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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