May 08, 2025 Getting It Together – Ending Lab Animal Use
In 2007, the National Academy of Sciences (NAS) produced a report on Toxicology Testing in the 21st Century at the request of the U.S. Environmental Protection Agency. The goal was to review scientific advancements and outline the future of toxicology testing for chemicals in the environment. The expert committee convened by the NAS concluded that new laboratory methods based on these advancements would significantly reduce the need for animal testing.
Following the report, I predicted that animal testing would end by 2025. As we have reached 2025, it is clear that while the number of animals used in safety testing for chemicals and drugs has decreased by as much as 75% in some countries, we have not yet eliminated animal testing.
However, this year, the three major federal agencies that support or require animal test data—the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA)—have all announced major initiatives aimed at reducing and potentially eliminating the need for animal testing. Professor Hartung of the Johns Hopkins Center for Alternatives to Animal Testing recently noted, “these coordinated actions demonstrate a level of regulatory alignment rarely seen in such significant policy shifts.”
On April 10 of this year, Dr. Makary, the new FDA Commissioner sworn in on April 1, 2025, introduced an ambitious roadmap aimed at rapidly reducing animal testing in preclinical safety assessments. The roadmap highlights that the FDA can accelerate the validation and adoption of human-relevant methods, known as New Approach Methods (NAMs), by partnering with other federal agencies such as the NIH and VA through the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). This collaboration aims to improve predictive accuracy while decreasing the use of animals in testing. For those interested, please refer to the WBI recap regarding the establishment of ICCVAM.
On the same day, Lee Zeldin, the new EPA Administrator, announced the renewal of the EPA’s previous goals to reduce the number of vertebrates used in safety testing and committed to eliminating such tests by 2035. Additionally, on April 29, Dr. Jay Bhattacharya, the new head of the NIH, announced the establishment of the Office of Research Innovation, Validation, and Application (ORIVA), which will support the expansion of “innovative, human-based science while reducing animal use in research.”
Dr. Bhattacharya’s comments are noteworthy and deserve to be quoted in detail. He stated, “[B]y integrating advances in data science and technology with our growing understanding of human biology, we can fundamentally reimagine the way research is conducted—from clinical development to real-world application. This human-based approach will accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments. It marks a critical leap forward for science, public trust, and patient care.”
This initiative builds on the NIH’s establishment of the Complentarie program, which recently allocated $1 million to twenty projects aimed at advancing New Approach Methods.
The recent changes in approach are truly remarkable when considering that NIH personnel have avoided discussing “alternatives” to animal use for nearly fifty years during the 20th Century. However, signs of this shift have been evident for some time. Previous NIH Directors have noted that animal models have not yielded the expected breakthroughs. For instance, Dr. Francis Collins predicted during a 2016 budget hearing that new non-animal technologies would “mostly replace animal testing for drug toxicity and environmental sensing,” providing results that are more accurate, cheaper, and allow for higher throughput. Dr. Bhattacharya’s initiative is a logical extension of the direction suggested by earlier NIH Directors.
For decades, animal advocates have turned to Europe for support in developing new alternative methods to animal testing (NAMS) to reduce and eventually eliminate the need for laboratory animals. However, Professor Hartung notes in his recent commentary that while Europe has long been “positioned as a global leader in ethical science, particularly regarding the reduction of animal testing, the EU’s current ‘methodical approach risks being outpaced by its faster-moving global counterparts.” The EU is developing a roadmap that outlines the necessary actions to reduce laboratory animal use. Still, the finalization of this roadmap is expected in early 2026, and the timeline for actual implementation remains uncertain.
Professor Hartung advocates for a global strategy to tackle the “mounting evidence of animal-model failures, mature NAM toolboxes, and regulatory pressure against animal testing.” He emphasizes that these advanced new methods should be implemented worldwide, not just in the industrial nations of the OECD.