The U.S. Food and Drug Administration (FDA) has recently denied an application for using MDMA, a promising psychedelic, to treat post-traumatic stress disorder (PTSD). PTSD affects about 13 million Americans. The FDA’s decision means that Lykos Therapeutics, the company behind the application, will need to conduct another large-scale study, which could take years.
In response to the slow federal process, several states have taken proactive steps to provide safe and effective psychedelic-assisted therapies for those suffering from PTSD, including veterans and sexual assault survivors.
Since the early 1970s, psychedelic research has been hindered by the war on drugs. However, there has been a resurgence in medical studies and clinical trials exploring the use of psychedelics like MDMA (also known as ecstasy), psilocybin (magic mushrooms), and ibogaine to treat various mental health conditions. The FDA has previously designated MDMA and psilocybin as “breakthrough therapies,” allowing for a faster approval process.
Despite this, the recent FDA rejection raises doubts about the speedy approval of psychedelic treatments. Therefore, state leaders are encouraged to build on the progress made in Oregon and Colorado, where voters have approved the establishment of licensed psilocybin therapy centers. These centers offer supervised, adult-only psilocybin consumption. Massachusetts will vote on a similar measure in November, and New Jersey’s legislature passed a legalization bill this summer.
Other states have also joined the movement. Utah has launched a psilocybin pilot program through its major healthcare networks, while Arizona’s Republican-controlled legislature enacted a supervised psilocybin program. However, Governor Katie Hobbs vetoed this initiative. Instead, she signed a bill that would have provided MDMA treatment coverage for Arizona’s police and firefighters, contingent on FDA approval of the Lykos application.
Veterans, first responders, mental health advocates, and neuroscientists are pushing for broader acceptance of psychedelics to improve mental health outcomes. The Heroic Hearts Project, a nonprofit aiding veterans, reports that existing FDA-approved treatments help fewer than 10 percent of veterans with PTSD. In contrast, research conducted with King’s College, London, suggests that over 80 percent of veterans experience significant improvement after participating in psychedelic therapy.
While the rejected FDA application was limited to treating PTSD, states have the flexibility to offer psychedelic treatments for a range of mental health conditions. In Oregon, for example, psilocybin therapy is not restricted to one condition, allowing for broader applications. The Healing Advocacy Fund found that over 3,500 clients received psilocybin-assisted therapy in Oregon in 2023, often at a lower cost compared to FDA-approved MDMA therapies.
Congress has recognized the delays and high costs associated with FDA drug approval. In 2016, lawmakers required the FDA to consider “real-world” data in its evaluations. For widely used substances like psilocybin and MDMA, there is substantial real-world and scientific evidence of their benefits and safety.
However, the FDA still insists on blind placebo-controlled trials, which are challenging and expensive for psychedelics. It is difficult to deceive patients into believing they received a placebo instead of a hallucinogen, and conducting such trials requires significant resources.
Concerns about increased drug use and crime following psychedelic legalization have not materialized. Data from the Reason Foundation shows no rise in psychedelic-related hospital incidents or crime in Colorado since legalization. Similarly, Oregon has seen a decline in hallucinogen-related DUIs and other crimes since the state approved regulated psychedelic services in 2020.
With the FDA’s slow progress on psychedelics it has classified as “breakthrough” therapies, state governments have a key opportunity to lead in expanding access to transformative mental health treatments. The time to act is now.
Leonard Gilroy is Vice President of Government Reform at the Reason Foundation, and Greg Ferenstein is a Senior Fellow on Psychedelics Policy.
