Likely enactment of this federal bill signals a new era in developing cruelty-free medicines
WASHINGTON, D.C. — The Center for a Humane Economy and Animal Wellness Action today celebrated passage of the FDA Modernization Act (FDAMA) 3.0, H.R. 2821, by the U.S. House of Representatives. Led by Reps. Buddy Carter, R-Ga., Nanette Barragán, D-Calif., Diana Harshbarger, R-Tenn., and Rosa DeLauro, D-Conn., the legislation will ensure that FDA regulations no longer mandate animal testing of new drugs when the law does not require it. The Senate passed an identical measure, albeit with a different bill number, in December 2025.
Today’s House vote brings the nation one step closer to a new era of cruelty-free medicines. In 2022, Congress passed FDAMA 2.0, repealing an 84-year-old federal animal testing mandate and allowing the use of scientifically valid animal-free test methods where appropriate. Unfortunately, in the years since then, the FDA’s animal testing regulations have not been updated, creating a mismatch between the law and regulatory requirements, and producing a climate of confusion for drugmakers. Testing of new drugs remains one of the largest categories of animal use in laboratory settings, with perhaps three-quarters of all animals coming from Ridglan Farms, Marshall BioResources, and other animal suppliers going to drug-screening protocols.
In May, the House Energy and Commerce Committee approved FDAMA 3.0 in a unanimous vote of 44-0, and in December 2025, the full U.S. Senate unanimously passed an identical measure, S. 355, led by Senators Cory Booker, D-N.J., and Eric Schmitt, R-Mo. Only one more Senate vote on the House-passed bill remains before the legislation can be signed into law by President Trump.
“Four years ago, many people believed weaning the nation away from an archaic, ineffective animal-testing requirement for drug screening was a mightily difficult transition, but make no mistake, we are methodically moving in that direction,” said Wayne Pacelle, president of the Center for a Humane Economy and Animal Wellness Action. “With the imminent enactment of the FDA Modernization Act 3.0, we can as a nation embrace scientifically superior methods that can speed the development of safer medicines, reduce costs, and spare countless animals from counterproductive testing on them.”
“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,” said Rep. Buddy Carter (R-GA). “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.”
In President Trump’s second term thus far, the FDA has released a roadmap envisioning animal testing as an exception rather than the norm, issued draft guidance expanding the use of animal-free New Approach Methodologies (NAMs), revised monoclonal antibody guidance to reduce animal testing requirements, and advanced additional policies encouraging developers to use scientifically valid alternatives. The National Institutes of Health (NIH) has also expanded investments in animal-free research technologies, while other federal agencies have launched initiatives to reduce reliance on animal testing.
“Removing outdated animal testing mandates from federal law can help get drug treatments to patients faster,” said Rep. Nanette Barragán (D-CA), the lead Democratic co-sponsor of the legislation. “The FDA Modernization Act 3.0 helps ensure federal implementation keeps up with modern scientific innovation and the growing availability of human-relevant research methods.”
“Today’s floor vote is another important step toward modernizing how we bring safe and effective drugs to market,” said Congresswoman Diana Harshbarger. “The FDA has the authority to move beyond outdated, cruel testing methods, and our bill simply directs the FDA to follow through and update its regulations accordingly. I’m proud to work alongside Congressman Buddy Carter and my colleagues to keep this bipartisan effort moving forward.”
“Science has advanced dramatically, and federal regulations must advance with it,” said Dr. Zaher Nahle, senior scientific advisor for the Center for a Humane Economy. “Human-relevant technologies are increasingly demonstrating greater predictive value than traditional animal models in many areas of biomedical research.”
“FDA Modernization Act 3.0 closes that gap by directing the FDA to align its regulations with the law Congress already enacted. Once signed into law, this legislation will provide greater regulatory certainty, encourage broader adoption of New Approach Methodologies, and further accelerate the transition toward faster, more predictive, and more humane drug development, said Tamara Drake, director of research and regulatory policy for the Center for a Humane Economy. This is the culmination of years of bipartisan work by Congress, federal agencies, scientists, patient advocates, and advocates for animals to modernize the way medicines are developed for the benefit of both people and animals.”
Since spearheading the campaign that led to passage of FDAMA 2.0 in 2022, the Center for a Humane Economy has worked closely with Congress and federal agencies to advance policies that encourage the development, validation, and regulatory acceptance of modern, human-relevant methods capable of improving medical research while reducing reliance on animal testing.
Today’s House vote represents another major milestone in that effort and reflects a growing bipartisan consensus that the future of biomedical research lies in scientifically advanced methods that better predict human outcomes, improve patient safety, reduce development costs, foster innovation, and dramatically decrease the use of animals in testing.