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.
Impact
If enacted, SB2561 could significantly impact state law regarding the use of ibogaine, a psychoactive substance, for medical purposes. The bill requires the designated consortium to apply for an Investigational New Drug (IND) application with the FDA and to pursue a breakthrough therapy designation. It mandates detailed reporting and matching fund requirements, reinforcing that the state will only provide funding upon verification that the consortium can secure additional financial backing from non-state sources.
Summary
Senate Bill 2561 is known as the Ibogaine Drug Development Clinical Trial Act. This bill aims to authorize the establishment of a consortium that will be responsible for conducting a clinical trial to secure FDA approval for ibogaine as a treatment for opioid use disorder, as well as co-occurring substance use disorders and other neurological or mental health conditions. The bill outlines the specific entities that must be involved in this consortium, including drug developers, institutions of higher learning, and hospitals, emphasizing the necessity of collaboration for successful drug development.
Contention
The bill is poised to generate discussion surrounding the implications of using ibogaine in clinical settings, particularly regarding safety and ethical considerations in its application for treating substance use disorders. With thorough administrative requirements outlined for trial conduct, there is potential for debate on the allocation of revenues generated from any intellectual property arising from the drug development process. Furthermore, provisions for supervising ibogaine treatment by licensed physicians may also be scrutinized in both professional and public health circles.