The U.S. Department of Health and Human Services announced Monday a new series of agency-wide initiatives aimed at expanding human-based biomedical research and reducing reliance on animal testing.
HHS said its agencies have launched more than 20 initiatives since Secretary Robert F. Kennedy Jr. took office, including efforts involving human organoids, tissue models, artificial intelligence and computational modeling.
“We are moving HHS toward a new era of biomedical research that puts human biology at the center of science,” Kennedy said.
NIH Expands Human-Based Research
The National Institutes of Health announced more than $88 million in funding for biomedical infrastructure projects nationwide. The agency also announced a challenge offering more than $7 million in awards for quantum-enabled approaches to laboratory-based New Approach Methodologies, or NAMs.
NIH plans to establish a laboratory at the NIH Clinical Center combining standardized human organoid models, robotics, artificial intelligence, and advanced data capabilities.
The agency is also recruiting grant reviewers with expertise in human-based science and requesting input from the scientific community on assessing the feasibility of an annual public report tracking the number of vertebrate animals used in NIH-funded research.
NIH said it has closed its last intramural beagle laboratory and allows grant funding to be used to retire or rehome research animals.
“NIH is building the scientific infrastructure needed to develop, validate, and scale technologies that better reflect human biology,” NIH Director Jay Bhattacharya said.
FDA Updates Animal Testing Rules
The Food and Drug Administration issued a direct final rule clarifying that nonanimal testing may be used where appropriate for testing the safety of products intended for humans.
“The rule removes language that could suggest that animal testing is the only acceptable way to generate safety information for regulatory decisions in products intended for human use. It does not eliminate or prohibit animal studies, change evidentiary standards, or impose new costs or requirements on drug developers,” the FDA noted in a press release.
The agency has also issued guidance intended to reduce animal studies during drug development and established programs to evaluate and incorporate NAMs into regulatory decisions.
HHS said some of those changes are expected to spare hundreds of non-human primates and more than 1 million horseshoe crabs annually.
“FDA is modernizing its regulatory framework so developers can use the best science available to demonstrate that medical products are safe and effective,” Acting FDA Commissioner Kyle Diamantas said.
CDC and ARPA-H Expand Alternatives
The Centers for Disease Control and Prevention is reducing its laboratory animal colony and adding additional review of proposed animal research to determine whether it aligns with the agency’s public health mission.
CDC is also working to place healthy non-human primates in qualified sanctuaries and is conducting more than a dozen studies using NAMs.
Meanwhile, the Advanced Research Projects Agency for Health is investing in artificial intelligence and computational modeling through its CATALYST program. The initiative is intended to improve predictions of drug safety, optimize dosing, and reduce reliance on preclinical animal testing.
Together, HHS said the initiatives are intended to develop and validate research methods that better reflect human biology while providing researchers and regulators with additional tools to evaluate the safety and effectiveness of medical products.
HHS has published a webpage detailing more than 20 actions taken by the department to reduce animal testing and advance human-based research methods.
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