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HB25-1270

Patients' Right to Try Individualized Treatments

Concerning granting eligible patients the right to try individualized investigational medical treatments.
Session:
2025 Regular Session
Subjects:
Health Care & Health Insurance
Professions & Occupations
Bill Summary

The bill allows, but does not require, an eligible patient to request from a manufacturer the manufacturer's individualized investigational drug, biological product, or device, which is a drug, biological product, or device that is unique and produced exclusively for use by an individual patient based on the patient's own genetic profile. The manufacturer must be operating within an institution that operates under federal rules for the protection of human subjects. An eligible patient is an individual who has:

  • A life-threatening or severely debilitating illness, as attested to by the patient's treating physician;
  • Considered all other treatment options currently approved by the United States food and drug administration;
  • Received a recommendation from the patient's treating physician;
  • Given written, informed consent for the use of the individualized investigational drug, biological product, or device; and
  • Documentation from the treating physician that the individual meets the definition of "eligible patient".

The bill authorizes, but does not require, a manufacturer to make the individualized investigational drug, biological product, or device available to an eligible patient at no charge, but the manufacturer may require payment to cover the cost.

If any harm is caused to the eligible patient resulting from the use of the individualized investigational drug, biological product, or device, a private right of action cannot be brought against the manufacturer or against any other individual or entity involved in the care of the eligible patient with regard to the eligible patient's use of the individualized investigational drug, biological product, or device, so long as the manufacturer, individual, or entity complied with the law and exercised reasonable care.

The bill prohibits any action against a health-care provider's license based on the health-care provider's recommendations regarding the use of the individualized investigational drug, biological product, or device.

Nothing in the bill affects a health-care insurer's obligation under current law relating to coverage for an insured's participation in a clinical trial.


(Note: This summary applies to the reengrossed version of this bill as introduced in the second house.)

Status

Introduced
Passed

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Bill Text

  • All Versions (5 )
    Date Bill Type Documents
    04/14/2025 Rerevised PDF
    04/11/2025 Revised PDF
    03/14/2025 Reengrossed PDF
    03/13/2025 Engrossed PDF
    02/18/2025 Introduced PDF