The bill amends Iowa's "Right to Try Act" to broaden the definition of an eligible patient to include those with life-threatening or severely debilitating illnesses, in addition to terminal illnesses. It establishes that these patients must have exhausted all FDA-approved treatment options, received a recommendation for individualized investigational treatment from their physician, provided written informed consent, and have documentation from their physician confirming their eligibility. The bill introduces the term "individualized investigational treatment," which refers to treatments customized to an individual patient's genetic profile, thereby enhancing access to investigational treatments for patients with severe health conditions.

Additionally, the bill clarifies the rights of manufacturers and eligible facilities regarding the provision of investigational drugs, biological products, or devices, as well as individualized investigational treatments. It specifies that while manufacturers are not required to provide these treatments, they may do so without compensation or may require patients to cover associated costs. The bill ensures that patients' heirs are not liable for treatment debts if the patient dies while receiving such treatments. It also updates the definition of written informed consent and defines an "eligible facility" as an institution compliant with federal regulations for the protection of human subjects, thereby ensuring that all parties involved adhere to applicable laws and regulations.

Statutes affected:
Introduced: 144E.2, 144E.3, 144E.1, 144E.5, 144E.6, 144E.7, 144E.8