Jack Gorsline, investigative journalist, covers four federal developments this week. The Department of Veterans Affairs launched a five-site psilocybin trial, and the drug it runs on belongs to a company preparing an application for approval. The Senate voted to delay the federal hemp THC ban by one month, though the House has not acted. The FDA finalized its guidance on psychedelic clinical investigations and set a September hearing, with two participation deadlines landing in the next two weeks. Contract research organization ICON is bringing Anthropic’s Claude into trial operations.
Department of Veterans Affairs Officially Launches Multi-Site Psilocybin Clinical Trial for Veterans
On August 5, the U.S. Department of Veterans Affairs (VA) launched PIVOT, a five-site clinical trial evaluating psilocybin for Veterans with treatment-resistant depression. The trial runs on COMP360, a synthetic psilocybin formulation donated by Compass Pathways. Compass is currently targeting a Q4 2026 New Drug Application (NDA) for the compound.
The two-dose comparison study will operate at VA facilities in Birmingham, Tuscaloosa, Portland, Philadelphia, and Puget Sound. The VA states this is in addition to 20 other active clinical trials involving psychedelic compounds across its network.
The trial establishes safety parameters and dosing protocols for Veterans, but the underlying tension is commercial. By relying on COMP360, federal research infrastructure is generating data that will support a proprietary asset. That federally backed research will help determine whose molecule becomes the industry standard and who benefits from public healthcare reimbursement.
Senate Blocks Fast-Track Ban on Hemp-Derived THC Products
On August 8, the Senate passed a continuing resolution containing provisions that delay most of a federal ban on hemp-derived THC products from November 12 to December 11. The vote was 90-6. Ahead of it, senators tabled an amendment from Ted Budd (R-NC) that would have stripped the delay, 61-32, on a motion from Amy Klobuchar (D-MN).
The ban itself is settled law, signed in November 2025. Starting November 12, only products containing no more than 0.4 milligrams of total THC per container remain federally legal, a threshold that removes most of the consumable hemp market. The CR does not move that date. It narrows what the provision reaches until December 11, so the per-container cap sits idle for roughly four weeks. A carve-out lets recriminalization proceed on November 12 for cannabinoids that cannot be naturally produced by the cannabis plant.
Under the Senate framing, that leaves delta-8 THC, delta-10, and THCP, which it treats as naturally producible, on shelves through December 11, while cannabinoids that cannot be naturally produced by the plant lose federal legality on November 12 as scheduled.
The delay was requested by the White House and drawn from the Hemp Planting Predictability Act, introduced by Klobuchar and Rand Paul (R-KY). It is not law yet. The House passed its own funding bill in July with no hemp language and does not return until September. If the House does not take up the Senate text, November 12 stands.
FDA Finalizes Psychedelic Drug Clinical Guidance and Schedules September Public Hearing
The FDA Center for Drug Evaluation and Research (CDER) finalized its formal guidance document, Psychedelic Drugs: Considerations for Clinical Investigations, on July 14. The document sets evidentiary standards for NDA-stage development, establishing explicit expectations for functional unblinding mitigations, abuse-potential risk evaluations, and post-marketing risk evaluation and mitigation strategies (REMS).
The FDA scheduled a public hearing for September 14, 2026, titled “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs” (Docket FDA-2026-N-7542). The hearing seeks input on the potential future therapeutic use of psychedelic drug products in supervised and supportive settings. Requests to present are due August 21, and written comments close October 5. The FDA explicitly excludes comments on legalization, decriminalization, state and local program merits, scheduling, and religious or ceremonial use, while welcoming data from state programs. Separately, the HRSA RFI from the same Federal Register notice closes August 13.
ICON Inks Deal with Anthropic to Incorporate AI into Future Clinical Trials
As first reported by Fierce Biotech, prominent contract research organization ICON has established a multiyear collaboration with artificial intelligence firm Anthropic to integrate the Claude AI model into clinical trial operations, a move that could reshape how drug sponsors design and execute development programs. The partnership will utilize Anthropic’s life sciences team to bolster ICON’s agentic AI platform, Orbis, aiming to improve site intelligence, study feasibility and trial protocol designs. According to Anthropic’s Pip White, operational challenges such as study enrollment cause delays in up to 80% of trials. By deploying Claude to detect real-time enrollment risks and automate repetitive tasks, the companies hope to clear traditional bottlenecks and accelerate the overall clinical development process.
The collaboration comes as Anthropic deepens its ties to the biopharma industry, despite recent regulatory friction at the federal level. Earlier this year, the Department of Health and Human Services restricted employee use of Claude, and President Donald Trump sought to block the company from federal contracts following disputes with the Department of Defense. Undeterred, Anthropic recently acquired AI startup Coefficient Bio in a $400 million deal, secured an enterprise partnership with Bristol Myers Squibb and added Novartis CEO Vas Narasimhan to its board of directors. For the psychedelic medicine sector, ICON’s adoption of frontier AI signals a shift toward tech-enabled trial infrastructure. If successful, these tools will dictate how psychedelic drug developers navigate regulatory protocols and manage patient enrollment.
This article was produced in partnership with Psychedelic State(s) of America – a nonprofit-sponsored news organization dedicated to rigorous independent psychedelic journalism. Learn more about PSA’s Media Partnerships Program and donate to the PSA Media Fund here.
Frequently Asked Questions
The following questions and answers were prepared by Psychedelics Today.
What is the VA’s PIVOT trial?
PIVOT (NCT07226232) is a five-site clinical trial the Department of Veterans Affairs launched on August 5, 2026, testing psilocybin for veterans with treatment-resistant depression. It runs at VA facilities in Birmingham, Tuscaloosa, Portland, Philadelphia, and Puget Sound, and uses COMP360, a synthetic psilocybin formulation from Compass Pathways.
Did the Senate ban or delay the federal hemp THC restrictions?
Neither takes effect on its own. On August 8, 2026, the Senate passed a continuing resolution, 90-6, that would delay most of the hemp THC ban from November 12 to December 11. It reached that outcome by tabling an amendment from Sen. Ted Budd, 61-32, that would have kept the November date. The delay is not law until the House approves the Senate bill and the president signs it. Until then, November 12 stands.
What does the federal hemp ban actually change?
The ban was signed in November 2025. Starting November 12, 2026, only products with no more than 0.4 milligrams of total THC per container remain federally legal, a threshold that removes most of the consumable hemp market. Under the Senate’s framing, delta-8 THC, delta-10, and THCP are treated as naturally producible and would stay legal through the delay, while cannabinoids that cannot be naturally produced by the plant lose federal legality on November 12.
What did the FDA finalize on psychedelics?
On July 14, 2026, the FDA published its final guidance, “Psychedelic Drugs: Considerations for Clinical Investigations.” It sets expectations for sponsors developing psychedelic drugs, including how to handle functional unblinding, abuse-potential assessment, and post-marketing REMS. It finalizes a draft first issued in June 2023.
How can the public weigh in on the FDA’s psychedelics hearing?
The FDA scheduled a public hearing for September 14, 2026, on the potential future therapeutic use of psychedelic drugs in supervised settings (Docket FDA-2026-N-7542). Requests to present were due August 21, and written comments close October 5. The agency excludes comment on legalization, decriminalization, scheduling, and religious or ceremonial use, but welcomes data from state programs.
What is the ICON and Anthropic clinical trial deal?
On July 28, 2026, contract research organization ICON announced a multi-year collaboration with Anthropic to bring its Claude AI models into ICON’s Orbis platform, covering site selection, enrollment-risk detection, and protocol design. The stated aim is to reduce operational bottlenecks in trial enrollment.
