Amendment vs bill Senate Committee Amendment, #1313, H&W, Adopted vs Enrolled

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Regular Session ENROLLED SENATE BILL NO.
SCASB43 3005 1313 SENATE COMMITTEE AMENDMENTS Regular Session AmendmentsproposedbySenateCommitteeonHealthandWelfareto OriginalSenateBill 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,MIKEJOHNSON,KERNER,KNOX,LAFLEUR, JACOB LANDRY, LYONS, MACK, MCMAKIN, MELERINE, MILLER, MOORE, MURRAY, RISER, SAWYER, SCHAMERHORN, SPELL, ST.
43 by Senator McMath AMENDMENT NO.
BLANC, STAGNI, TAYLOR, VENTRELLA, WALTERS, WRIGHT AND WYBLE AN ACT To enact Part IX of Chapter 1 of Title 28 of the Louisiana Revised Statutes of 1950, to be comprised of R.S.
1 On page 1, line 3, after "R.S.
28:211 and 212, relative to psychedelic-assisted therapy;
28:211" insert "and 212" AMENDMENT NO.
to establish the Psychedelic-Assisted Therapy Initiative within the Louisiana Department of Health;
2 On page 1, line 5, after "studies;" insert "to provide for drug development clinical trials;" AMENDMENT NO.
to provide for clinical studies;
3 On page 1, line 9, change "R.S.
to provide for clinical trial- enabling studies;
28:211, is" to "R.S.
to provide for drug development clinical trials;
28:211 and 212, are" AMENDMENT NO.
to provide for patienteligibility;toprovideforfunding;toprovideforreporting;andtoprovidefor related matters.
4 On page 1, line 12, change "Section" to "Part" AMENDMENT NO.
Be it enacted by the Legislature of Louisiana:
5 On page 1, between lines 15 and 16, insert the following:
Section1.PartIXofChapter1ofTitle28oftheLouisianaRevisedStatutesof1950, comprised of R.S.
"(2) "Drug developer" means a pharmaceutical company, biotechnology company, or contract development and manufacturing organization engaged in drug development and manufacturing.
28:211 and 212, is hereby enacted to read as follows:
(3) "Ibogaine" means ibogaine and ibogaine-based therapeutics, including ibogaine analogs." AMENDMENT NO.
PART IX.
6 On page 1, line 16, change "(2)" to "(4)" AMENDMENT NO.
ALTERNATIVE THERAPIES §211.
7 On page 2, line 2, change "(3)" to "(5)" AMENDMENT NO.
Psychedelic-assisted therapy;
8 On page 2, line 10, delete "assist" and insert "identify" and after "centers" delete "in" AMENDMENT NO.
clinical studies A.
9 On page 2, delete lines 18 and 19 and insert the following:
For purposes of this Part, the following definitions shall apply:
"C.TheLouisianaDepartmentofHealthshallmaintainarecordofallacademic health centers participating in the program.
(1) "Academic health center"means an organization thathas a medical school, one or more other health professional schools or programs, and one or more affiliated teaching hospitals.
(2)"Drugdeveloper"means apharmaceuticalcompany, biotechnology company,orcontractdevelopmentandmanufacturingorganizationengagedin drug development and manufacturing.
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Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions.
SB NO.
43 ENROLLED (3) "Ibogaine" means ibogaine and ibogaine-based therapeutics, including ibogaine analogs.
(4) "Psychedelic medication" means ibogaine, ibogaine-based therapeutics, ibogaine analogs, MDMA, psilocybin, psilocybin-based therapeutics, and mechanistically-similar analogs.
(5) "Psychedelic-assisted therapy" means an intervention that includes the administration of a psychedelic medication to an individual in a controlled clinical settingand manualized, trauma-informed preparatoryand integrative psychotherapy delivered by a qualified therapist to the individual before and after administration of the psychedelic medication.
B.
There is hereby established within the Louisiana Department of Health,officeofbehavioralhealth,thePsychedelic-AssistedTherapyInitiative.
The purpose of the initiative shall be all of the following:
(1) To identify academic health centers that are conducting clinical studies and clinical trial-enabling studies for the use of psychedelic-assisted therapy for the treatment of opioid use disorders, co-occurring substance use disorders, and treatment-resistant neurological or mental health conditions.
(2) To utilize the human service districts and authorities to identify eligible patients to participate in the program.
