FDA, NIH Officials Look To Curb Animal Testing in Drug Development

At a joint workshop, the FDA and NIH outlined efforts to reduce animal testing in drug development, emphasizing a shift toward New Approach Methodologies (NAMs) like computer simulations, AI, organoids, and organ-on-a-chip technologies. FDA Commissioner Marty Makary stressed the ethical and scientific importance of this transition, noting that animal testing often fails to predict human outcomes—over 90% of drugs passing animal trials don’t gain FDA approval.

Despite this, traditional practices persist due to industry habits and misconceptions about NAM validation. FDA officials said they are encouraging NAMs for certain tests, like skin irritation and pyrogenicity, and developing standards to support broader adoption. In oncology, the FDA now allows alternatives to some animal studies if scientifically justified.

NIH announced it will no longer fund research that relies solely on animal models, urging applicants to include NAMs in proposals. Both agencies emphasized the need to modernize testing while maintaining drug safety and public health.