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Bill Summary · SF 233

Summary — SF 233: Right to Try Act (amendments)

Senate File 233 — Introduced Feb 10, 2025; passed both chambers (unanimous votes); enrolled and signed by the Governor on May 19, 2025. Companion: HF 523.

Purpose and intent

SF 233 amends the state’s Right to Try (RTT) law to (1) incorporate “eligible facilities” (institutions operating under a federalwide assurance for protection of human subjects) into the statute; (2) broaden and clarify the definition of eligible patients to expressly include those seeking individualized, genomics‑based investigational treatments; and (3) clarify manufacturers’ and eligible facilities’ rights and responsibilities when making investigational or individualized investigational treatments available to eligible patients.

Key provisions

  • Definitions
    • Adds “eligible facility”: institutions operating under a federalwide assurance (42 U.S.C. §289(a) and 45 C.F.R. pt. 46).
    • Expands “eligible patient” to include:
    • (a) patients with a terminal illness (existing RTT category), and
    • (b) patients with life‑threatening or severely debilitating illnesses who have exhausted approved therapies and are recommended for an individualized investigational treatment based on genomic analysis.
    • Defines “individualized investigational treatment” as a product unique to and produced exclusively for an individual patient based on that patient’s genetic profile (examples: individualized gene therapy, antisense oligonucleotides, individualized neoantigen vaccines).
    • Retains the requirement that an “investigational” product must have completed at least phase 1 of an FDA‑approved clinical trial and remain under investigation.
  • Written informed consent
    • Specifies content required in consent forms for both categories of eligible patients, including:
    • explanation of approved treatments, physician attestation that approved options are unlikely to prolong life, identification of the specific investigational product, realistic description of best/worst/likely outcomes (including possibility of hastened death), statements on payer obligations, hospice eligibility impacts, and patient liability for expenses (including estate liability unless otherwise contracted).
  • Manufacturer / facility rights and provision
    • Clarifies that a manufacturer — or a manufacturer operating within, and compliant with requirements applicable to, an eligible facility — may make investigational or individualized investigational products available, and an eligible patient may request them.
    • Does not compel manufacturers to provide individualized investigational treatments.
    • Allows eligible facilities (or compliant manufacturers) to provide individualized investigational treatments without receiving compensation, or to require eligible patients to pay costs associated with manufacture.
  • Conforming/change notes
    • Makes conforming technical changes throughout the RTT chapter.
    • Includes a provision stating the chapter does not affect any mandatory health‑care coverage for participation in clinical trials under Title XIII, subtitle 1.

Who is affected

  • Patients: terminally or severely ill patients seeking access to investigational or individualized genomics‑based treatments.
  • Providers and eligible facilities: research institutions with federalwide assurance, treating physicians (documentation and consent responsibilities).
  • Manufacturers: clarified rights to make products available and explicit non‑obligation to provide individualized products.
  • Payers and hospice programs: informed by provisions addressing payer obligations and impact on hospice eligibility.
  • Patient estates: potential liability for treatment costs unless otherwise contracted.

Procedural/timeline notes

  • Introduced Feb 10, 2025. Passed both chambers with no recorded opposition. Enrolled and signed by Governor May 19, 2025, becoming law as amended.

Compiled from official sources — confirm details with the bill’s official record.

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