This bill amends Iowa Code chapter 144E, known as the Right to Try Act, to broaden the definition of "eligible patient" to encompass individuals with life-threatening or severely debilitating illnesses, in addition to those with terminal illnesses. The updated eligibility criteria stipulate that 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 specifically tailored to an individual patient based on their genetic profile.

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 investigational treatment and protects physicians from penalties related to their recommendations for access to investigational treatments. Additionally, it updates the definition of written informed consent and establishes that an "eligible facility" is an institution operating under a federalwide assurance for the protection of human subjects, thereby extending the rights of manufacturers to these facilities.

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