9 www.loubar.org November 2026 from existing funds to “support and partner” with state governments that have enacted or are developing psychedelic drug research programs for mental illnesses. Id. The Right to Try Act gives patients with life-threatening illnesses access to unap- proved, investigational treatments if they meet certain criteria. The Right to Try Act of 2017, Pub. L. No. 115-176, 132 Stat. 1372 (2018) (codified at 21 U.S.C. § 360bbb). To qualify, patients with life-threatening illnesses must have exhausted all approved treatment options, be unable to participate in a clinical trial and provide informed consent for participation. See https://www. fda.gov/patients/learn-about-expanded-ac- cess-and-other-treatment-options/right-try. Further, the investigational treatment must have completed an FDA-approved phase 1 clinical trial, be currently investigated in an ongoing clinical trial, not discontinued or put on hold by the manufacturer and “not been approved or licensed by the FDA for any use.” Id. (emphasis added). The FDA’s Expanded Access program has almost identical qualification criteria to the Right to Try Act, except it also requires that the benefits justify the risks to the patient and the patient’s use of the investigational product must not interfere with any inves- tigational trials of the product. See https:// www.fda.gov/news-events/public-health- focus/expanded-access. The difference be- tween the two is governmental oversight: the FDA authorizes and oversees the use of the investigational treatment under its Expanded Access program, while no such governmental oversight is required under the Right to Try Act. The Kentucky General Assembly passed The Kentucky Right to Try Act in March of 2017, which allows a manufacturer to make an investigational treatment avail- able to a terminally ill patient upon rec- ommendation of the patient’s healthcare provider. See KRS 217.5401-217.5408. While Kentucky’s statute is similar to its federal counterpart, it is not as compre- hensive. One of the most notable differ- ences is that the federal statute, unlike the Kentucky statute, eliminates liability for a swath of individuals and entities, includ- ing a sponsor, manufacturer, prescriber, dispenser “or other individual entity.” See The Right to Try Act of 2017, supra, § 3, cf. KRS 217.5401-217.5408. FDA Seeks Public Input on Clinical Trials of Ibogaine On October 6, 2026, the FDA published a request for information seeking public comment on the development of ibogaine clinical trials. According to the RFI, HHS “is funding clinical development of ibo- gaine, and the first federally supported trials are expected to study ibogaine in adults with opioid use disorder (OUD) and adults with post-traumatic stress disorder (PTSD).” As a result, the FDA is compiling guidance for clinical trials of ibogaine. The 40-day public comment period closes on November 20, 2026. Conclusion The reason behind the state legislation on ibogaine research and Executive Order 14401 is the need to complete an FDA- approved phase 1 clinical trial of ibogaine. Once a phase 1 clinical trial is completed, then ibogaine can be made available under the federal Right to Try Act to individu- als suffering from PTSD, substance use disorder and other mental health illnesses, all of which are arguably life-threatening illnesses because they can result in suicide and overdose. It is unlikely ibogaine will be available under Kentucky’s Right to Try Act because it requires that the individual be terminally ill. Given its hallucinogenic effects and high risk for cardiovascular complications and mortality, it is likely the only legalized use of ibogaine, if phase 1 clinical trials are completed, will be in a clinical setting with monitoring during treatment and for a very limited patient population, i.e., those who have failed conventional treatments for PTSD, substance use disorder and other mental health conditions. Leigh Schell is an Associate in Stoll Keenon Ogden’s Louisville office. Her primary focus is on the defense of profes- sional negligence claims made against physicians, healthcare personnel, hospitals and nursing homes. 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