Weekly Psychedelic Policy Briefing: October 27, 2026

Weekly Psychedelic Policy Briefing: October 27, 2026

By Jack Gorsline

In this week's briefing, Psychedelic State(s) of America founder Jack Gorsline details how federal agencies are preparing for the first psychedelic drug approvals. At the Psychedelic Healthcare Forum, the Oct. 15 industry day of the Horizons conference in New York, a Veterans Health Administration adviser said the VA has chosen ten sites for approved psychedelic therapies but expects reaching 1,000 patients in the first year to be a challenge. Gorsline attended and breaks down key takeaways below.

Comments closed Oct. 23 on a Drug Enforcement Administration proposal to place five tryptamines in Schedule I. One of them is the active compound in an investigational postpartum depression drug. In Washington, a DEA judge refused on Oct. 22 to reopen the cannabis rescheduling hearing and allowed written briefs on a federal audit instead.

VA Expects a Slow First Year for Psychedelic Care as Federal Agencies Prepare for Approvals

Federal officials described how agencies are preparing for the first approved psychedelic therapies at the Psychedelic Healthcare Forum in New York on Oct. 15. Horizons and Psychedelic Alpha co-presented the forum, and Psychedelic Alpha reported on the federal panel.

On that panel, moderated by POLITICO Deputy Health Care Editor Erin Schumaker, Andrew Gradison, a senior adviser to the Veterans Health Administration, said the VA covers 9 million veterans. He said 6.4 million receive VA care regularly and about 2.1 million of them have post-traumatic stress disorder, major depressive disorder, or treatment-resistant depression.

Gradison said he and colleagues presented a phased implementation plan to VA Secretary Doug Collins about three weeks before the forum, and the VA chose ten sites that tend to have psychedelic trial experience. He declined to name the sites. In what he called the rosiest scenario, with approved drugs available in January or February, the VA would begin treating patients right away.

Progress will be "slower going than our veteran population would like," Gradison said, because the treatments demand heavy staff time and the VA is putting safety first. To manage expectations, he said, it will be "a challenge in the first year to treat four digits' worth of patients."

Earlier that morning, in an interview with Psychedelic Alpha founder Josh Hardman, HHS Deputy General Counsel Matt Zorn said Executive Order 14401, signed April 18, does not change approval standards. "The title is 'accelerating'; it's not changing any of the standards we're applying," he said. He said approved treatments will need infrastructure "as simple as CPT or Medicare codes," and that the order lets HHS "start working on these questions before" approval rather than after.

Valentina Mantua, associate director for regulatory science in the Office of Neuroscience at FDA's Center for Drug Evaluation and Research, said FDA now has about 433 investigational new drug applications for psychedelics and that psychedelics now make up about a third of the workload in FDA's psychiatry division.

Al Bugazia, deputy director of proactive health at the Advanced Research Projects Agency for Health (ARPA-H), said he has "an issue with the overhype of psychedelics." He added, "These things are not panaceas. They're not for everybody, and they can harm some people." ARPA-H's ASCENT-IBO program funds early-stage ibogaine trials for opioid use disorder.

FDA is separately taking public comment on how early-phase ibogaine trials should be designed. Comments close Nov. 20 under Docket No. FDA-2026-N-10429.

DEA Tryptamine Comment Window Closes as Compass Nears Its Psilocybin Filing

Comments and hearing requests closed Friday, Oct. 23, on the Drug Enforcement Administration's proposed rule to place five tryptamine hallucinogens in Schedule I of the Controlled Substances Act (Docket No. DEA1715). The five are 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT.

The proposal changes nothing until the DEA finalizes it. The DEA's administrator will decide whether any hearing is needed.

One of the five, 4-OH-DiPT, is the compound behind luvesilocin, which Reunion Neuroscience describes as a prodrug of 4-OH-DiPT. FDA granted the investigational drug Breakthrough Therapy designation for postpartum depression on Feb. 23, 2026, according to the company.

In its small-business analysis, the DEA says the five substances are not subject to an investigational new drug application, citing HHS's review. The notice does not mention prodrugs in development, and it does not say whether Schedule I placement of 4-OH-DiPT would reach luvesilocin.

Approval itself starts a second process. Under 21 U.S.C. § 355(x), when HHS tells a sponsor it intends to recommend controls, the drug's approval does not take effect until the DEA issues an interim final rule. Under 21 U.S.C. § 811(j), the DEA must issue that rule within 90 days of the later of two dates: when it receives HHS's scheduling recommendation, or when HHS notifies it of the approval.

A Sept. 23 Government Accountability Office report (GAO-26-108623) found that both DEA and FDA lack comprehensive written policies setting out how staff evaluate and schedule substances. GAO also found that from 2020 through 2025, DEA's final decisions matched HHS recommendations for all 84 substances it finalized, and DEA scheduled all nine drugs that went through the new drug application process within the 90-day deadline.

Odette Hauke, an independent regulatory scientist and former associate director of regulatory affairs at AtaiBeckley, reviewed 10 state controlled substances acts for her latest Regulatory Dispatch column for Psychedelic State(s) of America, and found that only Oregon, Washington, and Missouri follow federal rescheduling automatically, and Washington and Missouri let an agency object within 30 days. Massachusetts, Ohio, Virginia, and Wisconsin require an agency rule. Colorado and Iowa generally require a bill, though Colorado's HB22-1344 makes FDA-approved MDMA prescriptions legal once federally rescheduled. Minnesota allows only a temporary order of up to 12 months.

Compass Pathways' synthetic psilocybin, COMP360, would pass through that sequence. The company says it will complete its rolling new drug application in the fourth quarter, which ends Dec. 31, and expects to launch in the first half of 2027, subject to FDA approval and DEA rescheduling.

DEA Judge Refuses to Reopen Cannabis Rescheduling Hearing, Allows Briefs on GAO Report

DEA Chief Administrative Law Judge Derek C. Julius on Thursday, Oct. 22, denied a motion by marijuana rescheduling opponents to reopen the hearing for new testimony and document discovery, Marijuana Moment reported. He granted their separate motion to admit the GAO report into the record (DEA Docket No. 1362, Hearing Docket No. 26-96).

The movants, the National Drug and Alcohol Screening Association, DUID Victim Voices, and Dr. Kenneth Finn, testified against rescheduling at the summer hearing. They argued the report's findings on gaps in written scheduling procedures called for new testimony and discovery.

Julius noted the record already holds more than 2,500 pages of witness testimony and thousands of pages of documents, according to NORML. Parties may file briefs on the report by Oct. 29 and replies by Nov. 5. Filing is optional, and the proceeding stays paused until briefing closes.

The dispute shows where hearings fall in drug scheduling: marijuana rescheduling runs as a formal rulemaking, with the hearing held before any final rule. For a newly approved drug that HHS recommends for Schedules II through V, 811(j) reverses that order: the interim final rule takes effect immediately, and comments and hearing requests come afterward.

After the Nov. 5 deadline, Julius can move toward a recommended decision. Parties can then file exceptions before the DEA administrator reviews it.

Disclosure: Odette Hauke, whose state law review is cited in this briefing, is a contributor to Psychedelic State(s) of America, which was founded by PSA Editorial Director and briefing author Jack Gorsline.