The Receipts and the Results: Louisiana's Ibogaine Trials - PSA's Regulatory Dispatch, Vol. 1

Psychedelic State(s) of America’s Regulatory Dispatch, Vol. I:

The Receipts and the Results: Louisiana's Ibogaine Trials

By Odette Alina Hauke, M.S.

Louisiana is funding ibogaine trials with opioid settlement money. The agreement governing that money requires someone to publish where every dollar went. The statute spending it requires nothing about what the trials find.

Louisiana will pay for its ibogaine trials with money that arrived because people died. On August 1, 2026, Act 956 took effect without the governor's signature.¹ It added a new Part IX to the state's health title, created a Psychedelic-Assisted Therapy Initiative inside the Department of Health, and directed the state's academic health centers to fund the work from the settlement the opioid manufacturers and distributors paid Louisiana for the overdose epidemic.

It is a careful law. That is the problem.

The Better Statute

Texas got there first, and the comparison does not flatter it. Louisiana's Part IX runs 1,296 words as codified against Chapter 491's 1,524.2 In that shorter space Louisiana requires every participating study to document a federally authorized pathway, an investigational new drug application or expanded access, a Drug Enforcement Administration Schedule I research registration, and approval by an institutional review board.¹ Ibogaine is Schedule I in Louisiana as well as federally, and Louisiana separately lists the plant it comes from, Tabernanthe iboga, among hallucinogenic plants whose preparation for human consumption is a felony.³ It requires "[a] safety monitoring and risk management plan for the clinical study" containing medical and psychiatric screening procedures, on-site emergency response procedures, "[a]dverse event and serious adverse event capture and reporting timelines," and "[p]redefined rules for pausing or stopping the clinical study."¹

Texas's chapter uses the words adverse event, monitoring, and institutional review board exactly zero times.²

Louisiana was also modest about money where Texas was not, and it was modest inside Texas's own sentence. Both statutes allocate the proceeds of consortium research "as follows," and both close the allocation with the same words: "the remainder to the members of the consortium in the amounts specified by written agreement of the members."1,4 What differs is the state's share. Texas wrote "not less than 20 percent to the state."⁴ Louisiana wrote "[n]ot less than a two and one-half percent of net sales running royalty to the state."¹ One clause, one substitution, an eighth of the percentage and a different base to take it from. The twenty percent did not originate in Louisiana's own drafting; it is Texas's figure, and the substitution that replaced it is traced in What Happened on the House Floor.

So this is the more rigorous statute, written by people who knew what a Phase 1 cardiac-risk trial involves, and who asked for an eighth of what Texas asked for. That is what makes the silence worth examining. Carelessness will not explain it.

Eighteen Words Neither Law Uses

Across the codified text of both statutes, and across all four printed versions of the Louisiana bill, none of the following eighteen words appears even once: publish, published, publishing, publication, publicly, share, shared, disseminate, dissemination, disclose, disclosure, available, availability, open access, peer review, journal, transparent, archive.²

Two near-misses are worth naming, because a reader checking this should not be tripped by them. The word access appears once in each, and in neither case does it concern data: Louisiana means an "expanded access program,"¹ a Food and Drug Administration (FDA) regulatory pathway, and Texas means "a plan to ensure ibogaine treatment access to uninsured individuals."⁴ The word deposit appears once, in Texas, where the comptroller is instructed to deposit revenue.⁴ The only deposit either legislature contemplated was of money.

What the two laws do say about data, they say in the same words. Both enumerate the commercial rights the state will share in, and both lists run in the same order through the same items: intellectual property and inventions, patents and trademarks and licenses, proprietary and confidential information, then "trade secrets, data, and databases," then tools and methods and processes, then treatment models or techniques.1,4 The phrase is verbatim in both. Whatever drafting pedigree produced it, "data" entered both statutes as an asset class before it entered either as a measurement.

