The U.S. Food and Drug Administration (FDA) has announced a plan to transition away from an animal testing requirement for monoclonal antibody therapies and other drugs in favor of more reliable and humane alternatives, according to a press release.

The FDA will start implementing the plan right away for investigational drug applications. It will also modify its guidelines so that data from these modern approaches can be considered.

Several approaches will be used to scale back, improve, or possibly eliminate the animal testing requirement. These include using AI models, lab-grown organs, and existing human data from abroad.

“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally,” FDA Commissioner Martin A. Makary said. “This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use.”

Animals exploited in laboratories live in fear and isolation, endure agonizing experiments, and are often cruelly killed when they are no longer considered useful. With the FDA’s new plan, we have a powerful opportunity to advance science while leaving this cruelty behind.

“For animal welfare, it represents a major step toward ending the use of laboratory animals in drug testing,” Makary said. “Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root.”

Lady Freethinker has long fought to end the cruelty of animal testing through investigations, petitions, and on-the-ground demonstrations — and we applaud this shift toward effective, cruelty-free research.