U.S. FDA unveils new roadmap to replace animal testing 

The U.S. Food and Drug Administration (FDA) has released a new roadmap to reduce and replace animal testing in drug development and regulation, in a landmark step towards more ethical and effective science. The agency’s new strategic plan signals a clear commitment to embracing modern, human-relevant approaches and moving away from outdated and unreliable animal-based methods.  

Cruelty Free International welcomes this bold and timely move. We are encouraged to see that the roadmap reflects many of the longstanding concerns and priorities we have raised through our scientific and policy work, including direct references to papers we are affiliated with. The inclusion of issues such as the need for meaningful incentives to adopt non-animal approaches, improved tracking of animal use in the U.S., fixed deadlines to replace certain animal tests, increased funding for non-animal methods, and recognition of the failures and scientific limitations of animal tests demonstrates a welcome alignment with the issues we have championed for decades.   

We will be reaching out to the FDA to offer our support and collaboration to help achieve the goals outlined in the roadmap.   

The FDA’s decision to initially focus on testing related to monoclonal antibodies (identical copies of an antibody, produced in a laboratory to bind to specific targets – like viruses, bacteria or cancer cells, to help  diagnose and treat diseases)and other biologicals (medicines made from living organisms or their components, such as vaccines, used to prevent or treat diseases) is a pragmatic and scientifically sound starting point. These products are often highly human-specific, meaning that animal test data has limited relevance or predictive value. This focus aligns closely with the rationale behind our Replace Animal Tests (RAT) List, which highlights ten animal tests that continue to be used despite the availability of non-animal replacements known to deliver reliable results. Many of these tests involve large numbers of animals and cause severe suffering.  

We therefore hope that the FDA will also consider prioritizing some of these tests as part of the short-term phase-out goals outlined in its roadmap for the next three years. The agency’s longer-term ambition, outlined as a three-to-five-year goal to “make animal studies the exception rather than the norm for pre-clinical safety/toxicity testing”, represents a transformative shift in regulatory science, one we hope will drive global momentum and help reshape scientific standards worldwide.   

We are also encouraged by the FDA’s recognition of reducing second species testing as an example of potential progress. This has been a key focus of our scientific work in recent years, and we are actively developing new initiatives in this space. Equally important is the FDA’s commitment to mapping out current testing requirements, identifying available non-animal methods, and pinpointing where critical gaps remain.  

We have previously published work taking a similar analytical approach – conducting workshops to develop a strategy for integrating non-animal methods into routine drug safety assessments, aligned with FDA regulatory needs, and identifying where further human-relevant approaches are needed.   

Finally, we welcome the FDA’s intention to work closely with the National Institutes of Health (NIH) to help drive the development, validation and uptake of non-animal approaches across federal research and regulatory systems. Cross-agency coordination is essential to ensure that innovation is shared, and that human-relevant technologies receive the broad support they need to succeed.  

This coordination is especially timely, as it echoes the goals of the HEARTS Act (Humane and Existing Alternatives in Research and Testing Sciences), a bipartisan bill reintroduced in Congress in February. The HEARTS Act seeks to modernize NIH-funded research by prioritizing non-animal methods wherever feasible. It proposes clear incentives for researchers, updated review requirements to ensure alternatives are properly considered, and the creation of a dedicated NIH center to support and advance human-focused science.  

As the FDA moves forward with its roadmap, we urge lawmakers to do their part by supporting the HEARTS Act and helping to accelerate the transition to more ethical, effective science in federally funded research.  

Our Deputy Director of Science and Regulatory Affairs, Laura Alvarez said, “We applaud the FDA’s bold announcement and their new roadmap to reduce animal testing requirements, and urge them to press forward with unwavering determination. In 2025, we should no longer cling to outdated science based on animal testing that was developed decades ago. Instead, we should leverage the power of modern technology to bring faster, more accurate and more humane solutions to the development and regulation of medicines. This is a pivotal moment – one that we hope will inspire other agencies to follow suit.”   

U.S. residents can help by contacting their U.S. Representative and asking them to cosponsor the HEARTS Act. Together, we can build a future where science protects both human health and animal welfare.