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To: Public Health and Human
Services
MISSISSIPPI LEGISLATURE REGULAR SESSION 2026
By: Representatives Creekmore IV, Arnold,
Carpenter, Byrd
HOUSE BILL NO. 314
(As Sent to Governor)
AN ACT TO BE KNOWN AS THE IBOGAINE DRUG DEVELOPMENT CLINICAL 1
TRIAL ACT; TO AUTHORIZE THE ESTABLISHMENT OF A CONSORTIUM TO APPLY 2
FOR SELECTION BY THE STATE DEPARTMENT OF HEALTH TO CONDUCT A DRUG 3
DEVELOPMENT CLINICAL TRIAL WITH IBOGAINE AND SECURE THE UNITED 4
STATES FOOD AND DRUG ADMINISTRATION'S (FDA) APPROVAL OF IBOGAINE 5
AS A MEDICATION FOR THE TREATMENT OF OPIOID USE DISORDER, 6
CO-OCCURRING SUBSTANCE USE DISORDER, AND ANY OTHER NEUROLOGICAL OR 7
MENTAL HEALTH CONDITION FOR WHICH IBOGAINE DEMONSTRATES EFFICACY; 8
TO REQUIRE THE CONSORTIUM TO SUBMIT TO THE DEPARTMENT A PROPOSAL 9
FOR PURPOSES OF CONDUCTING AN IBOGAINE DRUG DEVELOPMENT CLINICAL 10
TRIAL, AND SPECIFY WHAT THE PROPOSAL MUST INCLUDE; TO PROVIDE THAT 11
AFTER SELECTING A CONSORTIUM, THE DEPARTMENT SHALL ENTER INTO AN 12
INTERAGENCY CONTRACT WITH THE CONSORTIUM TO PROVIDE FUNDING TO 13
IMPLEMENT THE CONSORTIUM'S PROPOSED IBOGAINE DRUG DEVELOPMENT 14
CLINICAL TRIAL; TO SPECIFY WHAT THE INTERAGENCY CONTRACT MUST 15
INCLUDE; TO PROVIDE THAT THE DEPARTMENT MAY NOT DISBURSE FUNDS TO 16
OR FOR A SELECTED CONSORTIUM UNDER THE INTERAGENCY CONTRACT UNTIL 17
THE CONSORTIUM RECEIVES AND THE DEPARTMENT VERIFIES THE RECEIPT OF 18
MATCHING FUNDS FROM SOURCES OTHER THAN THE STATE; TO REQUIRE THE 19
SELECTED CONSORTIUM TO ENTER INTO AN AGREEMENT WITH THE LEAD 20
CONSORTIUM ESTABLISHED BY THE GOVERNMENT OF ANOTHER STATE THAT HAS 21
SUBMITTED AN INVESTIGATIONAL NEW DRUG (IND) APPLICATION TO THE FDA 22
AND HAS REQUESTED A BREAKTHROUGH THERAPY DESIGNATION FOR IBOGAINE 23
FROM THE FDA; TO REQUIRE THE SELECTED CONSORTIUM TO WORK WITH THE 24
FDA TO COORDINATE THE DRUG DEVELOPMENT TRIAL IN MISSISSIPPI WITH 25
IBOGAINE DRUG DEVELOPMENT TRIALS THAT ARE BEING CONDUCTED BY THE 26
LEAD CONSORTIUM AND IN OTHER STATES; TO PROVIDE THAT ONLY AN 27
INSTITUTION OF HIGHER LEARNING OR A HOSPITAL MAY SERVE AS A TRIAL 28
SITE FOR CONDUCTING AN IBOGAINE DRUG DEVELOPMENT CLINICAL TRIAL; 29
TO PROVIDE FOR ALLOCATION OF THE REVENUE ATTRIBUTABLE TO ALL 30
INTELLECTUAL PROPERTY RIGHTS AND OTHER COMMERCIAL RIGHTS ARISING 31
FROM THE DRUG DEVELOPMENT CLINICAL TRIAL CONDUCTED BY A CONSORTIUM 32
DURING THE PERIOD FOR WHICH THE TRIAL IS FUNDED AND ANY FOLLOWING 33
PERIOD OF COMMERCIALIZATION; TO PROVIDE THAT IF IBOGAINE IS 34
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APPROVED BY THE FDA TO TREAT A MEDICAL CONDITION, A PHYSICIAN WHO 35
HAS PRESCRIBED IBOGAINE FOR A PATIENT SHALL SUPERVISE THE 36
ADMINISTRATION OF IBOGAINE AT A HOSPITAL OR OTHER LICENSED HEALTH 37
CARE FACILITY TO ENSURE THE PATIENT'S SAFETY WHILE THE PATIENT IS 38
UNDER THE INFLUENCE OF IBOGAINE; AND FOR RELATED PURPOSES. 39
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI: 40
SECTION 1. Title. This act shall be known as the Ibogaine 41
Drug Development Clinical Trial Act. 42
SECTION 2. Definitions. As used in this act, the following 43
terms shall be defined as provided in this section: 44
(a) "Department" means the State Department of Health. 45
(b) "Drug developer" means a pharmaceutical company, 46
biotechnology company, or contract development and manufacturing 47
organization engaged in drug development and manufacturing. 48
(c) "FDA" means the United States Food and Drug 49
Administration. 50
(d) "Hospital" has the meaning as defined in Section 51
41-9-3. 52
(e) "Ibogaine" means ibogaine and ibogaine-based 53
therapeutics, including ibogaine analogs. 54
(f) "Lead consortium" means the consortium that is 55
first established by the government of another state. 56
SECTION 3. Establishment of consortium. (1) A consortium 57
may be established under this section and apply for selection by 58
the department under this act to conduct a drug development 59
clinical trial with ibogaine and secure the FDA's approval of 60
ibogaine as a medication for the treatment of: 61
(a) Opioid use disorder; 62
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(b) Co-occurring substance use disorder; and 63
(c) Any other neurological or mental health condition 64
for which ibogaine demonstrates efficacy. 65
(2) A consortium established under this section must include 66
one or more of each of the following entities: 67
(a) A drug developer, which shall be the same drug 68
developer that is part of the lead consortium; 69
(b) An institution of higher learning; and 70
(c) A hospital. 71
SECTION 4. Lead institution of consortium; administration; 72
personnel. (1) A consortium established under this act shall 73
select a lead institution of higher learning from among the 74
consortium's members to represent the consortium and perform 75
administrative functions under this act, including contracting 76
with and reporting to the department as required by this act. 77
