Federal agencies’ next moves to accelerate the availability of psychedelic therapies 

In the wake of President Donald Trump’s historic executive order on April 18 to accelerate access to psychedelic therapies, federal agencies have quickly responded with a series of related announcements. On April 24, the U.S. Food and Drug Administration (FDA) issued priority vouchers for psilocybin and methylone as treatments for serious forms of depression and post-traumatic stress disorder (PTSD), respectively. The agency also approved a Phase I study design for an ibogaine derivative as a treatment for alcoholism. So, what happens next? 

Separate formulations of psilocybin made by Compass Pathways and the Usona Institute, along with methylone, a compound similar to MDMA, face the fastest track. The FDA has moved these substances into a new pilot program called the Commissioner’s National Priority Vouchers. These vouchers essentially move recipients to the front of the line for agency review, which means applications for study and final drug approval can be reviewed in 1 to 2 months rather than 6 to 12 months. These substances are all in Phase 3 clinical trials, which is the final stage prior to submitting a new drug application that would allow the drugs to be marketed. Each one has also benefitted from a “Breakthrough Therapy” designation, which allows trial design and results to be evaluated by the FDA on a rolling basis rather than forcing the developer to complete an expensive trial and face the risk of subsequent agency rejection. 

In theory, the FDA could also revisit an application it rejected in 2024 that proposed to make MDMA available to treat PTSD. 

Assuming the FDA approves some or all of these drugs, the cost of accessing them will become a barrier for most people. Although the drugs themselves are inexpensive to make, psychedelic treatments would only be made available in supervised medical settings with trained facilitators and would be followed with intensive psychotherapy. As FDA Commissioner Marty Makary said this week, “If [the drugs] do get approved, these are not the medications you’ll just pick up at a pharmacy. These are given in a controlled, supervised setting in a hospital.” All of the related medical services could cost tens of thousands of dollars. Because these therapies are highly effective, however, they can often displace a lifetime of treatment through existing drugs and counseling that add to far greater expense. 

Still, most patients would be unable to afford these therapies on their own, which means coverage by third-party payor networks like Medicaid or private insurance would be necessary to make them accessible. That means agencies like the Centers for Medicare & Medicaid Services (CMS) must create or clarify appropriate billing codes that properly reimburse preparation, administration, and integration sessions. CMS is responsible for establishing these codes, and the private medical establishment generally follows suit.  

The Department of Veterans Affairs (VA) also must establish clear policies for formulary inclusion and veteran access programs. Trump’s executive order expressly directs the VA to sign a data-sharing agreement with the FDA to report on the results of clinical studies, which implies the VA intends to make these therapies available to veterans on an experimental basis prior to full FDA approval. The order recognizes that mental health problems are acutely concentrated within the veteran population, noting that “the current veteran suicide rate is more than twice as much as the non-veteran adult population.” 

Ibogaine analogs face a much longer timeline. Although the FDA will allow drug developer DemeRx NB to begin an initial clinical trial, it has specified alcohol use disorder as the condition for which it is evaluating treatment. Alcoholism affects millions of people, and ibogaine might be an effective therapy, but that’s not the condition that has generated interest from notable media personalities like Joe Rogan or Shawn Ryan. Ibogaine shows unique promise to help people rapidly overcome opioid addiction and to heal traumatic brain injuries. Nearly 80,000 Americans die each year from opioid overdose, according to statistics maintained by the Centers for Disease Control. 

Frustrated by the epidemic-level proportion of these deaths, several states have begun exploring a partnership to advance clinical trials of ibogaine on their own, with Texas, Arizona, and Mississippi having appropriated money for ibogaine research. The Trump executive order also commits $50 million to “support and partner with State governments” involved in this effort. Although this multi-jurisdictional public-private partnership is still taking shape, Reason Foundation has helped shape the effort by crafting model legislation that allows new states to join. Several states are currently considering some version of this legislation so they can join the consortium. 

Trump’s executive order initiated a series of actions that federal agencies must complete before psychedelic therapy realistically becomes available for members of the public suffering from mental health conditions. Quick announcements from the FDA provide an encouraging sign that government agencies intend to fast-track this effort, but much remains to be done. 

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