,i  #aacth ,,congress  #b;d ,session    
,h4 ,r4 #ddge  ,,in ,,the ,,house ,,of  
,,representatives  ,april #aj1 #bjad    
,mr4 ,griffith of ,virginia 7for himself
 and ,mr4 ,hanna7 introduced the        
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to allow the manufacture1   
importation1 distribution1 and sale of  
investigational drugs and devices       
intended for use by terminally ill      
patients who execute an informed consent
 document1 and for other purposes4  #a4 
,short title ,this ,act may be cited as 
the ,compassionate ,freedom of ,choice  
,act of #bjad4  #b4 ,drugs and devices  
for use by terminally ill patients ,the 
,federal ,food1 ,drug1 and ,cosmetic    
,act is amended by inserting after      
section #efa 7#ba ,u4,s4,c4 #cfj;bbb7   
the following3  #efa;,a4 ,drugs and     
devices for use by terminally ill       
patients  7a7 ,in general ,nothing in   
this ,act or section #cea of the ,public
 ,health ,service ,act prevents or      

restricts1 and the ,food and ,drug      
,administration shall not implement or  
enforce any provision of law preventing 
or restricting1 the manufacture1        
importation1 distribution1 or sale of an
 investigational drug or device intended
 for use by a terminally ill patient in 
accordance with subsection 7b74  7b7    
,patient requirements ,in order for an  
investigational drug or device to be    
intended for use in accordance with this
 subsection1 such drug or device must be
 intended for use by a patient who has--
  7#a7 been diagnosed with a terminal   
illness by a licensed physician2  7#b7  
been informed by a licensed physician   
that no drug or device that is lawfully 
marketed in the ,united ,states is      
likely to cure the illness2 and  7#c7   
executed a written informed consent     
document that states--  7,a7 the known  
and potential risks and benefits of such
 drug or device2 and  7,b7 any          
indications of the illness for which a  
drug or device is lawfully marketed1 or 

for which treatment is otherwise        
available1 in the ,united ,states4  7c7 
,prohibition on requiring the           
disclosure1 collection1 and reporting of
 certain information by ,food and ,drug 
,administration  7#a7 ,in general ,the  
,commissioner of ,food and ,drugs may   
not require the disclosure1 collection1 
or reporting of--  7,a7 any information 
related to the delivery1 administration1
 or use of an investigational drug or   
device pursuant to this section2 or     
7,b7 any information related to the     
clinical outcomes experienced by a      
terminally ill patient supplied an      
investigational drug or device pursuant 
to this section4  7#b7 ,exception       
,nothing in this subsection prevents the
 sponsor of a clinical trial from       
voluntarily disclosing1 collecting1 or  
reporting information to the ,food and  
,drug ,administration4  7d7 ,definition 
of investigational drug or device ,in   
this section1 the term investigational  
drug or device means a drug or device   

that--  7#a7 has not yet been approved1 
licensed1 or cleared for commercial     
distribution under section #eje1        
#eaj7k71 or #eae of this ,act or section
 #cea of the ,public ,health ,service   
,act1 and cannot otherwise be lawfully  
marketed in the ,united ,states2 and    
7#b7 is or has been the subject of one  
or more clinical trials4  4  #c4        
,liability protection ,the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cja et seq47 is amended by   
inserting after section #efa;,a1 as     
inserted by section #b of this ,act1 the
 following3  #efa;,b4 ,liability        
protection ,except in the case of gross 
negligence or willful misconduct1 any   
person who manufactures1 imports1       
distributes1 prescribes1 dispenses1 or  
administers an investigational drug or  
device in accordance with section       
#efa;,a shall not be liable in any      
action under ,federal or ,state law for 
any loss1 damage1 or injury arising out 
of1 relating to1 or resulting from--    

7#a7 the design1 development1 clinical  
testing and investigation1              
manufacturing1 labeling1 distribution1  
sale1 purchase1 donation1 dispensing1   
prescription1 administration1 or use of 
the drug or device2 or  7#b7 the safety 
or effectiveness of the drug or device4 
4