Psychedelics in D.C., FDA’s Framework, and New Zealand’s MDMA Prescribers

Welcome to the Psychedelic News Feed, a podcast from Psychedelic Alpha. Each episode brings you up to speed with the latest across psychedelic drug development, policy and access from around the world. It's presented by me, Josh Hardman, Psychedelic Alpha's founder and editor. These are intended to be concise summaries as opposed to deep dives. If you are looking for more nuanced analysis, exclusive interviews and unrivaled reporting on these topics and much more, head to psychedelicalpha.com.

Welcome to our first episode of the Psychedelic News Feed podcast. Each episode will cover the preceding two weeks, for now at least, of updates from psychedelic drug development, policy, research, and access. So this first episode covers September seventh through twentieth 2026 . We've got a lot to run through today, perhaps an unusually busy two weeks and therefore a bit of a busy first episode. There were three meetings in Washington DC, what I'm calling Psychedelics Week.

There was a commentary published in the New England Journal of Medicine by top FDA staff on the topic of psychedelics. New Zealand's limited approval of MDMA prescribing privileges gets underway, and many other stories from our coverage over the last two weeks, including a phase three readout from LSD drug developer, Definium, A neuroplastogen, one of these nonhallucinogenic psychedelics, enters phase one. Eli Lilly's acquisition of AtaiBeckley closes. RFK Jr. talks ibogaine with ibogaine advocate Bryan Hubbard, and much, much more. So let's get into it.

This episode of the Psychedelic News Feed is supported by UBC. As psychedelic therapies move toward potential approvals, UBC helps sponsors navigate the evidence generation, pharmacovigilance, and comprehensive risk management strategies that support a path forward grounded in patient safety. Learn more at ubc.com.

So first, let's look at these three federal meetings that took place last week in Washington DC, The US capital. The first, many of you will have heard about.

It was an FDA, a Food and Drug Administration public hearing that was hotly anticipated. It was on the topic of psychedelics and their potential use in medicine, and it took place on Monday last week at the agency's White Oak campus just outside of Washington DC in Maryland. Here's what FDA's deputy center director for substance use and behavioral health, Marta Sokolowska, had to say in opening the meeting.

Today's hearing is part of a whole of government effort to better understand the opportunities, challenges and public health considerations associated with this evolving area of psychedelic drug treatment. Most importantly, we are here today to listen.

There were around 300 people attending in person. The vast majority of them were sort of psychedelics insiders, I recognized most of them, whether they were advocates, researchers, entrepreneurs, or otherwise. So there was a generally jubilant mood among those attendees, you know, lots of clapping and applause after speakers' comments even when asked not to. There was a federal listening panel with FDA representatives as well as representatives from other agencies and institutes like the National Institute on Drug Abuse, SAMHSA, the Veteran Affairs Administration, and ARPA-H .

So, usually, that listening panel in these types of hearings, which are called part 15 hearings, would be asking questions of speakers or discussing the topics. But this time, they truly just listened with no questions or comments at all. I think part of that was because there was such a long, almost laundry list of speakers and comments to get through with around 80 people speaking on the day. And the FDA did say that they received more than 200 requests to speak, so they had randomly chosen a subset of those requests. So each speaker had just two minutes to rattle through their comments.

So given that format, a long list of speakers, and very brief comments, it's perhaps not surprising that there wasn't all too much time for any discussion or comments from the federal panelists. So in that sense, this was nothing like an advisory committee where the FDA convenes to discuss one particular drug product. It was definitely much more of a sort of listening session. We won't get into the topics discussed in any real detail here because you can head to our website to read an article that we wrote about the day's proceedings. But, generally, a lot of comments focused on encouraging the agency not to treat psychedelics as a stand alone drug therapy, instead recognizing that it's often delivered in a broader package of care.

But there is a tension between that broader model and access with some speakers saying something almost the opposite and encouraging the FDA and other federal partners to sort of approve the drug and and let the practice of medicine and practitioners decide how it is delivered. But that brings up the question of reimbursement with any label for the drug potentially informing what gets paid for and at what level by insurance companies and government payers. So there was a bit of back and forth there at least between speakers. Other questions focused on the sort of restrictiveness of any constraints that the agency might place on the rollout of psychedelics if approved. They're seeing things like risk evaluation and mitigation strategies.

Some speakers emphasize that if that's too burdensome or strict, it might just reduce access and push people to access psychedelics outside of the FDA approved model, while others said that whilst these are at least in the early days of delivery, if approved, then the REMS and other safety restrictions should be tighter and loosened as data are collected in the real world. So there was some sort of technical discussion around what rollout should look like if approved, but there was no outright critic of psychedelics aside from one person, Kevin Sabet, who is known for his outspoken stances against drugs, including psychedelics and cannabis. And there were also some words of caution or balance from several speakers. But, generally, this was incredibly positive in terms of the tenor of the comments made on the day, all very focused on rollout, as I mentioned, with approvals almost assumed by many people on the day. So advocates will be happy with the proceedings, which went ahead without a hitch.

And the agency for its part has presumably checked the box and that it's been seen to be listening to those with views on how this proceed. Now the two minute comments were, as I suggested, quite a crude way to convey what are often quite technical points. But there is a public docket open through early October where people can submit comments as lengthy as they wish. So as I say, read more on our website. And if you are interested in submitting a comment or perusing comments, you can head to the Federal Register website to do so.

Two more meetings I attended during my time in DC on Tuesday, ARPA-H , the advanced research projects agency for health, hosted a meeting of various ibogaine researchers and investigators and companies and entrepreneurs who are hoping to participate in ARPA-H's ibogaine sprint program, which is called Ascent iBo. And that program seeks to fund a project that will investigate ibogaine for opioid use disorder. Around a 100 people attended in person and a further 100 online. FDA, NIDA, and other federal representatives were present, so it provided an opportunity to mingle with other potential project proposals but also hear from those agencies. The mood was generally positive, but ARPA-H really sought to emphasize that it wants to move fast here, especially Matt Zorn, deputy general counsel at the Department of Health and Human Services, who was very blunt in saying that ARPA-H only intends to support a group that will move quickly on this matter.

But it's not clear how quickly things can move. There have been many efforts to get ibogaine into human studies in The US that have been sort of delayed by issues with opening an investigational new drug application and perhaps even more preclinical work is needed to do so before we get into humans, at least in The US. So our Psychedelic Alpha Plus subscribers can read much more in our dispatch from that day, which includes coverage of panels featuring FDA staff and those from other federal agencies.

Now the last formal meeting I attended in DC was hosted by the American Brain Coalition and the Congressional Neuroscience Caucus among others, and it saw around 50 people gather in the congressional offices on Capitol Hill but the proceedings opened by congressman Morgan Luttrell, who has become an outspoken proponent of psychedelic therapies, and he's also one of the co chairs of the Congressional Neuroscience Caucus. He said that psychedelics is a terrifying word that nobody likes to say.

He said it always sort of conjures up images of the nineteen sixties and nineteen seventies, and everyone's terrified. The term has a tendency to close doors, he said in terms of him speaking with members of Congress and the Senate. But still, he feels strongly about the class of drugs and potential medications. He, his wife, his brother, and friends have all tried ibogaine successfully, he said. And he shared that his efforts to sort of codify the executive order's provisions into law via the, and and bear with me here, initiating biomedical outcomes to garner advancements into innovative neuroplasticity efficacy act.

And if you were listening very closely, you would know that that spells our ibogaine. So congratulations to whichever staffer came up with that. But he said that, you know, efforts to codify the EO into law through that act are akin to pushing a wet noodle up a hill. So I think they're very difficult there and only made more difficult by the sort of difficulties going on in terms of lawmaking in The US political system in general right now. But he sees psychedelics as a way that we can move away from opioids and SSRIs, he said.

And he really encouraged those in attendance that we must get this right. And if we don't get this right, he said, we could lose psychedelics forever. So then there were other speakers in the panel which featured FDA's division of psychiatry director, Tiffany Farchione as well as a researcher, a drug sponsor, and a NIDA representative. But I won't go into too much detail here, but Tiffany Farchione did emphasize that there's a lot going on, and she doesn't want people to come away from the meeting thinking that, you know, there's little research going on and that it's too difficult to get these studies started. She reemphasized something she said before, which is that a third of her division's workload is related to psychedelics programs.

And she said they've been working on this for a decade or so. So even though there's plenty of excitement right now, it's really a culmination of many years of work. The panel went on to discuss questions around the state of research, access considerations, nonhallucinogenic psychedelics, the role of psychotherapy, and much more. So for more on this and all three meetings I attended last week, our Psychedelic Alpha Plus subscribers can listen to a separate field note audio dispatch where I go into much more detail, much more than is warranted for the purposes of these Psychedelic News Feed updates.

While FDA was silent at its public hearing last Monday, certain prominent staffers in the agency did share their perspectives on psychedelic drug development in a brief two page comment published in The New England Journal of Medicine the week before.

It largely reiterates positions expressed in its final guidance for industry, which issued in July, but the fact that it sought to extend the reach of that guidance through this publication in NEJM sort of shows that the agency expects to continue its close engagement with the field. It might be signal over substance in that sense. One element of the final guidance that it reiterates in the comment, which we also emphasized at the time of its publication, is the division of psychiatry's apparent loosening of its position on demonstrating durability of effect across various dosing paradigms. It explained in the guidance and reiterates prominently in this new NEJM publication that this work can be punted into the post marketing arena, which could remove or defer the need for sprawling redosing studies. In that sense, it looks to be setting a slightly lower bar than the data provided by Johnson and Johnson in its Spravato esketamine new drug application, at least in that regard.

