A bill for an act relating to the right to try Act. (Formerly SF 56.) Effective date: 07/01/2025.
Senate File 233 expands Iowa’s Right to Try Act to cover not only traditional investigational drugs, biological products, and devices, but also a new category of “individualized investigational treatment.” The bill defines that term to include treatments uniquely produced for a single patient based on that patient’s genetic profile, such as individualized gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines. It also broadens the eligibility framework to include patients with either terminal illness or life-threatening/severely debilitating illness who have exhausted approved treatment options and have a physician’s recommendation and informed consent.
The bill sets out detailed informed-consent requirements for both categories of eligible patients, including disclosures about risks, likely outcomes, possible acceleration of death, insurance noncoverage, hospice implications, and personal financial liability. It preserves the existing structure of the Right to Try Act by allowing manufacturers and eligible facilities to make these treatments available, but it does not require them to do so. It also allows providers and facilities to charge patients for manufacturing or related costs, while clarifying that insurers, health plans, governmental agencies, and hospitals are generally not required to cover or provide the treatment or related services.
SF 233 amends Iowa Code chapter 144E, the state’s Right to Try Act, by adding definitions and rules for individualized investigational treatments and by updating related provisions on patient eligibility, consent, provider protections, coverage, liability, and state interference. It extends legal protections to physicians who recommend these treatments, limits state action against access, and shields manufacturers, facilities, and other participants from private lawsuits when acting in good faith and with reasonable care. The bill also clarifies that heirs are not liable for treatment-related debts and that the chapter does not expand insurance mandates or require hospitals or government agencies to pay for or provide these therapies.
The overall sentiment around the bill appears strongly supportive and noncontroversial. The recorded votes were unanimous at each stage, including committee and floor votes in both chambers, indicating broad bipartisan agreement. The bill’s framing as an expansion of patient access to experimental or last-resort treatments likely contributed to its favorable reception.
There is little evidence of active contention in the available record, and no committee transcript excerpts were provided. The main policy issues inherent in the bill are the balance between patient access and medical risk, the possibility of hastened death or unproven outcomes, and the financial and insurance consequences for patients and families. Another potential point of concern is the creation of a pathway for highly personalized genetic or cellular therapies outside standard approval channels, though the bill addresses this by requiring physician attestation, informed consent, and preserving manufacturer discretion not to provide treatment.