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To: Public Health and
Welfare
MISSISSIPPI LEGISLATURE REGULAR SESSION 2026
By: Senator(s) Harkins
SENATE BILL NO. 2561
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 SUBMIT AN INVESTIGATIONAL NEW DRUG (IND) 20
APPLICATION WITH THE FDA AND SEEK A BREAKTHROUGH THERAPY 21
DESIGNATION FOR IBOGAINE FROM THE FDA; TO REQUIRE THE SELECTED 22
CONSORTIUM TO ENTER INTO AN AGREEMENT WITH A CONSORTIUM 23
ESTABLISHED BY THE GOVERNMENT OF ANOTHER STATE THAT HAS SUBMITTED 24
AN INVESTIGATIONAL NEW DRUG (IND) APPLICATION TO THE FDA AND HAS 25
REQUESTED A BREAKTHROUGH THERAPY DESIGNATION FOR IBOGAINE FROM THE 26
FDA; TO REQUIRE THE SELECTED CONSORTIUM TO WORK WITH THE FDA TO 27
COORDINATE THE DRUG DEVELOPMENT TRIAL IN MISSISSIPPI WITH IBOGAINE 28
DRUG DEVELOPMENT TRIALS THAT ARE BEING CONDUCTED IN OTHER STATES; 29
TO PROVIDE THAT ONLY AN INSTITUTION OF HIGHER LEARNING OR A 30
HOSPITAL MAY SERVE AS A TRIAL SITE FOR CONDUCTING AN IBOGAINE DRUG 31
DEVELOPMENT CLINICAL TRIAL; TO PROVIDE FOR ALLOCATION OF THE 32
REVENUE ATTRIBUTABLE TO ALL INTELLECTUAL PROPERTY RIGHTS AND OTHER 33
COMMERCIAL RIGHTS ARISING FROM THE DRUG DEVELOPMENT CLINICAL TRIAL 34
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CONDUCTED BY A CONSORTIUM DURING THE PERIOD FOR WHICH THE TRIAL IS 35
FUNDED AND ANY FOLLOWING PERIOD OF COMMERCIALIZATION; TO PROVIDE 36
THAT IF IBOGAINE IS APPROVED BY THE FDA TO TREAT A MEDICAL 37
CONDITION, A PHYSICIAN WHO HAS PRESCRIBED IBOGAINE FOR A PATIENT 38
SHALL SUPERVISE THE ADMINISTRATION OF IBOGAINE AT A HOSPITAL OR 39
OTHER LICENSED HEALTH CARE FACILITY TO ENSURE THE PATIENT'S SAFETY 40
WHILE THE PATIENT IS UNDER THE INFLUENCE OF IBOGAINE; AND FOR 41
RELATED PURPOSES. 42
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI: 43
SECTION 1. Title. This act shall be known as the Ibogaine 44
Drug Development Clinical Trial Act. 45
SECTION 2. Definitions. As used in this act, the following 46
terms shall be defined as provided in this section: 47
(a) "Department" means the State Department of Health. 48
(b) "Drug developer" means a pharmaceutical company, 49
biotechnology company, or contract development and manufacturing 50
organization engaged in drug development and manufacturing. 51
(c) "FDA" means the United States Food and Drug 52
Administration. 53
(d) "Hospital" has the meaning as defined in Section 54
41-9-3. 55
(e) "Ibogaine" means ibogaine and ibogaine-based 56
therapeutics, including ibogaine analogs. 57
SECTION 3. Establishment of consortium. (1) A consortium 58
may be established under this section and apply for selection by 59
the department under this act to conduct a drug development 60
clinical trial with ibogaine and secure the FDA's approval of 61
ibogaine as a medication for the treatment of: 62
(a) Opioid use disorder; 63
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(b) Co-occurring substance use disorder; and 64
(c) Any other neurological or mental health condition 65
for which ibogaine demonstrates efficacy. 66
(2) A consortium established under this section must include 67
one or more of each of the following entities: 68
(a) A drug developer; 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 drug development clinical a s 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
(2) A proposal submitted under subsection (1) of this 87
section must provide: 88
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(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 detailed plan to seek a breakthrough therapy 106
designation for ibogaine from the FDA under 21 USC Section 356; 107
(e) A proposal to recognize this state's commercial 108
interest in all intellectual property that may be generated over 109
the course of the drug development clinical trial, including: 110
(i) The treatment that is the subject of the 111
trial; 112
(ii) Administration protocols; 113
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(iii) Treatment models or techniques; and 114
(iv) Technology used in the trial; 115
(f) A plan to establish a corporate presence in this 116
state and to promote and maintain ibogaine-related biomedical 117
research, development, treatment, manufacturing, and distribution 118
in this state; 119
(g) A plan to secure third-party payor approval for 120
ibogaine treatment following approval by the FDA through: 121
(i) Private insurers; 122
(ii) Medicare; 123
(iii) Medicaid; and 124
(iv) The TRICARE program of the United States 125
Department of Defense; 126
(h) A plan to ensure ibogaine treatment access to 127
uninsured individuals following approval by the FDA; 128
(i) A plan to train and credential medical providers to 129
administer ibogaine treatment according to developed clinical 130
standards; and 131
(j) Financial disclosures that verify the consortium's 132
capacity to fully match state funding with funds received from 133
nonstate sources. 134
SECTION 6. Department selection of consortium. The 135
department, in its sole discretion, shall select a consortium 136
established in accordance with Section 3 of this act for the 137
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purpose of conducting an ibogaine drug development clinical trial 138
under this act. 139
SECTION 7. Contract with lead institution. (1) As soon as 140
practicable after selecting a consortium to conduct an ibogaine 141
drug development clinical trial under Section 6 of this act, the 142
department shall enter into an interagency contract with the lead 143
institution of higher learning of the selected consortium to 144
provide funding to implement the consortium's proposed ibogaine 145
drug development clinical trial. The funding shall be provided 146
from funds that are specifically appropriated by the Legislature 147
to the department for the purpose of this act. 148
(2) The interagency contract described by subsection (1) of 149
this section must specify: 150
(a) The goals and objectives of the proposed ibogaine 151
drug development clinical trial; 152
(b) The proposed budget; 153
(c) The timeline for completing the proposed 154
objectives; 155
(d) The for-profit, nonprofit, or public benefit 156
corporate entities collaborating with the consortium in the drug 157
development clinical trial under this act; 158
