FDA’s Historic Move Halts Animal Testing: A Triumph for Animal Welfare Advocates

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Beagles in animal testing
Beagles used in animal testing.

In a significant victory for the White Coat Waste Project, the Food and Drug Administration (FDA) has announced a plan to phase out animal testing requirements, focusing initially on monoclonal antibodies and expanding to other drug categories. The charge is being led by the newly appointed FDA Commissioner, Dr. Marty Makary.

Makary, a steadfast supporter of the White Coat Waste Project (WCW), which advocates against taxpayer-funded animal experiments, is leading this groundbreaking shift.

In a press release, the FDA declared, “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.”

Dr. Makary emphasized, “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.”

The move signifies a major policy change, replacing outdated animal testing mandates with advanced, human-relevant methods like computational models. Vanda Pharmaceuticals has been actively working with WCW to challenge the FDA’s antiquated animal testing protocols.

Senator Rand Paul has also collaborated with WCW on bipartisan legislation aimed at ending animal testing mandates at the FDA.

“This is a win-win for ethics and public health,” Dr. Makary reiterated on social media, highlighting the plan’s potential to streamline drug development and reduce lab animal usage.

The initiative builds on efforts from the Trump administration, with WCW acknowledging the groundwork laid by policies that scaled back FDA animal testing and prioritized lab animal welfare.

Anthony Bellotti, President and Founder of WCW, expressed his approval for Makary’s policy, stating:

“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 President Trump’s first term in 2018, WCW successfully pushed the FDA to end nicotine addiction tests on monkeys, retiring the animals to a sanctuary, and establishing a broad agency-wide lab animal retirement policy by 2020. They also contributed significantly to the reduction of the FDA’s in-house primate testing, which led to the closure of its largest monkey lab in 2023.

In a related development, the Environmental Protection Agency (EPA), under the leadership of newly appointed Administrator Lee Zeldin, is reviving a plan to phase out animal testing, which the Biden administration had suspended. This plan, originally introduced during President Trump’s first term, aims to eliminate testing on mammals by 2035.

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