(3) To provide information to parishes on utilizing opioid settlement funds to enroll eligible patients residing in the parish to participate in the studies or to support clinical trial-enabling studies that allow for the initiation of clinical trials that may enroll patients who reside in the parish.
(4) To designate a state point of contact to coordinate with federal agencies and other states with regard to psychedelic-assisted therapy and related drug development.
C.
The Louisiana Department of Health shall maintain a record of all academic health centers participating in the program.
Each participating academic health center shall maintain documentation ensuring compliance with state and federal regulations, Page 2 of 6 Coding:
Each participating academic health center shall maintain documentation" AMENDMENT NO.
Words which are struck through are deletions from existing law;
10 On page 2, line 22, after "application" insert ", expanded access program, or other federally authorized pathway" AMENDMENT NO.
words in boldface type and underscored are additions.
11 On page 3, delete lines 8 through 10 Page 1 of 3 SCASB43 3005 1313 AMENDMENT NO.
SB NO.
12 On page 3, line 11, change "(c)" to "(b)" AMENDMENT NO.
43 ENROLLED including all of the following:
13 On page 3, line 13, change "(d)" to "(c)" AMENDMENT NO.
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(1)Ensuringthattheclinicalstudywillbeconductedinaccordancewith a United States Food and Drug Administration investigational new drug application, expanded access program, or other federally authorized pathway.
14 On page 3, line 15, change "(e)" to "(d)" AMENDMENT NO.
(2)Ensuringthatanystudywillbeconductedon-siteinahospital,clinic, or research unit affiliated with the academic center, with confirmation of appropriate trial liability insurance coverage.
15 On page 4, line 4, change "D." to "E." AMENDMENT NO.
(3) Maintaining a United States Drug Enforcement Agency Schedule I research registration and any required state controlled substance registration.
16 On page 4, line 9, change "E." to "F." AMENDMENT NO.
(4)ObtainingInstitutionalReviewBoardapprovalfortheclinicalstudy.
17 On page 4, line 16, change "F." to "G." AMENDMENT NO.
(5) A clinical study protocol that includes all of the following:
18 On page 4, line 22, change "G." to "H." AMENDMENT NO.
(a) The study design, inclusion and exclusion criteria, objectives and endpoints,eligiblepatientvisitschedule,andscheduleoffollow-upassessments.
19 On page 4, after line 24, insert the following:
(b) Informed consent procedures and participant safeguards.
"§212.
(c) Data security and privacy protections, including for personal information.
Drug development of ibogaine treatment A.
(6) A drug administration plan for the clinical study that includes all of the following:
An academic health center may enter into an agreement with a drug developer to establish a consortium for purpose of conducting drug development clinical trials with ibogaine and securing the United States Food and Drug Administration's 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.
(a) The investigational drug product description, source, formulation, route of administration, and dosing regimen.
B.Aconsortiumseekingtoconductanibogainedrugdevelopmentclinicaltrial shall:
(b) A clinical staffing model and monitoring procedures for the administration of the investigational drug.
(1) Submit an investigational new drug application to the FDA in accordance with 21 CFR Part 312.
(c) Discharge criteria and transportation procedures for participants after psychedelic-assisted therapy.
(2)Seek a breakthrough therapy designation for ibogaine fromtheFDAunder 21 U.S.C.
(d) Procedures for the storage, handling, chain of custody, and disposal of controlled substances, and an accountability plan for violations of the procedures.
(7)Asafetymonitoring and risk managementplan fortheclinicalstudy that includes all of the following:
(a) Medical and psychiatric screening procedures.
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Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions.
SB NO.
43 ENROLLED (b) On-site emergency response procedures.
(c) Adverse event and serious adverse event capture and reporting timelines.
(d) Predefined rules for pausing or stopping the clinical study.
(8)Afidelityplanfortheclinicalstudythatincludesallofthefollowing:
(a) Clinician licensure and qualification requirements.
(b) A training, supervision, and fidelity monitoring plan.
(c) Ethical safeguards and a participant complaint and grievance process.
E.
Each academic health center may utilize the human service districts and authorities to identify eligible participants for the clinical studies.
Eligible participants include individuals with opioid use disorders, co-occurring substance use disorders,and treatment-resistantneurologicalormentalhealth conditions.
