00 HOUSE BILL NO. 456
01 "An Act establishing a statewide registry for clinical trials of drugs and biological
02 products; and relating to approval of drug studies."
03 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA:
04 * Section 1. AS 17.20 is amended by adding new sections to read:
05 Sec. 17.20.122. Clinical trials. (a) A person may not conduct clinical trials on
06 a prescription drug or biological product in the state without first registering with the
07 department under AS 17.20.125 and receiving the approval of an institutional review
08 board recognized by the commissioner.
09 (b) The commissioner may only recognize an institutional review board that
10 has complied with national and state standards established for conducting clinical
11 trials for prescription drugs and biological products and that provides information
12 necessary for publication in the clinical trials registry established under AS 17.20.125.
13 Sec. 17.20.125. Clinical trials registry. (a) There is created in the department
14 a clinical trials registry for prescription drugs and biological products to serve as a
01 comprehensive repository of information regarding all clinical trials conducted in the
02 state, including information about the results of clinical trials, regardless of outcome,
03 for access by the public.
04 (b) The commissioner shall establish and maintain the registry established
05 under (a) of this section based on standards established by regulation and information
06 available from the National Institutes of Health, United States Department of Health
07 and Human Services, and from all other credible sources.
08 (c) The registry must include
09 (1) the name of the drug manufacturer or clinical trial sponsor;
10 (2) a summary of the purpose of the clinical trial;
11 (3) the beginning and ending dates of the clinical trial;
12 (4) information pertaining to the results of the clinical trial, including
13 potential and actual adverse side effects of the drug or biological product associated
14 with the trial; and
15 (5) any other information determined by the commissioner to be
16 relevant and nonconfidential.
17 (d) A person or entity required to or authorized by the commissioner to report,
18 receive, or disclose information related to the clinical trials registry is immune from
19 liability for reporting, receiving, or disclosing the information.
20 * Sec. 2. AS 17.20.130 is amended to read:
21 Sec. 17.20.130. Exemptions. AS 17.20.110 does not apply to a drug
22 (1) that has been approved for clinical trial by an institutional
23 review board, is listed on the clinical trials registry under AS 17.20.125, and is
24 intended solely for investigational use by experts qualified by scientific training and
25 experience to investigate the safety in drugs if the drug is plainly labeled "for
26 investigational use only"; or
27 (2) regulated under 42 U.S.C. 262.
28 * Sec. 3. AS 17.20.135 is amended by adding new paragraphs to read:
29 (3) "clinical trial" means a clinical investigation as defined by the
30 United States Food and Drug Administration that involves an experiment to test the
31 safety or efficacy of a prescription drug or biological product with one or more human
01 subjects and is intended to be submitted to, or held for inspection by, the United States
02 Food and Drug Administration as part of an application for a research or marketing
04 (4) "institutional review board" means an independent body made up
05 of medical, scientific, and nonscientific members, whose responsibility it is to ensure
06 the protection of the rights, safety, and well-being of human subjects involved in
07 clinical trials of prescription drugs or biological products by, among other things,
08 reviewing, approving, and providing continuing review of trial protocol and of the
09 methods and materials to be used in obtaining and documenting informed consent of
10 the trial subjects.
11 * Sec. 4. The uncodified law of the State of Alaska is amended by adding a new section to
13 APPLICABILITY. This Act applies to clinical trials of prescription drugs and
14 biological products that begin in the state on or after the effective date of this Act.