“Sounds Great. Do You Want FDA Approval?” A Regulatory Analysis of Psychedelics

We have covered a lot of ground on this blog over the years:  Hatch-Waxman disputes, REMS programs, and everything in between.  Rarely have we had occasion to write a sentence like this one:  A podcast host texted the President of the United States about a Schedule I drug, the President responded, “Sounds great.  Do you want FDA approval?  Let’s do it,” and FDA is now fast-tracking review of psychedelics.

Pardonnez-moi?  Let’s unpack.

And Yet, Here We Are

On Saturday, April 18, 2026, President Trump signed an Executive Order (EO) directing FDA to prioritize review of certain psychedelic compounds for the treatment of serious mental illness.  See also here, here, and here.  The signing ceremony in the Oval Office featured HHS Secretary Robert F. Kennedy Jr., CMS Administrator Dr. Mehmet Oz, former Navy SEAL Marcus Luttrell . . . and Joe Rogan, who by his own telling had texted Trump information on ibogaine and received the previously quoted/titular response.  FDA Commissioner Marty Makary has since elaborated on the policy implications in interviews (see also here and here).  If you would have told us in law school this is how federal drug policy would be made, we may have studied something else.  Maybe Harvard Law needs to reach out to Alix Earle, or at the very least Elle Woods.  We lawyers here at HPM should consider reaching out to Joe Rogan as well; he seems to get things done at HHS and FDA these days. (**cough** Check out our two-part peptide blog post (part 1, part 2) **cough**)

What Does the EO Actually Do?

Setting aside the theatrics—and there were theatrics—the substantive regulatory provisions of the EO are worth taking seriously.

Among the key directives, the EO directs FDA Commissioner Makary to issue Priority Review Vouchers to psychedelic drugs that have already received Breakthrough Therapy designation and meet the criteria of the National Priority Voucher Program.  Commissioner Makary has stated that FDA will issue vouchers for three psychedelics currently under review as soon as this week (see coverage of this here)—this move represents the potential to expedite review to a matter of weeks rather than the standard 10 months (or 6 months for priority review).  This is the first time FDA has offered to expedite any psychedelic compound.  For reference, Breakthrough Therapy designation already signals that a drug has shown “preliminary clinical evidence” of substantial improvement over existing therapies—so these are not fringe substances without evidentiary footing.

Expanding the “Right to Try” Pathway

The EO directs FDA and DEA to establish a pathway for eligible patients to access investigational psychedelic drugs—explicitly naming ibogaine compounds—that are under FDA review and have met basic safety requirements under the Right to Try Act.  FDA’s existing Expanded Access pathway already provides one route for pre-approval access, and MAPS/Lykos utilized it for MDMA.  An application must be submitted to FDA and approved by an institutional review board before a patient can receive an investigational drug under Expanded Access.  However, the Right to Try framing here effectively bypasses FDA entirely, as FDA does not review or approve Right to Try requests.  Note that DEA will need to determine how to issue DEA registrations to physicians that allow for the prescribing of Schedule I drugs.  By definition, drugs in Schedule I have “no currently accepted medical use in treatment in the United States” and DEA practitioner registrations only include Schedules II-V.

The EO also directs the Attorney General to initiate rescheduling reviews following successful completion of Phase 3 trials, so DEA action can proceed as quickly as possible upon FDA approval.  By statute, DEA has 90 days from the date of FDA approval to act on a scheduling recommendation.  Psilocybin and ibogaine remain Schedule I drugs, meaning the federal government’s official position is still that they have “no currently accepted medical use and a high potential for abuse.”  The EO is an unmistakable signal that this administration intends to change that, for at least some compounds.  Note the EO mentions ibogaine twice by name.

Woof—$50 Million in Federal Matching Funds

The EO also directs HHS to allocate “at least” $50 million through the Advanced Research Projects Agency for Health (ARPA-H) to match state government investments in psychedelic research programs.  This provision appears to have been at least partially motivated by Texas, which recently enacted a law funding ibogaine research and sought a private match of equal size (here, here, and here).  HHS and FDA are also directed to collaborate with the Department of Veterans Affairs and the private sector to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs—with priority given to products that have received Breakthrough Therapy designation.

The Ibogaine Wrinkle

The EO’s explicit and repeated focus on ibogaine is worth a pause because it’s also the provision most likely to generate scientific and regulatory friction.  Ibogaine—derived from the root of an African shrub—has attracted intense advocacy, particularly from the veteran community, as a potential treatment for PTSD and traumatic brain injuries.

The regulatory reality is more complicated.  Last week, FDA announced that it is allowing an early phase clinical study of noribogaine hydrochloride to proceed following submission of an investigational new drug application.  This is the first time FDA has allowed a clinical study in the United States of an ibogaine derivative.  For a product to be eligible as an “experimental drug” under the Right to Try Act, the drug must have successfully completed a Phase I clinical trial and remain under investigation in a clinical trial approved by FDA.  FDA has historically resisted ibogaine research partly because of certain cardiovascular safety concerns, meaning robust U.S. Phase I data have been difficult to generate.  In other words, the EO instructs that ibogaine should have a Right to Try pathway available—for a compound that may not yet have cleared the eligibility threshold the Act otherwise requires.

None of this is to say the promise is not real.  Stakeholders and some researchers believe ibogaine’s potential for hard-to-treat PTSD is significant, and there is genuine unmet medical need.  But the gap between the EO and approved therapy involves clinical trials, safety data, and DEA scheduling action—none of which a presidential signature can precipitate . . . yet.

What It Means for FDA and Industry

Let’s be clear about what the EO does not do:  It does not change the evidentiary standards FDA applies to drug approvals.  As Commissioner Makary himself has stated, the gold standard of safety and efficacy still governs.  What the EO does make clear is that the Trump administration is tired of the bureaucratic delays:  The President wants accelerated timelines where discretion allows, and—perhaps most significantly—to send an unmistakable political signal to FDA, DEA, and the research community about administration priorities.

For those of us who actively participate as members of the FDA regulatory bar and these bloggers who have spent their (very long or somewhat shorter) careers watching promising therapies stall at the intersection of stigma and scheduling, this EO is worth taking seriously—even if some of the optics of the signing ceremony might give pause (i.e., Rogan’s involvement, which deserves its own blog about podcasters influencing therapeutic approvals).  The clinical path remains demanding; the DEA’s role in rescheduling adds another variable; and ibogaine’s safety profile is a genuine open question.

But, the administration’s trajectory is clear, and the downstream regulatory and compliance implications for sponsors, investors, and practitioners in this space are significant.

We will be watching closely and reporting back to you—perhaps in reliance on Joe Rogan once again.