H.R. 9559 — IBOGAINE Act

This section defines the term "ibogaine" in the Controlled Substances Act to include all parts of the plant Tabernanthe iboga and any similar compound or analog that acts on neuroplasticity, opioid receptors, or serotonergic pathways to interrupt addiction cycles and restore neurological function disrupted by trauma, chronic substance use, or traumatic brain injury, provided the compound or analog is distinct in mechanism from breakthrough therapies designated under section 506 of the Federal Food, Drug, and Cosmetic Act.

This section establishes a National Health Priority Voucher Pilot Program under which the Secretary awards a nontransferable voucher to the sponsor of an approved human drug application for a national health priority product. The voucher entitles the holder to priority review, completed within 6 months, of one subsequent human drug application submitted under section 505(b)(1) or section 351 of the Public Health Service Act. Eligible products include those addressing urgent public health threats, breakthrough therapies with novel mechanisms, large unmet medical needs, domestic manufacturing and supply chain resilience, or improved affordability and access. Sponsors may receive only one voucher per 24-month period and may not apply for an additional voucher while holding one. The Secretary may collect user fees equal to the average cost of priority review in the prior fiscal year, in addition to other required fees, and must provide development advice to applicants.

This section exempts eligible investigational drugs from provisions of the Controlled Substances Act that prohibit their unauthorized use, possession, distribution, dispensation, or transportation when accessed under the federal Right to Try law.

This section establishes a special registration process under the Controlled Substances Act for physicians to directly administer schedule I eligible investigational drugs to eligible patients under the Right to Try law. It requires the Attorney General to approve or issue an order to show cause on applications within 45 days, deems supplemental notifications for additional quantities approved after 30 days unless an order to show cause is issued, allows a single registration for treatment sites in the same city or county under the same control, and directs an interim final rule within 240 days and a final rule within 2 years.

This section requires the Attorney General to revise annually established production quotas for schedule I controlled substances within 90 days and for schedule II substances within 60 days upon any of five triggering events, including FDA approval or clearance, breakthrough therapy designation, phase 3 clinical trial approval, investigational use exemptions, or rescheduling. It directs the Attorney General to establish annual sufficiency standards for each quota at levels meeting legitimate medical, scientific, research, clinical, and industrial needs of the United States, to consult the Secretary of Health and Human Services when determining whether to set quotas in dosage form, and to allow registered manufacturers to apply for expedited mid-year quota adjustments upon any triggering event.

This section authorizes the Secretary of Health and Human Services, acting through the Director of the Advanced Research Projects Agency—Health, the Director of the National Institutes of Health, and the Assistant Secretary for Mental Health and Substance Use, to partner with States, territories, and Indian Tribes to advance research on and development of psychedelic drugs, including ibogaine, for treating serious mental illnesses. Partnerships may include awarding Federal funds, providing technical assistance, and sharing data subject to privacy laws.

This section directs the Secretary of Health and Human Services, in collaboration with the Secretary of Veterans Affairs, to establish a program partnering with the private sector to increase clinical trial participation, data sharing, and real-world evidence generation for psychedelic drugs, prioritizing those designated as breakthrough therapies. It requires interagency agreements to provide data from federally supported clinical trials to the Food and Drug Administration to facilitate drug approvals, subject to privacy laws.

This section requires the Attorney General, in consultation with the Secretary of Health and Human Services, to initiate and complete proceedings to reschedule a schedule I drug intended to treat a serious mental health disorder as quickly as practicable after it completes phase 3 clinical trials. It also directs the Attorney General to take all necessary steps within 60 days of enactment to determine whether to transfer ibogaine and ibogaine compounds from schedule I to schedule II.

This section directs the Under Secretary for Health of the Department of Veterans Affairs to designate, within 90 days of enactment, a senior official to oversee policy, programs, and activities related to emerging therapeutic interventions. It requires the Secretary to brief the House and Senate Veterans’ Affairs Committees on the designation and implementation of the official’s roles, responsibilities, and authorities within the same period.

This section requires the Under Secretary for Health of the Department of Veterans Affairs to submit biannual reports, beginning within 60 days of enactment, to the House and Senate Veterans’ Affairs Committees on emerging therapeutic interventions, including psychedelic-assisted therapies. The reports must cover research activities and clinical trials, key findings from outcomes, the number of veterans enrolled, interagency coordination with the FDA and DEA, and recommendations for delivery and legislative or administrative actions. It also directs the Under Secretary to develop a workforce implementation-readiness plan that includes a readiness assessment, a standardized competency-based training framework for clinicians and peer support specialists, and a plan to apply training and credentialing standards across Veterans Integrated Service Networks.

This section directs the Secretary of Veterans Affairs, in collaboration with the Commissioner of Food and Drugs and the Administrator of the Drug Enforcement Agency, to report within 180 days of enactment to the House Committees on Energy and Commerce and Veterans’ Affairs and the Senate Committees on Health, Education, Labor, and Pensions and Veterans’ Affairs on implementation of Executive Order 14401 regarding acceleration of medical treatments for serious mental illness.