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Trump Orders Accelerated Psychedelic Reviews, FDA Fast-Tracks

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Trump Orders Accelerated Psychedelic Reviews, FDA Fast-Tracks
Key Points
  • Trump's executive order accelerates psychedelic drug reviews, including ibogaine.
  • Ibogaine is banned but shows promise for PTSD and opioid addiction, despite safety concerns.
  • The FDA will issue priority vouchers for psychedelics and clear the way for ibogaine trials.

President Donald Trump signed an executive order directing his administration to speed up reviews of certain psychedelic drugs, including ibogaine, according to sources. The administration is taking steps to ease access to psychedelics that Trump said were already designated as potential breakthroughs by federal regulators, sources reported. Trump's action surprised many longtime advocates and researchers in the psychedelic field, sources indicated. Joining Trump in the Oval Office were his top health officials, conservative podcaster Joe Rogan, and Marcus Luttrell, the former Navy SEAL whose memoir about a deadly mission in Afghanistan was the basis of the film 'Lone Survivor,' sources said. The issue of easing access to psychedelics for medical use has won rare bipartisan support, sources noted.

Focusing on ibogaine, this substance is banned under the federal government's most restrictive category for illegal, high-risk drugs, sources reported. Veteran organizations and psychedelic advocates have long contended that ibogaine has great promise for hard-to-treat conditions such as post-traumatic stress disorder and opioid addiction, sources said. However, ibogaine is known to sometimes trigger potentially fatal heart problems, sources indicated. The National Institutes of Health briefly funded research on ibogaine in the 1990s but discontinued the work due to ibogaine's 'cardiovascular toxicity,' sources reported. It has been incredibly difficult to study ibogaine in the U.S. because of its known cardiotoxicity, sources noted.

You're going to save a lot of lives through it.

Marcus Luttrell, Former Navy SEAL

In the political context, Trump's action surprised many longtime advocates and researchers in the psychedelic field, sources reiterated. The issue of easing access to psychedelics for medical use has won rare bipartisan support, sources emphasized.

Upcoming regulatory developments include the FDA's plan to issue national priority vouchers for three psychedelics next week, sources reported. The FDA's commissioner, Marty Makary, said the vouchers will allow certain drugs to be approved quickly if they are in line with national priorities, according to sources. It is the first time the FDA has offered that fast-tracking to any psychedelics, sources indicated. Additionally, the FDA is taking steps to clear the way for the first-ever human trials of ibogaine in the United States, sources said. This move marks a significant shift in federal policy toward psychedelic research and potential medical applications.

It absolutely changed my life for the better.

Marcus Luttrell, Former Navy SEAL

If they are in line with our national priorities.

Marty Makary, FDA commissioner
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