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How are US organisations that promote animal research responding to recent developments?

Recent developments in the US have taken us all by surprise, not only because they were unanticipated, but also due to their breadth and ambition. First the Food and Drug Administration (FDA) declared its plans to replace the use of animals with human-based approaches in the development of monoclonal antibody therapies and other drugs,¹ then the Environmental Protection Agency (EPA) stated that it planned to reinstate a deadline to eliminate the use of mammals in testing by 2035,² and the National Institutes of Health (NIH) announced the formation of a new department dedicated to expanding human-based science and reducing animal use³.

This was followed by a statement from the US Navy that it will end its research on cats and dogs.⁴ The most recent announcement, during a workshop held by the FDA and the NIH, was that all new NIH funding opportunities will henceforth incorporate language encouraging consideration of non-animal, new approach methodologies (NAMs) and that proposals exclusively for animal models will no longer be funded.⁵So, how are the US organisations that promote and advocate for animal research responding to these developments?

We searched online for these organisations, explored their websites for statements or letters responding to these developments and analysed the responses. We found four organisations: the National Association for Biomedical Research (NABR), Americans for Medical Progress (AMP), the Foundation for Biomedical Research (FBR) and the Federation of American Societies for Experimental Biology (FASEB), all of which advocate for the use of animals in biomedical research, focusing in varying degrees on education, outreach and policy. Table 1 shows the number and type of response, all of which were presented as news items on the organisations’ websites.

Table 1: Responses from US organisations advocating for the use of animals in biomedical research

Four overarching themes emerged from the responses:

Theme 1: Animal studies have been and continue to be essential

Two organisations mentioned the use of animals historically, with the National Association for Biomedical Research (NABR) stating, ‘From vaccines to cancer therapies to insulin, research involving animals has played a key role in nearly every major medical advance of the past century’ and Americans for Medical Progress (AMP) recommending ‘public education about the critical role of animal models in human health discoveries, including the important roles of long-lived non-rodent mammals for translation’. Three organisations stated that animal research remains necessary: to ensure that new drugs and treatments are safe and effective for humans (NABR), for public health (AMP), and for improved understanding of human health and the translation of knowledge into clinical interventions (Federation of American Societies for Experimental Biology, or FASEB). AMP suggested that the FDA’s plan to phase out animal testing for monoclonal antibody therapies was enabled by progress brought about by animal research.

Theme 2: Concerns about NAMs

The organisations raised four main concerns relating to NAMs, the first being that NAMs cannot fully replace animals. NABR, AMP and FASEB claimed that this was not possible because NAMs were not yet capable of replicating ‘the full spectrum of whole-body physiological processes’ or capturing the temporal aspects of disease such as onset, latency, and progression. FASEB stated that drug development requires an understanding of the complex, interacting processes across organ systems, and that the investigation of chronic illnesses and neurodegenerative disorders requires research with living systems, meaning animals remain essential. FASEB stated that while combinations of different NAMs are often proposed as the solution, these still face technical challenges.

NABR, AMP and FASEB all stated that NAMs and animal studies are complementary and that NAMs should not be viewed as replacements for animal studies. NABR wrote, ‘We support innovation and the responsible integration of scientifically validated approaches, such as artificial intelligence, organ-on-chip systems and cell-based assays, as adjuncts.’ (our italics) AMP argued that animal studies and NAMs should operate collaboratively as ‘complementary partners, not competitors’ and that animal studies ‘play a critical role in informing the development, refinement, and validation of NAMs’. FASEB stated that ‘reviews into the current state of biomedical methodologies repeatedly highlight the continued need for animal studies alongside development of NAMs’.

Two organisations focused on the need for NAMs to be scientifically rigorous, validated and well reported. AMP highlighted the need for better reporting, rigorous validation of NAMs’ ability to consistently replicate the complexity of living systems and a NAMs ‘Rigor and Reproducibility Task Force’. FASEB emphasised the need for NAMs to consistently demonstrate reproducibility, biological relevance, and translational utility across a range of experimental and disease contexts, for their limitations to be acknowledged, for assessment on a case-by-case basis to ensure scientific rigor and safety, and for timelines to reflect the need to conduct validation work.

