Relating to the right to try Act

This bill relates to Code chapter 144E, the right to try Act. Under current law, an “eligible patient” under the Code chapter is, in part, a person who has a terminal illness. Under the bill, an “eligible patient” is instead, in part, a person who has a life-threatening or severely debilitating illness. Under current law, the Code chapter applies to an “investigational drug, biological product, or device” meaning a drug, biological product, or device that has successfully completed phase I of a United States food and drug administration (FDA)-approved clinical trial but has not yet been approved for general use by the FDA and that remains under investigation in an FDA-approved clinical trial. Under the bill, the Code chapter instead applies to an “individualized investigational treatment”, meaning a drug, biological product, or device that is unique to and produced exclusively for use by an individual patient based on the individual patient’s own genetic profile and includes individualized gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines. The bill amends the definition under the Code chapter for “written informed consent” to reflect the changes made to “eligible patient” and the application of the Code chapter to individualized investigational treatments. The bill provides a definition of “eligible facility” to mean an institution that is operating under a federalwide assurance for the protection of human subjects pursuant to federal law. The bill amends provisions relating to a manufacturer’s rights under the Code chapter to provide that a manufacturer of an individualized investigational treatment operating within an eligible facility and in compliance with all laws applicable to an eligible facility may make available, and an eligible patient may request, the manufacturer’s individualized investigational treatment under the Code chapter. However, the Code chapter does not require a manufacturer of an individualized investigational treatment to provide or otherwise make available the individualized investigational treatment to an eligible patient. The bill provides that an eligible facility or a manufacturer may provide an individualized investigational treatment to an eligible patient without receiving compensation, or require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the individualized investigational treatment. The bill makes other conforming changes in the Code chapter to reflect the bill provisions.9, which provides that the Code chapter shall not be construed to allow a patient’s treating physician to assist the patient in committing or attempting to commit suicide.