What Happened on the House Floor

The bill Senator Patrick McMath filed did not mention intellectual property at all. It ran 888 words and read as a research authorization: identify the academic health centers already doing this work, set conditions for participation, report once a year.⁵

The ownership apparatus arrived in the Senate Committee on Health and Welfare, which added the enumerated commercial rights and a revenue share: "Not less than twenty percent to the state."⁶ That is Texas's figure in Texas's sentence. The Senate passed the bill on April 15, 2026, by thirty-seven votes to nothing.⁷

Then the House rewrote it. On May 7, 2026, floor amendments by Representative Neil Riser did five things that matter here. Amendment 18 deleted the twenty percent line and inserted "Not less than a two and one-half percent of net sales running royalty to the state." Amendment 13 changed "shall:" to "may do all of the following:", so that filing an investigational new drug application, requesting breakthrough therapy designation, pairing with another state's consortium and coordinating with FDA all became permissive rather than mandatory. Amendment 6 directed the department to "support and encourage the use of opioid settlement funds and other related monies as matching funds for federal or other external funding opportunities." Amendment 4 directed the state point of contact to coordinate with other states, and Amendment 3 added MDMA to the covered drugs.⁸ The House passed the amended bill ninety-seven to nothing.⁹

On May 18, 2026, the Senate refused the House version, thirty-four to one.¹⁰ A conference committee convened on May 25, 2026, and recommended that Riser's floor amendments be adopted.¹¹ McMath, whose filed bill carried no revenue share at all but who had voted a week earlier to reject the removal of the twenty percent his committee added, signed the report. The House adopted it on May 31, 2026, again ninety-seven to nothing.¹²

Four printed versions, two chambers, six sets of amendments and a conference committee. Across all of them, not one of those eighteen words appears.² Figure 1 sets the two texts side by side.

The silence is not an accident that slipped through in a hurry, and it is not something a lobbyist carved out late. It was never there to carve. Across four drafts and two chambers, nobody once proposed that the results be published. The omission is not a wound in the law. It is the shape of it.

Figure 1. What each legislature wrote down. Word counts in the codified text of Louisiana R.S. 28:211-212 (1,296 words) and Texas Health & Safety Code ch. 491 (1,524 words); "consortium" is omitted, appearing 5 and 29 times, because Texas's chapter is structured around one. The eighteen absent terms are absent from all four printed versions of the Louisiana bill, not only the enacted text. Author's calculations.

Fifty-Two Parishes Hold Nothing

Louisiana's opioid settlement money is not governed by a statute. A sweep of the section, part and chapter headings of all fifty-four titles of the Revised Statutes finds no opioid settlement fund, no abatement corporation and no task force; the tobacco settlement, by contrast, is codified.¹³ The governing instrument is a memorandum of understanding (the MOU) signed for the state by the attorney general in October 2021.14

Under the MOU, twenty percent of the local money goes to sheriffs and eighty percent to other local governments.¹⁴ Three parishes with populations above 300,000, Jefferson, East Baton Rouge and Orleans, are paid directly. Every other parish is paid "on a regional basis consistent with Louisiana Department of Health Regions," with the regional share going to one designated Lead Parish.14,15 Nine Lead Parishes hold the rest. Twelve entities, in a state of sixty-four parishes, hold settlement money of their own.

Act 956 tells academic health centers to "coordinate with parishes to utilize opioid settlement funds to enroll eligible patients residing in the parish."¹ For fifty-two parishes there is no parish fund to coordinate with. The statute imagines sixty-four doors and there are twelve.

There is also no state money. The General Appropriation Act for the same year, 275 pages, contains no occurrence of psychedelic or ibogaine, and the fiscal office scored the initiative as increasing departmental costs "by an indeterminable but minimal amount."16,17 The initiative was created with an instruction to spend somebody else's restricted funds, and with an instruction to use them as leverage: the department is to "support and encourage the use of opioid settlement funds and other related monies as matching funds for federal or other external funding opportunities."¹ Texas conditioned its program on a match from non-state sources and stalled when no drug company qualified. Louisiana's answer was to nominate the settlement money as the match.

