IBOGAINE Act
- Bill Number
- H.R. 9559
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Status
- Introduced
- Latest Action
- 2026-06-30: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2026-07-07T05:08:21Z
AI-Generated Summary
Purpose of the Legislation This bill, titled the IBOGAINE Act, seeks to accelerate the development of and access to psychedelic drugs, particularly ibogaine and related compounds, for treating serious mental illness in the United States. It emphasizes reversing mental health crises through faster regulatory pathways, expanded research, and improved access mechanisms while maintaining controls against diversion.
Key Provisions Outlined
- Definitions: Amends the Controlled Substances Act to define "ibogaine" broadly, covering the plant Tabernanthe iboga and analogs acting on neuroplasticity, opioid receptors, or serotonergic pathways to interrupt addiction or restore neurological function, distinct from certain breakthrough therapies.
- National Health Priority Voucher Pilot Program: Creates a new FDA program (Section 524C) issuing non-transferable priority review vouchers for products addressing public health crises, breakthrough therapies, large unmet needs, supply chain resilience, affordability, or other priorities. Vouchers allow 6-month priority review; includes user fees, a GAO study, and a sunset after September 30, 2029.
- Right to Try Amendments: Expands the federal Right to Try law to exempt certain Controlled Substances Act restrictions for eligible investigational drugs. Establishes a special DEA registration process for physicians to administer Schedule I eligible investigational drugs to eligible patients, with application requirements, 45-day approval timelines, quantity limits, electronic submissions, and provisions for related treatment sites. Requires interim and final rulemaking.
- DEA Quota Adjustments: Revises production quota considerations under the Controlled Substances Act to include clinical needs, mandates expedited mid-year adjustments for triggering events (e.g., FDA approvals, breakthrough designations, phase 3 trials), and requires annual sufficiency standards.
- Federal-State and Interagency Collaboration: Authorizes HHS partnerships with states, territories, and Indian Tribes for psychedelic research, including ibogaine. Requires HHS-VA collaboration with the private sector for clinical trials and data sharing on psychedelic drugs, prioritizing breakthrough therapies, and data provision to FDA subject to privacy laws.
- Timely Rescheduling: Requires the Attorney General to initiate and complete rescheduling proceedings for Schedule I drugs after successful phase 3 trials for serious mental health disorders. Mandates specific steps within 60 days to evaluate moving ibogaine and its compounds from Schedule I to Schedule II.
- VA Oversight and Reporting: Directs the VA to designate a senior official for emerging therapeutic interventions within 90 days, with roles in policy coordination. Requires biannual reports on psychedelic-assisted therapies, including research summaries, clinical outcomes, veteran enrollment, and recommendations. Mandates a workforce readiness plan with training frameworks and credentialing.
- Implementation Report: Requires a report within 180 days on the implementation of Executive Order 14401 regarding accelerating treatments for serious mental illness.
Significant Changes to Existing Law Introduced
- Establishes a new priority review voucher program outside existing rare disease or tropical disease incentives.
- Modifies the Right to Try statute and adds a new special registration subsection to the Controlled Substances Act for Schedule I drugs.
- Alters DEA quota-setting processes to prioritize clinical and research needs with faster adjustments.
- Amends Controlled Substances Act scheduling procedures to require expedited rescheduling post-phase 3 trials.
- Introduces new definitions and interagency data-sharing mandates not previously codified for these purposes.
Potential Impacts on Government Agencies, Citizens, or International Relations
- Government Agencies: Increases FDA workload for voucher reviews and user fee collection; expands DEA responsibilities for registrations, quotas, and rescheduling; requires new VA structures for oversight, training, and reporting; promotes HHS coordination across agencies.
- Citizens: May enable faster access to investigational psychedelic treatments for mental illness via Right to Try and priority pathways, potentially benefiting patients and veterans; could affect domestic drug manufacturing and supply chain resilience.
- International Relations: Limited direct effects, though provisions on onshoring manufacturing and supply chain security may reduce foreign dependencies without explicit international provisions.
Main Stakeholders Affected
- Patients and veterans with serious mental illness or substance use disorders.
- Pharmaceutical sponsors, manufacturers, and private sector entities involved in psychedelic drug development.
- Physicians and clinicians seeking registrations or training for administration.
- Federal agencies including FDA, DEA, HHS, and VA.
- State governments, territories, and Indian Tribes through potential research partnerships.
- Congressional committees on energy/commerce, health, and veterans' affairs.
Notable Legal, Constitutional, or Political Implications
- Raises questions about balancing expedited access to Schedule I substances with existing controlled substances frameworks and diversion prevention.
- Involves federal preemption considerations in Right to Try expansions and state collaborations.
- Politically framed around addressing mental health crises with a focus on ibogaine, introduced with bipartisan sponsorship; includes a GAO study to evaluate program effectiveness. No explicit constitutional challenges are addressed in the text.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Luttrell, Morgan [R-TX-8]
Cosponsors (3)
Rep. McCaul, Michael T. [R-TX-10], Rep. Bergman, Jack [R-MI-1], Rep. Correa, J. Luis [D-CA-46]
Recent Actions
- 2026-06-30: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2026-06-30: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2026-06-30: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2026-06-30: Introduced in House
- 2026-06-30: Introduced in House
Bill Versions
- Initiating Biomedical Outcomes to Garner Advancements into Innovative Neuroplastogen Efficacy Act — issued 2026-06-30 — PDF (27 pages)