Understanding the Role of the FDA in Advancing Psychedelic Therapy – Medriva

Understanding the Role of the FDA

The U.S. Food and Drug Administration (FDA), a division of the Department of Health and Human Services, is entrusted with safeguarding public health. This involves ensuring the safety, effectiveness, and security of a wide range of products, including drugs, vaccines, medical devices, food supply, cosmetics, dietary supplements, and tobacco products. Among the many areas under its purview, the FDA also oversees the regulatory aspects of psychedelic clinical trials, and the current research in this area is gaining momentum.

In a bid to advance the field of psychedelic research, the FDA has announced a two-day virtual public workshop titled Advancing Psychedelic Clinical Study Design in collaboration with the Reagan-Udall Foundation. The workshop aims to gather researchers, regulated industry representatives, and other stakeholders to discuss scientific issues related to working with psychedelics in clinical trials and drug development. The FDA issued its first draft psychedelics guidance for the industry in June 2023, offering general considerations to sponsors developing psychedelic drugs for the treatment of medical conditions.

Research into the therapeutic benefits of psychedelic drugs dates back 80 years. However, government regulations have long hindered progress in this field. In recent years, there has been a resurgence of interest in the benefits of psychedelic medicines, leading to clinical trials for treating conditions like treatment-resistant depression and PTSD. The FDAs new draft guidance for researchers investigating the use of psychedelic drugs for potential medical treatment signals a promising pathway to approval. Despite the logistical challenges of conducting clinical research and ensuring patient safety, there is a potential move towards refining the therapeutic benefits of these drugs while minimizing their psychedelic effects.

The American Medical Association has set new standards for assigning specific codes to psychedelic therapies for data collection on novel treatments. In July, the AMA approved Current Procedural Terminology (CPT) III codes for psychedelic medicines, facilitating health providers in seeking coverage and reimbursement for these treatments. Alongside this, the FDA is considering an application to approve MDMA as a prescription drug, with MAPS PBC requesting an expedited six-month review instead of the standard 10-month review. If approved, it would mark a historic moment, making MDMA the first psychedelic to be approved as a pharmaceutical to be administered with psychotherapy and other supportive services.

The FDAs draft guidance for researchers interested in developing psychedelic drugs for the treatment of medical conditions has sparked optimism in medical communities. This shift in attitude is seen against the backdrop of the historical context of psychedelics, the Controlled Substance Act, and the resurgence of research funding for psychedelics. Notably, the FDA has already approved esketamine for the treatment of depression in adults, paving the way for further research and harnessing the potential therapeutic benefits of psychedelic drugs.

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Understanding the Role of the FDA in Advancing Psychedelic Therapy - Medriva