00 SENATE BILL NO. 113
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 treatment
12 options currently approved by the United States Food and Drug Administration; and
13 (3) given informed consent in writing for the use of the investigational
14 drug, biological product, or device.
01 (d) A hospital or health facility may not interfere with the physician-patient
02 relationship by restricting or forbidding the use of investigational drugs, biological
03 products, or devices when prescribed, dispensed, or administered by a physician under
04 (c) of this section.
05 (e) In this section,
06 (1) "investigational drug, biological product, or device" means a drug,
07 biological product, or device that has successfully completed Phase 1 studies of
08 clinical trials for investigation, but has not been approved for general use by the
09 United States Food and Drug Administration;
10 (2) "terminal illness" means a disease that, without life-sustaining
11 procedures, will result in death in the near future or a state of permanent
12 unconsciousness from which recovery is unlikely.
13 * Sec. 2. AS 09.65 is amended by adding a new section to read:
14 Sec. 09.65.325. Immunity relating to use of investigational drugs,
15 biological products, and devices. (a) A person is not liable in an action for damages
16 for the injury or death of a patient with a terminal illness resulting from the patient's
17 use of an investigational drug, biological product, or device if the person acting in
18 good faith and with reasonable care is a
19 (1) physician who prescribed, dispensed, or administered the
20 investigational drug, biological product, or device to the patient and, before
21 prescribing, dispensing, or administering the drug, product, or device, the physician
22 (A) obtained the informed consent of the patient in writing after
23 presenting to the patient all treatment options currently approved by the United
24 States Food and Drug Administration for treatment of the patient's terminal
25 illness; and
26 (B) provided written notice of the immunity provided under
27 this section to the patient; or
28 (2) manufacturer, importer, or distributor of the investigational drug,
29 biological product, or device and, before providing the drug, product, or device to the
30 patient's physician, presented to the physician all treatment options currently approved
31 by the United States Food and Drug Administration for treatment of the patient's
01 terminal illness and provided written notice of the immunity provided under this
02 section to the patient.
03 (b) In this section, "investigational drug, biological product, or device" and
04 "terminal illness" have the meanings given in AS 08.64.367.
05 * Sec. 3. AS 17.20.110 is amended by adding a new subsection to read:
06 (b) This section does not apply to a physician who prescribes or administers a
07 new drug in accordance with the conditions set out in AS 08.64.367(c).