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Two weeks ago, I (Psychedelic Alpha Editor Josh Hardman) visited Washington, D.C., to take the temperature on psychedelics among those who, whether through influence, expertise, or proximity to power, might shape the field’s future. From lawyers, lobbyists and advocacy groups to agency staffers, drug developers and well-connected individuals, I heard a wide array of views on where things stand, and what might come next.
There is significant tumult not only across U.S. politics and the regulatory apparatus, but also within the psychedelics field itself, which does not appear to have landed on a clear or coordinated ‘ask’. But beneath the noise, there appeared to be a quiet confidence among some that multiple FDA approvals of psychedelics are close at hand, with as many as three possible over the next 18 months.
Here, I share the gist of what I learned, a couple of policy tweaks or clarifications that I have been mulling over, and other observations on how psychedelics are viewed in the nation’s capital.
Who Speaks for Psychedelics?
One of the overarching themes I noticed, and have been reflecting on, was the amount of noise and lack of coordination among certain corners of the loosely defined psychedelics field.
There are the schmoozers, who think they’re close to the action but probably aren’t; the climbers, who appear to aim to ride the wave of psychedelics enthusiasm to further their careers; the clinger-ons, who enjoy being, or feeling, adjacent to power; and on and on it goes. Many of these folks will weave a fine story about how they are bending the ears of those in power to psychedelic-friendly ends.
Then there are the nonprofits, lobbyists (both official and de facto, registered and not), and advocates making noise, both in public but also behind closed doors with lawmakers. But they’re not always singing from the same hymn sheet or pulling in the same direction.
I understand, for example, that at least three psychedelics-related federal Bills are expected to be introduced in the coming weeks, with at least one fly-in scheduled. While I did not (and do not) cover the cannabis field, it saw a similar process of fragmentation on the policy front (see, for example, SAFE Banking, SAFER Banking, STATES Act, STATES 2.0 Act, MORE Act, Administration and Opportunity Act, HOPE Act, and so on), which many feel had negative consequences.
Now, if groups and sponsors can coalesce around one flagship bill, perhaps that’s sufficient. But I wonder, genuinely, what good will come of these efforts. Will they deliver meaningful changes, or only political wins? Until more can be shared about them, publicly, it’s tricky to speculate in these pages.
Even outside of the ‘advocacy’ realm, which one might expect to contain diverse agendas, I also struggled to discern a clear message on the drug development or ‘psychedelic pharma’ front. Sure, in public, many of the later-stage drug developers in the field implore the FDA not to provide any special treatment. But surely they could coalesce on a few things that might make their pursuit of approval and access easier?
One potential example of discord among developers is Resilient Pharmaceuticals’ (née MAPS PBC, then Lykos) apparent departure from the Association for Prescription Psychedelics1. Has the MDMA drug developer had enough of its peers openly hoping that the FDA will not help it out?
I do wonder what all this lack of clear message means for the field. Just as some philanthropists, investors, and professional bodies appear to have tired of the psychedelics field’s ‘drama’, so too might government and political figures. Political and social capital is not infinite, after all.
Political and Practical Blockers to Psychedelics
While the deck seems to have been stacked pretty favourably for psychedelics following Trump’s election last November, nothing has really happened that would ‘help’ any group within the field.
I heard that this lack of action isn’t simply the result of a dearth of ideas or clear messages. Instead, there are some more political and practical blockers.
Key among those, at least recently, was the federal shutdown, which put a pause on agency meetings and politicking. That’s now over, though presumably there is an enormous backlog of priorities that must now be managed. And, the midterms and associated campaign period are just around the corner, meaning that pipeline of priorities could become a quiet funnel to the back burner, at least until late 2026.
Aside from these factors, political support is not a certainty, either, despite many in the psychedelics field touting the issue as decidedly bipartisan.
Many I spoke with, for example, worry that key advisors and friends of the President must be won over in order to pass any substantial psychedelics-related changes, or else the White House itself could remain a blocker to reforms. (Without making this too crossword-clue-like, one such advisor ironically shares their surname with the window of political acceptability.)
How to manage this delicate political reality is contested, at least among the various folks I spoke with in D.C. Some believe there’s merit to going ‘straight to Trump’ (though that is more difficult, and perhaps expensive, than ever), while others endorse a ‘win over his friends and advisors’ approach. Some emphasised that the somewhat amorphous MAGA still needs to be convinced, too. (Aligning MAGA and MAHA has been a point of friction on this and other topics.)
