The U.S. Department of Health and Human Services (HHS) announced a new set of agency-wide actions to expand human-based research methods and reduce reliance on animal testing. This initiative spans the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Advanced Research Projects Agency for Health (ARPA-H).
“We are moving HHS toward a new era of biomedical research that puts human biology at the center of science,” said HHS Secretary Kennedy in the press release. “We are modernizing outdated regulations, investing in human-based technologies, and breaking down barriers that have kept researchers dependent on animal models when better tools are available.”
New Approach Methodologies (NAMs) are research approaches that include human organoids, tissue models, computational modeling, AI, and other technologies. HHS agencies are investing in developing, validating, and scaling these methods to give researchers and regulators additional ways to study human biology and evaluate medical products.
The shift doesn’t mean animal studies are being completely eliminated across biomedical research. FDA says the new approach is intended to give researchers greater flexibility to use scientifically appropriate methods, including animal studies when they remain appropriate and validated alternatives when they can provide the necessary evidence.
“CDC is reducing animal use while ensuring that our scientists have the tools they need to protect Americans from health threats,” said CDC Director Erica Schwartz. “We are applying greater scrutiny to animal research and focusing our resources on science that directly advances our public health mission.”
The NIH announced more than $88 million in funding for biomedical infrastructure projects nationwide, along with a new challenge offering more than $7 million in awards for quantum-enabled approaches to NAMs. NIH is also establishing a laboratory at the NIH Clinical Center that will combine human organoids, robotics, AI, and advanced data capabilities. The agency is also recruiting grant reviewers with expertise in human-based research and seeking public input about the feasibility of publicly reporting the number of vertebrate animals used in NIH-funded research.
The FDA issued a direct final rule updating its regulations to recognize a broader range of nonclinical testing approaches, including scientifically valid methods that do not use animals. The agency says the rule does not eliminate or prohibit animal studies or change existing evidentiary standards. FDA has also issued guidance and established programs to support the development and use of NAMs in drug development and regulatory decision-making.
Human-based models could provide researchers with additional ways to study disease, evaluate potential therapies, and assess safety. However, many of these new technologies are still being developed and validated. This announcement should be seen as an investment and direction for research, rather than evidence that animal studies have been eliminated.
Here’s what’s likely coming down the pipeline following this announcement:
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