No CRS summary available for this bill.
This section expands the right-to-try framework to cover investigational individualized medical treatments, defined as drugs or biological products based on a patient’s unique genomic profile. It adds eligible patients diagnosed with a life-threatening disease or condition or severely debilitating illness who have considered approved treatments, as certified by a physician who attests to the diagnosis and is not compensated by the manufacturer. It requires additional written informed consent detailing approved treatments, the patient’s concurrence that they are unlikely to help, the specific proposed treatment, and potential outcomes. It permits manufacturers operating in eligible health care facilities under federal human subjects protections to provide such treatments but does not require them to do so, and it extends existing exemptions from drug approval and informed consent rules to these treatments.