Open Letter To Incoming Trump Administration About Psychedelic Policy Reform
A four-step policy proposal to pave the path forward for healing, freedom, and recovery. How long can our ailing veterans, victims of trauma, and sufferers of treatment-resistant depression wait?
Read the original iteration we wrote prior to the election:
To: Donald Trump, JD Vance, Robert F. Kennedy Jr., and Elon Musk
Congratulations on your historic presidential victory. As you conduct the critical transition process, we propose a long-overdue reformation of our federal approach to psychedelics – a class of plant and synthetic compounds with a history of therapeutic and spiritual use.
One of us is a leading psychedelic researcher (Matthew), helping pioneer groundbreaking studies at Johns Hopkins on psychedelic treatment for addiction, depression, and end-of-life anxiety. The other (Rav) is an internationally published journalist who has been investigating and writing about psychedelic medicine over the past half-decade.
Decades ago, psychedelics were associated with left-wing causes, but they are not inherently political. Their effects on the brain are pharmacological and not fundamentally tied to any ideological perspective. When used judiciously, users widely report a bolstered sense of agency and moral responsibility to make changes in their life they previously neglected – values which transcend politics but are especially appealing to conservatives. This is demonstrated by the many veterans who have faced their demons and overcome debilitating PTSD with psychedelics. The historical draconian approaches of criminalizing psychedelics are yet another example of authoritative government overreach that undermines the autonomy of American citizens to the detriment of American progress.
Several individuals within the nascent Trump administration have voiced their support for psychedelic therapy over the past few weeks alone. "[The FDA] should let MDMA through, honestly. I think it would help a lot of people,” Elon Musk stated on Joe Rogan’s podcast on the eve of the presidential election. Meanwhile, Robert F. Kennedy Jr. posted on X, “FDA’s war on public health is about to end,” mentioning the “aggressive suppression of psychedelics” first on his list of practices unjustly prohibited or neglected by the federal government.
Trump is recognized for his willingness to think independently and cross traditional party lines, evident in initiatives like ending the forever-wars, criminal justice reform, and support for IVF.
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 an 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 treatment-resistant depression. Psilocybin has also shown promise in alleviating end-of-life distress in terminally ill cancer patients and treating other 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. 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, thus posing a difficult or impossible approval standard.
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, including those in third-world nations, exposing themselves to potential harm.
When Joe Rogan raised the topic of psychedelics in his interview with Vice President-elect JD Vance, Vance asked what concrete steps may be taken to pave the path forward for psychedelic therapy. Here we offer a four-step proposal:
Remove psychedelics from the Controlled Substances Act or move them from 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 abuse potential than legal substances like alcohol and tobacco.
Create a specialized pathway at the FDA tailored to the unique properties of psychedelics for their development and approval as medications, including right-to-try for terminal and treatment-resistant illness, and prioritization for veterans. Psychedelic treatments, unlike traditional psychopharmacological interventions, are not administered daily but involve a few intensive therapeutic sessions over several months. The FDA must adapt its evaluation criteria accordingly.
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. While FDA would still regulate approval for medical treatment with psychedelics, this new framework would regulate the broader ongoing use of psychedelics outside of medical contexts. 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.
Expand federal funding for psychedelic therapeutic research. Although recently the federal government has committed a limited amount of funding for psychedelic medicine, the promise of existing studies and the enormous unmet need warrant substantial and focused funding far beyond these perfunctory efforts.
We 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 and America-first 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.
Much like psychedelics are known to disrupt entrenched mental patterns at the heart of conditions like depression and PTSD, the Trump administration has vowed to restructure the political establishment in D.C. With millions suffering from chronic mental illness, judicious reform of psychedelic regulation could offer transformative tools for addressing mental health conditions and the meaning crisis that conventional treatments often struggle to resolve.
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.
 | A guest post by
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"Recently, an application for MDMA-assisted psychotherapy for PTSD was rejected by the FDA. While the full reasons for the rejection remain unclear..."
The reasons are very clear.
The Multidisciplinary Association for Psychedelic Studies (MAPS) and its for-profit branch LYKOS had its Phase III trials de-published for covering up a suicide attempt, failing to report data that FDA explicitly asked for, and recruited therapists and participants into a grandiose, exaggerated organizational culture that made blinding of trials impossible. This organization was also held criminally liable for the death of a 20-year old in their care, is alleged to have stolen money from an elderly man, and has covered up sexual and physical abuse multiple times. Moreover, these treatments would have cost $15,000 or more if FDA had given these entities "exclusive authorization" (a monopoly) to sell them for six years. The approval process is flawed, yes. But "evergreening" and exclusivity rules are even worse for innovation over all.
Certainly, the federal government should de-schedule psilocybin mushrooms. But MDMA has a much more acute harm profile than other psychedelics, and the federal government should not do business with organizations that have lied to medical journals and the FDA.
I have an elderly friend, who for her 80th birthday went to the desert last year, with a small group of people who signed up for the ayahuasca ritual. She had images for a short amount of time of a computer with Japanese figures from a game, then she fell asleep. She was very disappointed. No epiphany or metaphysical answers she was hoping for. When I was young, I spent a lot of time with Dr. Timothy Leary, and his friends, including those studying the therapeutic effects of LSD on human consciousness. I learned a lot. During his time working at Harvard, he and Richard Alpert were involved in the Harvard Psilocybin project. They were fired due to various concerns on methodology. I think it is a shame that therapeutic exploration on mind altering substances were neglected until recently. However, I know recklessness in this domain is lethal, so I support proceeding with great caution. I have seen the dark side of an immature approach on the body, mind and spirit.