Two organisations raised specific concerns about AI, noting that AI depends on the data it is trained on. NABR suggested that unknown variables might present the biggest risk, while FASEB stated that the data fed into AI is ‘often only available from animal research and (is) currently missing for many active areas of research’.

Theme 3: Concerns about specific aspects of plans and proposals

Several concerns were raised about specific aspects of the proposed changes. AMP was particularly concerned about the new plans for reviewing funding and wanted assurance that proposals involving animals would be evaluated fairly. The organisation was concerned that changes to the peer review system might introduce new biases that would ‘undervalue’ animal studies or ‘elevate proposals solely because they replace animals’, and worried that plans to diversify scientific review panels might ‘unintentionally open the door to individuals with advocacy-driven agendas’. FASEB also stated its concern that the rigor of the peer reviewed funding process might be undermined. Additionally, AMP stated that publicly reporting research spending on NAMs versus animal studies would not measure progress and proposed focusing instead on publicising how often studies include 3Rs implementation, such as refinement strategies or reduction methods.

AMP also requested clarity on the recent policy changes, observing that they had generated ‘significant concern and confusion’ and that key details were missing (such as what exactly the changes would entail and when they would take effect). Additionally, it highlighted a potential loophole, namely that a research proposal would satisfy the new requirement (not to be exclusively based on animal studies) even if the NAM component was minor in relation to the animal study component. Furthermore, AMP was concerned that the timelines were premature, with speed being prioritised over ‘scientific readiness’. Rather than ‘arbitrary deadlines’, it suggested adopting a ‘milestone-based approach’, where progress was tied to demonstration of NAMs’ validation, real-world performance, and regulatory acceptance. Finally, AMP noted the need for a rehoming plan for the long-term care of animals currently in laboratories.

Theme 4: Requests for stakeholder involvement

NABR, AMP and FASEB requested more involvement as stakeholders. NABR stated they were ready to work with FDA, while AMP suggested the FDA and NIH should commit to regular, transparent public engagement mechanisms. AMP suggested that draft policies should be reviewed (by NAMs experts and animal scientists) prior to implementation and recommended an ‘approach focused on inclusive stakeholder engagement’. AMP expressed concern about whether stakeholder input would be sought to help shape policy and asked that changes be implemented transparently and with stakeholder involvement. FASEB noted that since the proposed changes would have a significant impact on research infrastructure, funding mechanisms and workforce training, the animal research community should have greater opportunity for stakeholder engagement on elements such as transition timelines, criteria for determining where NAMs are appropriate, and strategies to support the continued use of animal models ‘where necessary’.

Summary

The main messages that these organisations seem keen to convey are that NAMs, or even combinations of NAMs cannot replace a whole living system, that the scientific rigour of NAMs needs to be established and that NAMs should only be viewed as adjuncts to – and not replacements for – animal studies. While the organisations appear to accept that change is inevitable, they are keen to retain a role for animal studies, are concerned about the possibility of NAMs being favoured over animal studies and would like to be consulted about future developments.

References

1. Food and Drug Administration (FDA). FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. https://www.fda.gov/news-events/press-announcements/fda-announces-plan-phase-out-animal-testing-requirement-monoclonal-antibodies-and-other-drugs (2025).
2. Dinan, S. Zeldin to pursue new ban on animal testing at EPA. The Washington Times (2025).
3. National Institutes of Health. NIH to prioritize human-based research technologies. https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies (2025).
4. Kime, P. Cats and Dogs Will No Longer Be Used in Navy Research, Secretary Says. Military.com (2025).
5. Safer Medicines Trust. FDA-NIH Workshop: Reducing Animal Testing. Safer Medicines Trust website (2025).