Victory! U.S. Senate Passes FDA Modernization Act 3.0

The United States Senate has taken a major step toward advancing safer, more effective, animal-free science by passing the FDA Modernization Act 3.0 with unanimous consent—a powerful show of bipartisan support for compassionate, common-sense legislation.

This bill builds on the groundbreaking FDA Modernization Act 2.0, passed into law in 2022, which ended the federal requirement that experimental drugs must be tested on animals before entering human clinical trials. However, despite the law’s passage, the FDA failed to update its regulations and application forms, which continued to require explanations of animal testing—effectively forcing scientists to keep using animals.

The FDA Modernization Act 3.0 addresses this problem directly by requiring the FDA to update its regulations and forms within one year, replacing the word “animal” with “nonclinical” when referring to tests, data, studies, models, and research. This change will finally align FDA practices with the law and remove unnecessary barriers to modern, humane science.

This is a major victory, and it would not have been possible without the dedication of advocates across the country. More than 12,000 members of the Species Unite community reached out to their Senators, urging them to support this crucial legislation.

By opening the door to advanced methods such as AI-driven models, organ-on-chip technology, and other human-relevant approaches, this bill helps move science toward tools that are more accurate, more efficient, and more predictive of human outcomes. FDA Commissioner Martin Makary has voiced strong support for this shift, noting that “by leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably.” Ending reliance on animal testing also has the potential to save billions of taxpayer dollars currently spent on drug trials that fail 90–95% of the time when they reach human testing, while sparing millions of animals from suffering.

The FDA Modernization Act 3.0 will now move to the United States House of Representatives. We are updating our petition to focus on members of the House, and even if you have already taken action, you can use the form again to help keep this momentum going by contacting your member of the U.S. House of Representatives.

Animal testing is outdated, expensive, and ineffective. The FDA Modernization Act has the power to drive real change right now. Thank you for standing with us and supporting this important legislation.