In a surprising move, President Donald Trump signed an executive order on Bicycle Day—the anniversary of the first LSD trip—to accelerate research into psychedelic drugs and increase access to them. The order, which also included a lighthearted comment from Trump about trying ibogaine, has been hailed as a 'threshold moment' by advocates but raises concerns over Indigenous rights and commercialization.
FDA Fast-Track Reviews
The executive order directs the US Food and Drug Administration (FDA) to fast-track reviews of three psychedelic drug candidates that have already received breakthrough therapy designations. According to industry analyst Josh Hardman, founder of Psychedelic Alpha, these are likely psilocybin for two types of depression and MDMA for PTSD. The move sent psychedelic company stocks soaring and represents the biggest greenlight the potential multibillion-dollar market has yet received.
Right to Try and DEA Clash
The order also makes investigational psychedelic drugs like ibogaine available under 'right to try' legislation, which is typically reserved for terminally ill patients. However, this sets up a potential clash with the Drug Enforcement Administration (DEA), which has previously deemed Schedule I compounds ineligible for right to try, according to Logan Davidson of Vets (Veterans Exploring Treatment Solutions).
New Funding and Research Initiatives
The Department of Health and Human Services announced a $139 million initiative to spur new therapies for behavioral health, including the safe use of psychedelics. At least $50 million will be earmarked to match state psychedelic research initiatives, paving the way for a US-first human trial on ibogaine. The order also calls for increased clinical study participation, especially among veterans.
Concerns Over Indigenous Rights and Commercialization
While the order is seen as a breakthrough, critics warn that Indigenous communities who stewarded psychedelics like ibogaine and psilocybin may not be fairly compensated. Sandor Iron Rope, former chair of the Native American Church of North America, described the order as 'biopiracy dressed in clinical language.' Ismail Ali of the Multidisciplinary Association for Psychedelic Studies (Maps) noted that people will continue to be criminalized for psychedelic-related offenses, and pharmaceutical interests are the immediate beneficiaries.
Historical Context and Future Implications
Psychedelics have been federally illegal since the 1970 Controlled Substances Act, which Joe Rogan noted in the Oval Office was designed to target the civil rights and anti-war movements. The order indicates that rescheduling will accompany any FDA approvals, but this requires DEA approval. Trump indicated his administration is working on rescheduling, but concerns remain about the pace.
Jeffrey Singer of the Cato Institute warned that under the current pathway, the FDA will likely restrict prescribing to licensed clinicians who often lack meaningful training in psychedelic-assisted therapy. The order also raises questions about the role of traditional and underground practitioners who have been systematically persecuted.
International and Ethical Dimensions
Earlier this year, a delegation from Americans for Ibogaine attended the first International Conference on Iboga and Ibogaine in Gabon, where the plant is a national cultural heritage. However, a report in Africa Coeur News stated that no free, prior, and informed consent was obtained from traditional communities, and no royalties or profit-sharing mechanisms were discussed. Bryan Hubbard, CEO of Americans for Ibogaine, expressed gratitude to Gabon in the Oval Office.
The psychedelic renaissance is increasingly defined by who controls the direction of travel, who profits, and who gets left behind. Ali cautioned that psychedelics can reinforce problematic social dynamics if not applied responsibly. 'Even if we're healing our individual trauma, if we're not applying what we're learning to our human relationships and our geopolitical reality, then all we're going to do is use psychedelics to enhance the ego of one dominant nation and continue perpetuating violence and oppression,' he said.
Just a minute after signing the order, Trump pivoted to Iran, reverting to matters of war. The long-term impact of this executive order remains to be seen, but it marks a significant shift in federal policy toward psychedelics.
