New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022. The change—long sought by animal welfare organizations—could signal a major shift away from animal use after more than 80 years of drug safety regulation.
“This is huge,” says Tamara Drake, director of research and regulatory policy at the Center for a Humane Economy, a nonprofit animal welfare organization and key driver of the legislation. “It’s a win for industry. It’s a win for patients in need of cures.”
In place of the 1938 stipulation that potential drugs be tested for safety and efficacy in animals, the law allows FDA to promote a drug or biologic—a larger molecule such as an antibody—to human trials after either animal or nonanimal tests. Drake’s group and the nonprofit Animal Wellness Action, among others that pushed for changes, argue that in clearing drugs for human trials the agency should rely more heavily on computer modeling, “organ chips,” and other nonanimal methods that have been developed over the past 10 to 15 years.
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