House Bill 314

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 ENTER INTO AN AGREEMENT WITH THE LEAD 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 BY THE LEAD CONSORTIUM AND 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 House of Representatives

• Sam Creekmore IV

  Sponsor

• Senate floor amendmentAdopted

  Adopted Mar 5

• Senate floor amendmentAdopted

  Adopted Mar 10

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

In the House of Representatives Jan 8 – Jan 21

1. Jan 8Referred to the House committee on Public Health and Human Services
2. Jan 20Reported from committee in the House: title sufficient, do pass
3. Jan 21Passed the House

In the Senate Jan 27 – Mar 5

1. Jan 27Sent to the Senate
2. Feb 13Referred to the Senate committee on Public Health and Welfare
3. Feb 25Reported from committee in the Senate: title sufficient, do pass
4. Mar 5Amended in the Senate
5. Passed the Senate as amended

Back in the House of Representatives Mar 9 – Mar 18

1. Mar 9Motion in the Senate to reconsider entered
2. Mar 10Reconsidered in the Senate
3. Amended in the Senate
4. Passed the Senate as amended
5. Mar 12Returned to the House to concur in the Senate's amendments
6. Mar 17Concurred in the House in the Senate's amendments
7. Mar 18Enrolled bill signed in the House

To the Governor Mar 19 – Mar 26

1. Mar 19Enrolled bill signed in the Senate
2. Mar 26Approved by the Governor