New direct rule advances non-animal testing methods and reforms sought by Humane World for Animals and Humane World Action Fund to modernize drug development

WASHINGTON (September 21, 2026)—Humane World for Animals and Humane World Action Fund, formerly called the Humane Society of the United States and Humane Society Legislative Fund, commend the U.S. Food and Drug Administration today for issuing a direct final rule to implement significant changes to its drug and biologics regulations. Specifically, the FDA seeks to remove outdated references to animal testing, a major step toward clearing regulatory barriers and encouraging drug companies to make greater use of cutting-edge non-animal testing methods.

Despite publicly indicating a commitment to advancing non-animal test methods, the FDA’s drug regulations continue to emphasize the use of animals, causing companies to believe that animal testing is legally required in the drug approval process. The rule, which could take effect as soon as February 4, 2027, directly addresses a key request in a 2024 legal petition filed by Humane World for Animals and Humane World Action Fund for the FDA to update regulations to clarify that animal testing is not required.

The petition requested that the FDA take a series of steps to make it plain and clear that animal testing isn’t legally required for drug approval, and today’s rule reflects decades of advocacy by the groups and others. The new rule also advances the FDA’s stated goal of making animal tests “the exception rather than the norm” for preclinical safety and toxicity testing over the next three to five years.

Sara Amundson, president of Humane World Action Fund, said:

“This is a historic milestone in our long-standing effort to dismantle outdated federal policies that have kept animal testing entrenched in drug development. For far too long, the FDA and the industries it regulates have been at a standstill regarding the shift away from animal testing. That’s why we petitioned the FDA two years ago to change its regulations and lobbied Congress to press the agency, too. Companies weren’t going to act without absolute assurance from the federal government that animal testing data wasn’t required for drug approvals. Today, the FDA made that clear. This action will deliver better science, accelerate innovation and spare animals from needless suffering, if the regulated industries step up their strategies for moving away from animal testing.”

This latest action builds on a series of actions taken by the FDA under the Trump administration to reduce reliance on animals in drug testing. Since April 2025, the agency has taken steps on its own roadmap to reduce testing on non-human primates for certain therapies, encourage pharmaceutical companies to submit data from non-animal methods and clearly communicate when and in what contexts non-animal methods have been accepted.

Kitty Block, president and CEO of Humane World for Animals, said:

“Millions of dogs, rabbits, monkeys, mice and rats are used to evaluate the safety and efficacy of drugs, but animal tests do a notoriously bad job of predicting human responses and cause immense suffering. That’s why we have fought relentlessly to move science beyond animal tests conceived and relied upon in a bygone era. The landscape has changed, science has evolved, and human cell-based systems, advanced organ-on-a-chip technologies and computational models offer a better path forward. Removing outdated animal testing references from FDA drug regulations will clear the way for these technologies to play a much greater role in how medicines that help people are developed.”

Across the federal government, a fundamental shift to reduce reliance on animal experiments and advance human-based, clinically relevant science is underway. For example, the National Institutes of Health has prioritized human-based research technologies and established a new office to coordinate the development and adoption of non-animal methods, while the Environmental Protection Agency has recommitted to ending mammal testing by 2035.

The FDA will accept public comments until December 7, 2026.

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