In recent years, an unprecedented level of interest in the promise of psychedelics has taken hold. In the United States, many types of psychedelics are being investigated for use in treating an array of mental health conditions. The U.S. nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) has announced promising phase 3 clinical trial results for MDMA in post-traumatic stress disorder (PTSD) and indicated its intent to submit an application for FDA approval this year. FDA has granted “breakthrough therapy” status for MDMA and psilocybin and recently issued new draft guidance detailing how it will evaluate psychedelic drugs seeking approval. Congress has taken a keen interest in furthering this promising area of research, introducing numerous bipartisan bills and forming the bipartisan Congressional Psychedelics Advancing Therapies (PATH) Caucus.
States, however, are not waiting for federal action. Two states (Oregon and Colorado) have legalized the use of certain psychedelics, and many others are considering similar decriminalization reforms.
The potential of the budding psychedelics market is significant, but the challenges can be daunting. In the first of a new CLE-eligible webinar series on the emerging psychedelic drug market, Manatt provides an overview of the numerous legal and regulatory complexities surrounding the increased investment and interest in psychedelics. Click here to register. Key topics include:
- An overview of the current legal landscape across the country
- An update on activities relating to FDA review and approval of psychedelics
- Key insights into how mental health parity and other relevant regulations are likely to impact coverage of psychedelic-assisted therapy
- The implications of health policy reforms on the market
- A look ahead at what to expect next—and how you can prepare for success