Nelson Hardiman has advised clients on ketamine-related issues for close to two decades, from the time period after it was added to DEA Controlled Substances list as a Schedule III synthetic compound and doctors began to be disciplined for providing it until today, when interest in therapeutic uses continues to rise substantially. Beyond its historic use as an anesthetic or for pain relief, the driving interest has been its promise as a psychedelic for its ability to induce dissociative states and neuroplasticity. While research is continuing, the promise of ketamine to treat depression and post-traumatic stress disorder (PTSD), among other conditions, has driven significant and ongoing growth. Nelson Hardiman provides counsel nationally on risk issues, development of ketamine-related clinics and delivery by telemedicine, pharmacy-related issues for infusion and development of trocys, as well as the full array of regulatory issues (licensing, operations, reimbursement, FDA compliance and corporate practice of medicine issues).
Nelson Hardiman is also serving as a leading resource nationally for clients interested in therapeutic use of other psychedelics. In 2020, Oregon voters made their state the first in the country to decriminalize psilocybin for therapeutic use. 2022 is likely to see California and several other states follow this trend of psilocybin decriminalization, with a continued trajectory expected to spread state by state, paralleling cannabis decriminalization. Beyond psilocybin, Nelson Hardiman regularly receives requests for guidance on therapeutic use of other psychedelics, including Ibogaine, Ayahuasca, MDMA, and others. Although psychedelics (other than ketamine) remain Schedule I criminalized controlled substances, in 2019 the FDA granted psilocybin a designation status permitting its study for potential medicinal uses. Studies are also proceeding on other psychedelics in the United States and internationally. Nelson Hardiman is glad to serve as legal counsel for clients interested in therapeutic uses of psychedelics.