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 written informed consent. The bill outlines the criteria for what constitutes an "individualized investigational treatment," which includes drugs and biological products tailored to a patient's unique genetic profile. It also specifies the requirements for informed consent, including a detailed explanation of potential outcomes and liabilities associated with the treatment.
Additionally, the bill clarifies that manufacturers are not obligated to provide these treatments but may do so under certain conditions, including the option for patients to cover associated costs. It protects healthcare providers from disciplinary actions related to their recommendations for these treatments and ensures that patients' estates may be held liable for treatment-related debts only under specific circumstances. The act does not expand insurance coverage requirements and emphasizes that it will not create a private cause of action against manufacturers or providers if they comply with the law. The bill will take effect upon publication in the statute book.