Legislation, dealing with largest category of animal testing, aligns regulations with law that Congress passed more than two years ago and that Biden FDA ignored
Washington, D.C. — Senate Republicans and Democrats have united again to reintroduce the FDA Modernization Act 3.0. and work to usher in a new era of healthier living and longevity by facilitating the development of better, safer, and less costly new drugs for patients in need. 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.
An identical bill, a substitute version of S. 5046, passed the Senate by unanimous consent in December 2024, but the House did not take up the issue before the end of the 118th Congress. Reps. Buddy Carter, R-Ga., Nanette Barragán, D-Calif., Diana Harshbarger, R-Tenn., and Rosa DeLauro, D-Conn., led the House companion bill, H.R. 7248, and it, too, enjoyed broad bipartisan support and no opposition.
“It is time to start winding down the inhumane, costly, and ineffective era of screening drugs on beagles, primates, and other animals and to step decisively into the era of human-biology-based screening methods for experimental drugs,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy. “This new era will spare animals and produce safer and less costly drugs, delivering a better range of cures and palliative treatments to patients in need in amore timely way.”
An astonishing 90-95% of drugs that pass animal tests go on to fail in human clinical trials, wasting precious time for patients. Data show that it typically takes 10 to 15 years and an average investment of $1 billion and up to $6 billion for a new drug. Animal tests are inaccurate predictors of human response to medicines. This antiquated process of pharmaceutical innovation slows delivery of palliatives and cures for patient groups, drives up drug costs, and sacrifices countless animals.
“It’s been over two years since Congress ended the statutory mandate that investigational new drugs (INDs) undergo mandatory animal testing before human clinical trials,” said Senator Booker. “We cannot allow the FDA to continue to delay on implementing this critical law. If passed, this bipartisan legislation will require FDA to finally update its regulations and will pave the way for more scientifically reliable and humane methods of drug development.”
“The FDA Modernization Act 3.0 is aimed to do exactly what this bipartisan legislation is named to accomplish – modernize the FDA and remove overbearing animal testing mandates and regulations on new drugs. I am thankful for the support of my colleagues in helping to ensure passage, and I look forward to President Trump signing this legislation into law,” said Sen. Schmitt.
“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.
Shortly after FDAMA 2.0’s enactment in December 2022, a legislative campaign led by Sens. Paul and Booker and Rep. Vern Buchanan, R-Fla., in the 117th Congress, there have been more than 1,000 news articles, commentaries, scientific reviews, and primary papers published about the legislation’s potential to usher in a paradigm 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, 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 Drug Development Experts and Scientists
“FDAMA 3.0 is much needed legislation to support the adoption of non-animal methods for the benefit of patients. The scientific consensus is clear and it is time for regulators and industry to adopt NAMs. The passage of FDAMA 3.0 will improve safety and lead to more innovative therapeutics,” said Simon Burns, co-founder and CEO of VIAL, a biotech and pharmaceutical company.
“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.