The IBOGAINE Act would change several federal rules to speed research, approval, and access to ibogaine and similar psychedelic drugs. It adds a definition of "ibogaine" to the Controlled Substances Act that includes the Tabernanthe iboga plant and similar compounds acting on neuroplasticity, opioid receptors, or serotonergic pathways. The bill creates a short-term National Health Priority Voucher pilot at the FDA that gives a sponsor one priority review (six-month target) for a future drug application when a qualifying product is approved. It amends the Federal Right to Try law and creates a special Drug Enforcement Administration (DEA) registration process so doctors can apply to directly administer Schedule I investigational drugs to eligible patients under Right to Try. The bill requires the Attorney General to set new rules on quotas, allow faster mid-year quota adjustments when a drug moves toward medical use, and to take steps to reschedule ibogaine from Schedule I to Schedule II within 60 days. It authorizes HHS programs to partner with states, territories, and tribes, and directs HHS and VA to work with the private sector on trials and data sharing. The Department of Veterans Affairs must name a senior official for emerging therapeutic interventions, report regularly on related activities, and prepare workforce training plans. The bill also requires several reports, a GAO study of the voucher program, and deadlines for agency rulemaking and reports.
Patients: The bill aims to expand pathways for access to investigational psychedelic treatments, including changes to Right to Try and actions that could speed FDA review. VA patients could see increased planning and possible programs because the VA must report and prepare workforce plans for these therapies.
Doctors and clinics: Physicians could apply for a new DEA special registration to directly administer certain Schedule I investigational drugs to eligible patients under Right to Try. The bill sets application details, storage and record rules, and rulemaking timelines for the Attorney General. Doctors would be limited to amounts listed in their approved applications.
Drug developers and manufacturers: Sponsors of qualifying products may receive a National Health Priority Review voucher that gives priority review for one later application. The bill allows FDA to charge a user fee for voucher use and to provide advice to sponsors. Manufacturers may request faster quota increases if a drug advances in development.
Federal agencies and states: HHS, FDA, DEA, and VA would coordinate more closely, share clinical data (subject to privacy laws), and HHS agencies could fund and support state or tribal research partnerships.
The bill allows the FDA to set a user fee for using a priority review voucher and requires those fees to be deposited as offsetting collections to the FDA account, but it does not state total costs or specific appropriation amounts. The bill authorizes federal funding for state, territory, and tribal partnerships but provides no dollar amounts. It also requires agency rulemaking and reports that may carry administrative costs. No publicly available information on total federal costs or budget offsets is provided in the bill text.
The bill's sponsors state the purpose is to accelerate development of, and access to, psychedelic drugs that could save lives and help reverse the crisis of serious mental illness. Supporters in the text seek faster FDA review paths, clearer DEA processes for investigational use, better federal-state and private sector collaboration, steps to reschedule promising drugs quickly, and VA actions to prepare clinicians and services for these therapies.
No publicly available information.