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HHS Accelerates Shift to Human-Based Research, Reduces Reliance on Animal Testing

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HHS Accelerates Shift to
Human-Based Research
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The U.S. Department of Health and Human Services (HHS) announced a new wave of agency-wide actions to accelerate the shift toward human-based research methods and reduce unnecessary animal testing. Since Secretary Robert F. Kennedy, Jr. took office, HHS agencies have launched more than 20 initiatives expanding the use of technologies including human organoids, tissue models, artificial intelligence, and computational modeling. The announced actions span HHS research, regulatory, and public health agencies, and a new webpage provides a comprehensive accounting of the department’s actions to advance New Approach Methodologies (NAMs).

Key Highlights
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  • The FDA issued a direct final rule updating its regulations to remove references to animal testing and implement the FDA Modernization Act.
  • The NIH announced more than $88 million in funding for biomedical infrastructure projects, a challenge with over $7 million in awards for quantum-enabled approaches in lab-based NAMs, and a state-of-the-art laboratory at the NIH Clinical Center integrating human organoid models, robotics, and artificial intelligence.
  • NIH has closed its last intramural beagle laboratory and allows grant funding to be used to retire or rehome research animals.
  • The FDA has issued multiple guidances expected to spare hundreds of non-human primates and more than one million horseshoe crabs annually.
  • The CDC is substantially reducing its laboratory animal colony, working to permanently place healthy non-human primates in a qualified sanctuary, and conducting more than a dozen studies using NAMs.
  • ARPA-H is investing in artificial intelligence and computational modeling through its CATALYST program to better predict drug safety and reduce reliance on preclinical animal testing.
  • HHS launched a webpage providing a comprehensive accounting of more than 20 actions taken to reduce animal testing and advance NAMs.

Statements
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We are moving HHS toward a new era of biomedical research that puts human biology at the center of science. We are modernizing outdated regulations, investing in human-based technologies, and breaking down barriers that have kept researchers dependent on animal models when better tools are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. Under President Trump, we will use the best science to protect patients, accelerate medical breakthroughs, and end unnecessary animal testing.

  • HHS Secretary Robert F. Kennedy, Jr.

NIH is building the scientific infrastructure needed to develop, validate, and scale technologies that better reflect human biology. Our goal is to give researchers better tools to understand human disease and translate discoveries into treatments that improve patients’ lives.

  • NIH Director Jay Bhattacharya, M.D., Ph.D.

FDA is modernizing its regulatory framework so developers can use the best science available to demonstrate that medical products are safe and effective. By removing outdated barriers to new approach methodologies, we can reduce unnecessary animal testing while making product development more predictive and efficient.

  • Acting FDA Commissioner Kyle Diamantas, J.D.

About the Organizations
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The U.S. Department of Health and Human Services is the federal department responsible for protecting the health of Americans and providing essential human services, including biomedical research through NIH and regulatory oversight through FDA.

Learn More
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HHS Press Release: HHS Accelerates Shift to Human-Based Research, Reduces Reliance on Animal Testing
HHS Webpage: Actions to Reduce Animal Testing and Advance New Approach Methodologies