A recent opinion article published by Psychology Today and authored by Dr. Mark S. Gold discussed the new U.S. federal approach to psychedelic therapies in terms of emerging mental health treatments. The Executive Order (EO) on psychedelics, issued earlier in April by the White House, is a policy initiative aimed to speed up the development of psychedelic-based treatments for serious mental illnesses such as PTSD, depression, and addiction.
“The President’s order directs federal agencies to facilitate clinical trial participation, expand access pathways such as Right-to-Try mechanisms, and prioritize regulatory review,” wrote Dr. Gold. “This creates real momentum—compressing development timelines, signaling to regulators, researchers, and investors that psychedelics are a federal priority. However, it does not alter statutory requirements for approval: the FDA still requires substantial evidence of safety and efficacy.”
The article also discussed how the EO has already influenced the U.S. regulatory landscape, with several companies developing psychedelic-based therapies receiving FDA priority incentives and increased clinical development opportunities, including the first U.S. clinical pathway for an ibogaine-derived treatment targeting alcohol use disorder.
However, some U.S. health experts have also pointed out that psychedelic therapies remain investigational and must still demonstrate safety and efficacy through rigorous clinical trials before they can be integrated into routine clinical practice. In addition, Dr. Gold has listed several existing issues around psychedelic therapies, including difficulties with placebo blinding, limited available long-term data, uncertain durability of treatment effects, and concerns about whether study results can be applied to wider patient populations. Moreover, he highlighted additional issues such as potential drug interactions, the influence of psychotherapy and patient expectations on outcomes.
According to Dr. Gold, the experience with the ketamine therapy Spravato shows that even promising psychiatric treatments require strong clinical evidence, long-term safety monitoring, and supervised administration, raising questions about whether similar systems could be used for psychedelic therapies.
“The EO accelerates the pathway to development, but FDA approval requirements are rigorous demonstration of safety and efficacy through randomized controlled trials,” he concluded. “The EO signals a new priority to NIH, which will influence funding allocation and may affect reviewers’ mindsets. Anchoring in the VA system provides an important real-world data infrastructure, large, centralized patient populations, and built-in longitudinal follow-up. This VA partnership could be the big game-changer, materially accelerating evidence generation.”
