A New Executive Order on Psychedelics: Q & A with I. Glenn Cohen and Mason Marks

On April 18, 2026, President Donald Trump signed an executive order which he stated would “dramatically accelerate access to new medical research and treatments based on psychedelic drugs.” 

The order directs the U.S. Food & Drug Administration (FDA) to prioritize review of psychedelic compounds and instructs the Drug Enforcement Administration (DEA) and other federal agencies to reduce restrictions that may hamper research. It also allocates $50 million for federal-state collaboration. 

Petrie-Flom Center Executive Director Susannah Baruch asked Faculty Director I. Glenn Cohen and Senior Fellow and Project on Psychedelics Law and Policy (POPLAR) Lead Mason Marks to talk about the implications.

We know what the EO says, but at a very high level what does it mean? What has changed?

IGC: Here is what stands out to me. The EO solidifies the potential for FDA Commissioner Priority Review Vouchers for psychedelic drugs and suggests these substances may be eligible for the Right to Try Act. I am not sure the first is truly new but does send a significant signal. I know Mason has thoughts on the second. The EO also also instructs HHS, FDA, and VA to engage in more data sharing to facilitate clinical trials and sets aside some money to support state initiatives. Those are new even if they are not particularly sexy headlines. 

MM: The Executive Order requires HHS to allocate $50 million “to match investments made by state governments to advance research into psychedelic programs.” That provision may have been motivated by recent events in Texas which recently enacted a law requiring publicly-funded ibogaine research. Clinical research laws are one type of psychedelic legislation that I discuss in “State Drug Laws,” which was published recently by Fordham Law Review. Texas lawmakers allocated $50 million for the project, and required the state find a private partner to commit another $50 million. When Texas failed to find a suitable institutional partner, it announced that the state would supply the entire $100 million. This executive order provision that provides matching funds to state programs may have been drafted in response. Of course, in the context of FDA-sanctioned clinical research, $50 million might not go very far. But it could encourage additional investment from the private sector.

The order also requires the FDA and the DEA “to establish a pathway for eligible patients to access investigational psychedelic drugs, including ibogaine compounds, that are under FDA review and that have met basic safety requirements under President Trump’s landmark Right to Try Act.” One FDA pathway, called expanded access, already exists. The MAPS Public Benefit Corporation (later renamed Lykos) utilized that path to provide people access to MDMA. 

What do you find surprising about the EO?

IGC: The EO explicitly mentions ibogaine twice, first in its purpose and policy section then in its right to try section. On the one hand, this is unsurprising since the substance has been a focus of veteran advocacy. Indeed, I saw W. Bryan Hubbard, CEO of Americans for Ibogaine, Joe Rogan, Congressman Morgan Luttrell, and his brother Marcus Luttrell (a former Navy Seal), all of whom have been big supporter of Ibogaine for veterans, all behind the President at the signing ceremony. Former Texas Governor and Energy Secretary Rick Perry has also been a prominent backer. So politically, the emphasis on Ibogaine makes sense. But among others, Nora Volkow, the longtime director of the National Institute on Drug Abuse pointed in 2024 to concerns about cardiac toxicity for ibogaine as a major concern that might stand in the way of approval. Moreover, the existing clinical trial and drug commercialization processes are further ahead for other drugs. 

MM: Yes, referencing ibogaine directly in this provision is unexpected because, of all the psychedelics, ibogaine is one that has arguably not “met basic safety requirements” necessary for eligibility under the federal Right to Try Act. That statute requires completion of Phase I clinical trials, but the FDA has resisted ibogaine research partly due to concerns about heart-related risks. Most ibogaine research has been conducted abroad. 

However, it is also worth noting that this provision could impact the availability of other psychedelics, such as psilocybin, under the federal Right to Try Act. The eligibility of psilocybin under the Act has been a point of contention between the DEA and doctors and patients seeking access, even generating a lawsuit. The Ninth Circuit ruled against those doctors and patients last year.

What are your thoughts about an EO approach to changing psychedelics law? 

MM: The extent to which an executive order can impact drug policy is variable and debatable. For example, Professor Rob Mikos, an affiliated researcher of POPLAR, has persuasively argued that presidents cannot compel rescheduling of a controlled substance. Instead, presidents can request scientific and medical review by the DEA and HHS, as Biden recently did for marijuana. But in other areas, such as influencing federal drug control priorities, presidents can have substantial influence, for instance, regarding budgets and federal enforcement priorities. Of course, there is always the possibility that the executive could influence policy at the DEA or FDA by applying pressure from the top down. I discuss the President’s drug policy role, as well as that of DEA and HHS, in “Separation of Drug Scheduling Powers,” published recently by the Yale Law Journal Forum.