(2) A consortium selected by the department under this act 78
may employ personnel, including clinical, administrative, and data 79
management personnel, necessary to support any consortium member's 80
activities related to a drug development clinical trial conducted 81
under this act. 82
SECTION 5. Consortium proposal. (1) The lead institution 83
of higher learning of a consortium shall submit to the department 84
a proposal for purposes of conducting an ibogaine drug development 85
clinical trial in accordance with this act. 86
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(2) A proposal submitted under subsection (1) of this 87
section must provide: 88
(a) The identity of all consortium members; 89
(b) A detailed description of the planned strategy for 90
obtaining approval for the drug development clinical trial from 91
the FDA; 92
(c) A detailed drug development clinical trial design 93
that includes: 94
(i) A description of the composition of the 95
consortium's drug development clinical trial team and the 96
expertise of the team members; 97
(ii) A drug development clinical trial participant 98
recruitment plan; 99
(iii) Patient screening criteria and cardiac 100
safety protocols; 101
(iv) Administration protocols; 102
(v) An aftercare and post-acute treatment support 103
plan; and 104
(vi) A data integrity plan; 105
(d) A plan to coordinate with the lead consortium to 106
seek a breakthrough therapy designation for ibogaine from the FDA 107
under 21 USC Section 356; 108
(e) A proposal to recognize this state's commercial 109
interest in all intellectual property that may be generated over 110
the course of the drug development clinical trial, including: 111
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(i) The treatment that is the subject of the 112
trial; 113
(ii) Administration protocols; 114
(iii) Treatment models or techniques; and 115
(iv) Technology used in the trial; 116
(f) A plan to establish a corporate presence in this 117
state and to promote and maintain ibogaine-related biomedical 118
research, development, treatment, manufacturing, and distribution 119
in this state; 120
(g) A plan to secure third-party payor approval for 121
ibogaine treatment following approval by the FDA through: 122
(i) Private insurers; 123
(ii) Medicare; 124
(iii) Medicaid; and 125
(iv) The TRICARE program of the United States 126
Department of Defense; 127
(h) A plan to ensure ibogaine treatment access to 128
uninsured individuals following approval by the FDA; 129
(i) A plan to train and credential medical providers to 130
administer ibogaine treatment according to developed clinical 131
standards; and 132
(j) Financial disclosures that verify the consortium's 133
capacity to fully match state funding with funds received from 134
non-state sources. 135
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SECTION 6. Department selection of consortium. The 136
department, in its sole discretion, shall select a consortium 137
established in accordance with Section 3 of this act for the 138
purpose of conducting an ibogaine drug development clinical trial 139
under this act. 140
SECTION 7. Contract with lead institution. (1) As soon as 141
practicable after selecting a consortium to conduct an ibogaine 142
drug development clinical trial under Section 6 of this act, the 143
department shall enter into an interagency contract with the lead 144
institution of higher learning of the selected consortium to 145
provide funding to implement the consortium's proposed ibogaine 146
drug development clinical trial. The funding shall be provided 147
from funds that are specifically appropriated by the Legislature 148
to the department for the purpose of this act. 149
(2) The interagency contract described by subsection (1) of 150
this section must specify: 151
(a) The goals and objectives of the proposed ibogaine 152
drug development clinical trial; 153
(b) The proposed budget; 154
(c) The timeline for completing the proposed 155
objectives; 156
(d) The for-profit, nonprofit, or public benefit 157
corporate entities collaborating with the consortium in the drug 158
development clinical trial under this act; 159
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(e) The percentage of the revenue arising from the drug 160
development clinical trial to be paid to the state; and 161
(f) Any other information required by the department. 162
(3) As soon as practicable after entering into an 163
interagency contract under subsection (1) of this section, the 164
department shall report the existence of the contract to the 165
Legislature. 166
(4) The department may not disburse funds to or for a 167
selected consortium under the interagency contract described by 168
subsection (1) of this section until the consortium receives and 169
the department verifies the receipt of matching funds from sources 170
other than the state. 171
SECTION 8. Agreement with lead consortium. (1) As soon as 172
