The U.S. Food and Drug Administration (FDA) has announced a significant shift in drug development, aiming to replace animal testing with more effective, human-relevant methods. This move is designed to enhance drug safety, accelerate evaluations, and reduce both animal experimentation and R&D costs, ultimately lowering drug prices.
The FDA’s new approach will reduce, refine, or replace animal testing through New Approach Methodologies (NAMs), including AI-based computational models and human cell/organoid toxicity testing. The agency will also utilize pre-existing, real-world human safety data from countries with comparable regulatory standards. Implementation begins immediately for investigational new drug applications, with a roadmap outlining the transition.
FDA Commissioner Martin A. Makary emphasized the paradigm shift, stating the initiative promises to accelerate cures while reducing animal use. He highlighted the benefits of AI modeling, human organ-based lab testing, and real-world human data for safer, faster, and more reliable treatments.
Key components of the plan include advanced computer simulations to predict drug behavior, the use of human-based lab models like organoids to mimic human organ responses, and regulatory incentives for companies using non-animal testing. This shift is expected to expedite drug development, enabling faster access to therapies without compromising safety.
The FDA aims to solidify its global leadership in regulatory science, promoting humane testing methods. By partnering with agencies like the NIH and the Department of Veterans Affairs, the FDA will accelerate the validation and adoption of these methods. A public workshop is planned for stakeholder input, and a pilot program will allow select developers to use primarily non-animal-based testing strategies.
Commissioner Makary emphasized the far-reaching impact, noting improved treatment pipelines, enhanced safety through human-based test systems, and a significant reduction in animal use. This initiative marks a major step towards modernizing drug evaluation and promoting ethical, efficient healthcare.