In a sign of progress for animals used in laboratories, the U.S. Food and Drug Administration has announced a strong commitment to reduce animal testing and advance new, superior approaches that don’t use animals for pharmaceutical testing.
The Roadmap to Reducing Animal Testing in Preclinical Safety Studies details the next steps of this commitment; we are pleased to see that the very reforms we urged in a legal petition we submitted to the agency last year are included. We requested that the FDA make it clear to companies in both the regulations and guidance documents that animal testing isn’t required, to create a new guidance document focused solely on new approaches that is updated regularly, and to commit to adding information to all guidance documents underscoring the agency’s acceptance of non-animal methods.
In the roadmap, the FDA also states that it plans to provide incentives for companies to send the agency test results from non-animal methods rather than animal tests. Companies feel compelled to conduct extensive animal experiments in order to align with the agency’s expectations. Incentivizing the submission of non-animal test results promises to significantly reduce animal testing. We were pleased to see FDA state that 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.”
It has long been known that relying on animal testing to determine the safety and effectiveness of human drugs results in high drug failure rates of approximately 90%. This harms both animals used in pre-clinical tests and people who suffer injury from unsafe products during clinical trials. Some non-animal approaches, including when used in combination with each other, are proving to be superior to animal tests, in terms of being faster, providing more human-relevant results and often at a lower cost. These approaches include artificial intelligence and other computer modeling, organ-on-a-chip technologies, organoids, and many others.
Of course, we are motivated by our desire to bring an end to the cruelty and suffering involved in animal testing. But our work is grounded in scientific evidence, often published in peer-reviewed journals, including one that was featured in the FDA’s roadmap. It is also driven by our sincere belief that non-animal methods will bring greater benefits for human health and safety.
A further indication of the magnitude of this news was the decrease in stock value of companies centered on animal testing as a business, such as the notorious Inotiv (parent company of Envigo) and Charles River Laboratories. We have seen welcome signs of Charles River Laboratories investing in non-animal approaches and hope to see a large shift in investment continue throughout the sector.
We have a long track record of calling for these reforms. In the U.S., we have worked with the FDA to coordinate non-animal science across all parts of the agency and prioritize uptake of new methods, lobbied Congress for funding to develop new methods, and advanced state legislation that will compel companies to use accepted alternatives and invest in development of the methods. We have also revealed through undercover investigations the suffering that animals endure when being used for testing of drugs, pesticides and other products.
For nearly a decade, we have led a global effort alongside our partners in the Animal-Free Safety Assessment Collaboration to remove obsolete animal test requirements for vaccines and other biological medicines. These efforts have been strongly supported by the FDA and its counterparts in Europe, Canada and other countries, as well as industry leaders, and have resulted in lifesaving changes for animals worldwide.
Earlier this year, the pharmaceutical industry in Europe identified nine broad categories of animal tests “for which alternative technologies already exist, or which are not scientifically necessary.” We’re proud to have led the global effort to end the use of several animal tests within this industry and are eager to see this momentum continue.
This announcement comes on the heels of the U.S. Environmental Protection Agency stating its recommitment to phase out animal testing for chemicals and pesticides. The U.S. Secretary of Health and Human Services also indicated that the National Institutes of Health will announce further efforts to reduce animal testing; we will report on that as more details emerge.
Any immediate moves by laboratories in this regard should ensure proper placement of animals, such as into loving homes in the case of dogs, cats, or other small animals, or to sanctuaries in the case of primates, other wildlife or farm animals—in any case, an outcome that the animals deserve.
We intend to continue to stay engaged on all these fronts until our vision of a world with no animal experiments is a reality.
Sara Amundson is president of Humane World Action Fund.
