The Food and Drug Administration (FDA) has announced plans to phase out animal testing requirements, starting with monoclonal antibodies and expanding to other drugs.
The initiative is being led by newly appointed FDA Commissioner Dr. Marty Makary.
The NIH should be doing a long-term study of natural immunity instead of torturing thousands of beagle puppies, including cutting their voice box to avoid barking sounds (sick). All taxpayer funded. All our health agencies need fresh new leadership. https://t.co/KCG6lF0Put
— Marty Makary MD, MPH (@MartyMakary) October 27, 2021
Makary is a longtime supporter of the White Coat Waste Project (WCW), a taxpayer watchdog group that has championed ending the agency’s reliance on animal experiments.
Puppy Beagles and other dogs are not ours to abuse in barbaric medical experiments.
Thank you @NancyMace for leading a broadly bipartisan bill to ban NIH research that mistreats dogs. Agree it’s “outdated, unnecessary, and cruel” https://t.co/9KiTNucXCc
— Marty Makary MD, MPH (@MartyMakary) December 11, 2022
In a press release about the shift, the FDA said:
Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs, and ultimately, drug prices.
“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices. It is a win-win for public health and ethics.”
The changes mark a significant policy shift, replacing outdated animal testing mandates with advanced, human-relevant methods like computational models.
Vanda Pharmaceuticals has been working with WCW to fight the FDA’s outdated animal testing mandates.
For every new drug the FDA demands routine lethal toxicity “studies” in 4-month-old beagle dogs with no evidence of any predictive value for humans. This brutal FDA requirement should be replaced by available modern highly predictive human relevant methods and put an end to the…
— Vanda Pharmaceuticals (@vandapharma) January 17, 2025
Sen. Rand Paul had also previously worked with WCW on bipartisan legislation to end animal testing mandates within the FDA.
Glad to meet Beesly today and see her rescued! @WhiteCoatWaste brought her and her parents by to chat about my #bipawtisan legislation FDA Modernization Act to end animal testing mandates. pic.twitter.com/apFEqay4RT
— Senator Rand Paul (@SenRandPaul) July 20, 2022
“This is a win-win for ethics and public health,” Dr. Makary stated in a post on X, emphasizing that the plan will streamline drug development while reducing the use of animals in labs.
The initiative builds on efforts from the first Trump administration, which WCW credits for laying the groundwork through policies that cut FDA animal testing and prioritized lab animal welfare.
Anthony Bellotti, WCW’s President and Founder, praised Makary’s policy in a statement provided to The Gateway Pundit, saying:
“For years, White Coat Waste has been leading campaigns to cut FDA’s in-house animal testing and red tape that forces federal agencies and companies to waste money and time poisoning puppies and other animals in cruel and unnecessary drug tests. Following WCW efforts, Trump 45’s FDA canceled nicotine addiction tests on primates and for the first time ever sent the survivors to a sanctuary, enacted an agency-wide lab animal retirement policy, and launched an initiative to cut dog testing. We applaud Commissioner Makary for picking up where Trump left off and prioritizing efforts to cut wasteful animal tests conducted and required by the FDA.”
Under Trump’s first term in 2018, WCW successfully pushed the FDA to end nicotine addiction tests on monkeys, retire the animals to a sanctuary, and establish an agency-wide lab animal retirement policy in 2020. The organization also played a key role in dramatically reducing the FDA’s in-house primate testing, culminating in the closure of its largest monkey lab in 2023.
As The Gateway Pundit reported earlier this week, the Trump administration’s Environmental Protection Agency (EPA) pledged to eliminate animal testing, reinstating a plan originally introduced during President Donald Trump’s first term.
Trump EPA Recommits to Ending Animal Testing, Reversing Biden-Era Policy
This decision comes after taxpayer watchdog White Coat Waste Project (WCW) exposed the Biden administration’s cancellation of the earlier initiative, which aimed to phase out testing on mammals by 2035.
Under the leadership of newly appointed Administrator Lee Zeldin, the EPA will now revive and enforce the phase-out.
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