Just who is most appropriate to be the face of the field is yet another debate, too. Should it be the buttoned-up psychedelic pharma CEOs, the billionaires, veterans, lobbyists, nonprofits, well-connected individuals, or others? It also depends on what you’re asking for, of course.
Over at the FDA, meanwhile, I heard of absolute chaos, with anecdotes in line with STAT’s characterisation of a ‘soap opera’ (or, in Shakespearean terms, an omnishambles). It really does seem that alleged infighting, bullying, and a focus among certain HHS and FDA leadership on ‘quick wins’ or press release-friendly policies and political point scoring are hampering plans to deliver productive changes. Staffing issues and a culture of fear are also slowing the daily operation of the agency, I heard, and both insiders and outsiders are concerned that programs like the Commissioner’s National Priority Voucher are corrupt.
Still, if FDA staffers can keep their heads down, we might expect to see some psychedelics-related clarifications and developments soon, as well as changes to the way psychiatric drugs are appraised more generally. The Department of Psychiatry appears to have avoided some of the more intense drama that has beset the agency, at least.
Indeed, several people I spoke to think there could be as many as three approvals for psychedelics in the next 18 months, with two potentially handed down in 2026.
Resilient has got its head down, with a smart new team doing what it can to win over the agency with a thorough review of its existing data and a sensible forward plan, I understand. If it can do so, it could indeed secure an approval prior to completing an additional Phase 3. It could, of course, volunteer to do an additional Phase 3 study, anyway.
Another of those potential 2026 approvals would likely be Compass Pathways, which has accelerated its launch timeline by up to a year following a “positive” September FDA meeting and strong enrolment in its second, larger Phase 3 study.
But Usona Institute, the nonprofit psilocybin developer, might not be as far behind as many of us had originally envisioned. Its one Phase 3 study, with an estimated N of just 240 vs. Compass’ 827 across its two Phase 3 trials, might be sufficient for approval. To make that case Usona could, for example, point to investigator-initiated trial data from studies that used their psilocybin product, to make up for what could otherwise be viewed as an insufficient internal safety database (in terms of quantity of patients, that is).
If that were the case, Usona might come to market months, not years, after Compass, which could refigure the commercial landscape. In that scenario, Compass will face pressing questions around its ability to block its nonprofit competitor from the market, particularly in the U.S. Readers will remember that Compass survived a U.S. patent challenge back in 2023, but Usona presumably hopes it can avoid or neuter Compass’ patent thicket. If the nonprofit psilocybin developer can do so, we should expect it to have a simple strategy: relentlessly undercut COMP360’s pricing.
But the penalties for marketing a drug that infringes a competitor’s IP are enormous. That means that, regardless of how committed Usona’s deep-pocketed and ideologically resolute backers are, if there is reasonable uncertainty about its ability to evade Compass’ lawyers, that could temper a more cavalier strategy.
Of course, if both companies do come to market, or at least have the ability to do so (such as, for example, the FDA approval of both programs), another potential scenario is that the parties reach some sort of agreement. It is tough to imagine what that might look like, however, given what seem to be very different ethoses and business models of the pair.
The timing of these approvals remains unclear. While Resilient could score one pre-midterms, the others will likely follow that intensely political period. (Compass would surely need that time, anyway, to prepare its new drug application (NDA).)
So, while people I met seem insistent that ‘things will get done’, the question of whether programs, reforms, and even concessions will be delayed or even torpedoed by chaos and politics (and not of the Psymposia flavour!) remains an open one.
Common-Sense Policies?
Given this state of flux and political sensitivity, calling for wildcard actions might be unwise. But there might be some ‘common-sense’ tweaks that are acceptable to MAGA, MAHA, the White House and its advisors, but also to the public.
Below are just two examples that I have been mulling over. They are focused primarily on the research and drug development and post-approval access side of the equation, as opposed to other angles like early access programs.
Streamlining Label Expansion in Psychiatry
Bringing a drug to market is an enormous endeavour, with the associated costs measured in hundreds of millions of dollars (and sometimes exceeding a billion) and timelines often taking more than a decade.
