FDA Leading The Decline Of Animal Testing
By Ray Dogum, Chief Editor, Drug Discovery Online
Despite recent staff turnover, the FDA is still one of the most widely respected institutions entrusted to guard human health. It provides safety measures that protect us from chemicals and active substances that would otherwise be sold under false pretenses. Consider the enormous effort it must take to align such diverse and often competing interests from the public, farmers, biotech companies, hospitals, legal representatives, and many others.
So, when the FDA teams up with the NIH, NIST, VA, ARPA-H, and other international regulators on a mission to reduce animal testing, the biopharma industry is compelled to adapt. It’s especially critical for early-stage drug developers, who spend a significant amount of time planning and executing preclinical animal studies, to refine their regulatory strategies accordingly.
The Problems with Animal Testing
During the FDA’s July 7th workshop with the NIH, FDA Commissioner Martin A. Makary, M.D., M.P.H., explained how the poor reproducibility and accuracy, as well as the economic burden, of animal testing behooves us to move to more human-relevant tools such as organoids and AI-powered toxicity models.
Makary went on to say, “it's more humane and more ethical for animals. God did not make animals on planet earth for us to abuse and torture. And so, we have to respect animals, and this workshop is aimed at reducing animal testing in every way we can while safeguarding the public with medications.”
In their initial roadmap to reducing animal testing for monoclonal antibodies, the FDA reaffirmed that “over 90% of drugs that appear safe and effective in animals do not go on to receive FDA approval in humans, predominantly due to safety and/or efficacy issues.” That’s a big problem. It seems the time has come for biopharma companies and regulators to reset industry standards with respect to preclinical studies using animals.
In addition to protecting human health, the FDA’s announcement to phase out animal testing requirements and the cross-institutional workshop have made it clear that there will be a huge impact on the lives of many animals moving forward.
NIH to Stop Funding Animal-Only Proposals
The gold standard practice of conducting animal studies for evaluating toxicity, pharmacodynamics, and immunogenicity is being challenged by innovative alternatives – New Approach Methods (NAMs).
During the workshop, the NIH announced, they “will no longer seek proposals exclusively for animal models.” This means sponsors will not be able to receive funding for their animal studies if they aren’t including NAMs in their research proposals.
There is now a clear incentive to leverage NAMs and to design reliable in vitro and in silico tests that can exceed the value that animal studies have brought to the industry. With the aforementioned gold standard producing a 90% failure rate in translating to humans, it’s not hard to see why NAMs are poised to outperform animal studies.
This policy milestone has been decades in the making. Since the 1990s, foundational guidance on replacing, reducing, and refining animal use has shaped regulatory expectations, making the new NAM requirement for NIH funding a logical and timely progression. One standout speaker at the July 7th workshop, Nicole Kleinstreuer, PhD, Acting Deputy Director at the NIH for the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), has dedicated much of her career to advancing human-relevant research methods and reducing reliance on animal testing. Her vision, along with many other supporters including PETA, is now becoming reality.
Green Light for NAMs
By requiring NAMs, we can expect the collective data generated from them to significantly increase over time. Hopefully, this explosion of NAMs data will lead to more robust AI models that can be used for future testing applications. Examples of NAMs include human-cell based organoids, microphysiological systems (MPS) (often called “organs-on-chips”), and in silico based predictive models.
These policies will attract more interest from biotech innovators seeking to artificially mimic human physiology and metabolism. The innovative companies and research groups working on developing NAM tools and technologies have just received a big green light on any major advances they were planning. There is a concerted effort to ensure proposed NAMs undergo rigorous checks for quality, reproducibility and predictability before they are accepted for regulatory or scientific use.
Flashing Yellow for Animal Services
On the other hand, companies focused on providing animal testing services, facilities, tools, and assays are facing a flashing yellow light, meaning they need to proceed with caution as demand for animal testing may be reduced. I say, “may be reduced” because there is still this persistent belief that animal testing is the gold standard, and drug developers may refuse to bring a new drug to the clinic without traditional tox animal studies.
From conversations with early stage biotechs, it seems that the actual reduction of animal testing may not be as dramatic as one might expect. Do we really expect biotech companies to risk investing millions into a clinical trial before they’ve tested it in animals? That largely depends on the therapeutic modality, the associated biological risks, and the financial resources available to the biotech. But one thing is certain, they will need to include NAMs studies alongside any animal studies they wish to conduct.
Opportunity Ahead
These government agencies’ commitments carry significant weight for professionals across industries and for the broader public health community. As attention turns to NAMs, it is becoming clear that the FDA and its partners are also prioritizing animal welfare. This growing focus reflects a meaningful shift toward more ethical and innovative scientific practices.
We all can agree that animal testing has had its place in the evolution of drug discovery. As someone who’s professionally cared for thousands of B6 mice, I’ve come to appreciate both the scientific value and the charm of these furry research companions. I’m looking forward to seeing how all NAMs will evolve and improve over the next few years.
In the coming months, I’ll be shining a spotlight on the different types of NAMs, their respective limitations and advantages, and how drug developers can effectively incorporate them into their early-stage planning.