The Center applauds bipartisan momentum toward advanced human-relevant testing
WASHINGTON, D.C. — In the wake of the ongoing transfer of 1,500 beagles from Ridglan Farms to animal care organizations, Animal Wellness Action and the Center for a Humane Economy applauded the House Energy and Commerce Health Subcommittee for advancing yesterday afternoon the FDA Modernization Act 3.0, H.R. 2821. This bipartisan legislation, with an even number of Republicans and Democrats as co-sponsors, ensure that FDA regulations and implementation fully align with the landmark FDA Modernization Act 2.0 enacted by Congress in 2022 to eliminate an animal-testing mandate for experimental drugs. The bill, approved unanimously, now heads to the full House Energy and Commerce Committee for consideration next week.
The Senate passed the companion bill, S. 355, led by Senators Cory Booker, D-N.J., and Eric Schmitt, R-Mo., by unanimous consent on December 16. The Senate passed a nearly identical bill in the 118th Congress, and Animal Wellness Action has been eagerly awaiting House action to send this bill to the President for his signature and add momentum to ongoing efforts by the public health agencies and the Congress to wind down animal testing. In April 2025, Commissioner Makary release a “Roadmap to Reduce Animal Testing in Preclinical Safety Studies,” calling for a phase out in drug development within five years.
“When the law and regulations are in conflict on animal testing, drug developers are confused and default to the archaic, outdated animal tests,” said Wayne Pacelle, president of the Center for a Humane Economy and Animal Wellness Action. “Congress and the FDA need to signal to all drug developers that they must move with intentionality to employ human-biology-based drug screening methods and to leave the dogs, primates, and other animals out of the R&D programs.”
Animal tests, in large part, are not predictive of the human response to drugs, with 90 to 95 percent of drugs and vaccines found safe in animal tests failing during human clinical trials. The cost for developing a single new drug may be from $1 – $6 billion, while the average timeline of development of a potential drug and vaccine from the lab to market is 10-15 years.
The legislation advances amid growing national attention on the unnecessary and detrimental use of animals in testing and research, including the recent release and rehoming efforts involving 1,500 beagles formerly bred for laboratory testing at Ridglan Farms in Wisconsin. Advocates say the unprecedented rescue effort has intensified public scrutiny of outdated animal testing models and accelerated calls for the adoption of modern human-relevant research methods.
“The advancement of FDA Modernization Act 3.0 marks another major step toward a more modern, effective, and humane system for evaluating medicines,” said Rep. Buddy Carter, R-Ga., lead sponsor of the legislation. “Congress already acted in 2022 to remove unnecessary barriers to innovative non-animal testing methods, and this bill helps ensure FDA implementation fully reflects both the law and today’s scientific capabilities.”
“Removing outdated animal testing mandates from federal law can help get drug treatments to patients faster,” said Rep. Nanette Barragán, D-Calif., 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.”
“Three years ago, Congress eliminated an 84-year-old requirement for extensive, multi-species animal testing for all new drug development programs, but the agency still hasn’t drafted regulations to apply that standard. Our bill requires the FDA to work aggressively to shift away from animal tests and to more reliable, human-cell-based drug screening methods. It’s a win for patients, a win for innovation, and a win for animal welfare. I’m proud to join this bipartisan measure to accelerate safer, more humane, and more effective medical breakthroughs,” said Rep. Troy A. Carter Sr., D-La., an original co-sponsor of H.R. 2821.
Most diseases have no treatment available, and adverse drug reactions are one of the major causes of mortality and hospitalization in the U.S. Use of human biology-based test methods would better predict how humans will respond to drugs in clinical trials.
“The FDA Modernization Act 3.0 is not a new policy initiative so much as the next phase of implementation,” said Tamara Drake, director of research and regulatory policy for the Center for a Humane Economy. Supporters point to recent FDA and NIH initiatives promoting organoids, organ-on-chip systems, computational toxicology, and other advanced approaches as evidence that the transition toward more predictive, human-relevant science is already underway.