MISSISSIPPI LEGISLATURE
2026 Regular Session
To: Public Health and Human Services
By: Representative Creekmore IV
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.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:
SECTION 1. Title. This act shall be known as the Ibogaine Drug Development Clinical Trial Act.
SECTION 2. Definitions. As used in this act, the following terms shall be defined as provided in this section:
(a) "Department" means the State Department of Health.
(b) "Drug developer" means a pharmaceutical company, biotechnology company, or contract development and manufacturing organization engaged in drug development and manufacturing.
(c) "FDA" means the United States Food and Drug Administration.
(d) "Hospital" has the meaning as defined in Section 41-9-3.
(e) "Ibogaine" means ibogaine and ibogaine-based therapeutics, including ibogaine analogs.
SECTION 3. Establishment of consortium. (1) A consortium may be established under this section and apply for selection by the department under this act to conduct a drug development clinical trial with ibogaine and secure the FDA's approval of ibogaine as a medication for the treatment of:
(a) Opioid use disorder;
(b) Co-occurring substance use disorder; and
(c) Any other neurological or mental health condition for which ibogaine demonstrates efficacy.
(2) A consortium established under this section must include one or more of each of the following entities:
(a) A drug developer;
(b) An institution of higher learning; and
(c) A hospital.
SECTION 4. Lead institution of consortium; administration; personnel. (1) A consortium established under this act shall select a lead institution of higher learning from among the consortium's members to represent the consortium and perform administrative functions under this act, including contracting with and reporting to the department as required by this act.
(2) A consortium selected by the department under this act may employ personnel, including clinical, administrative, and data management personnel, necessary to support any consortium member's activities related to drug development clinical a s conducted under this act.
SECTION 5. Consortium proposal. (1) The lead institution of higher learning of a consortium shall submit to the department a proposal for purposes of conducting an ibogaine drug development clinical trial in accordance with this act.
(2) A proposal submitted under subsection (1) of this section must provide:
(a) The identity of all consortium members;
(b) A detailed description of the planned strategy for obtaining approval for the drug development clinical trial from the FDA;
(c) A detailed drug development clinical trial design that includes:
(i) A description of the composition of the consortium's drug development clinical trial team and the expertise of the team members;
(ii) A drug development clinical trial participant recruitment plan;
(iii) Patient screening criteria and cardiac safety protocols;
(iv) Administration protocols;
(v) An aftercare and post-acute treatment support plan; and
(vi) A data integrity plan;
(d) A detailed plan to seek a breakthrough therapy designation for ibogaine from the FDA under 21 USC Section 356;
(e) A proposal to recognize this state's commercial interest in all intellectual property that may be generated over the course of the drug development clinical trial, including:
(i) The treatment that is the subject of the trial;
(ii) Administration protocols;
(iii) Treatment models or techniques; and
(iv) Technology used in the trial;
(f) A plan to establish a corporate presence in this state and to promote and maintain ibogaine-related biomedical research, development, treatment, manufacturing, and distribution in this state;
(g) A plan to secure third-party payor approval for ibogaine treatment following approval by the FDA through:
(i) Private insurers;
(ii) Medicare;
(iii) Medicaid; and
(iv) The TRICARE program of the United States Department of Defense;
(h) A plan to ensure ibogaine treatment access to uninsured individuals following approval by the FDA;
(i) A plan to train and credential medical providers to administer ibogaine treatment according to developed clinical standards; and
(j) Financial disclosures that verify the consortium's capacity to fully match state funding with funds received from non-state sources.
SECTION 6. Department selection of consortium. The department, in its sole discretion, shall select a consortium established in accordance with Section 3 of this act for the purpose of conducting an ibogaine drug development clinical trial under this act.
SECTION 7. Contract with lead institution. (1) As soon as practicable after selecting a consortium to conduct an ibogaine drug development clinical trial under Section 6 of this act, the department shall enter into an interagency contract with the lead institution of higher learning of the selected consortium to provide funding to implement the consortium's proposed ibogaine drug development clinical trial. The funding shall be provided from funds that are specifically appropriated by the Legislature to the department for the purpose of this act.
