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FDA no longer requires animal tests before human drug trials

January 10, 2023
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A newly signed law permits the FDA to clear a drug for human clinical trials while bypassing animal trials.

Key Highlights

  • The FDA now has discretion to determine whether non-animal testing (e.g. chip analogues, AI modeling) of drugs or biologics is sufficient to proceed to human trials. Previously, animal studies were required by law.
    • Animal rights advocates and some drug companies cheer the decision as it targets inhumane or inefficient practices, respectively.
    • Some scientists are concerned about loss of fidelity in understanding side effects without animal models.

    In December 2022, as part of the Consolidated Appropriations Act, President Biden signed a law that has become a point of great discussion (and contention) in the pharmaceutical industry, upending a long-standing law passed in 1938: the United States Food, Drug & Cosmetic Act. The 1938 law mandated animal testing for drug development, among other industries; now, that requirement has been lifted. One important nuance to note is that this is not a blanket relaxation of industry standards, but rather provides an alternative path if the FDA decides that non-animal testing data is sufficient.

    Animal advocacy groups are naturally excited at the announcement, but so are many drug and research companies. Some drug manufacturers posit that the old animal testing requirement increased drug development costs unnecessarily and slowed down research timelines. Others are anticipatory at the potential growth of what was once niche, non-animal model testing solutions. Still, others resist the idea that the new law signals a sudden paradigm shift; rather, this may only be the beginning of a slow, gradual transition, as non-animal alternatives have provided mixed results in relieving the overarching concern for human toxicity and side effects.

    Read the original article in Science Journal here.

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