Whether these are the right restricted funds is a fair question, and it is a question rather than an accusation. The MOU's Approved Purposes are defined by its Exhibit A, whose research item authorizes support for "opioid abatement research," illustrated by monitoring and surveillance and evaluation of the listed strategies, research into non-opioid treatment of chronic pain, and research on service delivery for modalities such as screening, brief intervention and referral to treatment (SBIRT).¹⁵ Interventional drug trials are not among the illustrations. The list is expressly not exhaustive, so an interventional trial is not excluded by its absence. But nobody has been asked to decide, and the state's own auditor has explained why: "No entity has been specifically tasked with enforcing the terms of the opioid settlement agreements in Louisiana."¹³

The One Place the Word Appears

The word that appears nowhere in either state's ibogaine statute does appear in the document that controls Louisiana's money.

Clause B.⁸ of the MOU requires that "[a]t least annually, the State and the Taskforce shall publish a report detailing for the preceding time-period (1) the amount of the State Share received, (2) the allocation of any awards approved (listing the recipient, the amount awarded, the program to be funded, and disbursement terms), and (3) the amounts disbursed for approved allocations."¹⁴

That is a publication duty, and it is exact: the recipient, the amount, the program funded, the disbursement terms. It attaches to the money and follows it. It says nothing about results, because it was never meant to. It is a receipts clause, and receipts are what the dead bought. The parallel duty for local money under clause B.⁷ runs upward only, to the state and the task force, and applies to at most the twelve parishes that hold funds. Clause E.² requires records of abatement expenditures to be kept at least five years "so that it can be verified that funds are being or have been utilized in a manner consistent with the Approved Purposes definition." Clause E.³ gives the Legislative Auditor "the right to audit the Opioid Funds."¹⁴

So the money already travels with an accountability apparatus attached. It is pointed at the ledger, and only at the ledger.

What it has produced is uneven. No task force report under B.⁸ was found posted, which is a statement about what is published and not about what exists.¹⁴ The Louisiana Opioid Abatement Task Force (LaOATF) does publish a twenty-one-year projection of what each parish and each sheriff is expected to receive, $497.5 million to parish governments and $124.4 million to sheriffs.¹⁸ It does not publish expenditures. The auditor reported roughly $600 million flowing to parishes and sheriffs between 2022 and 2038, of which $98.5 million had been distributed by October 2024, and found that the MOU "does not give LaOATF the authority to ensure that parish and sheriff expenditures comply with the MOU."¹³

The legislature was not unaware. In the same 2026 session that created the initiative, it asked the Legislative Auditor for a written report on settlement expenditures,¹⁹ and urged LaOATF and the attorney general to amend the MOU to impose reporting duties on sheriffs.²⁰ It created a research program funded by this money in the same months it was asking who was watching it.

Five Kinds of Missing

It is worth separating the categories, because they are not the same and the remedies differ.

Unreported: the record of participating academic health centers that Act 956 requires the department to maintain, and the state point of contact it requires the department to designate. Neither is posted.¹

Unmeasured: nothing yet. No trial has been identified as running under this initiative, so there is no measurement to fault.

Inaccessible: the cooperative endeavor agreements between the Opioid Abatement Administration Corporation and each parish, which the auditor describes as the instruments that arguably let anyone enforce compliance, and which are not posted.¹³

Incompatible: the live risk. Act 956 authorizes a Louisiana consortium to "[e]nter into an agreement with a consortium established by the government of another state" that has filed an investigational new drug application and requested breakthrough therapy designation for ibogaine, and to "[w]ork 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."¹ That is interstate trial machinery written into state law, and after the House floor rewrote the clause it is machinery a consortium "may" use rather than one it must.⁸ Neither statute specifies a data format. Neither does the executive order that put federal money behind state psychedelic programs, which promises only "data sharing as appropriate and consistent with applicable law."²¹ Neither does FDA's own ibogaine notice, which contains no occurrence of CDISC, SDTM, common format or interoperability.²² Two consortia may lawfully combine their trials and produce records that will not combine.

Withheld: nothing. No one has asked for these data and been refused, because the reports that would contain them are not due until January.

What the Department Already Decides

The useful thing about Act 956 is that the lever is already inside it, and it belongs to an agency rather than a legislature.

