USFDA Pushes Shift from Animal Testing, Draft Guidance Backs AI and Human-Based Drug Research

Drug developers often test experimental treatments in animals such as macaques to screen for harmful effects, but many candidates that pass ‌these studies ⁠still fail ⁠to win FDA approval due to safety and efficacy issues in humans, the agency said.

The ​FDA had issued a similar draft guidance in December aimed at reducing the use of ​non-human primates in testing certain monoclonal antibodies.

Under the new draft guidance, the FDA has recommended using newer non-animal testing tools - known as new approach methodologies, or NAMs - when companies submit nonclinical safety data to support ⁠a drug ‌application.

"This draft guidance advances our commitment to replace animal testing with human-relevant, scientifically rigorous methods," U.S. Health and Human Services Secretary ⁠Robert F.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 ​have been increasingly ⁠adopting artificial intelligence tools for discovery and safety testing, which experts believe could cut development timelines and costs by at least half within 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 said it has invested $150 million in human-based research aimed at reducing the use of animal models.