Comment from Brinson Jeanie

I strongly support the FDA’s efforts to reduce unnecessary animal testing and encourage continued progress toward modern, scientifically sound alternatives. First, I support the use of Weight of Evidence (WoE) packages whenever appropriate. If a company already has sufficient scientific evidence—including previous studies, human clinical data, published research, and validated non-animal methods—those data should be fully considered before requiring additional animal testing. Repeating studies simply because they were traditionally done on animals is not good science or good ethics. Second, I urge the FDA to ensure that reviewers fully evaluate all available scientific evidence, including human data, published literature, in vitro methods, organ-on-chip technologies, computational models, and other validated non-animal approaches. The best available science should guide regulatory decisions. Third, I encourage the FDA to measure and publicly report whether this guidance is actually reducing unnecessary animal studies. Tracking the number of animal studies avoided, the use of alternative methods, and regulatory outcomes will help determine whether these changes are making a meaningful difference. Fourth, if additional information is needed, companies should be given the opportunity to strengthen or supplement an existing Weight of Evidence package before being required to conduct new animal studies. This approach can prevent unnecessary duplicate testing while still ensuring that FDA decisions remain rigorous and protective of public health. As someone who cares deeply about animal welfare, I believe no animal should suffer when reliable scientific alternatives exist. Beagles and other animals used in research experience fear, pain, and confinement despite having no choice in the matter. Modern science has advanced tremendously, and our regulatory practices should advance with it. I respectfully ask the FDA to continue expanding the acceptance of validated non-animal methods while maintaining the highest standards for safety and effectiveness. Thank you for considering my comments.