Each participating academic health center must file a progress report with the Department of Health by January 1 each year, the first of them on January 1, 2027, and the department must compile those and report to the legislature by March 1.1 Between those two sentences sits this one: "The Louisiana Department of Health shall determine the data required for inclusion in the report."¹

That is a delegation with no floor and no ceiling. The department decides. Part IX imposes no rulemaking requirement, so there is no procedural obstacle and no notice-and-comment clock to run; the statute neither requires nor prevents the department from writing down what it wants.¹

What it should want is not exotic. Stated denominators and a prespecified observation window for every rate. Every electrocardiogram (ECG) as an interval in milliseconds, with the correction formula named and the time from dose recorded. Plasma ibogaine and noribogaine concentrations time-matched to those tracings. Concomitant medications and baseline electrolytes. A certificate of analysis for the drug administered. A format: the study data standards FDA already requires for marketing applications, so that a Louisiana cohort and a Texas cohort can be added together rather than merely cited together.²²

Four decisions could still be made before this becomes retrospective. The Department of Health's Office of Behavioral Health can define the January report contents, and nothing is stopping it today. LaOATF can put the initiative on an agenda, which it has not done in 2026, and can decide whether an interventional drug trial is within the Approved Purposes before the first parish writes the first check. The Legislative Auditor, already asked by the legislature for a report on settlement expenditures, can ask the same question of this program. Until November 20, 2026, anyone at all can put the format requirement on the record in FDA's open ibogaine docket.²²

Louisiana has already decided that the public is owed a published accounting of where this money goes. What remains undecided is whether it is also owed one of what the money found. The settlement bought receipts. It has not yet bought an answer, and the people who paid for both cannot ask for one.

Author disclosure. Odette Alina Hauke, M.S., is an epidemiologist and regulatory scientist in independent practice, advising sponsors developing oncology, rare disease and psychedelic drugs, including LSD, MDMA, DMT and ibogaine. She was previously Associate Director of Regulatory Affairs at AtaiBeckley and has served as a regulatory consultant to its ibogaine, R-MDMA and DMT programs. She is the regulatory lead for teams preparing Solution Summaries under Advanced Research Projects Agency for Health (ARPA-H) Special Notice ARPA-H-SN-26-158 (ASCENT-IBO) for the October 15, 2026, deadline. With more than thirteen years of experience before FDA, DEA, EMA, MHRA and Health Canada, she has authored hundreds of investigational new drug applications in oncology and rare disease. She has no financial interest in, and no advisory relationship with, the Louisiana Department of Health, the Louisiana Opioid Abatement Task Force or Administration Corporation, any Louisiana academic health center or parish government, UTHealth Houston, the University of Texas Medical Branch, the IMPACT consortium, Stanford, Ambio Life Sciences, or any Texas state agency. She presented at FDA's September 14, 2026, public hearing on the potential future therapeutic use of psychedelic drugs, filed a comment in the associated docket, FDA-2026-N-7542, and intends to file a comment in FDA-2026-N-10429, the docket this article urges readers to address.