(2) The interagency contract described by subsection (1) of this section must specify:
(a) The goals and objectives of the proposed ibogaine drug development clinical trial;
(b) The proposed budget;
(c) The timeline for completing the proposed objectives;
(d) The for-profit, nonprofit, or public benefit corporate entities collaborating with the consortium in the drug development clinical trial under this act;
(e) The percentage of the revenue arising from the drug development clinical trial to be paid to the state; and
(f) Any other information required by the department.
(3) As soon as practicable after entering into an interagency contract under subsection (1) of this section, the department shall report the existence of the contract to the Legislature.
SECTION 8. Investigational new drug application. (1) Upon the department's notification that a consortium is selected to conduct an ibogaine drug development clinical trial under this act, a drug developer or hospital member of the selected consortium or the lead institution of higher learning of the consortium, as specified by written agreement of the consortium members, shall, as soon as practicable:
(a) Submit an investigational new drug (IND) application to the FDA in accordance with 21 CFR Part 312; and
(b) Seek a breakthrough therapy designation for ibogaine from the FDA under 21 USC Section 356.
(a) Has submitted an investigational new drug (IND) application to the FDA in accordance with 21 CFR Part 312; and
(b) Has requested a breakthrough therapy designation for ibogaine from the FDA under 21 USC Section 356.
(3) The consortium selected by the department shall work with the FDA to coordinate the drug development trial in Mississippi with ibogaine drug development trials that are being conducted in other states.
SECTION 9. Drug development clinical trial sites. For purposes of conducting an ibogaine drug development clinical trial under this act, only an institution of higher learning or a hospital may serve as a trial site.
SECTION 10. Disbursement of funds by department. (1) The department and consortium members may solicit and accept gifts, grants, and donations of any kind received from sources other than the state for purposes of funding the drug development clinical trial under this act.
(2) Disbursements of funds by the department may be made incrementally based on the completion of clearly defined objectives as negotiated in the contract described by Section 7 of this act, including verifiable documentation demonstrating the efficient expenditure of both state and matching funds.
SECTION 11. Reporting requirements. (1) A consortium selected to conduct the ibogaine drug development clinical trial shall quarterly prepare and submit to the department:
(a) A report on the progress of the drug development clinical trial conducted under this act; and
(b) A financial status report, including information to verify expenditures of state funds and required matching funds.
(2) The department shall submit a report to the Legislature on the progress of the drug development clinical trial conducted under this act not later than December 1 of each year.
SECTION 12. Allocation of revenue attributable to intellectual property and other rights. (1) The revenue attributable to all intellectual property rights and other commercial rights arising from the drug development clinical trial conducted by a consortium under this act during the period for which the trial is funded and any following period of commercialization shall be allocated as follows:
(a) Not less than twenty percent (20%) to the state as specified in the contract under Section 7 of this act, which shall be deposited into the State General Fund; and
(b) The remainder to the members of the consortium in the amounts specified by written agreement of the members.
(2) For purposes of this section, intellectual property rights and other commercial rights arising from the drug development clinical trial conducted under this act include any of the following as related to the trial:
(a) Intellectual property, technology, and
inventions;
(b) Patents, trademarks, and licenses;
(c) Proprietary and confidential information;
(d) Trade secrets, data, and databases;
(e) Tools, methods, and processes;
(f) Treatment models or techniques;
(g) Administration protocols; and
(h) Works of authorship.
SECTION 13. Ibogaine treatment administration. (1) This section applies only if ibogaine is approved by the FDA to treat a medical condition.
(2) A physician licensed in this state 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.
(3) This section does not preclude a physician from administering ibogaine in accordance with federal law.
SECTION 14. Waivers. If before implementing any provision of this act, the department or another state agency determines that a waiver or authorization from a federal agency is necessary for implementation of that provision, the agency affected by the provision shall request the waiver or authorization and may delay implementing that provision until the waiver or authorization is granted.
SECTION 15. This act shall take effect and be in force from and after July 1, 2026.