Representative Buddy Carter (R-GA) is celebrating the House passage of the FDA Modernization Act 3.0, a bill directing the U.S. Food and Drug Administration (FDA) to fully implement provisions to reduce unnecessary animal testing for drug development.
What does the bill do exactly? Sponsored by Rep. Carter, the bill requires the FDA to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023.
This provision authorized the use of certain alternatives to animal testing to support investigational use of a new drug.
The interim rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications.
The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.
What lawmakers are saying:
- Rep. Buddy Carter: “The House passage of the FDA Modernization Act 3.0 marks a major step toward a more modern, effective, and humane system for evaluating medicines. My bill will help update testing practices to reduce unnecessary animal harm, remove barriers to innovative, safe, and effective non-animal testing methods, and ensure the FDA’s implementation fully reflects both the law and today’s scientific capabilities.”
- Representative Vern Buchanan (R-FL): “Patients deserve access to the most advanced medical technology available. The FDA Modernization Act 3.0 ensures that drug testing reflects today's innovations, helping to bring promising healthcare to families faster without compromising safety through unnecessary reliance on animal testing. As the Health Subcommittee Chairman of Ways and Means and the champion of the FDA Modernization Act 2.0, I am proud to see my bill's impact be reinforced by this critical piece of legislation.”
Further Context: Each year in the United States, millions of animals, including an estimated 50,000 dogs, are used in laboratory experiments and testing.
This bill would also require the FDA to fully implement the FDA Modernization Act 2.0, ensuring that safe and effective treatments are developed using advanced, innovative non-animal testing methods when possible.
