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Committee hears "right to try" bill for individualized treatments; regulator urges clarity on consent and estate liability
Summary
The committee heard Senate Bill 250, which would create a pathway for patients with life‑threatening or severely debilitating illnesses to obtain individualized investigational treatments (bespoke therapies based on a patient’s genetic profile). Supporters said the bill modernizes right‑to‑try law for genomic medicine; the Kansas State Board of
The House Committee on Health and Human Services heard Senate Bill 250, a proposal to enact a “right to try for individualized treatments” that would allow manufacturers to provide an individualized investigational treatment to an eligible patient — defined in the bill as someone with a life‑threatening or severely debilitating illness who has exhausted other FDA‑approved options and has a physician recommendation.
Carly (committee staff) summarized the bill’s provisions, including definitions, a manufacturer’s option (rather than requirement) to provide treatment, provisions that allow but do not require insurers or governmental payers to cover costs, and language shielding manufacturers and providers from a private cause of action in some circumstances. The staff summary noted that the bill passed the Senate 36‑4 and would go into effect July 1, 2025, upon publication in the statute book.
Supporters said genomic and bespoke therapies designed for an individual’s DNA require a different regulatory pathway than conventional drug trials. Dr. Patrick Bailey, director for health‑care policy at the Goldwater Institute, said the current federal clinical‑trial system was built to evaluate medications intended for large populations and “has simply not kept pace with advancements in medicine.” He described individualized treatments for ultra‑rare conditions that are tailored to a single patient’s genetic profile and urged Kansas to offer a pathway for patients who otherwise must travel abroad to access potentially life‑saving care.
Committee members asked practical questions about how this proposal differs from enrolling in clinical trials, who determines whether a treatment is “investigational,” and whether institutional review‑board (IRB) or other ethical safeguards would be bypassed. Dr. Bailey said by definition individualized treatments are manufactured for a single DNA profile and therefore are not readily amenable to large clinical trials; he said the bill does not require payers to cover costs and that manufacturers may provide treatments without compensation, or patients may be billed for direct costs.
Susan Veil, director of the Kansas State Board of Healing Arts, testified in a neutral capacity and urged clearer protections for patients. She recommended that witnesses for informed consent not be affiliated with the physician or the product marketer, that the bill not place unreasonable evidentiary burdens on patients (for example, asking a patient to “attest” that standard treatments are unlikely to prolong life), and that estate liability language be clarified so prospective patients understand whether their estates — and which estate assets — could be pursued to recoup costs if the patient dies during treatment.
Legislators asked whether individualized treatments already approved or used elsewhere could be provided in Kansas under the bill, whether the bill would allow an institution with federal‑wide assurance to administer the therapy, and whether insurers would be compelled to pay (the staff and witnesses said insurers would not be required to pay under the bill).
No committee vote was recorded. Members expressed interest in clarifying informed‑consent language, witness independence, and payment/estate implications before further action.
