Psychedelics And Mental Health: FDA Stalls, But States Forge Ahead

The recent rejection by the Food and Drug Administration (FDA) of an application that would have authorized the use of MDMA for the treatment of post-traumatic stress disorder (PTSD) reignited the already ongoing discussion on psychedelic-assisted therapies. This not only affects the 13 million Americans who suffer this condition, but also delays by years the possible access to a life-changing treatment.

What’s Behind The FDA’s Decision?

Perhaps more importantly is how to address these sensitive issues in a legal framework? As noted by The Hill on Monday, the recent rejection raises questions about whether the emerging psychedelic pharmaceutical industry will be able to meet the agency’s stringent requirements in the near future. This scenario triggers different actions by state governments.

States Take The Lead Amid Federal Delays

While the FDA’s decision may seem like a setback, states don’t have to wait for federal action. Several states have already implemented regulations to provide veterans, sexual assault survivors, and others with safe and effective access to psychedelic-assisted therapies. This movement towards state-level regulation is a response to the stagnation caused by federal bureaucracy.

Psychedelic research faced significant obstacles beginning in the 1970s due to the war on drugs. Despite these challenges, there has been a resurgence of interest in the medical use of psychedelic compounds like MDMA (commonly known as ecstasy), psilocybin (magic mushrooms), and ibogaine. These substances have shown promise in treating a range of mental health conditions, including PTSD, anxiety, major depressive disorder, and alcohol use disorder. The FDA even designated MDMA and psilocybin as "breakthrough therapies," a status intended to expedite their approval process.

State-Level Innovations In Psychedelic Therapies

In response to federal delays, state leaders are pushing forward with their own initiatives. Oregon and Colorado are at the forefront, with voters in both states approving ballot measures to legalize and regulate psilocybin therapy centers. These centers offer supervised, adult-only consumption of psilocybin in a controlled environment. Massachusetts and New Jersey are considering similar measures, with Massachusetts voters set to decide on the issue in November and NJ’s legislature already advancing a bill.

Even states with more conservative leanings, such as Utah and Arizona, have begun exploring psychedelic therapies. Utah has established a psilocybin pilot program through its largest healthcare networks. Arizona's Republican-controlled legislature passed a bill to create a supervised psilocybin program, though it was vetoed by Governor Katie Hobbs. Despite this, Hobbs signed another bill that would have allowed police and firefighters in Arizona to receive coverage for MDMA treatments – had the FDA approved Lykos Therapeutics’ application.

A Joint Push For Change

The push to shift public perception of psychedelics is being led by veterans, first responders, mental health advocates and neuroscientists. These groups argue that psychedelics offer significant potential to improve mental health outcomes, especially for conditions that traditional medicines and therapies have failed to address.

The Heroic Hearts Project, a nonprofit organization supporting veterans, reports that FDA-approved treatments are effective for fewer than 10% of veterans with PTSD. In contrast, their research in collaboration with King's College London suggests that over 80% of veterans see significant improvement after participating in just one psychedelic program.

Read Also: Colorado’s Psilocybin Industry Takes Off: New Rules For Magic Mushroom Businesses

Expanding Access Beyond PTSD

While the FDA’s rejection focused on treating PTSD, states have the flexibility to allow psychedelic therapies for a broader range of conditions. In Oregon, for instance, the authorized use of psilocybin is not limited to a single mental health condition, providing greater access to those in need. The Healing Advocacy Fund reported that over 3,500 clients received psilocybin-assisted therapy at Oregon’s first psilocybin service center in 2023. The cost of these treatments is typically much lower than what is projected for FDA-approved MDMA therapies.

Real-World Data Vs. FDA Red Tape

Even Congress has acknowledged that the FDA's approval process can be too slow and costly. In 2016, lawmakers mandated that the FDA consider "real-world" data when approving new drugs. For widely used compounds like psilocybin and MDMA, there is already a wealth of real-world data and scientific studies demonstrating their benefits. However, the FDA continues to require expensive and time-consuming placebo-controlled trials, which are particularly challenging for psychedelics due to the nature of the substances.

Public Safety And Crime Concerns

Opponents of psychedelic legalization often cite concerns about increased drug use and crime. However, data from Colorado and Oregon suggest otherwise. Since legalization, Colorado has not seen an increase in psychedelic-related hospital incidents or crimes. Similarly, Oregon has experienced a decrease in hallucinogen-related DUIs, property crimes, and crimes against persons since voters approved regulated psychedelic services in 2020.

Cover image made with AI