Bill > SB0237

This bill establishes a legal framework for individualized investigational treatment (IIT) in Indiana, which refers to a unique medical intervention produced exclusively for an individual patient based on their genetic profile, such as gene therapy or personalized vaccines. The bill allows patients with life-threatening or severely debilitating diseases to access experimental treatments under specific conditions. To qualify, a patient must: (1) have a diagnosis confirmed by their physician, (2) have considered existing FDA-approved treatments, (3) receive a physician recommendation based on genomic analysis, and (4) provide written informed consent. The informed consent must comprehensively explain the treatment, potential outcomes, risks, and financial responsibilities, including acknowledgment that health insurance may not cover the treatment and that new or worse symptoms could occur. Manufacturers are not required to provide the treatment but may do so without compensation or by charging the patient for manufacturing costs. The bill protects physicians from medical licensing board disciplinary actions for recommending such treatments and ensures that a patient's heirs are not liable for outstanding treatment debts if the patient dies. Importantly, the bill does not create a legal cause of action against manufacturers for potential harm resulting from the investigational treatment.

Health and Social Services

https://iga.in.gov/legislative/2025/bills/senate/237/details