Interesting too that the White House press release states that the order “directs the Attorney General to initiate reviews of relevant products upon successful completion of their Phase 3 clinical trials so that they can be rescheduled as soon as possible upon FDA approval, where appropriate.” However, this change will likely have little impact because the DEA is already required by statute to reschedule drugs within 90 days of their approval by the FDA. It’s unclear that this provision would meaningfully accelerate that process.

What can you tell us about the priority review voucher language in the EO?

IGC: The FDA Commissioner’s Priority Review Voucher program is a potent new way to get drugs approved on a much faster timeline (a target of 1-2 month review timeline). The CNPV Review Council “meets with the primary review team to discuss part of an application and makes a non-binding recommendation to the relevant Center Director on approvability with respect to that part of the application.” There was media reporting in February that Compass Pathways’ synthetic psilocybin product was on the initial list for these vouchers but that the White House removed it. This makes the fact that the EO goes out of its way to suggest priority review vouchers here a bit mysterious. Was there a change in analysis at the White House? Or was this effort about broadening the pool beyond Compass? I really don’t know and am hoping we get some reporting from insiders.

The actual language of the EO is also a little hard to pin down. It reads: “The Commissioner of Food and Drugs shall provide Commissioner’s National Priority Vouchers to appropriate psychedelic drugs that have received a Breakthrough Therapy designation and are in accordance with the criteria of the National Priority Voucher Program.” The “shall” here sounds dramatic, but if they still have to meet the criteria of the National Priority Voucher Program to qualify for the “shall”, and that program’s criteria leave considerable discretion to the FDA commissioner, I am not sure whether the EO really changes the state of play here except to send a signal that the White House views these as appropriate drugs for the program. But. ironically, the reporting suggests it was the White House that stood in the way in February to grant just such a voucher, so maybe this is as much a signal about the White House’s change in attitude as anything else.

There is a further question of whether getting a priority review voucher is a mixed blessing for companies seeking to commercialize in this space. While it speeds the way to approval, some worry that it will signal to the public and especially to payers that the evidence behind the approval is weaker. Especially for the first drugs on the market in this space that might be detrimental.

You mentioned payers, any takeaways from the EO on reimbursement?

IGC: I was heartened to see the EO state as a goal “to increase access to psychedelic drugs that could save lives and reverse the crisis of serious mental illness in America.” While FDA approval is important, I think it is necessary but not sufficient for access — one needs to also think hard about reimbursement and the delivery mechanism. The EO has less to say about this aspect. Perhaps some of the $50 million to be “re-allocated from existing funds to support and partner with State governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses” may go to this. And Dr. Oz, the head of CMS, in comments about the EO seemed attuned to the cost issues which, are real. As I have discussed in a prior article, what kind of Risk Evaluation and Mitigation Strategy (REMS) FDA attaches to any ultimate approval of these drugs will heavily determine the delivery model, the cost involved, and how many Americans can ultimately get access. There is a version of this that looks a lot more like Ketamine clinics and a version that looks more like prescribing Prozac by a GP — those are very different models. 

As I also discuss in that article, there is a raging debate between those who view psychedelic therapy as essentially drug therapy with some psychosocial support as scaffolding and others who view it as an adjutant to psychotherapy, so psychedelic assisted therapy. The EO does not really speak to this debate. But FDA and the federal government have often viewed themselves as focused on the drug-discovery and approval side and quite hands-off when it comes to integration into psychotherapy. Indeed, they have shown themselves somewhat concerned about evaluating the role of psychotherapy in the safety and efficacy data they have been presented during the MAPS/Lykos New Drug Application review process.

Did anything else stand out to you?

IGC: There was no discussion at all of the religious use of psychedelic drugs. We see psychedelic churches and other religious organizations whose worship is built around ayahuasca and other psychedelic substances. The organizations have faced significant threats from the DEA as to their religious worship. A few intrepid ones have sued and won under federal or state Religious Freedom Restoration Acts or settled.

The Executive Order could have explicitly suggested protection for these churches and other groups of worship or a change in how DEA evaluates their claims. It did not. To me, this is some evidence of an argument I have made elsewhere that there is some regulatory competition between three different pathways — the FDA route, the religious freedom route, and a residual route focused on access for non-therapeutic and non-religious reasons (including mental well-being that is not about mental health, creativity, spirituality outside religion, or recreation). The EO seems to most firmly favor the first route.

MM: I agree with Glenn that religious use is a pathway that the executive order overlooks. Throughout the states, churches are ostensibly utilizing psychedelics, including ibogaine, for spiritual purposes. In 2024, the U.S. Government Accountability Office called for improvements to the DEA process for granting religious exemptions for psilocybin and other controlled substances. That would have been an appropriate topic for the executive order to address. Veterans and others appear to increasingly rely on the religious pathway to access psychedelics and find community.