HB 47: "An Act establishing a statewide registry for clinical trials of drugs and biological products; and relating to approval of drug studies."

00 HOUSE BILL NO. 47 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) A clinical trials registry for 14 prescription drugs and biological products is created in the department 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 03 permit; 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 12 read: 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.