Washington, D.C. — Animal Wellness Action, the Center for a Humane Economy, and Animal Wellness Foundation applauded Senators Cory Booker, D-N.J., Eric Schmitt, R-Mo., Rand Paul, R-Ky., Mike Braun, R-Ind., Angus King, I-Maine, John Kennedy, R-La., Sheldon Whitehouse, D-R.I., Ben Ray Luján, D-N.M., and Richard Blumenthal, D-Conn., for introducing today the bipartisan FDA Modernization Act (FDAMA) 3.0 to kickstart the U.S. Food and Drug Administration’s implementation of the FDA Modernization Act 2.0, enacted in 2022. That statute eliminated a 1930s-era animal testing mandate, giving drug sponsors the option to screen new drug candidates using innovative animal-free methods. To date, the FDA has not updated its regulations to conform with the law.
The bill introduced today is a Senate companion to the FDA Modernization Act 3.0 introduced in the U.S. House of Representatives in February by Reps. Buddy Carter, R-Ga., Nanette Barragán, D-Calif., Diana Harshbarger, R-Tenn., and Rosa DeLauro, D-Conn. Currently, there are 20 Republicans and 21 Democrats cosponsoring that legislation pending before the Committee on Energy and Commerce.
“The FDA has been delinquent in not following the directives of Congress and revamping its archaic regulations relating to animal testing mandates for new drug screening,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy. “Human-relevant models must be put to use in our drug development programs to benefit patients and drug sponsors and to spare beagles, primates, and other animals needless torment.”
An astonishing 90-95% of drugs that pass animal tests go on to fail in human clinical trials, wasting precious time for patients.
“The FDA Modernization Act 2.0 was a landmark achievement for both animals and public health, paving the way for 21st century human-relevant science,” said Sen. Booker. “It’s time our country takes full advantage of technologies that can more accurately predict human responses and accelerate our nation’s drug development. This bipartisan legislation will ensure the FDA finally aligns its regulations with the law.”
“The FDA Modernization Act 3.0 is aimed to do exactly what the bill is named to do — modernize our FDA and remove overbearing and often unnecessary animal testing requirements on new drugs. I’m proud to join Sen. Cory Booker on this important bipartisan legislation,” said Sen. Schmitt.
Shortly after FDAMA 2.0’s enactment, led by Senators Booker and Paul, Animal Wellness Action and the Center for a Humane Economy furnished the FDA with a list of outdated regulations and a suggested template for updating them.
“In 2022 I was proud to lead the charge on the FDA Modernization Act 2.0, which was a critical step in reforming our drug approval process — getting life-saving treatments to patients faster, cutting costs, and embracing non-animal testing methods. Now, with FDA Modernization Act 3.0, it’s time to build on that success and ensure reforms can proceed expeditiously. Swift passage of this legislation will continue breaking down unnecessary barriers so Americans can access safe, effective drugs without delays and at reduced costs,” said Dr. Rand Paul.
The FDA’s failure to implement FDAMA 2.0 has caused confusion in the scientific community and biotech communities, which lauded Congress for enacting the measure. More than 660 publications, including news articles, commentaries, scientific reviews, and primary papers, have been published since enactment, noting 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.”
A coalition of hundreds of animal welfare groups, biotech and pharmaceutical companies, and patient advocacy groups backed the FDA Modernization Act in the 117th Congress, led by Sens. Rand Paul, R-Ky., and Cory Booker, D-N.J., and U.S. Rep. Vern Buchanan, R-Fla. In addition to Animal Wellness Action and the Center, key players included 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.
Additional Perspectives from Drug Development Experts and Scientists
“The FDA’s obsessive reliance on artificial animal models that do not replicate human biology and disease pathology is indefensible when so many diseases, rare and common, remain without cures despite decades of animal testing, which proved to be misleading, distracting, and utterly unwise investments. We have innovative, human-relevant models that can and must be embraced to break this logjam,” 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.