Is DOGE the Swan Song for Animal Testing?

The intent of the new administration to create the Department of Government Efficiency (DOGE) and reduce federal spending by more than a trillion dollars is an eye-catching goal. While it is not the first time that a new administration has promised major cuts to spending — only to see those efforts crash and burn — this plan might jibe with an emerging understanding that there are inefficiencies baked into our nation’s drug development programs. The underlying flaw: an unwarranted faith in animal testing to model human response in health and disease.

Animal testing is a relic from a bygone era but still promoted fervently by interest groups and government agencies as the “gold standard” in experimental sciences for predicting response in people. That is even though — in drug development, for instance — animals are notoriously poor predictors of drug safety and efficacy in humans. To this end, exclusive reliance on animal testing translates into irrecuperable delays in the development of medicines, missed opportunities due to misguided regulatory principles, and exorbitant costs ultimately passed onto consumers.

A jarring 90-95% of experimental drugs fail in clinical trials after acceptable outcomes data in animals are used to justify their advancement for testing on humans. Moreover, scores of potentially life-saving drugs are prematurely abandoned once they confer no benefits to animals, exacerbating an already inefficient animal-centric drug discovery paradigm. Failed oncology trials alone are estimated to cost $50-$60 billion annually. Most new-generation therapies (e.g., cell therapy, immunotherapy) are by design human-specific, and testing on animals is a fool’s errand.

Through decisive actions, DOGE could in principle curb unreliable testing on animals in favor of prioritizing technology-driven, human-relevant alternatives. By doing so, it would — in a singular swoop — reduce waste across federal contracts and grants, promote modern drug development, lower healthcare and prescription drugs cost, bolster national competitiveness, improve environmental health and safety testing, and modernize practices within all health and regulatory agencies.

Francis S. Collins, the longest-serving former director of the National Institutes of Health, wrote in the journal Nature a decade ago that “preclinical research, especially work that uses animal models, seems to be the area that is currently most susceptible to reproducibility issues.” Consistently, 89% of preclinical studies, most of which involve animals, cannot be reproduced!

Reducing the dependency on the key variable (i.e., animal models) associated the most with irreproducibility (e.g., the failure to translate results from the laboratory to the clinic) is one sensible approach to limit fiscal waste in medical research and, more broadly, healthcare.

The cost of developing a single new drug is a stupefying $2 billion with an average development time of 10-15 years from target identification in the laboratory to market release, not factoring in withdrawals or recalls. Poor reliability of animal models in the drug discovery workflow compounds sky-high research and development costs to disincentivize investment in many disease domains. Case in point, 95% of the 7000-plus rare diseases that affect 25-30 million Americans have not a single FDA approved drug to treat them.

Regrettably, little has been done by government watchdogs to address the grossly wasteful spending on animal testing. On the contrary, spending on animal testing, including funding high-end facilities and housing infrastructures (reviewed here), is uncontrollable. The use of animals in research is estimated to have reached nearly 200 million annually, with the United States being in the top three countries by number of animals used, along with China and Japan.

Should DOGE take on the task of weaning America from the reliance on animal testing in modeling human response, the consequences could be historic vis-à-vis trimming waste and bolstering efficiency in the biomedical discovery space. This shall benefit all Americans. Of note, such an undertaking will be facilitated by the existence of the FDA Modernization Act 2.0 (FDAMA 2.0), a U.S. law shepherded to passage by the Center for a Humane Economy in 2022. This important policy reform has garnered strong bipartisan support and shined the spotlight on the complex issues of reliability and relevance in biomedical investigations, specifically the futility of animal testing.

FDAMA 2.0 lifted the mandate on requiring animal testing on drugs in preclinical research prior to advancing to clinical trials if modern 21^st century tools can be used instead. Some of the modern tools that now outperform animal testing in many applications include human-based organoids, organ-chips, advanced human cell models and AI methodologies (reviewed here).

Yet to this day, inexplicable delays in implementing the FDA Modernization Act 2.0 (FDAMA 2.0) are causing significant regulatory confusion among drug sponsors. The failure to act on the part of the FDA, the regulatory agency chiefly responsible for implementing this policy mandate, is in turn a good example of government discordancy, if not malfeasance.

In 2023, a bipartisan group of Senators, led by Rand Paul, R-Ky., and Cory Booker, D-N.J., sent a letter to the FDA demanding an explanation for the stultification and an implementation timeline of the enacted law. When no progress materialized, alarmed lawmakers introduced in February of 2024 the FDA Modernization Act 3.0 (FDAMA 3.0) in the U.S. House of Representatives (and later in the U.S. Senate) to assure FDAMA 2.0 implementation and accomplish further improvements.

The failure of the FDA to implement a law Congress passed without dissent is inexcusable. It is an alarming erosion in the core tenants of responsible governance. To put it bluntly, such bootlessness makes a mockery of the earnest and time-consuming legislative process and undermines the efforts of democratically elected lawmakers and everyone else involved. The new public-health team by President Trump should seize this opportunity and shake up the working of the FDA and its parent agency.  

Organizations like the Center for a Humane Economy and Animal Wellness Action that championed FDAMA 2.0 alongside their partners across industry, academia, and nonprofit organizations have shown no abatement in their advocacy efforts thus far and will not until the full, clear, and indivisible implementation of FDAMA 2.0 is accomplished.

Rarely could tackling a single challenge present that many opportunities for simultaneous improvement in multiple sectors of our economy. Yet in this instance, the single, multifactorial issue of animal testing is a prime example of wasteful and entrenched practices that DOGE is precisely created to eliminate.

The author is an award-winning executive scientist and the senior scientific advisor for the Center for a Humane Economy and Animal Wellness Action.