WASHINGTON—Humane World for Animals and Humane World Action Fund (formerly called the Humane Society of the United States and Humane Society Legislative Fund) welcomed the announcement by the U.S. Food and Drug Administration to phase out animal testing for certain monoclonal antibody therapies and drugs. This historic step includes a 3- to 5-year plan to make animal studies the exception rather than the norm for pre-clinical safety and toxicity testing. The FDA is prioritizing human-relevant science while seeking to reduce animal suffering.
“We’re thrilled to see the FDA take this important step to phase out animal testing for certain therapies and drugs,” said Kitty Block, president and CEO of Humane World for Animals. “This dramatic shift in direction will spare countless animals from suffering while encouraging faster, more reliable and safe drug development that helps people. It’s proof that compassion and cutting-edge science can—and should—go hand in hand.”
Every year, countless dogs, rabbits, primates, mice and other animals are subjected to painful toxicity tests—force-fed, injected or exposed to chemicals in ways that often fail to predict human outcomes. By contrast, modern non-animal methods such as organ-on-a-chip, 3D bioprinting, artificial intelligence technologies and advanced cell models offer faster, more predictive tools and methods for assessing drug safety. The FDA’s move follows the Environmental Protection Agency’s renewed commitment this week to phase out mammal testing—a policy first launched in 2019 and later paused.
“FDA and EPA have been pressed for decades to champion innovative methods that use human cells, 3D printing, robotics, computer models and other technologies to assess the safety and efficacy of a host of chemicals, products, devices and drugs without the suffering and death of literally hundreds of thousands of animals,” said Sara Amundson, president of Humane World Action Fund. “We’re confident that with a substantial commitment to assessing scientific validity and prioritizing implementation of such methods we can place new animal testing in the dustbin of history where it belongs.”
The FDA’s announcement helps remove a major barrier to progress. For years, Humane World for Animals and Humane World Action Fund have led efforts to modernize drug testing by urging the FDA to prioritize non-animal testing methods. Through a formal legal petition submitted last year, we pushed for regulatory amendments to clarify that animal testing is not legally required for drugs under the Federal Food, Drug, and Cosmetic Act. The petition, importantly, also requested that the agency create guidance documents focused on non-animal methods. This guidance was incorporated into a recent roadmap published by the FDA.