President Donald Trump signed an executive order on Friday directing the U.S. Food and Drug Administration to expedite the review and approval of psychedelic-based therapies, including ibogaine, for post-traumatic stress disorder and other severe mental health conditions. The directive marks a significant shift in federal drug policy and comes amid growing interest in psychedelics as potential treatments for conditions resistant to conventional therapies.

The executive order explicitly highlights ibogaine, a psychoactive substance derived from the root bark of an African shrub, despite its limited clinical research and documented safety risks. The policy calls for expanded funding for psychedelic research, streamlined FDA approval pathways, and new access routes for patients with life-threatening or severely debilitating mental illnesses. It also aligns with Trump’s recent public statements supporting the reclassification of medical cannabis, signaling a broader reconsideration of federal restrictions on controlled substances.

FDA to prioritize psychedelic drug applications

Under the new directive, the FDA will prioritize applications for psychedelic therapies, including MDMA and psilocybin, which are currently in advanced clinical trials for PTSD and depression. The agency has been exploring faster approval processes for drugs that show early promise in treating conditions with high unmet medical needs. The executive order formalizes this approach, directing the FDA to work with the National Institute of Mental Health to identify and support the most promising therapies.

Critics warn that the rush to approve psychedelic treatments could outpace scientific validation. Ibogaine, for example, has been linked to cardiac complications and lacks robust clinical evidence supporting its efficacy. The order does not waive standard safety requirements but does reduce bureaucratic delays in the approval process. Supporters argue that the mental health crisis demands urgent innovation, especially for veterans and trauma survivors who have seen little relief from existing medications.

Trump administration expands federal research funding

The executive order also allocates new federal funding for psychedelic research, targeting institutions and researchers studying these compounds. The National Institutes of Health will play a key role in distributing grants to study mechanisms, dosing protocols, and long-term outcomes. The policy reflects a growing bipartisan consensus that mental health care requires new tools, though it remains controversial among some medical and addiction specialists.

The move follows Trump’s recent remarks calling for the reclassification of medical cannabis from Schedule I to Schedule III, a change that would acknowledge its accepted medical use and lower regulatory barriers. While cannabis and psychedelics are distinct substances, both represent a federal shift away from strict prohibition and toward evidence-based drug policy. The administration argues that such reforms could improve treatment access and reduce the underground market for these substances.

Safety concerns persist amid policy shift

Despite the policy shift, significant questions remain about the safety and efficacy of psychedelic therapies. Ibogaine, in particular, has been associated with fatal arrhythmias and requires careful medical supervision. The executive order does not eliminate safety protocols but accelerates their integration into the approval process. Mental health advocates and some lawmakers have praised the move as a step toward modernizing treatment options, while others caution against prioritizing speed over science.

The FDA has indicated it will maintain its rigorous evaluation standards while working to reduce unnecessary delays. Patient advocates hope the policy will lead to faster access for those in crisis, especially veterans, first responders, and survivors of sexual assault who have not responded to traditional therapies. The order does not create a fast-track approval program per se but signals a clear federal intent to prioritize these treatments in the regulatory pipeline.

Looking ahead, the executive order sets the stage for potential legislative action and further regulatory changes. The Department of Veterans Affairs is expected to play a key role in expanding access for military personnel, a population disproportionately affected by PTSD. If successful, the policy could pave the way for broader acceptance of psychedelic-assisted therapies in mainstream medicine. However, unresolved safety and efficacy concerns will remain central to the debate as clinical trials continue.

What You Need to Know

  • Source: Healthline
  • Published: May 16, 2026 at 10:31 UTC
  • Category: Health
  • Topics: #health · #wellness · #medicine · #politics · #government · #trump-administration-aims

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Curated by GlobalBR News · May 16, 2026

🇧🇷 Resumo em Português

O governo Trump deu um passo ousado ao acelerar o uso de terapias com substâncias psicodélicas, como a ibogaína, para tratar transtorno de estresse pós-traumático (TEPT). Em uma medida que pode redefinir os rumos da saúde mental global, a Casa Branca ordenou à FDA que agilize pesquisas e aprovações para essas substâncias, abrindo caminho para tratamentos inovadores que prometem revolucionar a abordagem a doenças como o TEPT.

No Brasil, onde o acesso a terapias avançadas ainda enfrenta barreiras regulatórias e financeiras, a notícia chega em um momento crucial. O país registra altas taxas de TEPT, especialmente entre veteranos, vítimas de violência urbana e sobreviventes de tragédias, como o rompimento da barragem em Brumadinho. Enquanto a Anvisa ainda discute a regulamentação de substâncias psicodélicas, a medida americana pode pressionar por avanços locais, oferecendo esperança a milhões que dependem de soluções mais eficazes e menos invasivas. Além disso, a decisão reforça o debate sobre a descriminalização e a pesquisa com plantas medicinais, como a ayahuasca, já estudada em universidades brasileiras.

Ainda é cedo para prever quando essas terapias chegarão ao SUS, mas a corrida global por inovações em saúde mental já acendeu um alerta: o Brasil precisa se preparar para não ficar para trás.

🇪🇸 Resumen en Español

La administración Trump ha dado un giro radical a la investigación y tratamiento de los trastornos de estrés postraumático (TEPT) al impulsar terapias con sustancias psicodélicas, como la ibogaína, que hasta ahora se encontraban en un limbo legal y científico. El mandatario firmó un decreto que acelera los procesos regulatorios de la FDA para incorporar estos compuestos en protocolos médicos, abriendo una puerta que muchos expertos ven como revolucionaria pero también polémica.

El contexto es clave: el TEPT afecta a millones de personas en todo el mundo, con opciones terapéuticas limitadas y altas tasas de resistencia a los tratamientos convencionales. La ibogaína, una sustancia derivada de una planta africana, ha mostrado resultados prometedores en estudios preliminares para aliviar los síntomas, aunque su uso sigue rodeado de controversia por sus riesgos cardíacos y su estatus legal en muchos países. Para los hispanohablantes, este avance podría significar un acceso más rápido a alternativas innovadoras, aunque expertos advierten sobre la necesidad de regular su uso con rigor para evitar efectos adversos o usos indebidos. La decisión también refleja un cambio global hacia la reconsideración de las drogas psicodélicas en medicina, una tendencia que podría redefinir la salud mental en las próximas décadas.