Comment from Michael McCue

Dear FDA , I am writing to you as a concerned citizen from Louisville Kentucky. The continued reliance on animal models in basic biomedical research is one of the most important scientific and ethical issues of our time, and I believe your leadership can help drive real progress in the United States. Recent information obtained under Freedom of Information from the UK Government in 2023 has confirmed a startling fact: the entire process of animal testing has never been scientifically validated. Even more concerning, the widely promoted “3Rs” framework (Replacement, Reduction, Refinement) — which is supposed to govern animal use worldwide — has also never been scientifically validated as an effective or reliable approach. Despite this, governments and research bodies continue to justify the use of animals for patient and product safety and for basic research. This is no longer tenable. A new Technical Feasibility Briefing (attached) demonstrates that a complete, phased replacement of animals in basic biomedical research is not only possible — it is fully achievable within 24 months. The briefing shows: •The shift to modern non-animal methods (NAMs) is the 21st-century equivalent of the digital revolution, but moving far faster because the core technologies are already mature. •Human iPSC organoids, vascularised multi-organs-on-chips, generative AI trained on decades of archived data, PBPK/QSP modelling, and VR/AR simulators can deliver faster, more accurate, and more human-relevant results. •90–96% of current procedures already use rodents and fish, and all historical animal data is permanently preserved in FAIR-compliant public repositories — meaning zero loss of foundational scientific knowledge. •With focused effort, upskilling, infrastructure changes (converting animal facilities into NAM hubs), and redistribution of funding, the transition can be completed without disrupting discovery rates. The benefits of making this change are profound: •Faster and more reliable scientific progress •Major economic and innovation advantages in the global biotech race •Genuine human-relevant data instead of species-specific artefacts •Significant ethical advancement •Better return on public research funding I have attached the 24-month roadmap for full replacement. I hope for a response that addresses these specific technological milestones and the UK FOI admission, rather than a generic statement about the 3Rs or current regulation. As a government representative, I respectfully ask you to: 1.Acknowledge the UK Government’s 2023 FOI admission that animal testing and the 3Rs have never been scientifically validated. 2.Read the attached briefing and champion a 24-month transition plan to non-animal methods in basic research in the U.S. 3.Push for the immediate redirection of research funding toward mature NAM technologies and the necessary infrastructure and training changes. Thank you for taking the time to consider this important issue. Your action on this could help accelerate a true modernisation of life sciences worldwide. Yours sincerely, Michael McCue Michael.A.McCue@gmail.com