In addition to NAVS’ recent comments to the NIH and the FDA regarding cosmetics, NAVS also submitted comments to the FDA regarding the agency’s draft guidance on the use of “New Approach Methodologies” (NAMs) in drug development.
This FDA guidance is especially important because it could shape how quickly and broadly non-animal methods are accepted in the regulatory process for new drugs. The guidance has the potential to influence whether NAMs become true replacements for animal testing or are merely added on top of existing animal-based requirements.
In its comments, NAVS urged the FDA to take stronger action to accelerate the transition away from animal testing and toward more scientifically relevant, human-based methods. NAVS emphasized that animal models have well-documented scientific limitations and often fail to accurately predict human responses to drugs. We argued that the FDA should explicitly recognize these limitations rather than continuing to treat animal testing as the default standard.
NAVS also called on the FDA to ensure that NAMs are not subjected to unfair validation requirements that are more demanding than those historically applied to animal tests. The comments stressed that human relevance—not the ability to replicate animal data—should be the central standard for evaluating scientific methods.
In addition, NAVS urged the FDA to establish measurable timelines and goals for replacing animal studies in areas where effective NAMs already exist. The organization warned that without clear accountability, non-animal methods risk being used only as supplementary tools while animal testing continues unchanged.
Finally, NAVS called on the FDA to eliminate unnecessary duplicate animal testing. The comments emphasized that requiring animal studies alongside scientifically adequate NAMs data perpetuates outdated testing paradigms, delays innovation, increases costs, and causes avoidable animal suffering.
Through these comments, NAVS is advocating for a regulatory system that prioritizes modern, human-relevant science while accelerating the replacement of animal testing in drug development.
