On Wednesday, the U.S. Food and Drug Administration (FDA) released draft guidance aimed at helping pharmaceutical companies reduce the use of animal testing for experimental drugs. The guidance encourages the adoption of modern alternatives, including computer simulations and devices that replicate human organ functions.
Traditionally, drug developers test experimental treatments in animals, such as macaques, to identify potential harmful effects. However, many drug candidates that perform well in these animal studies still fail to gain FDA approval because of safety or efficacy issues when tested in humans.
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The FDA previously issued a similar draft guidance in December, targeting the reduction of non-human primate use in testing certain monoclonal antibodies.
In the new draft guidance, the FDA recommends that companies adopt modern non-animal testing tools referred to as new approach methodologies (NAMs)—when submitting nonclinical safety data to support drug applications.
“This draft guidance advances our commitment to replace animal testing with human‑relevant, scientifically rigorous methods,” U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said.
These methods, which also include lab‑based cell tests and 3D models such as organoids – mini organs grown from human cells – are aimed at making the drug development process more efficient, cheaper and ethical, the FDA said.
“Modern science has given us far more effective and humane ways of evaluating drug safety than animal testing,” FDA Commissioner Marty Makary said.
“This reform may reduce the amount of time it takes to bring a drug to market and lower research and development costs, which can translate into lower drug prices.”
Drug developers are increasingly using artificial intelligence (AI) tools for drug discovery and safety testing. Experts believe that these technologies could reduce development timelines and costs by at least 50% over the next three to five years.
The expanded use of NAMs was a key recommendation in the MAHA Commission’s Strategy Report to “reduce reliance on animal studies that often fail to replicate complex human conditions,” the FDA said.
Separately, the National Institutes of Health (NIH) announced that it has invested $150 million in human-based research initiatives designed to reduce the reliance on animal models.
