HB 215: "An Act relating to prescribing, dispensing, and administering an investigational drug, biological product, or device by physicians for patients who are terminally ill; and providing immunity for persons manufacturing, distributing, or providing investigational drugs, biological products, or devices."
00 HOUSE BILL NO. 215 01 "An Act relating to prescribing, dispensing, and administering an investigational drug, 02 biological product, or device by physicians for patients who are terminally ill; and 03 providing immunity for persons manufacturing, distributing, or providing 04 investigational drugs, biological products, or devices." 05 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 06 * Section 1. AS 08.64.367 is amended by adding new subsections to read: 07 (c) A physician may not be subject to disciplinary action by the board for 08 prescribing, dispensing, or administering an investigational drug, biological product, 09 or device to a patient if the patient has 10 (1) a terminal illness; 11 (2) considered, after consultation with the physician, all other 12 treatment options currently approved by the United States Food and Drug 13 Administration; and 14 (3) given informed consent in writing for the use of the investigational
01 drug, biological product, or device. 02 (d) A hospital or health facility may not interfere with the physician-patient 03 relationship by restricting or forbidding the use of investigational drugs, biological 04 products, or devices when prescribed, dispensed, or administered by a physician under 05 (c) of this section. 06 (e) In this section, 07 (1) "investigational drug, biological product, or device" means a drug, 08 biological product, or device that has successfully completed Phase 1 studies of 09 clinical trials for investigation, but has not been approved for general use by the 10 United States Food and Drug Administration; 11 (2) "terminal illness" means a disease that, without life-sustaining 12 procedures, will result in death in the near future or a state of permanent 13 unconsciousness from which recovery is unlikely. 14 * Sec. 2. AS 09.65 is amended by adding a new section to read: 15 Sec. 09.65.325. Immunity relating to use of investigational drugs, 16 biological products, and devices. (a) A person is not liable in an action for damages 17 for the injury or death of a patient with a terminal illness resulting from the patient's 18 use of an investigational drug, biological product, or device if the person acting in 19 good faith and with reasonable care is a 20 (1) physician who prescribed, dispensed, or administered the 21 investigational drug, biological product, or device to the patient and, before 22 prescribing, dispensing, or administering the drug, product, or device, the physician 23 (A) obtained the informed consent of the patient in writing after 24 presenting to the patient all treatment options currently approved by the United 25 States Food and Drug Administration for treatment of the patient's terminal 26 illness; and 27 (B) provided written notice of the immunity provided under 28 this section to the patient; or 29 (2) manufacturer, importer, or distributor of the investigational drug, 30 biological product, or device and, before providing the drug, product, or device to the 31 patient's physician, presented to the physician all treatment options currently approved
01 by the United States Food and Drug Administration for treatment of the patient's 02 terminal illness and provided written notice of the immunity provided under this 03 section to the patient. 04 (b) In this section, "investigational drug, biological product, or device" and 05 "terminal illness" have the meanings given in AS 08.64.367. 06 * Sec. 3. AS 17.20.110 is amended by adding a new subsection to read: 07 (b) This section does not apply to a physician who prescribes or administers a 08 new drug in accordance with the conditions set out in AS 08.64.367(c).