No CRS summary available for this bill.
This section expands the right-to-try framework to allow eligible patients diagnosed with a life-threatening disease or condition or severely debilitating illness to request investigational individualized medical treatments based on analysis of the patient’s genomic profile. It defines eligible health care facilities operating under federal human subjects protections, requires additional informed consent that includes an explanation of approved treatments and the physician’s recommended treatment, authorizes manufacturers to provide such treatments at eligible facilities without obligation to do so, and extends existing exemptions from FDA approval, labeling, and clinical trial requirements to these treatments.