WASHINGTON, D.C. — Federal regulators say efforts to reduce animal testing in drug development are advancing, with the Food and Drug Administration reporting early progress on a plan aimed at improving safety predictions and lowering costs for new medications.
What This Means for You
- New drug testing methods may lead to safer, more effective treatments
- Reduced development costs could help lower drug prices over time
- Fewer animals may be used in testing as alternatives expand
The update comes one year after the FDA launched its 2025 roadmap to reduce animal testing in preclinical safety studies — the early phase of drug development that evaluates whether a treatment is safe before it is tested in humans.
FDA officials say the initiative is focused on replacing traditional animal studies with “human-relevant” methods, meaning tools that better reflect how drugs behave in the human body.
Why the Shift Is Happening
Historically, animal testing has been a standard step in drug development, but regulators say it often fails to predict how drugs will perform in people.
According to the FDA, more than 90 percent of drugs that pass animal testing do not ultimately receive approval, frequently due to safety or effectiveness issues discovered in human trials.
To address that gap, the agency is promoting new approach methodologies, or NAMs — scientific tools such as lab-grown human cells, computer-based models, and other systems designed to simulate human biology more accurately.
Key Changes Underway
The FDA said it has taken several steps over the past year to expand the use of these alternatives.
These include issuing draft guidance to reduce or eliminate the use of nonhuman primates in certain drug testing, particularly for monoclonal antibodies — laboratory-made proteins used to treat a range of conditions, including cancer and autoimmune diseases.
The agency also updated recommendations to move away from testing methods that rely on horseshoe crab blood, which is traditionally used to detect contamination in drugs and medical products.
In addition, regulators are working to reduce animal testing requirements for drugs that have already demonstrated safety through widespread use in other countries.
Expanding Technology and Data Use
The FDA said it has broadened the use of “weight-of-evidence” approaches, which allow drug developers to combine multiple types of data — including laboratory and computational results — to support safety decisions.
The agency also qualified its first artificial intelligence-based drug development tool, signaling increased use of advanced modeling to evaluate potential treatments.
To support developers, the FDA launched a searchable database identifying where alternative testing methods are acceptable and expanded collaboration with international regulators.
Infrastructure and Next Steps
Officials said the agency has established new systems to sustain the transition, including a formal pathway for approving innovative testing tools and closer coordination with the National Institutes of Health.
FDA Commissioner Marty Makary said the effort is intended to improve both scientific accuracy and affordability.
“In addition to ushering in more scientifically accurate way to test drugs before they are used in humans, the agency has made great strides to reduce research and development costs, which will lower drug prices for everyday Americans,” Makary said.
The FDA said it will continue working with government agencies, industry, and academic institutions to expand the use of these methods and further reduce reliance on animal testing.
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