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“I remember when I received the email from the agency telling me the [psilocybin compassionate use] program was approved… I was sitting in my office in Mannheim, and I was almost crying.” Gerhard Gründer, Central Institute of Mental Health, Mannheim, speaking at TAIP 2026. Read more on our website: psychedelicalpha.com/news/be…

“Right now, we have in the Division of Psychiatry 433 INDs... about 40% of them are active, and clinical trials that involve psychedelics account for a third of our workload.” Valentina Mantua, Associate Director for Regulatory Science, U.S. Food and Drug Administration, speaking at The Psychedelic Healthcare Forum.

“It’s tempting to move quickly once approval comes through, but I’d really encourage people to start slowly and build gradually. And hold onto the integrity of the psychotherapeutic frame, including the therapist dyad. That isn’t something you set up once and tick off. It’s an ongoing commitment, and it’s what protects the quality of care.” Joe Starke spoke with us for the seventh Issue of The Psychedelic Practitioner, which focuses on psychedelic preparedness (systems). Read now on our website: psychedelicalpha.com/news/th…

“The worst are maybe the young, enthusiastic physicians with only one or two amazing experiences, then they think they have seen it and they know what’s happening, and that’s probably more dangerous than having no experience at all.” Helena Aicher, Psychotherapist & Researcher, University of Zurich, speaking at TAIP 2026. Read more on our website: psychedelicalpha.com/news/be…

“When the president puts out an executive order, that priority moves to the top of the list, at least amongst the politicals. We formed work groups, and we’re now engaged. That’s the biggest effect of the executive order.” Matt Zorn, Deputy General Counsel, U.S. Department of Health and Human Services, speaking at The Psychedelic Healthcare Forum.

“Expect enthusiasm from patients and clinicians on day one, and expect payers not to be ready. With Spravato, some payers built a prior auth process quickly and others took much longer. For the first few weeks, whoever answered the phone, person or chatbot, often didn’t know how to help. That happens with most new drugs, and psychedelics will be no exception.” Carlene MacMillan spoke with us for the seventh Issue of The Psychedelic Practitioner, which focuses on psychedelic preparedness (systems). Read now on our website: psychedelicalpha.com/news/th…

Mostly Supportive, Somewhat Divided: Stakeholders Respond to FDA’s Psychedelics Docket In July, the U.S. Food and Drug Administration (FDA) issued a request for comments associated with a Part 15 public hearing it hosted on the topic of psychedelics.  That docket was open through October 5th, though it has taken some time for comments to be posted to Regulations.gov. At the time of writing, however, all comments appear to have been made available, and so we share our analysis. Here, we first provide a meta-analysis of the 610 comments before delving into specific topics and points of contention that arose. Read more on our website: psychedelicalpha.com/news/mo…

“Evidence-based training and participation in a consultation community are two important ways to encourage the steady growth of psychedelic medicine, and these are resources that we didn’t really have in the early days of Ketamine Infusion Therapy (KIT), in part because we had folks from many disciplines providing the treatment.” L. Alison McInnes, spoke with us for the seventh Issue of The Psychedelic Practitioner, which focuses on psychedelic preparedness (systems). Read now on our website: psychedelicalpha.com/news/th…

Across Europe, psychedelics are entering a new chapter, one defined less by proof-of-concept studies and more by implementation and early-access schemes that don’t rely on conventional drug approvals. On 8–9 October, more than 270 clinicians, researchers, policymakers, advocates and members of the public gathered at the National Library of Estonia in Tallinn for TAIP 2026, Estonia’s first international scientific conference on psychedelic-assisted therapy. There, they discussed various innovative models of regulated psychedelics access.  Ryan Khan was on-site for Psychedelic Alpha. Today, we share his 5,000+ word Dispatch. Read more on our website: psychedelicalpha.com/news/be…

Since President Trump's psychedelics-focused Executive Order in April, a slew of federal agencies and departments have engaged in related activities: from funding psychedelic research through to public hearings and requests for information.

“Conversion of codes from Category III to Category I requires their usage and reporting for relevant services. There is also the consideration of the AMA’s CPT Editorial Meeting calendar. It may take about 12-18 months for this conversion.” Steve Levine, spoke with us for the seventh Issue of The Psychedelic Practitioner, which focuses on psychedelic preparedness (systems). Read now on our website: psychedelicalpha.com/news/th…

“It’s going to be slower going than our veteran population would like... So, as far as numbers of patients we’ll be able to treat, I think to manage expectations, it’ll be a challenge in the first year to treat four digits worth of patients.” Andrew Gradison, Senior Advisor, U.S. Department of Veterans Affairs, speaking at The Psychedelic Healthcare Forum

Ten VA Sites, REMS and Ibogaine’s “Uphill Battle”: Feds Weigh In on Psychedelic Access At the Psychedelic Healthcare Forum, which took place in New York City last Thursday and was co-hosted by Psychedelic Alpha, a panel of federal officials participated in a discussion moderated by POLITICO Deputy Health Care Editor Erin Schumaker. Read more on our website: psychedelicalpha.com/news/te…

The Institute for Clinical and Economic Review (ICER), an independent organisation that reviews healthcare interventions with a mind to cost-effectiveness, today announced that it will assess the comparative clinical effectiveness and value of Compass Pathways’ psilocybin for treatment-resistant depression.  This will be the second psychedelic therapy that the organisation has assessed. In June 2024, ICER reviewed MDMA for PTSD, concluding that the available evidence was insufficient to determine benefit due to methodological issues.

Poacher Turned Gamekeeper: HHS’ Matt Zorn on Ibogaine, Right to Try and the Psychedelics Executive Order At The Psychedelic Healthcare Forum that we co-hosted last Thursday in New York, our Editor Josh Hardman sat down with Matt Zorn, Deputy General Counsel at the U.S. Department of Health and Human Services, for a wide-ranging discussion. It was the first in-depth one-to-one interview that Zorn has participated in since taking the role.  Read the full interview on our website: psychedelicalpha.com/news/po…

“If psychedelic treatments are offered predominantly in fancy clinics in large cities, or if insurers cover the drug but not the staff time, monitoring, and the preparation and integration sessions (and any other follow-up visits), then in practice psychedelic treatments will be accessible only to those who are well resourced.” Marcus Hughes, spoke with us for the seventh Issue of The Psychedelic Practitioner, which focuses on psychedelic preparedness (systems). Read now on our website: psychedelicalpha.com/news/th…

“The first few years of Spravato were a bit of a bust because of logistics. Let’s not repeat that.” Carlene MacMillan, spoke with us for the seventh Issue of The Psychedelic Practitioner, which focuses on psychedelic preparedness (systems). Read now on our website: psychedelicalpha.com/news/th…

Early Healthcare Forum Takeaways, FDA’s Ibogaine Blueprint, and Compass Talks Pricing In this episode of The Psychedelic News Feed podcast, Psychedelic Alpha’s editor Josh Hardman runs through the last two weeks in the psychedelics field, including these stories: • Early Notes from The Psychedelic Healthcare Forum • FDA Floats an Ibogaine Trial Design, Asks Field for Input • Compass Talks Pricing, Label and a Slow Launch • New Mexico Nears Medical Psilocybin Launch • Six More Potential Psychedelic Brand Names Listen on our website or on your favourite podcast app: psychedelicalpha.com/news/po…

On Thursday, Psychedelic Alpha co-hosted The Psychedelic Healthcare Forum at the New York Academy of Medicine. There, drug developers, regulators, investors, care delivery experts and others came together to discuss the potential rollout of psychedelic therapies in the U.S. healthcare system. More to follow.