The US Food and Drug Administration (FDA) has announced that it will no longer require animal testing for new drugs, citing “more effective, human-relevant methods” to test their safety and efficacy. The agency claims this change will improve drug safety, accelerate the evaluation process, and reduce costs.
Currently, scientists must demonstrate a new therapy’s safety and effectiveness in both lab experiments and animal tests before it can be tested on humans. However, animals are not ideal stand-ins for humans due to differences in biology and disease susceptibility.
The FDA Modernization Act 2.0, passed in 2022, paved the way for this shift by amending the Federal Food, Drug, and Cosmetic Act to allow sponsors of new drugs to use alternative methods instead of animal testing. These alternatives include AI-based computational models, humanoid models, and real-world human data.
The FDA plans to update its guidelines to incentivize companies that submit strong safety data from non-animal tests, potentially offering streamlined reviews. Experts, including Dr. Paul Locke, a professor at Johns Hopkins Bloomberg School of Public Health, welcome this move, citing the potential for improved public health and more efficient use of resources.
Locke acknowledges that animal models have limitations due to their differences in biology and disease susceptibility. However, he believes technology has advanced enough with AI and organoids to provide effective alternatives for testing novel therapies, which were previously not accepted by the FDA. The agency’s gradual approach towards phasing out animal testing is seen as a positive step towards reducing animal use in biomedical research.
Source: https://edition.cnn.com/2025/04/10/health/fda-animal-testing-drug-approval/index.html