House Bill No. 3717 proposes the establishment of a grant program under the newly added Chapter 491 of the Health and Safety Code, aimed at funding drug development trials for ibogaine. The goal of these trials 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 administer this program, which includes creating a selection committee to review applications and recommend suitable candidates for conducting the trials.
The bill outlines the application process for potential grant recipients, requiring them to demonstrate their capacity to conduct the trials, provide detailed plans for trial execution, and ensure the establishment of a corporate presence in Texas. Additionally, the commission is authorized to use appropriated funds and accept donations to finance the grants, with the stipulation that selected applicants must match the grant amount with their own funding. The bill also includes provisions for the establishment of trial sites and oversight by an institutional review board to ensure compliance with FDA requirements. If necessary, the implementation of the bill may be delayed until any required federal waivers or authorizations are obtained.
Statutes affected: Introduced: ()
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