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CSSB 113(HSS): "An Act relating to prescribing, dispensing, and administering an investigational drug, biological product, or device by physicians for patients who are terminally ill; providing immunity for persons manufacturing, distributing, or providing investigational drugs, biological products, or devices; and relating to licensed health care facility requirements."

00                       CS FOR SENATE BILL NO. 113(HSS)                                                                   
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; providing                              
03 immunity for persons manufacturing, distributing, or providing investigational drugs,                                   
04 biological products, or devices; and relating to licensed health care facility                                          
05 requirements."                                                                                                          
06 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA:                                                                
07    * Section 1. AS 08.64.367 is amended by adding new subsections to read:                                            
08            (c)  A physician may not be subject to disciplinary action by the board for                                  
09       prescribing, dispensing, or administering an investigational drug, biological product,                            
10       or device, or providing related treatment, to a patient if the patient                                            
11                 (1)  has a terminal illness;                                                                            
12                 (2)  is ineligible or unable to participate in a current clinical trial for the                         
13       investigational drug, biological product, or device;                                                              
01                 (3)  has considered, after consultation with the physician, all other                                   
02       treatment options currently approved by the United States Food and Drug                                           
03       Administration; and                                                                                               
04                 (4)  has given informed consent in writing for the use of the                                           
05       investigational drug, biological product, or device.                                                              
06            (d)  In this section,                                                                                        
07                 (1)  "investigational drug, biological product, or device" means a drug,                                
08       biological product, or device that has successfully completed Phase 1 studies of                                  
09       clinical trials for investigation and remains in ongoing clinical trials under Phase 2 or                         
10       Phase 3, but has not been approved for general use by the United States Food and                                  
11       Drug Administration;                                                                                              
12                 (2)  "terminal illness" means a disease that, without life-sustaining                                   
13       procedures, will result in death in the near future or a state of permanent                                       
14       unconsciousness from which recovery is unlikely.                                                                  
15    * Sec. 2. AS 09.65 is amended by adding a new section to read:                                                     
16            Sec. 09.65.325. Immunity relating to use of investigational drugs,                                       
17       biological products, and devices. (a) A person is not liable in an action for damages                           
18       for the injury or death of a patient with a terminal illness resulting from the patient's                         
19       use of an investigational drug, biological product, or device if the person, acting in                            
20       good faith and with reasonable care, is a                                                                         
21                 (1)  physician or member of the medical team who prescribed,                                            
22       dispensed, or administered the investigational drug, biological product, or device, or                            
23       provided related treatment, to the patient and, before prescribing, dispensing, or                                
24       administering the drug, product, or device, or providing related treatment, the                                   
25       physician or member of the medical team                                                                           
26                      (A)  obtained the informed consent of the patient in writing after                                 
27            presenting to the patient all treatment options currently approved by the United                             
28            States Food and Drug Administration for treatment of the patient's terminal                                  
29            illness; and                                                                                                 
30                      (B)  provided written notice of the immunity provided under                                        
31            this section to the patient; or                                                                              
01                 (2)  manufacturer, importer, or distributor of the investigational drug,                                
02       biological product, or device and, before providing the drug, product, or device to the                           
03       patient's physician, presented to the physician all treatment options currently approved                          
04       by the United States Food and Drug Administration for treatment of the patient's                                  
05       terminal illness and provided written notice of the immunity provided under this                                  
06       section to the patient.                                                                                           
07            (b)  In this section, "investigational drug, biological product, or device" and                              
08       "terminal illness" have the meanings given in AS 08.64.367.                                                       
09    * Sec. 3. AS 17.20.110 is amended by adding a new subsection to read:                                              
10            (b)  This section does not apply to a physician who prescribes or administers a                              
11       new drug in accordance with the conditions set out in AS 08.64.367(c).                                            
12    * Sec. 4. AS 47.32.030 is amended by adding a new subsection to read:                                              
13            (d)  The department may not require a licensed entity to increase services for                               
14       the sole purpose of accommodating a physician's practice of prescribing, dispensing,                              
15       or administering an investigational drug, biological product, or device, or providing                             
16       related treatment, to a patient. In this subsection, "investigational drug, biological                            
17       product, or device" has the meaning given in AS 08.64.367.