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STAT+: FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’
The move comes after lawmakers sought to force the agency to update regulations that would allow alternatives to animal testing.
In an unexpected move, the U.S. Food and Drug Administration announced plans to reduce — and possibly replace — animal testing with other methods for developing certain medicines in a bid to lower R&D costs and, eventually, the prices for prescription drugs.
The agency will encourage researchers to use computer modeling and artificial intelligence to predict how a drug will perform, as well as organs-on-a-chip, which are miniaturized devices that mimic organs and tissues. And to determine effectiveness, the FDA will begin using existing, real-world safety data from other countries where a drug has already been studied in humans.
“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 Makary in a statement.
