The FDA’s Continued Use of Human and Animal Testing in Drug Approval: A Question of Necessity

Congress unanimously passed the FDA Modernization Act 2.0 in December 2022, allowing drug companies to find alternative methods of assessing products without testing on animals or humans. The bill, sponsored by Sens. Rand Paul (R–Ky.) and Cory Booker (D–NH), aims to speed up the drug approval process and promote more humane testing methods. The FDA has not updated its regulations to align with the new law, despite previous positive statements about moving away from animal testing. In a letter to FDA Commissioner Robert Califf, Paul, co-signed by Booker and other senators, urged the agency to update its requirements for new drugs expeditiously. The delay serves as a reminder that even when Congress, the president, and the agency agree on deregulation, efforts can still hit a dead end. There is no reason to force scientists to experiment on living creatures if better testing methods are available.