Barbara Kirkmeyer

The act 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 act 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 act prohibits disciplinary 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.

The act does not affect 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 this bill as enacted.)