Sources

1. Louisiana Act 956 of 2026 (S.B. 43, McMath), enacting Part IX of Chapter 1 of Title 28 of the Louisiana Revised Statutes, R.S. 28:211 and 212, effective August 1, 2026 without the governor's signature. Quoted provisions: §211(B)(4) (state point of contact); §211(C) (record of participating academic health centers); §211(E) (conditions of participation, including a federally authorized pathway, Drug Enforcement Administration Schedule I research registration, and institutional review board approval); §211(E)(7) (safety monitoring and risk management plan, including adverse event capture and reporting timelines and predefined rules for pausing or stopping the study); §211(F) (coordination with parishes to utilize opioid settlement funds); §211(G) (January 1 progress report, the department's power to determine the data required, and the compiled report to the legislature by March 1); §212(B)(3)-(4) (agreement with another state's consortium; coordination of trials conducted in other states); §212(C) (2.5 percent of net sales running royalty; enumerated commercial rights). All statutory quotations are from the enrolled text; the legislature's codified statute viewer had not yet published R.S. 28:211-212 at the time of writing. https://legis.la.gov/Legis/ViewDocument.aspx?d=1481810 ↩
2. Author's calculations. Word and phrase counts are case-insensitive word-boundary matches on whitespace-collapsed codified text. Louisiana Part IX measures 1,296 words on the stated basis, the span from the Part IX heading through the end of §212 with three lost spaces in the PDF text layer repaired; the same span unrepaired gives 1,292, with headings removed 1,274, the enrolled bill from "AN ACT" 1,411, and the raw extraction with printed line numbers left in 1,538, which is not a valid basis. Texas ch. 491 measures 1,524 words from the chapter heading to the bill's Section 2. All counting bases, and the scripts that produced them, are available from the author on request. ↩
3. La. R.S. 40:964, Schedule I(C)(36) (ibogaine), and La. R.S. 40:989.1 (hallucinogenic plants, listing Tabernanthe iboga and criminalizing preparations intended for human consumption, with exceptions for aesthetic or landscaping use and for over-the-counter homeopathic dosage forms). https://legis.la.gov/legis/Law.aspx?d=98877 ↩
4. Texas S.B. 2308, 89th Legislature (enrolled), codified at Tex. Health & Safety Code ch. 491. Cited for §491.060(a)(1) (not less than 20 percent), §491.060(b) (enumerated commercial rights) and §491.061 (deposit of revenue). https://capitol.texas.gov/tlodocs/89R/billtext/html/SB02308F.htm ↩
5. Louisiana S.B. 43 (2026 Regular Session), Original version, 888 words of proposed statutory text, containing no intellectual property provision and no revenue share. https://legis.la.gov/Legis/ViewDocument.aspx?d=1438282 ↩
6. Senate Committee on Health and Welfare amendments to S.B. 43, which added the enumerated commercial rights and "Not less than twenty percent to the state." https://legis.la.gov/Legis/ViewDocument.aspx?d=1453813 ↩
7. Senate final passage roll call, April 15, 2026: 37 yeas, 0 nays, 2 absent. https://legis.la.gov/Legis/ViewDocument.aspx?d=1463078 ↩
8. House Floor Amendments to Reengrossed S.B. 43 proposed by Representative Riser, adopted May 7, 2026. Amendment 3 (MDMA); Amendment 4 (state point of contact to coordinate with other states); Amendment 6 (opioid settlement funds as matching funds for federal opportunities); Amendment 13 ("shall:" to "may do all of the following:"); Amendment 18 (deleting the twenty percent line and inserting the 2.5 percent net sales running royalty). https://legis.la.gov/Legis/ViewDocument.aspx?d=1470117 ↩
9. House final passage roll call, May 7, 2026: 97 yeas, 0 nays, 8 absent. https://legis.la.gov/Legis/ViewDocument.aspx?d=1470248 ↩
10. Senate roll call on the House amendments, May 18, 2026, rejecting them 34 to 1 with 4 absent; the single nay was Senator Jackson-Andrews, and the bill's author voted with the majority to reject. https://legis.la.gov/Legis/ViewDocument.aspx?d=1473763 ↩
11. Conference Committee Report on S.B. 43, May 25, 2026, recommending that the House committee amendments and "the House Floor Amendments proposed by Representative Riser and adopted by the House of Representatives on May 7, 2026, be adopted." Signed by Senators McMath, Luneau and Owen and Representatives Riser, Miller and Egan. https://legis.la.gov/Legis/ViewDocument.aspx?d=1473960 ↩
