APS Comment on FDA-NIH Workshop on Reducing Animal Testing

These comments are submitted on behalf of the American Physiological Society (APS) in response to the July 7, 2025 FDA-NIH Workshop on Reducing Animal Testing. APS appreciates the opportunity to provide feedback on the workshop and the broader goals outlined in the agencies’ plans to support New Approach Methodologies (NAMs).

APS represents a multidisciplinary community of more than 7,500 scientists and educators dedicated to understanding how living organisms function. Physiologists use a variety of experimental approaches to explore complex biological questions. Some of these approaches involve animals, while others do not.

APS supports the principles of the 3Rs (reduction, refinement and replacement) of animal research and the development and adoption of NAMs. However, many of these technologies still have significant limitations. While much of the workshop focused on preclinical testing and drug development, an essential part of the NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems. It is important to acknowledge that application of NAMs will be very different in basic or fundamental research than in the drug development regulatory pipeline. This distinction, as well as the limitations of NAMs, are important to recognize.

This workshop was an important step in the pathway to developing and implementing NAMs. Going forward, APS strongly encourage that NIH proactively engage with the scientific community and seek the input of the investigator community to inform policymaking. It is also essential that verbal policy announcements be accompanied by clearly written and publicly accessible policies to prevent misunderstandings and to encourage trust between the NIH and the scientific community.

As NIH seeks to implement changes related to the adoption of NAMs, changes to the peer review and funding processes should be examined to ensure that new biases are not being introduced.