Once a drug is approved for a given indication, off-label prescribing is, of course, possible. But, where the drug is relatively expensive, and where its use is governed by a REMS, off-label prescribing becomes much less likely due to the financial and clinical risk tolerances of payors and providers.
What this means, usually, is that manufacturers must conduct a large clinical development program for each additional indication, with label expansion taking years and hundreds of millions of dollars more.
When moving from one indication to another in some disease areas, or between disease areas, this might make perfect sense. But in psychiatry, where DSM-5 diagnoses and indications have substantial overlap in presentation and symptom clusters, is this process more arbitrary?
Like other psychiatric drugs, psychedelics have shown promising efficacy and relative safety in clinical trials across a range of mental health disorders, and their proposed mechanisms of action are often not specific to one condition. That means there might often be plausibility for why a given drug could be safe and effective in another indication, as well as (in many cases) signals from early or mid-stage trials.
As such, expecting manufacturers to run large Phase 3 trials in each additional psychiatric condition could unnecessarily delay access to potentially future on-label populations, as many pre- or early-revenue developers will not have the resources to run those studies, and if they do, trials take years, especially when participant recruitment and trial site availability are strained.
Instead, could the agency better characterise the acceptability of various forms of data to support a supplemental NDA? That could include, for example, real-world evidence programs funded by the manufacturer or in collaboration with payors.
The agency could, of course, still expect Phase 3 data in the new indication, but it might consider clarifying how the generation of such data could be most expeditious, such as through the use of adaptive trials that feature group sequential designs and stopping rules. It could also make it clear that a single Phase 3 might be sufficient, though that could become obvious if a group like Usona receives approval on the basis of just one Phase 3.
It might also tweak its expectations around durability or long-term data in further indications, again reducing the label expansion timeline. It could, of course, modify these expectations for first-in-class NDAs, too, but it would be an even lower lift for additional indications, given there would be longer-term real-world data in the adjacent indication (or indications, plural) that is already on-label.
The safety dataset, meanwhile, could be pooled and include data from those who received the drug on-label but have relevant comorbidities. A registry maintained by the sponsor could collect this, for example.
Of course, FDA already has guidance on the use of real-world data in drug development (PDF), but more clarity could help. Manufacturers could also consider focusing on sites that FDA might expect more robust data from, such as integrated healthcare systems like the VA’s or large behavioural health centres.
While it is possible, under current rules, to use real-world evidence in label expansion approvals, and guidance exists, it is not commonly done. That’s especially true in psychiatry, where just one out of six labelling expansion approvals handed down between 2022 and 2024 had FDA documents mentioning RWE (Deng et al., 2025).
The point might simply be one of clarification, then, providing clearer guidance to sponsors, particularly in psychiatry, about how to most efficiently meet requirements.
It’s obvious how this sort of regulatory flexibility is important to certain drug developers more than others, too. While large pharmaceutical companies like have the cash position to bankroll a whole suite of studies at any given time, pre-revenue developers, like almost all of the psychedelics companies, generally do not. Raising the requisite cash to fund a multi-RCT label expansion program while also commercialising the first indication is a lofty task, so there is real risk that patients are delayed in accessing a potentially beneficial medicine and/or that the current system continues to favour larger pharmaceutical companies.
If this new setup not only makes label expansion faster but also substantially cheaper, there is no reason that expectations could not be made of the manufacturers who benefit, either. There might be a mechanism through which some portion of the tens or hundreds of millions of dollars saved through a less resource-intensive label expansion pathway (and, the potential for greater revenues due to faster market access) could be earmarked for public priorities like patient access schemes, pricing negotiations, or other FDA priorities like pediatric studies.
Hopefully, this wouldn’t require too much politicking, either: it could be as simple as FDA providing clarification or more explicit guidance to developers.
A Smarter Approach to Scheduling
We have written plenty about bifurcated scheduling over the years. Essentially, based on precedent (e.g., GHB, cannabis-based medicinal products, and so on), we should expect to see psychedelic-containing approved medicinal products moved out of Schedule I, while all other forms of the psychedelic remain in Schedule I.
