Bill

Bill > SB2561


MS SB2561

MS SB2561
Ibogaine; authorize MSDH to select a consortium to conduct a drug development clinical trial to secure FDA's approval of.


summary

Introduced
01/19/2026
In Committee
01/19/2026
Crossed Over
Passed
Dead
02/03/2026

Introduced Session

2026 Regular Session

Bill Summary

An Act To Be Known As The Ibogaine Drug Development Clinical Trial Act; To Authorize The Establishment Of A Consortium To Apply For Selection By The State Department Of Health To Conduct A Drug Development Clinical Trial With Ibogaine And Secure The United States Food And Drug Administration's (fda) Approval Of Ibogaine As A Medication For The Treatment Of Opioid Use Disorder, Co-occurring Substance Use Disorder, And Any Other Neurological Or Mental Health Condition For Which Ibogaine Demonstrates Efficacy; To Require The Consortium To Submit To The Department A Proposal For Purposes Of Conducting An Ibogaine Drug Development Clinical Trial, And Specify What The Proposal Must Include; To Provide That After Selecting A Consortium, The Department Shall Enter Into An Interagency Contract With The Consortium To Provide Funding To Implement The Consortium's Proposed Ibogaine Drug Development Clinical Trial; To Specify What The Interagency Contract Must Include; To Provide That The Department May Not Disburse Funds To Or For A Selected Consortium Under The Interagency Contract Until The Consortium Receives And The Department Verifies The Receipt Of Matching Funds From Sources Other Than The State; To Require The Selected Consortium To Submit An Investigational New Drug (ind) Application With The Fda And Seek A Breakthrough Therapy Designation For Ibogaine From The Fda; To Require The Selected Consortium To Enter Into An Agreement With A Consortium Established By The Government Of Another State That Has Submitted An Investigational New Drug (ind) Application To The Fda And Has Requested A Breakthrough Therapy Designation For Ibogaine From The Fda; To Require The Selected Consortium To Work With The Fda To Coordinate The Drug Development Trial In Mississippi With Ibogaine Drug Development Trials That Are Being Conducted In Other States; To Provide That Only An Institution Of Higher Learning Or A Hospital May Serve As A Trial Site For Conducting An Ibogaine Drug Development Clinical Trial; To Provide For Allocation Of The Revenue Attributable To All Intellectual Property Rights And Other Commercial Rights Arising From The Drug Development Clinical Trial Conducted By A Consortium During The Period For Which The Trial Is Funded And Any Following Period Of Commercialization; To Provide That If Ibogaine Is Approved By The Fda To Treat A Medical Condition, A Physician Who Has Prescribed Ibogaine For A Patient Shall Supervise The Administration Of Ibogaine At A Hospital Or Other Licensed Health Care Facility To Ensure The Patient's Safety While The Patient Is Under The Influence Of Ibogaine; And For Related Purposes.

AI Summary

This bill, known as the Ibogaine Drug Development Clinical Trial Act, authorizes the Mississippi State Department of Health (MSDH) to select a consortium of entities, including a drug developer, an institution of higher learning, and a hospital, to conduct a clinical trial for ibogaine, a substance being investigated for treating opioid use disorder, co-occurring substance use disorder, and other neurological or mental health conditions. The selected consortium must submit a detailed proposal to the MSDH outlining their strategy for FDA approval, trial design, participant recruitment, safety protocols, and plans for intellectual property and commercialization. The MSDH will then enter into an interagency contract with the consortium's lead institution, providing state funding contingent upon the consortium securing matching funds from non-state sources. The consortium is required to submit an Investigational New Drug (IND) application to the FDA, seek a Breakthrough Therapy Designation, and coordinate their trial with similar trials in other states. Trial sites will be limited to institutions of higher learning or hospitals. If ibogaine is approved by the FDA, physicians prescribing it will be required to supervise its administration at a licensed healthcare facility to ensure patient safety. The bill also details the allocation of revenue generated from intellectual property and commercial rights arising from the trial, with a portion going to the state.

Committee Categories

Health and Social Services

Sponsors (1)

Last Action

Died In Committee (on 02/03/2026)

bill text


bill summary

Loading...

bill summary

Loading...
Loading...