House can now take up and pass legislation directing FDA to implement the FDA Modernization Act 2.0 and start the long-term wind down of inaccurate, expensive, animal testing in drug development
WASHINGTON, D.C. — Senate Republicans and Democrats have united to pass the FDA Modernization Act 3.0, S. 5046. The bill was introduced by Sens. 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. Sen. Roger Marshall, R-Kan., is also a cosponsor of the bill.
The bill passed 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. That bill has 22 Republicans and 23 Democrats cosponsors. FDA, BIO, and PhRMA have no objections to the legislation.
“It is time to start winding down the inhumane, costly, and ineffective era of screening drugs on beagles, primates and other animals and 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 it will produce safer and better drugs and get them to patients in need faster than ever.”
An astonishing 90-95% of drugs that pass animal tests go on to fail in human clinical trials, wasting precious time for patients and exploding costs for drug developers. 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 drugs. This antiquated process of pharmaceutical innovation slows delivery of palliatives and cures for patient groups, drives up drug costs, and sacrifices countless animals.
“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 this legislation is named to do-modernize the FDA and remove overbearing animal testing requirements and regulations on new drugs. By fully implementing FDAMA 3.0, drug development can be both more humane and more efficient, ultimately leading to faster and more reliable treatments for patients. I am proud to join my colleagues 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. The FDA Modernization Act 3.0 ensures FDA will make the updates expeditiously.
“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 725 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
“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.