This practice is concerning to various stakeholders in the psychedelics field for similarly various reasons. Among the more psychedelics advocacy clique, there is concern that their hope that FDA approval of a psychedelic would take said drug out of Schedule I will not be realised. Among researchers, there is growing concern that the rescheduling of a proprietary drug product will do nothing to make research with other forms of said drug less bureaucratically headache-inducing. In that case, they might opt to use the approved medicinal product in their research, but in this scenario the manufacturer could have a say in how research is conducted and who owns the resulting data.
But, as we have noted many times, this is not a fait accompli. Rather, it is precedent. That means there is no reason to think things couldn’t be done differently going forward2.
A potentially politically and scientifically palatable alternative in the case of psilocybin (assuming Compass Pathways’ COMP360 is the first psilocybin-containing drug to secure FDA approval) could be, for example:
- COMP360 is placed in Schedule III
- Psilocybin formulations which are under development by other sponsors or are being used in research settings are treated as Schedule II
This could be extended, at the least, to all candidates and formulations that have received FDA Breakthrough Therapy Designation, for they have, in the eyes of the FDA, demonstrated early signs of a substantial improvement over available therapies for a disease with high unmet need. The agency has also, through designating them such, signalled an interest in catalysing their development.
Deciding which drug formulations and/or contexts may benefit from Schedule II could take a little workshopping, but there are some less subjective ways of doing it. For example, you could consider all psilocybin formulations with an open IND as eligible.
It wouldn’t be the first attempt to reduce barriers to researching Schedule I drugs. The federal HALT Fentanyl Act was signed into law by Trump this summer and, aside from fentanyl-related policies, it envisaged some relatively minor tweaks to the DEA’s Schedule I Researcher Registration process, for example.
And in the UK, the Advisory Council on the Misuse of Drugs (ACMD) has pushed the British Home Office to reduce barriers to research with Schedule I controlled drugs. Its recommendations include treating those drugs as Schedule 2 when used in research taking place in universities and hospitals, as well as approved clinical trials. The Home Office has agreed in principle to some of the recommendations.
So, this appears to be a politically viable arrangement. Though, as is often the case, careful communication around the reasoning for, and limits of, the action would be paramount3.
Early Access
Beyond this, another thing I have heard mumbled around the field is a potential ‘VA-only approval’, which envisages a drug like MDMA being approved for use in the VA ahead of the general population.
There isn’t really a mechanism through which this could be achieved, however. Instead, a large N Phase 3 trial that recruits across VA sites is perhaps more realistic. It would, in many senses, be an implementation study or a kind of expanded access program. (Note that a 240-participant study of Compass’ psilocybin in veterans with TRD was registered last month.)
The question then would be who pays: the VA or the sponsor? (Or, both?)
While there are examples of innovation spillover from VA to broader healthcare, like in the cases of EHRs and remote healthcare, it remains quite a specific demographic, and the agency’s health system has a particular financial model, time horizon, and so on.
Still, the VA remains a good place to trial innovative psychiatry due to a high prevalence of mental health disorders among veterans.
Pα: While we expect to see psychedelics-specific action in the coming year, when it comes to funding, regulatory tweaks, and other movement: What’s good for psychiatry is probably good for psychedelics4.
Take ARPA-H’s $100M effort to ‘demystify’ mental health, for example. It focuses on rapid-acting therapeutics for behavioural health broadly, but cites neuroplastogens5 as a key area of interest.
If you cast your mind back to the mood this time last year, in the wake of the MDMA rejection, the psychedelics field felt down and out. But, far from the end of the road, 2026 could, finally, be the year for psychedelic approvals—plural. ∎
- That organisation began formal lobbying activity in the U.S. last quarter.
- HHS lawyer Matt Zorn has a keen interest in this topic, and has questioned the rationality and statutory fidelity of bifurcated scheduling.
- As I testified to Parliament, in the UK there is confusion around how the country’s dual system of drug classification (classes and schedules) operate, which might make changes to scheduling (which would enable research) but not to class placement (which would modify criminal penalties) politically challenging.
- Note, for example, that a significant portion of open INDs under the Division of Psychiatry’s remit are for psychedelic candidates
- It’s interesting to see the use of that term, here, versus ‘psychedelics’. Those in the psychedelic drug development field have often flip-flopped between the use of ‘psychedelics’ and less charged ones like ‘psychoplastogen’ or ‘neuroplastogen’, depending on which way the cultural and political winds are blowing. It looks like policy wonks are getting in on that linguistic action, too.
