Psychedelic Researchers Respond to FDA’s Push to Reduce Animal Testing

FDA initiatives aim to reduce animal testing in research tied to drug and monoclonal antibody therapies by shifting toward “new approach methodologies” (NAMs) such as organoids and AI or computational modeling. Scientists featured in the debate are split: some see NAMs as an opportunity to innovate and accelerate safer evaluation, while others worry that current models may not reliably replace established animal safety testing and could compromise safety. The article references examples of predictive modeling in drug discovery, including computational work around serotonin receptor binding, and discusses FDA guidance that includes organ-on-a-chip and organoid approaches. It also notes concerns about systemic dosing and the possibility that skipping animal safety testing could be risky.