Relating to the right to try Act

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 also 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 for “written informed consent” to reflect the changes made to “eligible patient” and the application of the Code chapter to individualized investigational treatments. “Eligible facility” is defined as 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 also apply to eligible facilities. The bill provides that a manufacturer of an investigational drug, biological product, or device or a manufacturer operating within, and in compliance with all requirements applicable to, an eligible facility may make available, and an eligible patient may request from a manufacturer of an investigational drug, biological product, or device, or a manufacturer operating within, and in compliance with all requirements applicable to, an eligible facility, the manufacturer’s investigational drug, biological product, or device, or the manufacturer’s individualized investigational treatment. 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 that is in compliance with all applicable requirements 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 conforming changes in the Code chapter.