Senate Resolution S.R. No. 703, introduced by Senator Parker, aims to suspend certain Senate rules to aid a conference committee in reconciling differences in Senate Bill 2308, which seeks to establish a consortium for conducting clinical trials on ibogaine as a treatment for opioid use disorder and other mental health conditions. The resolution allows the committee to make necessary amendments, such as updating definitions and removing outdated provisions, while also enabling the organization of the bill for better clarity. The consortium will consist of a drug developer, an institution of higher education, and a hospital, and will be responsible for submitting funding proposals to the Health and Human Services Commission (HHSC) for the clinical trials.
Furthermore, the resolution outlines the framework for conducting these trials under Chapter 491 of the Health and Safety Code, emphasizing the requirement for matching funds from non-state sources before any state funds are disbursed. It specifies that only higher education institutions or hospitals can serve as trial sites and mandates the submission of an investigational new drug application to the FDA. The resolution also establishes reporting requirements for the consortia, including quarterly updates to the HHSC, and sets a revenue allocation framework for any intellectual property generated from the trials, ensuring that at least 20% of the revenue benefits the state. The HHSC is tasked with beginning to accept proposals from consortia within 60 days of the resolution's effective date, facilitating a prompt start to the drug development process.