SB 43

2026 Regular Session  ENROLLED
  ACT No. 956
 SENATE BILL NO. 43
 BY SENATORS MCMATH, BARTHELEMY, BASS, BOUDREAUX, CARTER,
  CLOUD, CONNICK, DUPLESSIS, EDMONDS, FESI, HARRIS,
  HENRY, HENSGENS, JACKSON-ANDREWS, JENKINS,
  KLEINPETER, LUNEAU, MIGUEZ, MILLER, MIZELL, MYERS,
  OWEN, PRICE, SEABAUGH, SELDERS, STINE, TALBOT, WHEAT
  AND WOMACK AND REPRESENTATIVES ADAMS, BAYHAM,
  BERAULT, BILLINGS, BOYD, BOYER, BRASS, BROUSSARD,
  BRYANT, CARPENTER, CARVER, CHASSION, CHENEVERT,
  COATES, COX, CREWS, DESHOTEL, DEWITT, DICKERSON,
  DOMANGUE, ECHOLS, EGAN, FISHER, FREEMAN, FREIBERG,
  GLORIOSO, HEBERT, CHANCE HENRY, HILFERTY, HORTON,
  JACKSON, MIKE JOHNSON, KERNER, KNOX, LAFLEUR, JACOB
  LANDRY, LYONS, MACK, MCMAKIN, MELERINE, MILLER,
  MOORE, MURRAY, RISER, SAWYER, SCHAMERHORN, SPELL,
  ST. BLANC, STAGNI, TAYLOR, VENTRELLA, WALTERS,
  WRIGHT AND WYBLE
1AN ACT
2 To enact Part IX of Chapter 1 of Title 28 of the Louisiana Revised Statutes of 1950, to be
3comprised of R.S. 28:211 and 212, relative to psychedelic-assisted therapy; to
4establish the Psychedelic-Assisted Therapy Initiative within the Louisiana
5Department of Health; to provide for clinical studies; to provide for clinical trial-
6enabling studies; to provide for drug development clinical trials; to provide for
7patient eligibility; to provide for funding; to provide for reporting; and to provide for
8related matters.
9 Be it enacted by the Legislature of Louisiana:
10Section 1. Part IX of Chapter 1 of Title 28 of the Louisiana Revised Statutes of 1950,
11 comprised of R.S. 28:211 and 212, is hereby enacted to read as follows:
12PART IX. ALTERNATIVE THERAPIES
13§211. Psychedelic-assisted therapy; clinical studies
14A. For purposes of this Part, the following definitions shall apply:
15(1) "Academic health center" means an organization that has a medical
16school, one or more other health professional schools or programs, and one or
17more affiliated teaching hospitals.
18(2) "Drug developer" means a pharmaceutical company, biotechnology
19company, or contract development and manufacturing organization engaged in
20drug development and manufacturing.
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1(3) "Ibogaine" means ibogaine and ibogaine-based therapeutics,
2including ibogaine analogs.
3(4)   "Psychedelic     medication"    means    ibogaine,    ibogaine-based
4therapeutics, ibogaine      analogs,   MDMA, psilocybin,  psilocybin-based
5therapeutics, and mechanistically-similar analogs.
6(5) "Psychedelic-assisted therapy" means an intervention that includes
7the administration of a psychedelic medication to an individual in a controlled
8clinical setting and manualized, trauma-informed preparatory and integrative
9psychotherapy delivered by a qualified therapist to the individual before and
10after administration of the psychedelic medication.
11B. There is hereby established within the Louisiana Department of
12Health, office of behavioral health, the Psychedelic-Assisted Therapy Initiative.
13The purpose of the initiative shall be all of the following:
14(1) To identify academic health centers that are conducting clinical
15studies and clinical trial-enabling studies for the use of psychedelic-assisted
16therapy for the treatment of opioid use disorders, co-occurring substance use
17disorders, and treatment-resistant neurological or mental health conditions.
18(2) To utilize the human service districts and authorities to identify
19eligible patients to participate in the program.
20(3) To provide information to parishes on utilizing opioid settlement
21funds to enroll eligible patients residing in the parish to participate in the
22studies or to support clinical trial-enabling studies that allow for the initiation
23of clinical trials that may enroll patients who reside in the parish.
24(4) To designate a state point of contact to coordinate with federal
25agencies and other states with regard to psychedelic-assisted therapy and
26related drug development.
27C. The Louisiana Department of Health shall maintain a record of all
28academic health centers participating in the program.
29D. Each participating academic health center shall maintain
30documentation ensuring compliance with state and federal regulations,
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1including all of the following:
2(1) Ensuring that the clinical study will be conducted in accordance with
3a United States Food and Drug Administration investigational new drug
4application, expanded access program, or other federally authorized pathway.
5(2) Ensuring that any study will be conducted on-site in a hospital, clinic,
6or research unit affiliated with the academic center, with confirmation of
7appropriate trial liability insurance coverage.
8(3) Maintaining a United States Drug Enforcement Agency Schedule I
9research registration and any required state controlled substance registration.
10(4) Obtaining Institutional Review Board approval for the clinical study.