practicable after the department's notification that a consortium 173
is selected to conduct an ibogaine drug development clinical trial 174
under this act, the consortium must enter into an agreement with 175
the lead consortium after the lead consortium, whether acting 176
through an agent or joint venture, has taken both of the following 177
actions: 178
(a) Has submitted an investigational new drug (IND) 179
application to the FDA in accordance with 21 CFR Part 312; and 180
(b) Has requested a breakthrough therapy designation 181
for ibogaine from the FDA under 21 USC Section 356. 182
(2) The consortium selected by the department shall work 183
with the FDA to coordinate the drug development trial in 184
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Mississippi with ibogaine drug development trials that are being 185
conducted by the lead consortium and in other states. 186
SECTION 9. Drug development clinical trial sites. For 187
purposes of conducting an ibogaine drug development clinical trial 188
under this act, only an institution of higher learning or a 189
hospital may serve as a trial site. 190
SECTION 10. Disbursement of funds by department. (1) The 191
department and consortium members may solicit and accept gifts, 192
grants, and donations of any kind received from sources other than 193
the state for purposes of funding the drug development clinical 194
trial under this act. 195
(2) Disbursements of funds by the department may be made 196
incrementally based on the completion of clearly defined 197
objectives as negotiated in the contract described by Section 7 of 198
this act, including verifiable documentation demonstrating the 199
efficient expenditure of both state and matching funds. 200
SECTION 11. Reporting requirements. (1) A consortium 201
selected to conduct the ibogaine drug development clinical trial 202
shall quarterly prepare and submit to the department: 203
(a) A report on the progress of the drug development 204
clinical trial conducted under this act; and 205
(b) A financial status report, including information to 206
verify expenditures of state funds and required matching funds. 207
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(2) The department shall submit a report to the Legislature 208
on the progress of the drug development clinical trial conducted 209
under this act not later than December 1 of each year. 210
SECTION 12. Allocation of revenue attributable to 211
intellectual property and other rights. (1) The revenue 212
attributable to all intellectual property rights and other 213
commercial rights arising from the drug development clinical trial 214
conducted by a consortium under this act during the period for 215
which the trial is funded and any following period of 216
commercialization shall be allocated as follows: 217
(a) Not less than twenty percent (20%) to the state as 218
specified in the contract under Section 7 of this act, which shall 219
be deposited into the State General Fund; and 220
(b) The remainder to the members of the consortium in 221
the amounts specified by written agreement of the members. 222
(2) For purposes of this section, intellectual property 223
rights and other commercial rights arising from the drug 224
development clinical trial conducted under this act include any of 225
the following as related to the trial: 226
(a) Intellectual property, technology, and 227
inventions; 228
(b) Patents, trademarks, and licenses; 229
(c) Proprietary and confidential information; 230
(d) Trade secrets, data, and databases; 231
(e) Tools, methods, and processes; 232
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ST: Ibogaine; authorize SDH to select a
consortium to conduct a drug development
clinical trial with, to secure FDA's approval
of.
(f) Treatment models or techniques; 233
(g) Administration protocols; and 234
(h) Works of authorship. 235
SECTION 13. Ibogaine treatment administration. (1) This 236
section applies only if ibogaine is approved by the FDA to treat a 237
medical condition. 238
(2) A physician licensed in this state who has 239
prescribed ibogaine for a patient shall supervise the 240
administration of ibogaine at a hospital or other licensed health 241
care facility to ensure the patient's safety while the patient is 242
under the influence of ibogaine. 243
(3) This section does not preclude a physician from 244
administering ibogaine in accordance with federal law. 245
SECTION 14. Waivers. If before implementing any provision 246
of this act, the department or another state agency determines 247
that a waiver or authorization from a federal agency is necessary 248
for implementation of that provision, the agency affected by the 249
provision shall request the waiver or authorization and may delay 250
implementing that provision until the waiver or authorization is 251
granted. 252
SECTION 15. This act shall take effect and be in force from 253
and after July 1, 2026. 254