It's also potentially a lower bar than some of the farthest along psychedelic drug developers had been expecting to clear.

While The US prepares to get a more conventional access pathway to psychedelics off the ground via FDA approval, drug regulators Down Under are taking less traditional actions. Earlier this month, New Zealand's drug regulator MedSafe greenlit a limited MDMA prescribing scheme that allows two Kiwi psychiatrists to offer the drug to patients with PTSD. That comes a year after the country took the same move with psilocybin for treatment resistant depression. I spoke with one of the approved psychiatrists, Doctor.

Gary Wynn, who told me that the process took thirteen months. He hopes to dose the first patients in the next month or two. But the number of patients a psychiatrist like Winn could see is somewhat modest. He expects to dose up to 15 patients a year, for example. While it's starting with just two psychiatrists, more clinicians are expected to apply very soon, but a key barrier will continue to be cost, with no public funds available for this treatment in New Zealand.

The move by MedSafe to allow certain clinicians to prescribe both psilocybin and MDMA mirrors that of its larger neighbor, Australia, which did so three years ago. While uptake has been slow there too, it has made some progress on the reimbursement front with one private payer, Medibank, and one public payer, the Department of Veterans Affairs, reimbursing psychedelic assisted therapy there. You can read more about this story on our website.

There are lots of other headlines from the past two weeks, but in the interest of keeping this somewhat brief, we'll try and rattle through them here. Do note that most of these come from Psychedelic Bulletin two three one, which we published last week, which is exclusively for our Psychedelic Alpha Plus subscribers.

It runs at around 3,000 words. So if you're looking for more detail, that's the place to go. The first story is that LSD drug developer Definium Therapeutics shared last week data from its second phase three study of LSD, it calls DT120 , in generalized anxiety disorder. It was positive just like the first one, and it becomes the third successful phase three readout from the company since June. It expects to submit a new drug application for its LSD candidate in the first half of twenty twenty seven.

Psilocybin developer Compass Pathways, meanwhile, shared fifty two week follow-up data from its placebo controlled phase three trial of its psilocybin candidate for treatment resistant depression. The data was somewhat difficult to interpret, but the company reports that it observed notable additional benefit of a further open label dose of the psilocybin candidate in Part C of that study. It also announced the award of five training development grants, up from three that it had originally envisaged awarding, and emphasized that those training organizations will remain independent. This all comes as Compass expects to submit its new drug application to the FDA in the fourth quarter, and it hopes that it could launch its psilocybin product early next year. Elsewhere, Xylo Bio, the nonhallucinogenic psychedelic drug developer, is entering the clinic with its lead candidate XYL-1001 , a nonhallucinogenic drug that is developing for major depressive disorder.

It's dosed the first patients in that phase one study, which is taking place in Australia. It joins a growing crop of so called neuroplasticity developers, including Delix Therapeutics, which we reported last month, could be in line to receive fresh investment from various parties, including the large pharmaceutical firm Johnson and Johnson. Other drug developers working in this segment include Hong Kong based CSPC Pharmaceutical Group, which is also launching a phase one study of its nonhallucigenic candidate. Sticking with companies, Eli Lilly's acquisition of psychedelic drug developer AtaiBeckley has officially closed. Eli Lilly, the largest pharmaceutical company in the world by many measures, is shelling out $2,800,000,000 in cash to acquire the company with up to an extra billion dollars in milestones thereafter.

The vast majority of voting shareholders endorsed the deal. Through our reporting, we keep tabs on all sorts of filings, including trademark filings, and we noticed recently that Usona Institute, the nonprofit psilocybin drug developer, has filed for a trademark for the term Arumaya under class zero zero five, which covers pharmaceuticals. So this leads us to think that that could be the potential product name they're going for if indeed they do secure approval of their psilocybin product for major depressive disorder, which could happen as soon as the coming months. And finally, RFK junior, the US Department of Health and Human Services secretary, hosted Bryan Hubbard, the ibogaine advocate, on his podcast recently. Hubbard gave his usual pitch around ibogaine and its potential in medicine through a mix of anecdotes and references to data.

RFK junior, meanwhile, almost sort of sought to temper the hype. Ibogaine is not safe, he said at one point, emphasizing the potentially fatal cardiac risks of the drug. He also pointed to resourcing and access considerations, sort of saying that even if this were approved and available to veterans, it would be quite expensive and logistically challenging to deliver. But at the end, the pair both reminisced on the executive order that brought them both to the Oval Office, and RFK junior said that president Trump turned on a dime in terms of his approach to psychedelics.

So that's it for our first Psychedelic News Feed.

This one was longer than we expect the average episode to be, but that's owing to this being an incredibly busy two weeks. So let's see what the next two have in store.

That's it for this edition of the Psychedelic News Feed. For deeper analysis, exclusive interviews, and reporting that you won't find anywhere else, head to psychedelicalpha.com . Have a great day.