The bill amends Iowa's "Right to Try Act" to broaden the definition of an eligible patient to include individuals with life-threatening or severely debilitating illnesses, in addition to those with 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 tailored to a patient's unique genetic profile, and updates the definition of written informed consent to align with these new provisions.

Furthermore, 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 obligated to provide these treatments, they may do so without compensation or may require patients to cover associated costs. The bill also ensures that patients' heirs are not liable for treatment debts if the patient dies while receiving such treatments and protects physicians from penalties related to their recommendations for access to investigational treatments. Additionally, it establishes that an "eligible facility" is an institution operating under a federalwide assurance for the protection of human subjects and extends the rights of manufacturers under the Code chapter to these facilities.

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