Signed by Governor Pete Ricketts

Vote Smart's Synopsis:

Vote to pass a bill to authorize terminally ill individuals to access experimental drugs not fully approved by the US Food and Drug Administration (FDA).

Highlights:

• Requires a person to have the following to be considered an eligible patient (Sec. 3):

• Have an advanced illness, attested by the person’s physician;

• Have considered all other treatment options approved by the FDA at the time;

• Have a recommendation from their treating physician for an investigational drug, biological product, or device;

• Give written, informed consent for the use of the investigational drug, biological product, or device;

• Have documentation from their treating physician that they meet the requirements of the act; and

• Not be a patient receiving inpatient treatment in a hospital licensed pursuant to the Health Care Facility Licensure Act.

• Requires the written, informed consent to consist of a signed writing executed by an eligible patient, or their parent or legal guardian if they are a minor, and attested to by their treating physician that (Sec. 4):

• Explains the approved products and treatments available at that time for the disease or condition from which the patient suffers;

• Attests to the fact that the patient concurs with his or her treating physician that no treatment then approved by the FDA would likely prolong the patient’s life;

• Clearly identifies the specific proposed investigational drug, biological product, or device that the patient is seeking to use;

• Describes the potential outcomes, if known, of using the investigational drug, biological product, or device, the description including any possibility of worsening symptoms and death hastened by the treatment;

• Contains a statement that the patient’s health insurance carrier is not obligated to pay for the investigational drug, biological product, or device; and

• Makes clear that the patient understands that they are liable for all expenses of the investigational drug, biological product, or device.

• Specifies that this act does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient (Sec. 5).

• Prohibits the manufacturer from seeking reimbursement for any outstanding debt related to the treatment or lack of insurance due to the treatment from the eligible patient’s or their caretaker’s estate if the patient dies while being treated by the investigational drug, biological product, or device (Sec. 7).

• Prohibits a treating physician, while acting in good faith in the course of their professional practice as authorized by this act, from being subject to arrest, prosecution, penalty, or denial of any right or privilege granted otherwise (Sec. 9).

• Specifies that this act does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against another person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm done to the eligible patient resulting from treatment if the manufacturer or other person or entity has complied in good faith with the terms of this act (Sec. 11).

• Defines “advanced illness”s as any progressive disease or medical or surgical condition that entails significant functional impairment, that is not considered by a treating physician to be reversible even with administration of federally approved and available treatments, and that, without life-sustaining procedures, would likely result in death within 6 months (Sec. 2).

• Defines “investigational drug, biological product, or device” as any drug, biological product, or device that has successfully completed phase 1 of a clinical trial but has not yet been approved for general use by the FDA and remains under investigation in an FDA-approved clinical trial (Sec. 2).

Full Bill Text