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HB 456: "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. 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                                
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.