The U.S. Food and Drug Administration just rejected an application that would have authorized the use of a promising psychedelic compound, MDMA, for the treatment of post-traumatic stress disorder, a condition affecting 13 million Americans, In its denial, the FDA suggested the company, Lykos Therapeutics, instead conduct another large study — a proposal that could take years.
Fortunately, states need not wait for the sluggish federal bureaucracy to act. Some have already established promising regulations to give veterans, sexual assault survivors and others suffering from PTSD safe and effective access to psychedelic-assisted therapies.
Psychedelic research has been stymied since the early 1970s due to the failed war on drugs. Even so, there has been a resurgence of medical research and clinical trials into the use of psychedelic compounds like MDMA (commonly known as ecstasy), psilocybin (or so-called magic mushrooms) and ibogaine in the treatment of a wide array of mental health conditions, such as PTSD, anxiety, major depressive and alcohol use disorders. Promising early research results even prompted the FDA to designate MDMA and psilocybin as “breakthrough therapies,” authorizing an expedited path to approval.
But this latest rejection makes it unclear whether the nascent psychedelic pharmaceutical industry will be able to meet FDA’s demands any time soon.
As a result, state leaders should forge ahead and build upon what is taking place in Oregon and Colorado. Voters in those states approved ballot initiatives legalizing the establishment of licensed and regulated psilocybin therapy centers that provide on-site, adult-only consumption of psilocybin under professional supervision. In November, voters in Massachusetts will vote on a similar law; the New Jersey legislature passed a legalization bill out of committee this summer.
Red and purple states have also joined the action, with Utah establishing a psilocybin pilot program through the state’s largest healthcare networks and the Republican-controlled Arizona legislature enacting a supervised psilocybin program, which Gov. Katie Hobbs (D) then vetoed. The governor signed another bill that would have allowed Arizona’s police and firefighters to receive coverage for MDMA treatments — if the FDA had approved the Lykos application.
Veterans, first responders, mental health advocates and neuroscientists have led a national, bipartisan push to shift public perceptions about the potential psychedelics offer to improve mental health outcomes for millions of people suffering from conditions that traditional medicines and therapies have failed to help.
The Heroic Hearts Project, a nonprofit helping veterans, reports that current FDA-approved treatments are helpful to fewer than 10 percent of veterans suffering from PTSD. In contrast, the group’s research with King’s College, London, “suggests that over 80 percent of veterans experience significant improvement after participating in just one psychedelic program.”
While the application the FDA rejected would’ve only allowed those with PTSD to be treated, states can pave the way to help many more people with several other conditions. The psychedelic compounds authorized for use in Oregon and Colorado, for instance, are not constrained to a single mental health condition or set of protocols, allowing more individuals and therapists to meet a broader range of mental health needs.
The Healing Advocacy Fund found over 3,500 clients received psilocybin-assisted therapy in Oregon at the state’s first psilocybin service center in 2023, typically at a fraction of the cost projected for treatment using an eventually FDA-approved MDMA-assisted therapy.
Even Congress recognizes FDA’s red tape is taking too long and driving up prices. In 2016, lawmakers mandated that the FDA consider “real-world” data when approving a drug. For widely used compounds such as psilocybin and MDMA, the FDA has ample real-world and scientific journal studies showing the benefits and the number of adverse events from millions of users of the drugs.
However, the FDA still requires drug makers to attempt to blind patients in placebo-controlled trials. In this case, it is extremely difficult to fool a patient into believing he or she received a powerful hallucinogen and not a placebo in a blind study. What’s more, it costs hundreds of millions of dollars and many years to randomly assign patients in clinical trials overseen by large teams.
The most common concerns about the legalization of psychedelics are worries that it will lead to increases in drug use and crime. Data collected by Reason Foundation show Colorado has not shown an increase in psychedelic-related hospital incidences since legalization, however. Nor has there been a significant change in the number of psychedelic-related crime incidents.
Similarly, since legalization in Oregon, there has been a downward trend in hallucinogen-related DUIs, property crimes and crimes against persons since voters approved regulated, facilitated psychedelic services in 2020.
With the FDA slow-walking drugs it has already defined as “breakthrough” therapies, state governments have a significant opportunity to take the lead in expanding Americans’ access to transformative, life-saving mental health treatments. The time to move forward is now.
Leonard Gilroy is the vice president of government reform at the Reason Foundation, where Greg Ferenstein is a senior fellow on psychedelics policy.