May 1, 2025
Last month, multiple federal agencies announced commitments to phase out animal testing, highlighting what has become a notable difference between the alternating administrations of the last few years.
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it plans to phase out the requirement for animal testing for monoclonal antibodies and other drugs. The action will lead to the replacement of animal testing with human-relevant test methods, providing public health advancements through increased drug safety and accelerated drug evaluation timeframes. In addition to the immense enhancement of justice for nonhuman animals, this shift will reduce research and development costs that can be passed down to consumers through lower drug prices.
As the FDA reduces, and potentially eliminates in some cases, use of animal testing, approaches such as AI-based computational models and organoid toxicity testing in a laboratory setting will replace animal models. The transition away from animal testing began as of the date of the announcement for investigational new drug applications. The agency stated it will also look to already-completed human testing in other countries with regulatory standards comparable to those in the U.S. as a way to gather needed data and avoid animal tests.
With incentives geared toward non-animal tests, industry will be incentivized to invest in modern test methods that are specifically aimed at assessing drug safety for humans, rather than other animals. FDA states that it plans to partner with other federal agencies through the Interagency Coordinating Committee on the Validation of Alternative Methods to facilitate expedited validation and adoption of innovative test methods. The agency also announced plans for a public workshop and pilot program in the coming year. Considering that over 90% of drugs that pass nonhuman animal tests fail human safety and/or efficacy tests, this paradigm shift holds promise for greater efficiency and efficacy in human health advancements as well as much-needed relief for animals used in research.
On April 29, the National Institutes of Health (NIH) announced similar plans to prioritize human-based research technologies and reduce the use of animals in research the agency funds. Like that of FDA, NIH’s initiative aims to advance innovation in alternatives to animal research models. While it claims that animal models continue to be important in scientific advancement, it highlights the value of emerging technologies that are free from reliance on animals.
NIH does acknowledge the myriad differences between humans and other animals, and that these differences result in translational challenges in attempting to use tests on other animals to make determinations about human systems. The agency lists the emerging technologies identified by FDA—e.g., in vitro systems such as organoids and tissue chips, computational models, and existing real-world data—as available alternatives to animal tests. NIH plans to establish an Office of Research Innovation, Validation and Application to coordinate efforts toward use of non-animal models, including providing funding and training for the research community. NIH also committed to reporting its research spending publicly to measure progress away from animal tests and toward human-based models. This is a key step toward transparency, potentially addressing a major critique of the agency’s historic lack of data/data sharing on funding of animal studies.
Finally, U.S. Environmental Protection Agency (EPA) Administrator Lee Zeldin announced an intention to revive plans to reduce and, ultimately, eliminate animal testing at the agency. Under the first Trump administration, EPA had committed under then-Administrator Andrew Wheeler to reduce testing on mammals by 30% by 2025 and to completely eliminate it by 2035. The Biden EPA scrapped that plan. EPA conducts toxicity testing on animals for pesticides and other chemicals. With the Trump administration back for a second term, EPA is re-committing to its plans to do away with animal testing.