Senate Bill 2561

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.

In the Senate

• Josh Harkins

  Sponsor

l9n doesn't hold this bill's text yet.

In the Senate Jan 19 – Feb 3

1. Jan 19Referred to the Senate committee on Public Health and Welfare
2. Feb 3Died in committee in the Senate