Advancing non-animal science and public health progress in the 119th Congress – going for the win-win

By Dr. Paul Locke | March 6th, 2025

On January 3rd 2025, the 119th Congress started. About a month later, on February 6th, I was invited to testify before the House Committee on Oversight and Government Accountability, Subcommittee on Cybersecurity, Information Technology and Government Innovation. My testimony stressed the importance of human centric methods in biomedical research, and how and why we need to transition away from animal models.

I began by emphasizing that reducing and ultimately replacing animal models will lead to improvements in health, stronger environmental protection, and new and innovative cures and treatments for diseases like cancer and neurological conditions such as Parkinson’s and Alzheimer’s disease. To drive home this point, I focused on three issues.

First, the scientific questions facing us increasingly call into question our reliance on non-human animal tests, and demand that we move toward more human-centric science, including the use of microphysiological systems and organoids. Second, federal agencies must play a leadership role in the transition to these new human centric models. And third, the development and deployment of these models represent innovation and places where US businesses and science are, and must continue to be, at the cutting edge.

Many pundits point out that animal models and research based on them have led to scientific successes and have kept unsafe products off the market. But rather than looking back at past accomplishments, it is better to explore what we need for future success in public health and medicine. The complex scientific challenges we now face require that we move away from traditional animal models and embrace new technologies that do not involve animals but instead incorporate human biology. These technologies include small, engineered systems, such as organs-on-a-chip, or three-dimensional groups of cells, such as organoids, that allow groups of cells to self-organize in ways that mimic many of the important functions of human organs. I also include artificial intelligence, AI, in this group.

Second, while there is considerable enthusiasm around the promise of these new methodologies, unless U.S. federal agencies and departments support their development and recognize their promise, they will not be able to reach their full potential. Agencies such as the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) all have important roles to play in unlocking the potential that these technologies have for designing better drugs, protecting the environment, improving health, and ensuring safety.

There are currently major gaps in the regulatory framework needed to support new methodologies. To date, the federal approach has mostly been passive and reactive. What we need is for federal agencies and departments to lead efforts to develop, implement, and use these methods.

The EPA has several programs related to non-animal alternatives. Its pesticides office has been very active. It has released data on the cost savings associated with waiving animal tests when it is shown scientifically that they are not needed. According to EPA, it saved approximately $379,000 from 2018 to 2023 by waiving the requirement to conduct certain repeat dosing studies in animals. The 2016 amendments to the Toxic Substances Control Act (TSCA) include several new provisions to address the use of non-animal alternatives. Among other things, TSCA requires EPA to produce a work plan for alternatives and a list of approved alternatives.

While these efforts are important, much more needs to be done. There are about 85,000 chemicals already in commerce today, and we have adequate toxicological information on about 1000 of them. The only feasible way to assess these chemicals in a timely manner is to use non-animal methods.

New, human based biological methods are not getting the attention they deserve at the FDA. While the FDA has said publicly that it is willing to accept non-animal model toxicity data, it has yet to identify and communicate clear standards for the use of such data. In other words, the agency has not outlined validation criteria. Researchers who use alternatives in product development and in applications for regulatory approval thus have no guarantee about whether their data will be acceptable. FDA can, and often has, responded to those who use alternative methods with a simple statement that the data is insufficient and a demand for animal-based data.

The National Institutes of Health should also play a leadership role. It has launched a program called “Complement-AIRE” to speed up the development, standardization, validation, and use of human-based New Approach Methodologies (NAMs). This program is funded at about $35 to $40 million per year over a 10-year period, with a total funding commitment of about $400 million. Given that NIH’s annual budget is about $48 billion, that means less than one-tenth of one percent of NIH’s yearly annual budget is supporting this important research. (40M/48B x 100 ≈ .083%). More resources should be dedicated to this work.

Third, the development and deployment of these innovative models must continue to be sparked by U.S. based entrepreneurs. We have an enviable record as a world leader in scientific research, drug development and public health protection and many of these new methods are being developed by U.S. companies.

The U.S. must continue to lead the way in these human-centric technologies so that that we are setting the global standards in these fields, rather than following other nations. Regulatory agencies worldwide look to our nation for leadership and if we continue to lead in alternatives methods development and validation, our standards will shape international regulations, assist in high-tech job creation, and strengthen U.S. economic growth.

To summarize, scientific advancements have created multiple opportunities for us to develop and deploy more human-centric techniques in toxicology and biomedical research and therefore call into question our current reliance on animal testing. Championing these non-animal methods is a win-win situation. It will allow us not only to reduce the number of animals used but also produce data that is more relevant to human health while maintaining our lead as a nation that drives innovation.

The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.