House can now complete Congressional directive requiring FDA to implement the FDA Modernization Act 2.0
WASHINGTON, D.C. — Senate Republicans and Democrats have united to pass the FDA Modernization Act 3.0, S.355, reaffirming strong bipartisan support for the government-wide shift toward modern, human-relevant technologies. The bill was introduced by Sens. Cory Booker, D-N.J., Eric Schmitt, R-Mo., Rand Paul, R-Ky., Angus King, I-Maine, John Kennedy, R-La., Sheldon Whitehouse, D-R.I., Ben Ray Luján, D-N.M., Roger Marshall, R-Kansas, and Richard Blumenthal, D-Conn. in March.
“Under Commissioner Marty Makary’s visionary leadership, the FDA has embraced the most significant modernization of nonclinical science in a generation,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy. “FDA’s Roadmap to Reduce Animal Testing sets out a vision to embrace human-relevant approaches and leave ineffective and costly animal testing behind. Makary’s commitment promises to position FDA as a global leader in modernizing drug evaluation and accelerating safer, more effective treatments for patients.”
“The Senate’s action ensures that the agency’s progress is anchored in statute and regulations, giving drug sponsors clarity and maintaining momentum in reducing reliance on beagles, primates, and other animals in testing,” added Pacelle.
In April, NIH announced a major shift in its research strategy, expanding investments in organoids, tissue chips, and computational platforms to reduce reliance on non-human primates and other animals. Soon after, the CDC issued a historic directive to phase out its entire primate research program — the first time a U.S. agency has ended in-house primate testing. Together, these actions reinforce a government-wide commitment to more predictive, ethical, and innovative biomedical science.
“It has been nearly three years since Congress eliminated the legal requirement that animal testing be conducted as part of the new drug development process, and since then the FDA has taken meaningful steps to modernize nonclinical drug evaluation. The FDA Modernization Act 3.0 will help lock in these reforms, ensuring that FDA regulations mirror current law and reflect the best available science, supporting the agency’s transition toward more predictive, humane research tools. This is how we improve public health and follow the science, all while reducing unnecessary animal suffering,”said Sen. Cory Booker.
“I’m proud to see our bipartisan bill move past the Senate and get one step closer to becoming law. This legislation removes outdated and unnecessary animal testing requirements during the drug development process and allows drug developers to use modern methods that better promote public health,” said Sen. Schmitt.
The House companion bill, H.R.2821, was introduced in April this year. U.S. Representative Buddy Carter, R-Ga., is the lead author. Co-leaders of the bill include Representatives Nanette Barragán, D-Calif., and Diana Harshbarger, R-Tenn. (both on the Health Subcommittee), Troy Carter, D-La. (Energy & Commerce Committee), Representative Rosa DeLauro, D-Conn. (ranking Democrat on the Appropriations Committee), and Vern Buchanan, R-Fla. (lead author of the original House version of the FDA Modernization Act). The organizations urge the House to bring the bill to the floor for a vote.
The FDA Modernization Act 2.0 laid the foundation for every major federal reform now underway. By eliminating the decades-old statutory mandate requiring animal testing for Investigational New Drug applications, FDAMA 2.0 opened the regulatory door for the FDA to pursue scientifically advanced, human-relevant approaches. That change allowed the agency to develop its April 2025 Roadmap, issue new guidances reducing primate use and integrating modern non-animal methods and begin the broader transition away from animal-based toxicology. Without FDAMA 2.0, none of these shifts at FDA—and the parallel moves at NIH and CDC—would have been possible.
“The FDA Modernization Act 3.0 builds on the critical reforms we achieved with FDA Modernization Act 2.0, ensuring that modern, humane, and scientifically advanced testing methods can finally replace outdated animal testing. For too long, bureaucratic inertia has delayed the implementation of these changes, which are vital to saving lives, reducing costs, and bringing life-saving treatments to patients more efficiently. This legislation sends a clear message: Americans deserve a regulatory system that embraces innovation, not one stuck in the past,” said Dr. Rand Paul.
In addition to Animal Wellness Action and the Center for a Humane Economy, key endorsers of the FDA Modernization Act 2.0 were the Laurie C. McGrath Foundation, the Michelson Center for Public Policy, SPCA International, Teva Pharmaceuticals, PETA, the Rare and Undiagnosed Network, the International Cancer Advocacy Network, and the late Robert “Skip” Trimble, a pioneering animal advocate. There were more than 200 animal welfare organizations, patient advocacy groups, and biotech and pharmaceutical companies that backed the legislation.
Additional Perspectives from Experts and Scientists
“With its April Roadmap and recent draft guidances, the FDA has acknowledged what decades of data have shown: traditional animal models often fail to predict human outcomes, while human-relevant technologies offer far greater accuracy,” said Dr. Zaher Nahle, senior scientific advisor for the Center for a Humane Economy and Animal Wellness Action. “FDAMA 3.0 reinforces this scientific progress by aligning regulatory language with the agency’s modern practices. This is a pivotal moment — a transition toward a drug development ecosystem built on precision, efficiency, and meaningful benefits for patients.”
“The FDA has taken important steps to operationalize the transition away from mandatory animal testing, and FDAMA 3.0 gives the agency the statutory clarity it needs to finish the job,” said Tamara Drake, director of research and regulatory policy for the Center for a Humane Economy. “Updating the regulations will eliminate confusion for drug sponsors, help reduce unnecessary primate and beagle tests, and ensure that modern, human-specific tools continue to advance. It is essential that this progress be accompanied by a transparent and accountable regulatory process.”