In this week’s Psychedelic Policy Briefing, Psychedelic State(s) of America founder and investigative journalist Jack Gorsline covers a stay in the DEA’s marijuana rescheduling hearing, granted after opponents asked the judge to consider a GAO report finding that neither DEA nor FDA has written scheduling procedures. In New Mexico, advocates pushed back on proposed rules that would route every medical psilocybin patient through a prescribing clinician, and Oregon’s psilocybin program still faces a $3.8 million shortfall after regulators dropped a fee increase. The Advanced Research Projects Agency for Health (ARPA-H) also launched a program in Austin to redesign clinical trials, without saying whether Schedule I drugs qualify.
DEA Judge Pauses Broader Cannabis Rescheduling Case Over GAO Scheduling Audit
DEA Chief Administrative Law Judge Derek Julius halted the proceedings to reclassify marijuana from Schedule I to Schedule III on Sept. 29, issuing a stay with no specified end date, according to the judge’s stay order. The stay covers the rescheduling proposal for all marijuana, leaving in place the April 2026 order that covers FDA-approved marijuana products and state-licensed medical marijuana.
The pause followed a joint motion filed the previous day by three hearing participants opposing rescheduling: the National Drug & Alcohol Screening Association, DUID Victim Voices and Dr. Kenneth Finn. According to the judge’s order, the opponents requested three things: admit GAO-26-108623, allow supplemental briefing, and stay the case. The GAO report concluded that while the DEA aligned with HHS on all 84 substances finalized between 2020 and 2025, the DEA lacks formalized policies outlining its scheduling procedures, and the FDA has no policies or procedures for how staff conduct evaluations or develop recommendations. Both agencies concurred with GAO’s recommendations, and the GAO made no finding on where marijuana belongs.
The motion contends that the agencies arrived at a Schedule III determination without relying on any established written standard.
This delay will not directly impact future FDA approvals. Under 21 U.S.C. § 811(j), the DEA is mandated to issue an interim final rule within 90 days of the later of FDA approval or an HHS scheduling recommendation, and only when HHS recommends Schedule II through V. The DEA schedules the specifically approved product, not MDMA or psilocybin as broad substances. FDA concurred with GAO’s recommendation to write procedures for its eight-factor evaluations, including how it judges abuse potential. Those evaluations sit behind any future recommendation to schedule an approved MDMA or psilocybin product.
Julius directed the government to file a response to the motion by Oct. 13. Other parties may, but do not have to, respond by that date, and there is no deadline for a ruling.
ARPA-H Launches SURPASS and Three Projects to Rework Clinical Trials
The Department of Health and Human Services, operating through ARPA-H, introduced the SURPASS program on Sept. 30 to establish adaptive platform clinical trials, along with three related trial infrastructure projects, according to an ARPA-H release.
Detailed on the SURPASS program page, the initiative aims to use predictive modeling and digital twins to simulate clinical trial results before they officially launch. The program’s “phaseless design engine” is intended to test medications more quickly using fewer participants, while a distinct “continuous inference engine” seeks to minimize the reliance on large conventional control groups. A third technical area would build an agentic operations layer to automate trial startup and operations. ARPA-H also unveiled three related efforts: STACK, which aims to use artificial intelligence to expedite clinical site activation; COMMONS, creating a national framework for cross-system patient consent; and CINCH, designed to collect real-world data straight from patients.
Solution summaries are required and due Nov. 30, ahead of the Jan. 22, 2027, proposal deadline. The agency’s announcement does not clarify if Schedule I investigational drugs will be eligible for the platform. ARPA-H will host an informational webinar for potential applicants on Oct. 15.
Advocates Challenge New Mexico’s Proposed “Certifying Clinician” Rule as Oregon Faces $3.8 Million Shortfall
In New Mexico, a coalition comprising the Healing Advocacy Fund, the Psychedelic Mental Health Access Alliance and Rudick Law Group filed a joint public comment criticizing the Department of Health’s draft regulations for the state’s Medical Psilocybin Program. The organizations cautioned that the proposed “certifying clinician” model oversteps the Medical Psilocybin Act’s statutory authority. The coalition characterized the proposed rule as copying regulations “nearly word-for-word” from the state’s medical cannabis framework. The rule requires patients to be certified by a clinician who holds a New Mexico controlled substances number, after an in-person exam or a telehealth evaluation backed by an in-person exam within the previous six months. The department scheduled its public hearing on the rule for Oct. 2 in Santa Fe; written comment closed at the end of that hearing.
The joint public comment emphasized that psilocybin’s primary risks are psychological, alongside immediate medical concerns like intoxication or pregnancy that a single initial exam cannot adequately screen. The coalition argued that mandating a prescribing clinician will restrict access, box out qualified mental health diagnosticians, drive up administrative costs for the department and complicate insurance billing. They also objected to a requirement that a property owner sign off before a patient can receive care in a rented home, warning it invites discrimination claims. “Similar litigation in Oregon on behalf of home-bound patients has already cost the Oregon Health Authority hundreds of thousands of dollars and is still ongoing,” the coalition wrote.
Meanwhile, the Oregon Health Authority announced Sept. 22 that it had abandoned proposed rule changes that would have doubled the annual license fees for psilocybin licensees. Even without the fee increase, an OHA analysis projected a $3.8 million shortfall for the current biennium, the Oregon Capital Chronicle reported. Sam Chapman, founder and executive director of the Center for Psychedelic Policy, noted in a press release that his organization is performing an “independent economic analysis” ahead of the 2027 legislative session. The study aims to determine if “psilocybin therapy” can match the effectiveness of currently covered treatments at a lower cost.
OHA said it will open a new rulemaking on topics unrelated to fees, with public comment expected in December and a target effective date of Jan. 15, 2027. It has not said whether that package will revive the proposed bar on licensees “providing information or instruction related to home cultivation.”
