IBOGAINE Act
Sponsored By: Representative Luttrell, Morgan [R-TX-8]
In Committee
Summary
Accelerate development and access to psychedelic therapies to treat serious mental illness, with a special emphasis on ibogaine. This bill would create a federal pathway of priority-review vouchers, Right to Try expansions, a special Drug Enforcement Administration registration process, and VA readiness for clinical use.
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- Patients and clinicians: People with serious mental illness could get faster access to ibogaine and similar drugs through a voucher-based priority review targeting a 6-month timeline, Right to Try expansions, and an expedited rescheduling route after successful phase 3 trials.
- Researchers and drug developers: Developers could get priority review vouchers, mid-year Drug Enforcement Administration quota adjustments, and federal funding, technical assistance, and data sharing to support trials. Voucher authority ends Sept. 30, 2029 and the Government Accountability Office must study voucher effectiveness.
- Veterans and VA workforce: The Department of Veterans Affairs would need to name a senior official within 90 days, submit an initial report within 60 days and then report biannually, and build a national workforce readiness and credentialing plan for psychedelic-assisted therapies.
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Bill Overview
Analyzed Economic Effects
5 provisions identified: 2 benefits, 0 costs, 3 mixed.
VA plan to deliver new therapies
If enacted, the bill would require the VA Under Secretary for Health to name a senior official within 90 days to oversee emerging therapies. VA must give Congress an initial report within 60 days and then report every six months. Reports must list research, trials, outcomes, enrollment counts, coordination with other agencies, and recommendations. VA must also create a workforce readiness plan with standardized training and credentialing across VA networks.
New federal pathway for ibogaine access
If enacted, the bill would clarify that Right to Try applies even when an investigational drug is a controlled substance. It would require the Attorney General to register doctors who will give certain Schedule I investigational drugs, with the AG approving or issuing a show‑cause order within 45 days of a complete application. Supplemental quantity notices would be deemed approved after 30 days unless the AG objects. The AG would also be ordered to start a decision about moving ibogaine from Schedule I to Schedule II within 60 days of enactment and the law would add a statutory definition of "ibogaine."
Faster quota changes for drug makers
If enacted, the bill would require the Attorney General to update production quotas mid‑year after specific triggers. Schedule I basic classes would be revised within 90 days and Schedule II within 60 days after triggers like FDA approval or breakthrough designation. Registered manufacturers could apply for expedited mid‑year quota adjustments. The Attorney General must also set annual sufficiency standards to align production with medical and research needs.
Priority review vouchers for new drugs
If enacted, the bill would create a National Health Priority Voucher pilot that gives one priority review voucher to a sponsor when the FDA approves a qualifying product. A voucher would get one human drug application an FDA review and action within six months. Vouchers would generally be nontransferable except on a change in company ownership, limited to one per sponsor every 24 months, and the program would end on September 30, 2029. The FDA could set a yearly voucher user fee starting after September 30, 2026, but fees could only be collected if Congress provides the money.
Federal partnerships to boost trials
If enacted, the bill would let HHS partner with states, territories, and tribes to support psychedelic drug research, including grants and technical help. HHS and the VA would run a program with private partners to boost clinical trial participation and real‑world evidence, prioritizing breakthrough therapy drugs. Agencies would be allowed to share federally conducted trial data with the FDA consistent with privacy laws like HIPAA and the Privacy Act.
Sponsors & CoSponsors
Sponsor
Luttrell, Morgan [R-TX-8]
TX • R
Cosponsors
Rep. McCaul, Michael T. [R-TX-10]
TX • R
Sponsored 6/30/2026
Rep. Bergman, Jack [R-MI-1]
MI • R
Sponsored 6/30/2026
Rep. Correa, J. Luis [D-CA-46]
CA • D
Sponsored 6/30/2026
Rep. Collins, Mike [R-GA-10]
GA • R
Sponsored 8/31/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov