The proposed bill, known as the "Right to Try for Individualized Treatments Act," aims to provide eligible patients with access to individualized investigational treatments for life-threatening or severely debilitating illnesses. An "eligible patient" is defined as someone who has received a recommendation from their physician for such treatments, has considered all FDA-approved options, and has provided informed consent. The bill outlines the criteria for what constitutes an "individualized investigational treatment," which includes drugs, biological products, or devices tailored to the patient's genetic profile. It also specifies the requirements for informed consent, including the potential risks and costs associated with the treatment.
Additionally, the bill clarifies that manufacturers are not obligated to provide these treatments, but may do so either without compensation or by charging the patient for the associated costs. It protects healthcare providers from disciplinary actions based solely on their recommendations for these treatments and ensures that patients' heirs are not liable for debts incurred from such treatments if the patient dies. The act does not expand insurance coverage requirements but allows for the possibility of coverage for these treatments at the discretion of health plans or governmental agencies. Overall, the bill seeks to enhance patient autonomy in seeking experimental treatments while establishing safeguards for both patients and healthcare providers.