The Psychedelic News Feed (Oct 26 – Nov 1, 2026)

The Psychedelic News Feed

October 26 - November 1, 2026

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 HardmanFounder & Editor

Why pharma firms are betting billions on psychedelic drugs despite setbacks (Oct 27) ↗ Nature

Congressman Cohen Introduces Comprehensive Reform of Controlled Substances Act (Oct 29) ↗ Steve Cohen

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Next week’s Psychedelic News Feed will be found at the same web page.

Best wishes,

Josh Hardman

Founder & Editor