HHS Secretary Kennedy and FDA Commissioner Makary signal movement away from animal testing while a group of bipartisan lawmakers introduce the FDA Modernization Act 3.0
Washington, D.C. — Today, Animal Wellness Action, the Center for a Humane Economy, and Animal Wellness Foundation lauded a bipartisan set of lawmakers in the House of Representatives — many of whom were instrumental in passing the FDA Modernization Act 2.0 in the 117th Congress — for introducing legislation to require the U.S. Food and Drug Administration to take the necessary steps to implement that landmark 2022 law, which lifted a Depression-era animal testing mandate for all new drug candidates. The bill’s introduction coincides with a bombshell announcement by FDA Commissioner Marty Makary that the agency will begin to phase out the use of animal tests for monoclonal antibody therapies and other drugs.
U.S. Representative Buddy Carter, R-Ga., chair of the Health Subcommittee of the House Energy & Commerce Committee is the lead author of the FDA Modernization Act 3.0. 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. (House lead author of the original FDA Modernization Act).
The FDA Modernization Act 3.0 is the companion bill to the bipartisan Senate bill S.355, led by Senators Cory Booker, D-N.J., and Eric Schmitt, R-Mo., and requires the FDA to publish a final rule to implement the FDA Modernization Act 2.0 (FDAMA 2.0) by updating regulations that allow for non-animal test methods that can better predict drug safety and efficacy, speeding the time to market for new treatments and cures. A nearly identical bill passed the Senate by unanimous consent in December 2024, but the House did not take up the measure before the end of the 118th Congress.
“At long last, we may be at a pivot point where FDA is no longer obstructing the move away from animal testing,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy. “With today’s comments, Commissioner Makary is suggesting that the FDA will become a catalyst for the transition to 21st-century science grounded in human biology.”
“It is inhumane to rely solely on animal testing of medical products when other, harmless methods exist that are more predictive of human outcomes. The FDA Modernization Act 2.0, and recent actions by the Trump administration, have paved the way for modernizing FDA’s testing methods. This bill will put these wins into practice, accelerating innovation and getting safer, more effective drugs to market quickly by cutting unnecessary red tape,” said Rep. Buddy Carter (R-GA-01).
“Animals deserve humane treatment. They should not have to serve as lab experiments and be subjected to cruel tests for the purpose of human drug development. I am proud to rejoin Rep. Carter in leading this bipartisan effort to limit practices of animal testing for drug research,” said Rep. Nanette Barragán, D-Calif. “Carrying out stricter standards with the reforms included in the FDA Modernization Act 3.0 will not only encourage alternatives for more humane drug testing, but also support safer and more effective delivery of drugs to patients.”
“The FDA’s outdated animal testing rules are harming animals, hurting patients, and stalling medical innovation,” said Rep. Diana Harshbarger, R-Tenn. “The FDA Modernization Act 3.0 will cut burdensome red tape to allow drug manufacturers to use modern and more humane alternatives to improve safety for animals and patients alike. As a compound pharmacist for more than 30 years, I understand that ensuring East Tennesseans have affordable access to safe medicines is of the utmost priority, and this bill is a step toward delivering safe medicines in a more humane way.”
“This bill will transform drug development for the 21st century. By requiring full implementation of the FDA Modernization Act 2.0, this legislation ensures that advanced, human-based testing methods are actively adopted in the drug development process. 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.
“The FDA Modernization Act of 2021 was a monumental win that will streamline drug development and spur innovation without having to sacrifice at the expense of animal welfare,” said Rep. Vern Buchanan, R-Fla. “I look forward to building upon that success with Congressman Carter and ensuring the FDA follows through on delivering speedier cures for diseases without subjecting animals to inhumane and counterproductive experiments.”
The FDA’s failure to act for over two years is baffling, given the widespread support for FDAMA 2.0 both in the scientific community and among biotech companies and drug developers. More than 1,000 global publications, including news articles, commentaries, scientific reviews, and primary papers, have been published since enactment and noted the potential for a paradigmatic shift in drug development.
Recognizing the agency’s inaction, House appropriators in July 2024 inserted report language into the FY25 Ag/FDA appropriation calling for “continued implementation of the FDA Modernization Act 2.0, designed to modernize the drug development process and empower free market competition.” The appropriators also noted that “[s]ignificant delays may sow confusion among drug sponsors and stifle free-market innovation in new drug development.”
In addition to Animal Wellness Action and the Center for a Humane Economy, key endorsers of the legislation were the Laurie C. McGrath Foundation, the Michelson Center for Public Policy, SPCA International, Teva Pharmaceuticals, PETA, the Rare and Undiagnosed Network, and the International Cancer Advocacy Network. More than 200 animal welfare organizations, patient advocacy groups, and biotech and pharmaceutical companies backed the legislation.
Additional Perspectives from Drug Development Experts and Scientists
“FDA’s exclusive reliance on animal testing produced irrecuperable delays in the development of medicines, missed opportunities due to misguided regulatory principles, and exorbitant costs ultimately passed onto consumers. FDAMA 3.0 helps wean America from its dependency on artificial animal models — which proved to be misleading, distracting, and utterly unwise investments. It also asserts that human-relevant, technology-driven approaches must be the cornerstone of our drug development paradigm towards achieving results and eliminating inefficiencies and waste,” said Dr. Zaher Nahle, senior scientific advisor for the Center for a Humane Economy and Animal Wellness Action.
“Aligning the statute with regulations will eliminate confusion for drug sponsors, lead to more cures, cut drug-development time, lower drug prices, and confirm the FDA’s stated commitment to reducing and replacing animals in drug development,” said Tamara Drake, director of research and regulatory policy for the Center for a Humane Economy. “That must be complemented by a clear, accountable, and transparent regulatory process, including the full and speedy implementation of the existing law.”
“It is essential that FDA be proactive in using the most predictive scientific methods in its decision-making. Human-centric techniques such as organs-on-a-chip and organoids are developing rapidly and have the potential to improve, and even accelerate, bringing safe and effective products to the market. This legislation will focus FDA’s attention where it needs to be — improving regulations that will lead to better treatments, more cures,” said Paul A. Locke, JD, DrPH, professor, Johns Hopkins Bloomberg School of Public Health.