Last year was a significant year for psychedelic reform. While researchers worked hard to expand their understanding of psychedelics, several lawmakers strove to advance psychedelic reform policy at the local, state and federal levels. The result was historic psychedelic policy-related advancements throughout the year that further enabled psychedelic research and opened the door to the potential development of alternative mental health treatments.
This includes the first-ever federal legislation mandating psychedelic drug-clinical trials, a novel congressional hearing, guidance from the U.S. Food and Drug Administration (FDA) on researching entheogenic substances, the launch of psilocybin services in Oregon and the chance to legalize MDMA (ecstasy) as a prescribed treatment. Much of this political support is due to a growing body of scientific literature connecting psychedelics such as MDMA, LSD and psilocybin (magic mushrooms) to significant improvements in mental health at relatively low doses.
With the United States in the midst of a mental-health crisis, lawmakers are scrambling to find alternative mental-health therapies that are effective and do not cause severe side effects. Psychedelics have shown that they can be extremely effective at treating several mental-health conditions over the long-term and with few side effects, making them a potential alternative to conventional mental-health treatments.
President Joe Biden closed the year by signing the 2024 National Defense Authorization Act (NDAA), which contained language instructing the U.S. Department of Defense (DOD) to fund clinical trials exploring the potential of using psychedelics to treat active members of the military. Interestingly, Republican Representatives Morgan Luttrell and Dan Crenshaw were behind the push to include this provision in the 2024 NDAA. The legislation also requires that the DOD establish a process through which military service members with traumatic brain injury or post-traumatic stress disorder (PTSD) could take part in clinical trials involving 5-MeO-DMT, MDMA, psilocybin and ibogaine.
Congressional lawmakers also held the first-ever psychedelics hearing in U.S. history that focused on how substances such as MDMA and psilocybin can help treat mental-health challenges in military veterans. The historic hearing included a series of testimonies from witnesses from the scientific and advocacy communities as well as three VA officials who discussed the department’s current work with psychedelics and its expectations for future psychedelic applications in the military.
Last year also saw the U.S. Food & Drug Administration release a first-of-its-kind guidance on the considerations researchers should make while studying psychedelics, which the FDA noted had initial promise as a potential therapy. The FDA said the novel guidance was meant to outline the challenges involved in designing programs for psychedelic drug development and provide researchers with the information they need to address the challenges when they occur.
Psychedelic drug-development company MAPS Public Benefit Corporation also submitted a new drug application to the FDA asking the federal agency to expedite its review of MDMA as a PTSD treatment. If the FDA approves the drug and the U.S. Drug Enforcement Administration (DEA) reschedules MDMA, it would be the first-ever psychedelic to be approved as a pharmaceutical.
Entities such as Compass Pathways PLC (NASDAQ: CMPS) operating within the psychedelics space look forward to more reforms being made to the regulatory landscape so that some of the existing hurdles to psychedelic research and product development may be eased.
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