The bill proposes the establishment of a grant program under the newly added Chapter 491 of the Health and Safety Code, specifically aimed at funding drug development trials for ibogaine. The goal is to secure approval from the United States Food and Drug Administration (FDA) for ibogaine as a treatment for opioid use disorder, co-occurring substance use disorder, and other neurological or mental health conditions where ibogaine shows efficacy. The Health and Human Services Commission will oversee this program, which includes creating a selection committee to review grant applications and recommend suitable candidates for conducting the trials.
The bill outlines the eligibility criteria for applicants, which include being a corporate entity with the capacity to conduct FDA trials and a detailed plan for obtaining FDA approval. It also mandates that the commission will solicit applications and establish drug development trial sites equipped for cardiac intensive care. Additionally, the bill stipulates that funding for the grant program can come from various sources, including gifts and donations, and requires selected applicants to match the grant amount with their own funding. The provisions of the bill will only take effect if ibogaine is approved by the FDA for medical use.
Statutes affected: Introduced: ()