§ 69.77.040 — Patient eligibility for access and treatment with investigational product.

Washington § 69.77.040

• Jurisdiction: Washington
• Title 69: FOOD, DRUGS, COSMETICS, AND POISONS
• Ch. 69.77: INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES

Text

A patient is eligible to request access to and be treated with an investigational product if:

(1) The patient is eighteen years of age or older;

(2) The patient is a resident of this state;

(3) The patient's treating physician attests to the fact that the patient has a serious or immediately life-threatening disease or condition;

(4) The patient acknowledges having been informed by the treating physician of all other treatment options currently approved by the United States food and drug administration;

(5) The patient's treating physician recommends that the patient be treated with an investigational product;

(6) The patient is unable to participate in a clinical trial for the investigational product because the patient's physician has contacted one or more clinical trials or researchers in the physician's practice area and has determined, using the physician's professional judgment, that there are no clinical trials reasonably available for the patient to participate in, that the patient would not qualify for a clinical trial, or that delay in waiting to join a clinical trial would risk further harm to the patient; and

(7) In accordance with RCW 69.77.050 , the patient has provided written informed consent for the use of the investigational product, or, if the patient lacks the capacity to consent, the patient's legally authorized representative has provided written informed consent on behalf of the patient.

Legislative History

[2017 c 212 s 4.]