The End of Mandatory Animal Drug Testing

On December 29, 2022, President Biden signed the FDA Modernization Act 2.0 into law as part of that year's end-of-session legislation. The bill undid a rule written into the Federal Food, Drug, and Cosmetic Act of 1938, which had forced drugmakers to test every experimental medicine on animals before it could enter human clinical trials. Sponsored by Senators Cory Booker of New Jersey and Rand Paul of Kentucky, the measure did not ban animal testing. It let the FDA accept results from human cell cultures, organ-on-a-chip systems, and computer models instead, whenever the agency judged the method sound enough. The Senate had passed it by unanimous consent three months earlier, a rare bit of agreement on anything touching drug regulation.