The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological products and drugs, instead moving toward alternative testing models such computer simulations and “organoids.”
The agency said in a release that its animal testing requirements would be “reduced, refined, or potentially replaced using a range of approaches,” including “AI-based computational models of toxicity” and cell lines.
Animal tests are conducted and regulated by the FDA in instances where human efficacy studies are not “ethical or feasible.” The agency has previously said it “encourages and accepts scientifically valid alternatives to animal testing.”
There have been federal actions in recent years seeking to reduce animal testing. In 2023, former President Biden signed the FDA Modernization Act 2.0 into law, eliminating the requirement for drugs in development to undergo animal testing before being given humans.
As was noted by Science in 2023, the FDA usually required toxicity tests on one rodent species and one non-rodent species in order for drug approval to be granted. Some in the pharmaceutical industry have argued animal tests are slow and expensive.
“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,” FDA Commissioner Martin Makary said in a statement.
Makary said this move would offer newer treatments for patients more quickly while also reducing the cost of research and development.
As part of this move, the FDA is releasing a roadmap for alternative methodologies that will encourage the use of computer modeling and artificial intelligence (AI); lab-grown human “organoids” and organ-on-a-chip systems; and it will also be updating its guidelines to allow for the consideration of these new methods.
To determine the efficacy of these alternative evaluations, the FDA will be looking to “pre-existing, real-world safety data from other countries, with comparable regulatory standards, where the drug has already been studied in humans.”
Kathy Guillermo, senior vice president of People for the Ethical Treatment of Animals (PETA), applauded the announcement on Thursday.
“It’s a significant step towards meeting the agency’s commitment to replace the use of animals — which PETA has worked hard to promote,” Guillermo said in a statement. “All animal use, including failed vaccine and other testing on monkeys at the federally-funded primate centers, must end, and we are calling on the FDA to further embrace 21st-century science.”
