April 16, 2025

On April 16, Americans for Medical Progress issued the following statement regarding recent announcements from the Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) related to reducing animal research.

WASHINGTON, D.C. – Americans for Medical Progress (AMP) affirms the essential role of animals in biomedical research and recognizes the growing momentum toward reducing and eventually replacing animals in areas of research where it is scientifically appropriate. This effort is evident in the recent announcements made by the U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) to discontinue certain animal tests. As a national advocacy organization, we support strong science that generates safe, effective advancements for human and animal health. This includes the development of new approach methodologies (NAMs) that are highly valuable for preliminary studies and increasingly serve as complementary tools alongside animal studies, enhancing our ability to gather robust, multidimensional data throughout the scientific process.

The FDA’s recent announcement to phase out animal testing requirements for monoclonal antibody therapies marks an admirable advancement, demonstrating the significant progress in science, technology, and medicine thanks to animal research. While some view this as a major policy shift, this change actually reflects the scientific community’s longstanding and ongoing commitment to integrate NAMs when it is scientifically appropriate and safe to do so. However, while NAMs are rapidly advancing and offer exciting potential, they are not yet capable of fully replacing animal studies across all areas of biomedical research and safety testing. These emerging tools still require rigorous validation to ensure they can consistently replicate the complexity of living systems.

Therefore, we are concerned that a premature or overly broad phaseout of animal studies with arbitrary timelines could unintentionally compromise the health and safety of both humans and animals. For example, the FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies states, “In the long-term (3-5 years), FDA will aim to make animal studies the exception rather than the norm for pre-clinical safety/toxicity testing.” Although this objective is well-intentioned, it represents an impractical and short-sighted approach because scientific progress does not adhere to rigid timelines. Additionally, an accelerated plan could jeopardize research quality if scientists focus on fulfilling policy deadlines rather than prioritizing safety and scientific integrity.

Until NAMs are fully proven across a wide range of applications, it is critical that changes to longstanding research practices be implemented thoughtfully, transparently, and with the input of diverse stakeholders. This includes scientists developing non-animal methods, researchers who rely on these technologies in the lab, veterinarians and animal care staff with extensive knowledge of animal welfare, and industry sponsors who submit data (both animal and non-animal) to FDA for approval. Furthermore, public input must be a key component of this process to ensure that policy decisions are grounded in evidence and practicality.

Finally, any transition away from animal-based studies must include a clear and well-funded plan for the rehoming and long-term care of animals currently in research settings. Ensuring the health, comfort, and safety of these animals requires detailed logistics, adequate resources, and strong collaboration with sanctuaries, transport services, and animal care professionals.

AMP remains committed to advancing both science and animal welfare and believes these goals can and must be pursued together. We are prepared to engage constructively with regulatory agencies, researchers, and the public to help navigate this important step responsibly and ethically.

Download a PDF copy of AMP’s statement here.