FDA Says It Plans to Phase out Animal Testing for Drug Development

‘This initiative marks a paradigm shift in drug evaluation,’ the FDA’s commissioner said.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The Food and Drug Administration (FDA) on April 10 said it will be phasing out animal testing for monoclonal antibodies and other drugs.

FDA officials said that its animal testing requirement will be “reduced, refined, or potentially replaced” with other approaches, including advanced computer simulations utilizing artificial intelligence and lab-grown products that are designed to mimic human organs.

The agency will also start looking at preexisting, real-world safety data from other countries that have regulatory standards similar to those in the United States.

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

He said that the move “represents a major step toward ending the use of laboratory animals in drug testing.”

Companies that submit what the agency described as strong safety data from non-animal testing could receive faster review, according to the FDA.

Health Secretary Robert F. Kennedy Jr. told a Cabinet meeting in Washington that officials have found artificial intelligence “is much more precise in identifying the impacts of toxics in various products.”

Legislation enacted in 2022 called the FDA Modernization Act 2.0 enabled the step. The bill removed the requirement that sponsors of new drugs perform studies on animals in order to receive licenses from regulators.

“Phasing out inhumane, archaic animal testing will help get life-saving drugs to patients faster and spare countless animals from needless harm,” Sen. Rand Paul (R-Ky.), the bill’s sponsor, said on the social media platform X on Thursday.

Kathy Guillermo, senior vice president of the People for the Ethical Treatment of Animals, said in a statement that the FDA’s plan is “a significant step towards meeting the agency’s commitment to replace the use of animals—which PETA has worked hard to promote.”

The National Association for Biomedical Research, on the other hand, said there is no full replacement for animal models at this time in drug development.

“We all want better and faster ways to bring lifesaving treatments to patients,” Matthew R. Bailey, president of the group, said in a statement. “But no AI model or simulation has yet demonstrated the ability to fully replicate all the unknowns about many full biological systems. That’s why humane animal research remains indispensable.”