Statement from the Physicians Committee on House Passage of the FDA Modernization Act 3.0

The Physicians Committee for Responsible Medicine applauds the U.S. House of Representatives for passing the FDA Modernization Act 3.0, bipartisan legislation that reforms FDA regulatory requirements by recognizing nonanimal approaches for evaluating new medicines.

The FDA Modernization Act 3.0 directs the U.S. Food and Drug Administration (FDA) to replace references to animal testing in its regulations with broader "nonclinical" testing approaches, defined to include human-based methods—such as advanced 3D cell models, organs-on-chips, and computational models—in addition to animal studies. These changes better reflect today's scientific capabilities and provide greater flexibility to use the most appropriate methods to evaluate new therapies. 

“By passing this legislation, Congress is making a huge stride to modernize drug development and improve the evaluation of new therapies, for the benefit of both patients and animals,” said Emily Anderson, MS, advocacy and policy program manager at the Physicians Committee. “Previous legislation passed in Congress pushed the FDA toward greater acceptance of human-based methods, but the FDA Modernization Act 3.0 finally directs the agency to update its regulations.” 

The Physicians Committee has advocated for these regulatory changes for many years through congressional outreach, scientific publications, and engagement with FDA stakeholders. The legislation addresses outdated regulatory language that has remained in place despite tremendous advances in nonanimal technologies and growing support from government agencies, the pharmaceutical industry, Congress, and the public for transitioning toward more human-relevant approaches.

The legislation also advances an important objective outlined in the FDA's Roadmap to Reducing Animal Testing, which envisions making scientifically appropriate nonanimal methods the default for preclinical safety testing whenever possible. 

The bill passed the U.S. Senate in December 2025 and has now passed the House of Representatives with bipartisan support. The Physicians Committee urges the bill to be swiftly advanced to the President and signed into law.