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FDA Evaluation of Psychedelic Medicines

The FDA is beginning to work with pharmaceutical companies on an approval pathway for psychedelic drugs that currently fall under Schedule 1 of the Controlled Substances Act, according to authors of a Perspective article. “The FDA’s guidance for psychedelics research is a policy landmark and reflects shifting attitudes toward controversial substances,” the authors conclude. “We believe most of the guidance is well reasoned. But the FDA could consider changes in several areas, including changes regarding recommendations for psychological support, adverse-event reporting, and clinician credentials, to help improve psychedelics research.”

The authors also write: “The FDA suggests that if previous human trials have involved extensive exposure to a psychedelic and haven’t identified serious safety concerns, it might allow sponsors to start new human trials without performing animal testing. Although this policy wouldn’t affect ongoing trials for depression and post-traumatic stress disorder (PTSD), it might accelerate research on new indications.”

Source: New England Journal of Medicine