,i  #aacth ,,congress  #b;d ,session    
,h4 ,r4 #ehed  ,,in ,,the ,,house ,,of  
,,representatives  ,december #aa1 #bjad 
,mr4 ,grayson introduced the following  
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,to allow the importation1      
distribution1 and sale of               
investigational drugs and devices       
intended for use by terminally ill      
patients who execute an informed consent
 document4  #a4 ,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 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 
,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 ,act 7#db ,u4,s4,c4 #bfb71 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