Senate Releases FY 2027 Psychedelic Directives as ARPA-H Selects Mark Cuban's Cost Plus for Ibogaine Development

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WASHINGTON — The Senate Appropriations Committee released its fiscal year 2027 Agriculture-Food and Drug Administration and Military Construction-Veterans Affairs bills on Tuesday, Nov. 10, issuing Congress's strongest directives yet on psychedelic medicine without setting aside a dollar for the work. Released without a scheduled markup, the measures instruct agencies to prepare for psychedelic therapies while leaving intact a hemp crackdown starting Thursday, Nov. 12.

The package marks the fourth straight year Senate appropriators have instructed the Department of Veterans Affairs on psychedelics, directing the agency to deliver a readiness plan for Food and Drug Administration-approved treatments within 180 days of enactment. Yet those non-binding recommendations underscore a widening fiscal divide: across a 10-year arc, Congress has appropriated just $10.2 million for psychedelic research, leaving agency budgets flat while states and the White House outspend lawmakers. The Senate bill cuts VA Medical and Prosthetic Research to $922 million (down from $945 million in fiscal 2026 and below the House's $996 million) within $17.7 billion for mental health, including $3.67 billion for suicide prevention. Those reductions arrive as the VA grapples with a shrinking mental health workforce, grant cancellations cutting external federal funding at major VA research sites by at least a third, and administration proposals to slash federal healthcare and science budgets, including halving the National Science Foundation budget by 2027.

That contrast sharpened Thursday, Nov. 12, when Department of Health and Human Services Secretary Robert F. Kennedy Jr. and VA officials announced up to $4.9 million over five years from the Advanced Research Projects Agency for Health (ARPA-H) to lay the groundwork for clinical trials of ibogaine for post-traumatic stress disorder, alongside a $20 million National Institute of Mental Health funding opportunity to build a research network for rapid-acting psychotropics like ketamine and psilocybin. ARPA-H selected the Mark Cuban Cost Plus Drug Company, PBC, to establish the regulatory, chemical and domestic manufacturing processes for a single-molecule ibogaine hydrochloride product aimed at making the medicine available at production cost plus a fair margin if approved, while Cancun, Mexico-based ibogaine treatment provider Beond Inc. will supply safety, dosing and efficacy data. Both performers must open-source their findings to support Investigational New Drug applications ahead of future substance use disorder awards.

In the Military Construction-Veterans Affairs explanatory statement, appropriators credit the VA's multisite trials and Integrated Project Team, stating the committee "directs the Secretary of Veterans Affairs to develop a plan to expand VA-led clinical and implementation-focused research" and brief Congress within 180 days on research, planned spending and readiness milestones. That mandate tracks preparations disclosed Oct. 15 at the Psychedelic Healthcare Forum in New York, where Veterans Health Administration Senior Advisor Andrew Gradison said VA Secretary Doug Collins approved a phased rollout designating 10 experienced VA hospital sites as Phase 1 lead centers. While 100,000 of the 2.1 million veterans in VA care with post-traumatic stress disorder or depression could qualify upon approval as early as January 2027, Gradison warned heavy staffing demands will make reaching a four-digit patient count during the first year of deployment difficult. The statement also reminds the VA of a five-year longitudinal study required in Senate Report 119-43, encourages treatment-resistant PTSD research "including but not limited to ibogaine and other psychedelic compounds," and urges voluntary, de-identified data collection on veterans seeking ibogaine abroad, alongside provisions for cannabis studies and "rapid-acting novel therapeutics" research.

For a third straight year, the Agriculture-FDA explanatory statement says the committee "recognizes the increased interest and need to study psychedelics, including MDMA, psilocybin, ibogaine, and 5-MeO-DMT," urging the FDA to work with the VA, Defense Department and National Institutes of Health on public-private partnerships as an observer and update Congress in 180 days. It also seeks a 270-day report on botanical pain drug gaps citing European cannabinoid trials, a 90-day report on cannabinoid food additives after over 110 warning letters since 2018, and state hemp agreements. While lifting the Department of Agriculture Hemp Production Program from $10 million to $12.996 million and maintaining Agricultural Research Service hemp funding, the bill retains only the Section 737 rider protecting lawful hemp without delaying the hemp redefinition under Public Laws 119-37 and 119-103. A ban on non-naturally produced cannabinoids begins Nov. 12, before total-THC limits and a 0.4-milligram per-container cap take effect Dec. 11, stripping intoxicating products of protection.

The directives cap a shift from fiscal 2017 through 2022, when spending bills lacked psychedelic language and the House rejected amendments from Rep. Alexandria Ocasio-Cortez, D-N.Y., 91-331 in 2019 and 140-285 in 2021, before a $4 million National Institute on Drug Abuse grant in October 2021. Lawmakers added fiscal 2023 NIH and Government Accountability Office language related to psychedelics, and a fiscal 2024 amendment from Psychedelics Advancing Therapies Caucus co-chairs Reps. Lou Correa, D-Calif., and Jack Bergman, R-Mich., set aside $10.2 million for defense trials, which served as the decade's sole direct funding appropriation.

FDA Priority Voucher Program Shelved

Yet a cornerstone of that executive push now faces uncertainty. Reuters reported Thursday morning that the FDA has quietly shelved the Commissioner's National Priority Voucher pilot program, a fast-track initiative launched in June 2025 under former Commissioner Marty Makary to compress drug review timelines from 10 to 12 months down to one to two months.

According to internal documents reviewed by Reuters and agency sources cited by the outlet, no new vouchers have been awarded since Makary departed in May, the executive council of political appointees overseeing the reviews has gone dormant, and companies have been told new applications are no longer advancing.

While FDA career scientists have resumed overseeing timelines, Reuters noted that the fate of the nine drugs still in the program, including already-awarded priority review voucher holders Compass Pathways, Usona Institute and Transcend Therapeutics, remains unclear, even after Usona's Nov. 2 NDA submission, reported by Psychedelic Alpha, alongside Compass Pathways' Nov. 9 announcement of its psilocybin New Drug Application submission.

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