Phase-out of Animal Studies Requirement for Investigational New Drug Applications
FDA's announcement brings mixed reactions from regulators, industry, public, and the medical community
The FDA Modernization Act 2.0, which was signed into law in December 2022, removed a statutory requirement that animal testing be conducted on a proposed drug before the drug is tested on humans in a clinical trial. Until now, the FDA had not acted on that legislative change.
On April 10, 2025, FDA commissioner Martin Makary announced that the FDA has a plan to encourage the use of New Approach Methodologies (NAMs), such as AI-driven computational models, organoids, and organ-on-a-chip systems for Investigational New Drug Applications (INDs) for safety testing and will no longer mandate animal testing in “preclinical” (before human clinical trials) safety studies.
The agency will also begin using pre-existing, real-world safety data from other countries with regulatory agencies similar to the FDA. The plan was outlined in a roadmap, with an initial focus on encouraging NAMs for monoclonal antibody therapies, and eventually expanding the use of NAMs for all types of drugs.
FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs: Press release by Martin Makary, April 10, 2025
The press release includes the “Key Benefits of Replacing Animal Testing in Monoclonal Antibody Safety.”
The roadmap (11 pages): FDA Roadmap for New Safety Testing Methods
Explanation of monoclonal antibody therapy at Cleveland Clinic.
Mixed Reactions to Animal Testing Announcement
Reactions from the public, medical, and research communities are mixed. The Regulatory Affairs Professionals Society (RAPS) reports that The People for the Ethical Treatment of Animals (PETA), the Animal Wellness Action, and the Physicians Committee for Responsible Medicine have all expressed support for the change. On the other hand, The National Association for Biomedical Research (NABR) said in a press release that there is “no full replacement” for animal models in drug development and biomedical research.
Tyler Vandivort, associate director and regulatory lead at UCB Biopharma, said the actions are “well aligned with recent steps” taken by other regulatory entities such as the Environmental Protection Agency and European Medicines Agency.
RAPS: FDA seeks to reduce animal testing requirements for mAbs, other drugs
Dr. Irving Kent Loh, a preventive cardiologist and the director of the Ventura Heart Institute in Thousand Oaks, says caution is needed. He expressed his concerns about the FDA’s plan in a USA Today opinion column:
USA Today: Caution needed before phasing out animal testing of new medications
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