Real questions from real people exploring psychedelics because, while I’m not a doctor or scientist, “Ask April” is how meaningful dialogue begins.
On April 18, President Trump signed an executive order titled “Accelerating Medical Treatments for Serious Mental Illness.” It directs the FDA to fast-track psychedelic drug review through Commissioner’s National Priority Vouchers, allocates $50 million in matching funds for state research programs, and tells the FDA and DEA to build a Right to Try pathway for investigational psychedelics, with ibogaine named specifically. Six days later, the FDA issued three of those vouchers: a synthetic psilocybin derivative for treatment-resistant depression, a synthetic psilocybin derivative to treat major depressive disorder, and an MDMA derivative for PTSD.
No, this executive order does not legalize psychedelics. Psilocybin, MDMA, and ibogaine remain Schedule I under federal law. The EO doesn’t reschedule anything, and it can’t. That’s a separate process handled by the DEA. What the order does is accelerate the pathway for specific drug products to get FDA approval. When a product is approved, that specific formulation gets rescheduled. The underlying compound stays Schedule I. So when synthetic psilocybin comes to market next year, it will be rescheduled to make it prescribable, but psilocybin mushrooms will remain federally illegal. Right to Try, the other piece of the order, isn’t legalization either. It’s a narrow pathway for terminally ill patients to access investigational drugs that have cleared Phase 1 trials.
Drugs that have submitted a new drug application would have taken ten to twelve months to review. After the EO, that timeline shrinks to one or two months. The first two psilocybin analogs - synthetic psilocybin - will be on the market in the next 12 to 18 months, with an MDMA drug not far behind. But this isn’t the first time MDMA has been at bat.
In 2024, MDMA-assisted therapy went through rigorous trials, and 67% of participants no longer met diagnostic criteria for PTSD by the end of the study. The FDA rejected the application anyway and asked for another trial. Part of what tanked that approval should be obvious: the FDA doesn’t regulate therapy. It regulates drugs. And MDMA-assisted therapy is a protocol, not a pill. It’s the drug combined with a trained therapist holding space across an eight-hour session, plus integration sessions before and after. The FDA had no framework for evaluating the therapy half, so they evaluated the molecule, found the trial design messy in ways that were inseparable from the therapeutic container, and said no.
The system worked exactly as designed. The problem is that the system isn’t designed to prescribe therapy sessions in collaboration with a prescription drug. We are conditioned to take the pill and report side effects.
Since that initial rejection, drug developers have aimed to move away from what facilitators and patients alike have reported: psychedelic medicine coupled with integration creates more positive, longer-lasting outcomes. This is why SetSet exists, to make the therapeutic side of the protocol accessible to as many people as possible, particularly those consuming “in the wild” — outside of a clinical setting.
While not a classical psychedelic, the history of ketamine can bring this better into focus. Used in hospitals around the world since the 1960s, ketamine came off patent protection in the mid-90s. Today, it’s a low-cost, generic medication commonly used off-label for pain and mental health conditions. It’s a Schedule II controlled substance, which means it’s legal for therapists to use the medicine to help someone process trauma their nervous system never let them touch.
Ketamine is a racemic compound, meaning two mirror-image molecules. One produces the deeper therapeutic experience, and the other carries the antidepressant effect. Drug companies aren’t going to prove the efficacy of a generic drug because they’ll never recoup the R&D costs, so they have to fundamentally change the compound and then run trials for specific indications that are covered by insurance for treatment. Johnson & Johnson isolated just the antidepressant half, patented it, and got it FDA approved as Spravato. The half that facilitated deeper processing was engineered out, and the results are shorter windows of depression relief, requiring repeat clinic visits and more Spravato prescriptions.
No shade. This is just how the system works.
The psychedelic that was front and center at Trump’s EO is ibogaine, the active compound in the West African shrub iboga. Researchers already have a synthesized ibogaine analogue engineered with no hallucinatory component. Although I’ve never experienced ibogaine, the trip reports are steeped in how the visions produced by the plant are integral to profound trauma resolution. Remove the chemistry that delivers this critical piece of the experience, the way the R-enantiomer was removed from ketamine, and what remains manages symptoms rather than resolves them. We have already lived through what happens when the system optimizes for treating symptoms rather than resolving trauma. Purdue Pharma’s playbook is the cautionary tale.
I am not a scientific expert, but it’s fair to point out patterns of behavior that were created by a system that has not changed.
So what does this mean for access?
First, let’s be really clear about what “access” means: how much are these drugs going to cost patients?
Based on what’s transpired for patients since Spravato was approved for its first indication (treatment-resistant depression) in 2019, when psychedelic analogs come on the market, those with insurance will not have immediate access to these drugs without prior authorization. In the case of Spravato, patients must have failed two or three SSRIs first. treatment-resistant.
As with all healthcare billables, the costs of Spravato vary widely depending on patient coverage. Cash pay is $4,700+ for the first month, but commercially insured patients enrolled in Janssen’s (Johnson & Johnson) copay program pay under $200 for the full induction. Medicare with supplemental is often $0, Medicaid varies by state, and insured patients who don’t know to ask about the assistance program “Spravato withMe” can still expect to pay $2,000 to $9,500 out-of-pocket.
Expect the new crop of psychedelic pharmaceuticals to have an equally wide range of costs.
If you’re uninsured, FDA approval doesn’t help you directly. But self-insured employers (roughly 50% of all insured Americans) can choose to cover psychedelic-assisted therapy the day after approval. Some already cover ketamine. Dr. Bronner’s, Salesforce-adjacent companies, and a handful of progressive benefits leaders are already mapping this. If you work somewhere with a benefits team, ask them now what their plan is. If they don’t have one, plan to educate them.
Medicaid and Medicare are where it gets harder.
Medicaid won’t cover anything until FDA approval. Medicare follows a similar logic and has historically taken longer than commercial insurers to add new mental health treatments to its coverage, an additional one to three years.
Unless you live in New Mexico, where the Medical Psilocybin Act both authorized therapeutic psilocybin and created the first state-funded mechanism in the world to pay for psychedelic treatment for low-income patients. If New Mexico can demonstrate that publicly supported, equity-first psychedelic care delivers measurable outcomes and cost offsets for Medicaid, it changes the national conversation.
The most promising effect of the Executive Order, though, may be the political permission structure. It signals to payers, health systems, and employers that psychedelic medicine is no longer fringe.
Take care,
April
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