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SB 113: "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                             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).