F.(1) The academic health centers shall coordinate with parishes to utilize opioid settlement funds to enroll eligible patients residing in the parish to participate in the studies.
(2) In addition to utilization of opioid settlement funds, the department may seek and receive voluntary monies from any sources, including federal funds, gifts, grants, and donations, which shall be expended for the purposes provided for in this Section.
(3) To the extent feasible, the Louisiana Department of Health shall support and encourage the use of opioid settlement funds and other related monies as matching funds for federal or other external funding opportunities in support of Louisiana trial and trial-enabling studies.
G.NolaterthanJanuaryfirstof eachyear,eachacademichealthcenter participating in the program shall submit a progress report to the Louisiana Department of Health on clinical studies conducted by the academic health center.The Louisiana Department of Health shall determine thedata required for inclusion in the report.
The Louisiana Department of Health shall prepare Page 4 of 6 Coding:
Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions.
SB NO.
43 ENROLLED a compiled report of the data received from participating academic health centers and submit the report to the legislature by March first of each year.
H.
To the extent feasible, participating academic health centers shall coordinate with other states that are conducting clinical trials for use of psychedelic-assisted therapy.
§212.
Drug development of ibogaine and psychedelic medication treatments A.
An academic health center may enter into an agreement with a drug developer to establish a consortium for the purpose of conducting drug developmentclinicaltrialswithibogaineandpsychedelicmedicationtreatments and securing the United States Food and Drug Administration's approval of such treatments for the treatment of opioid use disorder, co-occurring substance use disorder, and any other neurological or mental health condition for which the treatments demonstrate efficacy.
B.
A consortium seeking to conduct a drug development clinical trial may do all of the following:
(1) Submit an investigational new drug application to the United States Food and Drug Administration in accordance with 21 CFR Part 312.
(2) Seek a breakthrough therapy designation from the United States Food and Drug Administration in accordance with 21 U.S.C.
(3) Enter into an agreement with a consortium established by the governmentofanotherstate,whetheractingthroughanagentorjointventure, that has taken both of the following actions:
(3) Enter into an agreement with a consortium established by the government ofanotherstate,whetheractingthroughanagentorjointventure,thathastakenboth of the following actions:
(a)Has submittedan investigational new drug application totheUnited States Food and Drug Administration in accordance with 21 CFR Part 312.
(a) Has submitted an investigational new drug application to the FDA in accordance with 21 CFR Part 312.
(b)Hasrequestedabreakthroughtherapydesignationforibogainefrom the United States Food and Drug Administration in accordancewith 21 U.S.C.
(b) Has requested a breakthrough therapy designation for ibogaine from the FDA under 21 U.S.C.
(4) Work with the United States Food and Drug Administration to coordinate the drug development trial in Louisiana with drug development trials that are being conducted in other states.
(4) Work with the FDA to coordinate the drug development trial in Louisiana with ibogaine drug development trials that are being conducted in other states.
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C.(1) Any revenue attributable to all intellectual property rights and other commercial rights arising from drug development clinical trials conducted by a consortiumpursuanttothisSection,duringtheperiodforwhichthetrialsarefunded, and any following period of commercialization shall be allocated as follows:
Words which are struck through are deletions from existing law;
(a) Not less than twenty percent to the state.
words in boldface type and underscored are additions.
SB NO.
43 ENROLLED C.(1)Anyrevenueattributabletonewlydevelopedintellectualproperty andothercommercialrightsarisingfromtrial-enablinganddrugdevelopment clinicaltrialactivityconductedbyaconsortiumpursuanttothisSection,during the period for which the trials are funded, and any following period of commercialization shall be allocated as follows:
(a) Not less than a two and one-half percentof net sales running royalty to the state.
(2) Intellectual property and other commercial rights arising from the drugdevelopmentclinicaltrialsconductedpursuanttothisSectionshallinclude any of the following as related to the trials:
Page 2 of 3 SCASB43 3005 1313 (2) Intellectual property rights and other commercial rights arising from the drug development clinical trials conducted pursuant to this Section shall include any of the following as related to the trials:
(h) Works of authorship.
(h) Works of authorship." Page 3 of 3
PRESIDENT OF THE SENATE SPEAKER OF THE HOUSE OF REPRESENTATIVES GOVERNOR OF THE STATE OF LOUISIANA APPROVED:
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Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions.