Federal health officials are taking steps that they say will help with “accelerating” therapeutic access to psychedelics for patients dealing with serious mental health conditions.
Following President Donald Trump’s signing an executive order aimed at expanding and expediting research on the medical benefits of psychedelics, the Food and Drug Administration (FDA) on Friday announced a series of regulatory actions to support the development of psychedelics as approved medications.
“Under President Trump’s leadership, we are accelerating the research, approval, and responsible access to promising mental health treatments—including psychedelic therapies like ibogaine—to confront our nation’s mental health crisis head-on, especially for our veterans,” Health and Human Services Secretary Robert F. Kennedy, Jr. said. “The FDA will prioritize therapies with Breakthrough Therapy designation, where early evidence shows meaningful improvement over existing options for serious mental illness.”
The new steps being announced on Friday include the issuance of national priority vouchers to three companies studying psilocybin for treatment-resistant depression and major depressive disorder, as well as methylone (MDMC) for post-traumatic stress disorder (PTSD).
FDA is also allowing an early phase clinical study of noribogaine hydrochloride to move forward following an Investigational New Drug (IND) submission, with sponsor company DemeRx NB exploring the substance as a
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