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House approves bill letting manufacturers provide individualized investigational treatments; liability and consent provisions added

2698892 · March 19, 2025
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Summary

The House passed a bill allowing manufacturers to make individualized investigational drugs, biologics or devices available to eligible patients with life‑threatening or severely debilitating conditions, including provisions limiting provider discipline for recommendations and clarifying estate liability if a patient dies.

TOPEKA — The Kansas House passed legislation that would create a statutory framework allowing manufacturers to supply individualized investigational treatments to eligible patients with life‑threatening or severely debilitating illnesses.

Representative John Steens, the bill’s carrier, described the measure as a limited pathway for patients seeking individualized investigational products when no approved options exist. “This bill would authorize a manufacturer operating in an eligible facility to make available individualized investigative treatments for individuals with life‑threatening or severely debilitating illnesses to request an individual investigational drug, biologic product, or device from such manufacturers,” Steens said from the well.

The bill’s supporters said the measure provides expanded access to experimental or tailored therapies not otherwise available in Kansas while clarifying that it does not mandate insurer coverage. The House adopted three floor amendments made in the House committee, including requirements that a consent witness be independent of the treating physician and a clarification that an estate — not family members — may be held liable for outstanding treatment costs if a patient dies during an investigational treatment.

Some members expressed concern about access inequities and the risk of unproven therapies being marketed to desperate patients. Representative Susan Ruiz described the issue as complicated: only a small number of patients would use the pathway, and costs would likely be substantial. Representative Price said he sympathized with patients seeking options but warned about unscrupulous actors taking advantage of vulnerable people.

Proponents noted existing protections: state licensing boards would not be permitted to discipline a provider solely for recommending an investigational treatment, and the bill preserves other licensing and reporting obligations. The House passed the bill on final action; the recorded vote was 97 yeas and 26 nays.

What this does — and does not — do: The bill creates a statutory right for manufacturers in eligible facilities to provide individualized investigational products on request, with informed‑consent protections and limitations on licensing discipline for recommending providers. It does not require insurers to pay for such treatments and includes estate liability provisions enacted after committee amendments.