11(5) A clinical study protocol that includes all of the following:
12(a) The study design, inclusion and exclusion criteria, objectives and
13endpoints, eligible patient visit schedule, and schedule of follow-up assessments.
14(b) Informed consent procedures and participant safeguards.
15(c) Data security and privacy protections, including for personal
16information.
17(6) A drug administration plan for the clinical study that includes all of
18the following:
19(a) The investigational drug product description, source, formulation,
20route of administration, and dosing regimen.
21(b) A clinical staffing model and monitoring procedures for the
22administration of the investigational drug.
23(c) Discharge criteria and transportation procedures for participants
24after psychedelic-assisted therapy.
25(d) Procedures for the storage, handling, chain of custody, and disposal
26of controlled substances, and an accountability plan for violations of the
27procedures.
28(7) A safety monitoring and risk management plan for the clinical study
29that includes all of the following:
30(a) Medical and psychiatric screening procedures.
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1(b) On-site emergency response procedures.
2(c) Adverse event and serious adverse event capture and reporting
3timelines.
4(d) Predefined rules for pausing or stopping the clinical study.
5(8) A fidelity plan for the clinical study that includes all of the following:
6(a) Clinician licensure and qualification requirements.
7(b) A training, supervision, and fidelity monitoring plan.
8(c) Ethical safeguards and a participant complaint and grievance
9process.
10E. Each academic health center may utilize the human service districts
11and authorities to identify eligible participants for the clinical studies. Eligible
12participants include individuals with opioid use disorders, co-occurring
13substance use disorders, and treatment-resistant neurological or mental health
14conditions.
15F.(1) The academic health centers shall coordinate with parishes to
16utilize opioid settlement funds to enroll eligible patients residing in the parish
17to participate in the studies.
18(2) In addition to utilization of opioid settlement funds, the department
19may seek and receive voluntary monies from any sources, including federal
20funds, gifts, grants, and donations, which shall be expended for the purposes
21provided for in this Section.
22(3) To the extent feasible, the Louisiana Department of Health shall
23support and encourage the use of opioid settlement funds and other related
24monies as matching funds for federal or other external funding opportunities
25in support of Louisiana trial and trial-enabling studies.
26G. No later than January first of each year, each academic health center
27participating in the program shall submit a progress report to the Louisiana
28Department of Health on clinical studies conducted by the academic health
29center. The Louisiana Department of Health shall determine the data required
30for inclusion in the report. The Louisiana Department of Health shall prepare
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1a compiled report of the data received from participating academic health
2centers and submit the report to the legislature by March first of each year.
3H. To the extent feasible, participating academic health centers shall
4coordinate with other states that are conducting clinical trials for use of
5psychedelic-assisted therapy.
6§212. Drug development of ibogaine and psychedelic medication treatments
7A. An academic health center may enter into an agreement with a drug
8developer to establish a consortium for the purpose of conducting drug
9development clinical trials with ibogaine and psychedelic medication treatments
10and securing the United States Food and Drug Administration's approval of
11such treatments for the treatment of opioid use disorder, co-occurring
12substance use disorder, and any other neurological or mental health condition
13for which the treatments demonstrate efficacy.
14B. A consortium seeking to conduct a drug development clinical trial
15may do all of the following:
16(1) Submit an investigational new drug application to the United States
17Food and Drug Administration in accordance with 21 CFR Part 312.
18(2) Seek a breakthrough therapy designation from the United States
19Food and Drug Administration in accordance with 21 U.S.C. 356.
20(3) Enter into an agreement with a consortium established by the
21government of another state, whether acting through an agent or joint venture,
22that has taken both of the following actions:
23(a) Has submitted an investigational new drug application to the United
24States Food and Drug Administration in accordance with 21 CFR Part 312.
25(b) Has requested a breakthrough therapy designation for ibogaine from
26the United States Food and Drug Administration in accordance with 21 U.S.C.
27356.
28(4) Work with the United States Food and Drug Administration to
29coordinate the drug development trial in Louisiana with drug development
30trials that are being conducted in other states.
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1C.(1) Any revenue attributable to newly developed intellectual property
2and other commercial rights arising from trial-enabling and drug development
3clinical trial activity conducted by a consortium pursuant to this Section, during
4the period for which the trials are funded, and any following period of
5commercialization shall be allocated as follows:
6(a) Not less than a two and one-half percent of net sales running royalty
7to the state.
8(b) The remainder to the members of the consortium in the amounts
9specified by written agreement of the members.
10(2) Intellectual property and other commercial rights arising from the
11drug development clinical trials conducted pursuant to this Section shall include
12any of the following as related to the trials:
13(a) Intellectual property, technology, and inventions.
14(b) Patents, trademarks, and licenses.
15(c) Proprietary and confidential information.
16(d) Trade secrets, data, and databases.
17(e) Tools, methods, and processes.
18(f) Treatment models or techniques.
19(g) Administration protocols.
20(h) Works of authorship.
  PRESIDENT OF THE SENATE
  SPEAKER OF THE HOUSE OF REPRESENTATIVES
  GOVERNOR OF THE STATE OF LOUISIANA
 APPROVED:
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