
“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 the Center for a Humane Economy and Animal Wellness Action. “The agency knocking down outdated regulatory language propping up ineffective animal testing strategies put new methods rooted in human biology. Over time, we’ll see better, safer, less costly drugs that help people struggling with disease.”
FDA also announced a new database containing 25 examples of New Approach Methodologies, or NAMs, drawn from publicly available FDA review materials, giving drug developers practical examples of how these technologies have already been used in the regulatory process.
FDA Action Part of Broader HHS Shift Toward Human-Based Research
FDA’s action comes as the U.S. Department of Health and Human Services (HHS) today announced a coordinated department-wide effort to accelerate human-based research and reduce reliance on animal testing across its agencies. HHS says FDA, the National Institutes of Health, the Centers for Disease Control and Prevention and the Advanced Research Projects Agency for Health have launched more than 20 initiatives aimed at modernizing how the federal government conducts, funds and evaluates biomedical research.
The effort positions HHS as a central hub for a broader transformation in federal biomedical research, bringing together regulatory reform at FDA, research funding and infrastructure at NIH, changes in federal laboratory practices at CDC, and investments in artificial intelligence and computational technologies through ARPA-H.
NIH today announced more than $88 million in biomedical infrastructure investments supporting human-based research and plans for a new laboratory at the NIH Clinical Center combining human organoids, robotics, artificial intelligence and advanced data capabilities. NIH also announced efforts to add scientists with human-based research expertise to its grant-review process and issued a request for information on the feasibility of annually reporting the number of live vertebrate animals used at NIH-funded institutions.
HHS is bringing research policy, regulatory policy, federal investment and emerging technologies together around a new vision for biomedical science centered on human biology rather than reliance on animal models.”
FDA Action Closely Tracks FDA Modernization Act 3.0
Today’s action closely parallels the bipartisan FDA Modernization Act 3.0 passed by the Senate in December 2025, and by the House in July. FDA Modernization Act 3.0 was designed to finish the work Congress began with FDA Modernization Act 2.0
“Congress changed the law in 2022, and today FDA has taken a major step toward making its regulations finally reflect that change,” said Tamara Drake, director of research and regulatory policy for the Center for a Humane Economy.
Notably, FDA’s rule and FDA Modernization Act 3.0 are not identical, a further impetus to advance the legislation in Congress, as planned. One legacy over-the-counter drug regulation specifically identified in the House bill is not amended by today’s rule, and 3.0 contains a statutory technical correction that FDA cannot make through regulation.
“FDA’s action today demonstrates the remarkable convergence taking place towards streamlining scientific discovery, regulatory policy and federal law,” said Dr. Zaher Nahle, senior scientific advisor for the Center for a Humane Economy.
Today’s action builds on FDA’s April 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies and subsequent agency initiatives aimed at expanding the development and regulatory use of NAMs. The Center and AWA led efforts to enact the FDA Modernization Act 2.0 and spearheaded congressional efforts to enact FDA Modernization Act 3.0.