Food and Drug Administration (FDA) officials are laying out the agency’s “new framework” for psychedelic medicines, including steps that are taking to “make psychedelic therapies available to patients more quickly, as warranted by the nation’s mental health crisis.”
“The ongoing mental health crisis in the United States continues to worsen,” four FDA staffers wrote in a piece published in the New England Journal of Medicine (NEJM) last week. The agency “recognizes that although some people benefit from available treatment options, for others our current medications are not enough.”
“One potential avenue for the development of better treatments includes psychedelic compounds,” they said, noting that substances such as psilocybin and DMT “have been used in traditional healing and spiritual practices since long before the advent of modern psychiatry.”
While there has been a “prolonged period of quiescence” in the development of psychedelic medicines for decades, “due to research restrictions,” there has recently been a “dramatic resurgence of interest in psychedelic-based treatment for mental illness and substance use disorders” as a result of “advances in neurobiology and shifting social discourse.”
In July, FDA published guidance to help researchers studying the therapeutic benefits of psychedelics navigate the “unique challenges” of such investigations. That
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