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Bipartisan congressional legislators are pleased with recent actions by the U.S. Food and Drug Administration (FDA) regarding psychedelic policy and research. Only a few days after the lawmakers filed a bill requesting that the agency craft measures to guide psychedelic research in the United States, the FDA published the country’s first draft guidance on psychedelic research.
Released in late June, the draft stated that psychedelics showed “initial promise” as potential therapies and outlined “unique” considerations for researchers to note during their research. The 14-page document provides America’s first-ever framework for psychedelic research and could aid in the eventual development of psychedelic-based treatments.
Representative Dan Crenshaw, who introduced the bill asking for guidance on psychedelic research alongside Representatives Ro Khanna and Mariannette Miller-Meeks said that he is glad the regulatory agency decided to publish guidance for clinical trials on psychedelics. He added that it was important for legislators and regulators to create a framework that allowed researchers to keep on studying psychedelics.
A military veteran, Crenshaw explained that the guidance should increase access to psychedelic clinical trials to ensure that active service members, veterans and people living with conditions such as substance abuse disorder, traumatic brain injuries and post-traumatic stress disorder (PTSD) can access psychedelic treatments.
Psychedelics have captured the attention of lawmakers such as Crenshaw and millions of other Americans due to their purported mental health benefits. A growing body of literature and anecdotal reports show that psychedelics can deliver profound mental-health benefits even where traditional psychiatric medications have failed. Hallucinogens such as psilocybin, MDMA and LSD have been found to offer long-term relief against various mental health disorders at minimal doses and with few, if any, side effects.
Miller-Meeks said that many veterans are already using guided psychedelic therapy to treat “excruciating, post-traumatic pain” with fewer side effects and better outcomes in pilot studies. She said that she knew the value of medical research because of her medical background, and she was encouraged by the FDA’s decision to issue guidance on psychedelic research and clinical trials.
Shortly after issuing the guidance, the FDA published a notice in the Federal Register and launched a 60-day comment period for the public to discuss the proposed guidance and offer opinions on how the final guidance should look.
Director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research Tiffany Farchione said that psychedelics are still “investigational products” and advised sponsors to “consider their unique characteristics” while designing psychedelic clinical studies.
Leading startups such as Compass Pathways PLC (NASDAQ: CMPS) are undoubtedly assessing the new guidelines to see whether many of their concerns are addressed. The feedback that the federal agency receives could reflect any concerns these companies have about the draft guidance.
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