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This week saw further turmoil at the FDA, with the prominent departure of Commissioner Marty Makary. Days later, Tracy Beth Høeg, a Makary ally and Director of the agency’s Center for Drug Evaluation and Research, which is responsible for reviewing new drugs, was fired.
Following her departure, the agency announced that Mike Davis has assumed the role of Acting Director. Prior to rejoining the agency last summer, Davis had a three-year stint as Chief Medical Officer at psilocybin drug developer Usona Institute. Many in the psychedelics field welcomed the news, as did FDA staffers I spoke with.
Elsewhere this week, a small open-label study of psilocybin in chronic suicidal ideation showed feasibility and promise in a population that has generally been excluded from psychedelic research. We interviewed psychiatrist and research Scott Aaronson about his group’s trial.
For my part, I have been on the road, first visiting Stanford and its various psychedelics researchers and groups, and now San Francisco for the American Psychiatric Association’s annual meeting.
While the meeting is just one day in at the time of writing this note, it is clear that many in the field of psychiatry feel that their vocation’s legitimacy has been called into question by ideological forces. At the opening plenary sessions, for example, APA leadership repeatedly highlighted the importance of keeping politics out of the practice of medicine and better communicating psychiatry’s contributions to society.
On the psychedelics front, there is a great deal to report from the conversations I have had during my travels, which stretch into late next week. I will be sharing much, much more with our Pα+ subscribers in due course.
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelic business, policy, research and beyond.
Josh Hardman
Founder & Editor
Turmoil continues at FDA, as reports claim that President Trump is planning to fire its Commissioner, Marty Makary. The agency is also seeing signs of pharma concern around its priority vouchers, with Sanofi asking for its diabetes drug to be pulled out of the program, apparently over concerns regarding potential political interference in its review.
Members of Congress, meanwhile, sent a letter to FDA seeking clarity on certain aspects related to the review of psychedelics. Thirty Members signed the letter, addressed to Makary, which requests written responses to four questions, some of which appear geared toward the Lykos/Resilient package.
In the European Union, meanwhile, advocates and policymakers met for a half-day discussion on the topic of psychedelic research and access in Ukraine, with participation from the Ukrainian Ministry of Health and a veteran of the present war. Later in the week, representatives from more than two-dozen psychedelics societies from across the continent held a forum in Brussels.
This week, I head to Stanford and San Francisco to meet with people from across the psychedelics field and attend the American Psychiatric Association’s 2026 Annual Meeting. One of my goals is to understand how the average psychiatrist views the field of psychedelics, especially as potential approvals approach at speed.
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelic business, policy, research and beyond.
Josh Hardman
Founder & Editor
This week saw mainstream media’s flurry of psychedelics-related stories fizzle out as President Trump’s executive order (EO) slid down the news cycle. Insiders, meanwhile, continue to grapple with the implications of the EO, and how to best navigate next steps.
To that end, I spoke with Americans for Ibogaine CEO W. Bryan Hubbard for our latest Pα+ interview. We were both in Denver, Colorado, for the National Council for Mental Wellbeing’s annual meeting, where there were three psychedelics-related panels.
Speaking of gatherings, this week, the Interdisciplinary Conference on Psychedelic Research (ICPR) unveiled its full speaker lineup and agenda. I am excited to once again be attending this June conference, which takes place in Haarlem, near Amsterdam, alongside other members of the Psychedelic Alpha team. I’ll be giving one of the opening talks on Thursday morning and hope to see you there.
Below, you will find your Psychedelic News Feed, a one-stop digest for the latest coverage of psychedelic business, policy, research and beyond.
Josh Hardman
Founder & Editor
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