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October 26 – November 1, 2026
A Note From the Editor
On Monday, we published our review of the 610 submissions to FDA’s psychedelics public comment docket, nearly 500 of which were distinct, by our count.
The overwhelming majority were supportive, much like the mid-September Part 15 hearing that took place at FDA’s White Oak Campus in Maryland. Like that meeting, however, the vast majority of respondents were very much in and of the psychedelics field, ranging from psychedelic drug developers and care delivery providers through to advocates and those who provide psychedelics in state-regulated models. This is worth keeping in mind when considering the balance of the comments.
Even so, opposition was sparse, and much of what there was came from coordinated template letters or outright duplicates. The substantive topics that were raised will not come as any surprise: questions like whether psychotherapy should be included in the model, whether there should be product-specific or class-wide rules and frameworks, and who must be in the room during dosing sessions are all well-trodden debates within the field of late.
Elsewhere on the regulatory front this week, NRx Pharmaceuticals received FDA approval for its preservative-free generic ketamine product, which carries an anaesthesia label. It’s not content with bringing its preservative-free product to market, however, and is also seeking to have ketamine products containing benzethonium chloride pulled from the market by FDA. That latter part of its plan remains pending, as FDA has yet to rule on a citizen petition the company submitted last year.
NRx’s product sits a little outside our usual reporting remit, but we expect FDA to weigh in on psychedelics in short order. That is likely to include Usona Institute’s psilocybin for major depressive disorder, which we understand is quite far along in the process. More to come.
As we have covered previously, there is plenty that needs to happen to translate an approval into patient access. One of those steps is DEA’s rescheduling of the drug product, which can take up to 90 days. After that, many states will also need to consider where the drug product fits into their own schedules. Efforts are underway to accelerate this process, both via state-level rescheduling trigger laws backed by developers like Compass Pathways and via political pressure, such as President Trump’s April executive order, which sought to speed up DEA’s review.
This week, U.S. Congressman Steve Cohen introduced a bill that seeks a more substantive shake-up of the U.S. drug scheduling system, which is governed by the Controlled Substances Act (CSA). The Public Health and Research Reforms in Controlled Substances Act of 2026 would shift primary scheduling authority from DEA to the Department of Health and Human Services (HHS). It would also create a dual-axis scheduling rubric that assesses substances based on risk and threat to public health on one axis, and therapeutic value on another. In addition, it would require HHS to prioritise the reevaluation of the scheduling of 32 substances within two years of enactment, including psilocybin, MDMA, LSD, mescaline, and ibogaine.
In other news, AtaiBeckley’s (which is now part of Eli Lilly) Phase IIb study of intranasal 5-MeO-DMT (BPL-003) for treatment-resistant depression (TRD) was published in JAMA and received mainstream media attention.
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
October 19 – 25, 2026
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Read the PerspectiveA Note From the Editor
Much of our coverage this week has revolved around The Psychedelic Healthcare Forum that we co-hosted in New York City last Thursday. That includes my interview with HHS Deputy General Counsel Matt Zorn as well as a look at what representatives from FDA, VA, and ARPA-H shared on-stage.
Outside of our New York event, there have been several gatherings in Europe in recent weeks. One of those was the TAIP Conference in Tallinn, Estonia, where researchers, providers, policymakers, and others gathered to compare notes on various models of psychedelic access across the bloc. Ryan Khan was on-site for Psychedelic Alpha, and you can read his lengthy Dispatch now.
Elsewhere, the Institute for Clinical and Economic Review (ICER) has announced that it will assess Compass Pathways’ psilocybin for treatment-resistant depression over the coming months. ICER is a nonprofit that reviews new healthcare interventions with an eye to cost-effectiveness, and is quite influential on the reimbursement front.
Compass’ psilocybin will be the second psychedelic therapy ICER will have assessed. In June 2024, it reviewed MDMA for PTSD and concluded that the available evidence was insufficient to determine benefit. Its scoping document for the Compass psilocybin assessment is open to public comment through November 10th.
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
October 12 – 18, 2026
We have had a very busy week in New York City, where on Thursday we co-hosted The Psychedelic Healthcare Forum.
That event saw federal officials, investors, drug developers, care delivery outfits, and others share their perspectives on the field as we approach the first potential approvals of psychedelics in the coming months.
For my part, I presented a State of the Industry and had two on-stage discussions: one with Matt Zorn, the lawyer who last year became a sort of ‘psychedelics czar’ when he joined the U.S. Department of Health and Human Services, and another with Carole Ho, who heads up Eli Lilly’s neuro division.
We will share insights from the Forum in the coming weeks.
In the brief moments of quiet over the past week or so I have been combing through the 609 submissions to FDA’s psychedelics-focused public comment docket. We will be sharing an overview 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
October 5 – 11, 2026
A Note From the Editor
It was another relatively quiet week in the psychedelics field.
On Monday, however, the U.S. Food and Drug Administration (FDA) announced a request for information (RFI) concerning early-stage ibogaine studies. In doing so, it also floated a potential trial design, telegraphing its thinking on key elements that it might expect to see in any investigational new drug applications.
At ARPA-H’s ASCENT-IBO Proposers’ Day last month, deputy director of FDA’s Division of Psychiatry Bernard Fischer told attendees that the agency was “thinking about how much information we need to put out there to proactively inform the field.” His comments were very well received then, and it appears that the agency has quickly delivered on that intention now. Investigators we spoke with welcomed the move. The RFI is open through November 20th.
Meanwhile, a National Institute of Mental Health grant opportunity that was expected to publish yesterday has yet to appear. The forecasted opportunity, Advancing Real-World Effectiveness Evidence for Rapid-Acting Psychotropic Interventional Drugs (RAPIDs), could provide up to $20 million in aggregate funding across three projects.
Just prior to this week, last Friday, New Mexico’s Department of Health held a public hearing related to its medical psilocybin program, which it hopes to implement by year-end. Key points of contention included a provision that requires landlord consent for psilocybin treatment to take place in a rented home, and a thirty-day window for the department to review patient applications.
I’m grateful for a quieter fortnight, as preparations for The Psychedelic Healthcare Forum in New York City enter their final stages. I hope to see many of you there this Thursday!
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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