Psychedelic Therapies Reach Turning Point Amid Federal Push, Says Scott Shannon, MD

In this episode of Managed Care Cast, psychiatrist and longtime psychedelic researcher Scott Shannon, MD, CEO of the Board of Psychedelic Medicine and Therapies, and founder of Wholeness Center, discusses how a new federal push to accelerate psychedelic therapies could reshape the future of mental health care. With more than 40 years in the field, Shannon has worked on MDMA-assisted psychotherapy since before the drug was scheduled in 1985 and has recently served as a phase 2/3 investigator in the MAPS trials (NCT04077437) with Resilient Pharmaceuticals (formerly Lykos). He has also contributed to studies of lysergic acid diethylamide (LSD) for generalized anxiety disorder and 5-MeO-DMT for treatment-resistant depression with Beckley and MindMed.

Shannon welcomed the recent presidential executive order aimed at speeding research and regulatory pathways for psychedelic therapies, seeing it as overdue recognition amid a worsening mental health crisis. He argues that traditional psychiatric medications largely follow a suppressive, symptom-management model, whereas psychedelics offer the potential for transformative change and even genuine healing, particularly for posttraumatic stress disorder and treatment-resistant depression.

“Psychedelics bring a new paradigm and a new model where healing comes back into the forefront, and we begin to understand that everybody has the capacity to heal and get better over time, and psychedelics bring that back to psychiatry,” he said.

However, he emphasized that the research pipeline remains slow, costly, and bureaucratic, citing the more than $100 million raised to bring MDMA-assisted therapy through phase 3 trials without major pharmaceutical backing. The order’s proposals, including regulatory vouchers and increased coordination among agencies like the FDA, HHS, and the Drug Enforcement Administration, could streamline reviews but do not fully fix the structural issues.

Shannon expressed disappointment that Resilient, the company advancing MDMA-assisted psychotherapy, did not receive a federal voucher under the presidential initiative, while other organizations developing methalone did. He noted that methalone, an MDMA analog, has far less supporting data and real-world experience than MDMA. Shannon suggested the omission was likely driven by concerns about political backlash or FDA sensitivities, calling it “surprising and sad” given MDMA’s breakthrough status and the strong phase 2/3 results documented.

There’s both opportunity and risk in bringing psychedelics into large systems like Veterans Affairs, which serves millions of veterans yet often moves slowly. Shannon worries that pressure for rapid commercialization could sideline embedded psychotherapy, reducing psychedelic treatments to another quick pharmacological fix. Ultimately, he believes meaningful success would mean a long-term shift away from daily medications and toward intermittent, deeply therapeutic interventions that restore the idea of healing to psychiatry.

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