2024 U.S. Election: A Citizens' Call for Psychedelic Policy Reform

An urgent plea to the next president to evaluate psychedelic policy. The removal of psychedelics from the Controlled Substances Act and creation of a specialized pathway at the FDA is long-overdue.

The 2024 U.S. presidential election stands as a defining moment in history, with profound implications for both the nation’s future and its global influence. Central issues such as free speech, censorship, parental rights, immigration, and pharmaceutical company regulation are at the forefront, impacting the health, well-being, and social fabric of the country. If personal sovereignty and health are fundamental to these debates, the future of psychedelics must also be a topic presidential candidates address. Psychedelics have shown extraordinary potential in treating mental health disorders and enhancing well-being, yet government restrictions remain a major barrier to safely realizing their potential. Overly restrictive and uninformed regulation of psychedelics denies individuals their fundamental right to self-exploration and healing.

Scientific evidence shows that psychedelics have been used for thousands of years, predating modern civilization. Societies have used them for religious, therapeutic, relational, artistic, and even scientific purposes. Those extolling their benefits have included Nobel Prize winning scientists, renowned artists, technology industry leaders, and, likely, ancient Greek thought leaders. Although scientific exploration of psychedelics began in the 1950s and 1960s, their recreational use surged in the late 1960s. The absence of safe-use guidelines and oversight led to harm in some individuals, and their association with the counterculture sparked rational concerns. However, over the past 20 years, rigorous scientific research on psychedelics—primarily as mental health treatments—has undergone a culturally ascendant renaissance. A deeper understanding has emerged about how psychedelics affect the brain, the associated psychiatric risks in certain populations, and their broader impacts on mental health.

For example, MDMA (methylenedioxymethamphetamine)-assisted therapy for PTSD—tested with combat veterans and sexual assault survivors—has led to substantial reductions in PTSD symptoms. Similarly, psilocybin (the active compound in "magic mushrooms") has demonstrated remarkable efficacy in treating depression, including treatment-resistant depression. Psilocybin has also shown promise in alleviating end-of-life distress in terminally ill cancer patients and others with life-threatening conditions. Additionally, it has been used successfully to treat addiction. One pilot study authored by one of us (Dr. Johnson) on psilocybin therapy for smoking addiction reported an 80% abstinence rate six months after treatment. Similar outcomes have been observed in studies on alcoholism.

The glaring asymmetry and injustice of current mindless drug laws are exemplified by the legal status of harmful substances like tobacco and alcohol—responsible for over 500,000 deaths annually in the U.S.—and the criminalization of far less risk-posing psychedelics like psilocybin, which has shown exceptional efficacy in treating addictions to the very substances that are legal. Classic psychedelics carry far lower risks of physiological harm—whether addiction, fatal overdose, liver disease, cancer, heart disease, or brain damage—compared to government-permitted substances such as tobacco, opioids, and alcohol. While we do not claim that psychedelics are without risk or a cure-all for psychiatric disorders, we call for a careful reevaluation of their legal status and movement toward wiser regulation at the highest levels of government—a reform that is long overdue.

The United States faces a simultaneous mental health and "meaning" crisis. At least twenty veterans die by suicide every day, on average, with many more continuing to suffer from debilitating post-traumatic stress disorder (PTSD) after traumatizing deployments in Afghanistan, Iraq, Syria, and Libya. As a result, the veteran community has become a leading voice in the push for psychedelic policy reform. At the same time, the U.S. leads the world in the prevalence of mental illnesses like depression, with 2.8 million Americans suffering from treatment-resistant depression annually (as one example). Psychedelics are not a cure-all for these complex conditions, but they offer healing potential for millions who suffer from trauma, mental illness, and a lack of meaning in their lives. Unlike traditional psychiatric medications, which often mask symptoms and require daily use, psychedelic treatments have been shown to produce lasting improvements after just a few monitored sessions. Additionally, large-scale mental health surveys suggest that lifetime psychedelic use is associated with decreased rates of mental health problems and addiction.

Recently, an application for MDMA-assisted psychotherapy for PTSD was rejected by the FDA. While the full reasons for the rejection remain unclear, it is evident that the agency’s drug approval standards are not well-suited to psychedelic treatments. Unlike conventional pharmaceutical products, which are typically developed by billion-dollar companies, psychedelic compounds like MDMA and psilocybin belong to the public domain, complicating the FDA approval process. Further complicating matters are concerns around "blinding"—the ability to keep patients unaware of whether they have received a psychedelic or a placebo. Research suggests that the psychedelic experience itself is key to the long-term efficacy of treatment, making traditional blinding techniques difficult to implement.

In addition to federal hurdles, some states, including Oregon and Colorado, have enacted laws regulating the responsible use of psychedelics for adults under supervision. However, many citizens, including veterans with PTSD, continue to seek treatment abroad or turn to underground, unregulated sources, exposing themselves to potential harm.

We call on the next U.S. president to lead a comprehensive reform of psychedelic policy, including the following proposals:

1. Remove psychedelics from the Controlled Substances Act or move them out of Schedule I, which is reserved for substances with "no accepted medical use" and "high potential for abuse." While psychedelics can be abused, scientific evidence shows they have far lower abuse potential than other Schedule I or II drugs, such as heroin and cocaine, and less than legal substances like alcohol and tobacco.

2. Create a specialized pathway at the FDA tailored to the unique properties of psychedelics for their development and approval as medications. Psychedelic treatments, unlike traditional psychopharmacological interventions, are not administered daily but involve a few intensive therapeutic sessions over several months. The FDA must recognize this multi-modal approach and adapt its evaluation criteria accordingly.

3. Develop a national regulated system for responsible psychedelic use outside the FDA’s medical framework.  An expert task force should assess state-level programs, like those in Oregon, and devise plans for a national regulatory body to oversee product standards and ensure safe, supervised adult use. This would be similar to the regulation of alcohol and tobacco by non-FDA bodies such as the Bureau of Alcohol, Tobacco, Firearms, and Explosives, and state-level alcohol boards.

We, the undersigned, believe that current psychedelic policy restricts medical development and increases harm to individuals who use psychedelics. Far from being a "magic bullet" or precursor for societal utopia, psychedelics offer ancient and enduring benefits which ought to be conserved and institutionalized. It is time to proactively address both the potential benefits and risks of psychedelics by implementing these long-overdue regulatory changes. This is not a right or left issue, but a human rights issue. We hope the next President will take steps to improve the health and safety of Americans and restore our birthright to explore our own consciousness for healing, without harming others.

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Matthew W. Johnson, PhD, conducts psychedelic science at Sheppard Pratt. From 2004-2024 he led research at Johns Hopkins on psychedelic treatment for tobacco addiction, cancer, depression & safety. He has been interviewed by Lex Fridman, Dr. Andrew Huberman, Big Think & 60 Minutes.

Rav Arora is an independent journalist known for writing in The New York Post, Globe and Mail, and Foreign Policy Magazine. He has appeared in podcasts with Jordan Peterson, Russell Brand, Ben Shapiro, Tim Pool, and Dave Rubin.