,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #hgh  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,febru>y #f1 #bjag    
,mr4 ,biggs 7= himself1 ,mr4            
,fitzpatrick1 ,mr4 ,cram]1 ,mr4         
,gro?man1 ,mr4 ,mess]1 ,mr4 ,pitt5g]1   
,mr4 ,/ew>t1 ,mr4 ,lance1 ,mr4 ,olson1  
,mr4 ,franks ( ,arizona1 ,mr4 ,lamborn1 
,mr4 ,c>son ( ,indiana1 ,ms4 ,mc,sally1 
,mr4 ,yoho1 ,mr4 ,rohraba*]1 ,mr4       
,duncan ( ,s\? ,c>ol9a1 ,mr4 ,lewis (   
,m9nesota1 ,mr4 ,b>r1 ,mr4 ,brid5/9e1   
,mr4 ,gohm]t1 ,mr4 ,banks ( ,indiana1   
,mr4 ,smuck]1 ,mr4 ,brat1 ,mr4          
,s5s5br5n]1 ,mr4 ,s*weik]t1 ,mr4 ,m>9o1 
,mr4 ,rokita1 & ,mr4 ,issa7 introduc$ ! 
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce1 & 9    
addition to ! ,committee on ! ,judici>y1
 = a p]iod to be subsequ5tly det]m9$ by 
! ,speak]1 9 ea* case = consid]ation (  
su* provisions z fall )9 ! jurisdiction 
( ! committee conc]n$  ,a ,,bill  ,to   
au?orize ! use ( unapprov$ m$ical       
products by pati5ts diagnos$ ) a t]m9al 

illness 9 accordance ) ,/ate law1 & =   
o!r purposes4  #a4 ,%ort title  ,?is    
,act may be cit$ z ! ,"r to ,try ,act ( 
#bjag4  #b4 ,use ( unapprov$ m$ical     
products by pati5ts diagnos$ ) a t]m9al 
illness  7a7 ,9 g5]al ,not)/&+ ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cja et seq471 ! ,controll$   
,sub/ances ,act 7#ba ,u4,s4,c4 #hja et  
seq471 & any o!r provision ( ,f$]al law1
 ! ,f$]al ,gov]nm5t %all n take any     
action to prohibit or re/rict-- 7#a7 !  
production1 manufacture1 di/ribution1   
prescrib+1 or disp5s+ ( an exp]im5tal   
drug1 biological product1 or device t-- 
7,a7 is int5d$ to treat a pati5t :o has 
be5 diagnos$ ) a t]m9al illness2 &  7,b7
 is au?oriz$ by1 & 9 accordance )1 ,/ate
 law2 &  7#b7 ! possession or use ( an  
exp]im5tal drug1 biological product1 or 
device-- 7,a7 t is describ$ 9           
subp>agraphs 7,a7 & 7,b7 ( p>agraph     
7#a72 &  7,b7 = :i* ! pati5t has receiv$
 a c]tification f a physician1 :o is 9  
good /&+ ) ! physician's c]tify+        

organization or bo>d1 t ! pati5t has    
exhau/$1 or o!rwise does n meet qualify+
 crit]ia to receive1 any o!r available  
treatm5t options4  7b7 ,no liability or 
use ( outcomes  7#a7 ,no liability      
,not)/&+ any o!r provision ( law1 no    
liability %all lie aga9/ a produc]1     
manufactur]1 di/ributor1 prescrib]1     
disp5s]1 possessor1 or us] ( an         
exp]im5tal drug1 biological product1 or 
device = ! production1 manufacture1     
di/ribution1 prescrib+1 disp5s+1        
possession1 or use ( an exp]im5tal drug1
 biological product1 or device t is 9   
compliance1 ) subsection 7a74  7#b7 ,no 
use ( outcomes ,not)/&+ any o!r         
provision ( law1 ! outcome ( any        
production1 manufacture1 di/ribution1   
prescrib+1 disp5s+1 possession1 or use (
 an exp]im5tal drug1 biological product1
 or device t 0 done 9 compliance )      
subsection 7a7 %all n be us$ by a ,f$]al
 ag5cy review+ ! exp]im5tal drug1       
biological product1 or device to delay  
or o!rwise adv]sely impact review or    

approval ( su* exp]im5tal drug1         
biological product1 or device4  7c7     
,def9itions ,9 ?is section3 7#a7        
,biological product ,! t]m biological   
product has ! mean+ giv5 to su* t]m 9   
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb74  7#b7        
,device2 drug ,! t]ms device & drug h ! 
mean+s giv5 to su* t]ms 9 section #bja (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cba74  7#c7 ,exp]im5tal
 drug1 biological product1 or device ,! 
t]m exp]im5tal drug1 biological product1
 or device t-- 7,a7 has successfully    
complet$ a phase #a cl9ical             
inve/igation2  7,b7 rema9s "u           
inve/igation 9 a cl9ical trial approv$  
by ! ,food & ,drug ,adm9i/ration2 &     
7,c7 is n approv$1 lic5s$1 or cle>$ =   
comm]cial di/ribution "u section #eje1  
#eaj7k71 or #eae ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee1 #cfj7k71 #cfj7;e77 or section #cea
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bfb74  7#d7 ,phase #a cl9ical

 inve/igation ,! t]m phase #a cl9ical   
inve/igation means a phase #a cl9ical   
inve/igation1 z describ$ 9 section      
#cab4ba ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations74  7#e7 ,t]m9al illness ,!  
t]m t]m9al illness has ! mean+ giv5 to  
su* t]m 9 ! ,/ate law specifi$ 9        
subsection 7a77#a77;,b74