(e) The percentage of the revenue arising from the drug 159
development clinical trial to be paid to the state; and 160
(f) Any other information required by the department. 161
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(3) As soon as practicable after entering into an 162
interagency contract under subsection (1) of this section, the 163
department shall report the existence of the contract to the 164
Legislature. 165
(4) The department may not disburse funds to or for a 166
selected consortium under the interagency contract described by 167
subsection (1) of this section until the consortium receives and 168
the department verifies the receipt of matching funds from sources 169
other than the state. 170
SECTION 8. Investigational new drug application. (1) Upon 171
the department's notification that a consortium is selected to 172
conduct an ibogaine drug development clinical trial under this 173
act, a drug developer or hospital member of the selected 174
consortium or the lead institution of higher learning of the 175
consortium, as specified by written agreement of the consortium 176
members, shall, as soon as practicable: 177
(a) Submit an investigational new drug (IND) 178
application to the FDA in accordance with 21 CFR Part 312; and 179
(b) Seek a breakthrough therapy designation for 180
ibogaine from the FDA under 21 USC Section 356. 181
(2) The consortium selected by the department must enter 182
into an agreement with a consortium established by the government 183
of another state, whether acting through an agent or joint 184
venture, that has taken both of the following actions: 185
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(a) Has submitted an investigational new drug (IND) 186
application to the FDA in accordance with 21 CFR Part 312; and 187
(b) Has requested a breakthrough therapy designation 188
for ibogaine from the FDA under 21 USC Section 356. 189
(3) The consortium selected by the department shall work 190
with the FDA to coordinate the drug development trial in 191
Mississippi with ibogaine drug development trials that are being 192
conducted in other states. 193
SECTION 9. Drug development clinical trial sites. For 194
purposes of conducting an ibogaine drug development clinical trial 195
under this act, only an institution of higher learning or a 196
hospital may serve as a trial site. 197
SECTION 10. Disbursement of funds by department. (1) The 198
department and consortium members may solicit and accept gifts, 199
grants, and donations of any kind received from sources other than 200
the state for purposes of funding the drug development clinical 201
trial under this act. 202
(2) Disbursements of funds by the department may be made 203
incrementally based on the completion of clearly defined 204
objectives as negotiated in the contract described by Section 7 of 205
this act, including verifiable documentation demonstrating the 206
efficient expenditure of both state and matching funds. 207
SECTION 11. Reporting requirements. (1) A consortium 208
selected to conduct the ibogaine drug development clinical trial 209
shall quarterly prepare and submit to the department: 210
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(a) A report on the progress of the drug development 211
clinical trial conducted under this act; and 212
(b) A financial status report, including information to 213
verify expenditures of state funds and required matching funds. 214
(2) The department shall submit a report to the Legislature 215
on the progress of the drug development clinical trial conducted 216
under this act not later than December 1 of each year. 217
SECTION 12. Allocation of revenue attributable to 218
intellectual property and other rights. (1) The revenue 219
attributable to all intellectual property rights and other 220
commercial rights arising from the drug development clinical trial 221
conducted by a consortium under this act during the period for 222
which the trial is funded and any following period of 223
commercialization shall be allocated as follows: 224
(a) Not less than twenty percent (20%) to the state as 225
specified in the contract under Section 7 of this act, which shall 226
be deposited into the State General Fund; and 227
(b) The remainder to the members of the consortium in 228
the amounts specified by written agreement of the members. 229
(2) For purposes of this section, intellectual property 230
rights and other commercial rights arising from the drug 231
development clinical trial conducted under this act include any of 232
the following as related to the trial: 233
(a) Intellectual property, technology, and 234
inventions; 235
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(b) Patents, trademarks, and licenses; 236
(c) Proprietary and confidential information; 237
(d) Trade secrets, data, and databases; 238
(e) Tools, methods, and processes; 239
(f) Treatment models or techniques; 240
(g) Administration protocols; and 241
(h) Works of authorship. 242
SECTION 13. Ibogaine treatment administration. (1) This 243
section applies only if ibogaine is approved by the FDA to treat a 244
medical condition. 245
(2) A physician licensed in this state who has prescribed 246
ibogaine for a patient shall supervise the administration of 247
ibogaine at a hospital or other licensed health care facility to 248
ensure the patient's safety while the patient is under the 249
influence of ibogaine. 250
(3) This section does not preclude a physician from 251
administering ibogaine in accordance with federal law. 252
SECTION 14. Waivers. If before implementing any provision 253
of this act, the department or another state agency determines 254
that a waiver or authorization from a federal agency is necessary 255
for implementation of that provision, the agency affected by the 256
provision shall request the waiver or authorization and may delay 257
implementing that provision until the waiver or authorization is 258
granted. 259
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ST: Ibogaine; authorize MSDH to select a
consortium to conduct a drug development
clinical trial to secure FDA's approval of.
SECTION 15. This act shall take effect and be in force from 260
and after July 1, 2026. 261