White House Fast-Tracks Psychedelic Treatments for Critical Mental Health Needs

Over the weekend, President Donald Trump signed an Executive Order (EO) that directs federal agencies to reduce administrative barriers to the research, review, and potential approval of medical treatment using psychedelic drugs for patients with serious mental health conditions. “Accelerating Medical Treatments for Serious Mental Health Conditions” marks a dramatic shift in the federal government’s approach to these emerging therapies and advances priorities reflected in ALEC model policies, including the Veterans Mental Health Innovations Act and Therapeutic Psilocybin Act for Veterans and First Responders.

The EO takes five major steps:

1. Directs the Commissioner of Food and Drugs to provide Commissioner’s National Priority Vouchers to psychedelic drugs that have received Breakthrough Therapy designations.
2. Directs the Food and Drug Administration and the Drug Enforcement Administration to establish a pathway for eligible patients to access psychedelic-assisted therapy, including ibogaine-assisted therapy, under the Right to Try Act.
3. Allocates at least $50 million from existing funds to support and partner with state governments that have enacted or are developing programs to advance psychedelic-assisted therapy.
4. Creates collaboration pathways between the Department of Health and Human Services, Food and Drug Administration, Department of Veterans Affairs, and private sector researchers to increase clinical trial participation, data sharing, and research on psychedelic drugs.
5. Directs the Attorney General to initiate a review of any product containing a Schedule I substance that has successfully completed Phase 3 clinical trials for a serious mental health disorder, in consultation with the Department of Health and Human Services.

The President’s directive significantly changes the federal government’s attitude toward psychedelic treatments for serious mental health conditions. While psychedelic compounds such as psilocybin and ibogaine have consistently shown promise in clinical research for patients who have not responded to traditional treatments, federal law and subsequent regulation have long made research, review, and patient access burdensome.

This led the ALEC Veterans and Military Affairs Task Force to develop two new model policies on psychedelic-assisted therapy in December. The Veterans Mental Health Innovations Act establishes a pathway for states to fund clinical trials using ibogaine as an investigational new drug, and the Therapeutic Psilocybin Act establishes a regulated framework for the medical use of psilocybin to treat qualifying mental health conditions. Under this new EO, states that advance these model policies will have support from the federal government.

That momentum was also reflected at the signing ceremony, where President Trump was joined by HHS Secretary Robert F. Kennedy Jr., podcaster Joe Rogan, former Navy SEAL Marcus Luttrell, and Americans for Ibogaine CEO Bryan Hubbard.

By cutting red tape, developing pathways for treatment access, supporting state efforts, and coordinating efforts across government agencies, this EO will dramatically accelerate research into these promising treatment options. For veterans, first responders, and others suffering from serious treatment-resistant mental health conditions, it represents hope for real progress on emerging treatments.

For more on the growing national conversation around ibogaine policy and treatment research, watch our ALEC TV interview with Bryan Hubbard, who spoke at the ALEC States & Nation Policy Summit in Ft. Worth last December.