Prescription Psychedelics: The Road from FDA Approval to Clinical Practice

This week, the American Journal of Medicine published a commentary on the route by which psychedelics could become prescribed following FDA approval, and the regulatory hurdles that must be passed on the way.

ABSTRACT:

"After languishing for decades from legal restrictions and stigma, research into psychedelic drugs is exploding – with the encouragement of the Food and Drug Administration. Recent clinical trial successes suggest some long-banned drugs could soon be authorized as treatments for debilitating illnesses. Yet because of these drugs’ history, FDA approval would be just one important step in a complex process to transform these compounds into therapies. Incorporating psychedelic drugs into clinical practice will require peeling back multiple layers of legal prohibition, clarifying prescribing guidelines, and developing treatment models that work for drug-makers, physicians, and payers.

Although the psychedelic research revival is yielding promising results, challenges remain before these drugs will find their way into clinical practice.

Yet this slow process from FDA approval to prescription psychedelics could enhance the likelihood that these will actually take root. Given the longstanding skepticism toward psychedelic interventions, moving too swiftly might risk a backlash that could further stall research. Proceeding with both caution and openness offers the best hope for harnessing the potential benefits of these drugs while mitigating their risks."

For more psychedelic news and research, visit the psychedelic health professional network homepage.