12. House roll call adopting the conference committee report, May 31, 2026: 97 yeas, 0 nays, 8 absent. Engrossed and Reengrossed versions of S.B. 43, used for the version-by-version comparison, are documents 1453913 and 1463128 in the same legislative record. https://legis.la.gov/Legis/ViewDocument.aspx?d=1479324 ↩
13. Louisiana Legislative Auditor, Opioid Settlement Funds, Louisiana Opioid Abatement Taskforce and Corporation, informational report, Audit Control #40240017, May 7, 2025. Source for the enforcement finding, the authority finding, the distribution figures, and the description of the parish cooperative endeavor agreements. The negative finding that no opioid settlement fund exists in the Revised Statutes was established by a sweep of section, part and chapter headings across all fifty-four titles, which would not catch a fund created inside a section with an unrelated heading. https://app.lla.state.la.us/PublicReports.nsf/0/D3E5D98B45E19A4C86258C8300677CDF/$FILE/0000784EA.pdf ↩
14. Louisiana State-Local Government Opioid Litigation Memorandum of Understanding, signed for the state by the attorney general, October 21, 2021. Cited clauses: A.6 (Approved Purposes, defined by reference to Exhibit A); B.7 (annual parish report to the state and task force); B.8 (annual published report on the State Share); C.1.a (20 percent to sheriffs); C.1.d-e (direct and regional payment); E.2 (five-year records); E.3 (Legislative Auditor's right to audit). The document is an image-only scan with no text layer; quotations were transcribed twice independently and agreed. https://laoatf.org/wp-content/uploads/2025/12/2021.10.21-MOU-Opioid-Litigation.pdf ↩
15. Memorandum of Understanding, Exhibits A and B. Exhibit A, Part Three, item L is the agreement's only research authorization. Exhibit B carries the per-parish percentages and designates nine Lead Parishes by Louisiana Department of Health region. https://laoatf.org/wp-content/uploads/2025/12/2021.10.21-MOU-Exhibits-A-and-B.pdf ↩
16. Louisiana Act 3 of 2026 (H.B. 1), General Appropriation Act, 275 pages, which contains no occurrence of psychedelic or ibogaine. https://legis.la.gov/legis/BillInfo.aspx?s=26RS&b=HB1
17. Louisiana Legislative Fiscal Office, fiscal note on S.B. 43 Enrolled, scoring the Department of Health's Office of Behavioral Health costs as increasing "by an indeterminable but minimal amount." https://legis.la.gov/Legis/BillInfo.aspx?s=26RS&b=SB43
18. Louisiana Opioid Abatement Task Force, "Opioid Abatement, Summary of Projected Funding, All Settlements," prepared October 1, 2025: twenty-one-year projections totalling $497,476,545 to the sixty-four parish governments and $124,369,136 to the sixty-four sheriffs. Projections, not expenditures. https://laoatf.org/wp-content/uploads/2026/05/Copy_of_Settlement_Allocations_21-Year_Projection_Summary_to_Locals_20251006.pdf ↩
19. Senate Concurrent Resolution No. 22 of 2026 (enrolled), requesting that the legislative auditor prepare a written, nonevaluative report on opioid settlement fund expenditures and present it to the Senate and House health and welfare committees. https://legis.la.gov/Legis/ViewDocument.aspx?d=1473724 ↩
20. House Concurrent Resolution No. 50 of 2026 (enrolled), urging the Opioid Abatement Task Force and the attorney general to modify the memorandum of understanding to impose reporting requirements on sheriffs. https://legis.la.gov/Legis/ViewDocument.aspx?d=1476517 ↩
21. Executive Order 14401 of April 18, 2026, "Accelerating Medical Treatments for Serious Mental Illness," 91 FR 21709 (April 22, 2026). Sec. 3 directs the Secretary of Health and Human Services, through ARPA-H, to allocate at least $50 million "to support and partner with State governments" advancing psychedelic drugs, "including through Federal funding, technical assistance, and data sharing as appropriate and consistent with applicable law." https://www.federalregister.gov/documents/2026/04/22/2026-07907/accelerating-medical-treatments-for-serious-mental-illness ↩
22. Food and Drug Administration, "Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information," Docket No. FDA-2026-N-10429, 91 FR 63563 (October 6, 2026); comments close November 20, 2026. The notice contains no occurrence of CDISC, SDTM, "common format" or "interoperab". CDISC is the Clinical Data Interchange Standards Consortium; SDTM is its Study Data Tabulation Model. FDA's requirement that study data be submitted in standardized form attaches to marketing applications under section 745A(a) of the FD&C Act, not to this notice. https://www.federalregister.gov/documents/2026/10/06/2026-20427/design-and-safety-considerations-for-clinical-trials-involving-ibogaine-drug-products-request-for ↩