Section 126-Z:1 - [Effective 1/1/2025] Definitions In this chapter:
I. "Eligible patient" means a person to whom all of the following apply: (a) The person has been diagnosed by the person's physician with a life-threatening disease or condition.(b) The person has already tried or is not a candidate for eligible United States Food and Drug Administration (FDA) approved treatment options for their disease or condition.(c) The person is unable to participate in a clinical trial involving the eligible investigational drug, biologic or device.(d) The person has given written informed consent for the use of the investigational drug, biological product, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written informed consent on the patient's behalf.(e) The physician providing access to an investigational drug, biologic, or device will not be compensated directly by the manufacturer for providing access to this therapy.II. "Investigational drug, biologic, or device" means a drug, biologic, or device that has successfully completed phase one of a clinical trial, but has not been approved for general use by the FDA and remains under investigation in a clinical trial.II-a. "Life-threatening disease" means: (a) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and(b) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis for new drugs, biologics, or devices for that disease or condition is survival.II-b. "Other protected access" includes: (a) "Expanded access" whereby the treating physician requests access to an investigational drug, biologic, or device from the FDA and is subject to oversight from an Institutional Review Board; and(b) "Off-label use" means prescribing an FDA approved drug, biologic, or device for a use not approved for that specific indication consistent with RSA 329:17, VI-b.III. "Physician" means the licensed physician who is providing medical care or treatment to the eligible patient for the terminal illness. Amended by 2024, 124:1, eff. 1/1/2025.Added by 2016 , 206: 2, eff. 6/6/2016. 2016, 206 : 2 , eff. June 6, 2016.
This section is set out more than once due to postponed, multiple, or conflicting amendments.