,,ii  #aae? ,,congress  #a/ ,session    
,s4 #bjd  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,janu>y #bd1 #bjag,mr4 
,johnson 7= himself1 ,mr4 ,b>rasso1 ,mr4
 ,blunt1 ,mr4 ,boozman1 ,mrs4 ,capito1  
,mr4 ,co*ran1 ,mr4 ,cork]1 ,mr4 ,cotton1
 ,mr4 ,crapo1 ,mr4 ,cruz1 ,mr4 ,da9es1  
,mr4 ,donnelly1 ,mr4 ,enzi1 ,mrs4       
,fis*]1 ,mr4 ,flake1 ,mr4 ,g>dn]1 ,mr4  
,graham1 ,mr4 ,grassley1 ,mr4 ,hat*1    
,mr4 ,hell]1 ,mr4 ,hoev51 ,mr4 ,inh(e1  
,mr4 ,isakson1 ,mr4 ,k5n$y1 ,mr4 ,k+1   
,mr4 ,lank=d1 ,mr4 ,lee1 ,mr4 ,man*91   
,mr4 ,mc,cain1 ,mr4 ,mc,connell1 ,mr4   
,moran1 ,ms4 ,murk[ski1 ,mr4 ,paul1 ,mr4
 ,p]due1 ,mr4 ,ris*1 ,mr4 ,r\nds1 ,mr4  
,rubio1 ,mr4 ,sasse1 ,mr4 ,%elby1 ,mr4  
,sullivan1 ,mr4 ,tillis1 ,mr4 ,toomey1  
,mr4 ,wick]1 & ,mr4 ,"y7 introduc$ !    
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,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 ! ,trickett ,w5dl] ,"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/$1 or o!rwise does n meet qualify+
 crit]ia to receive1 any o!r available  
treatm5t options4  7b7 ,no liability or 
use ( outcomes  7#a7 ,no liability      
,not)/&+ any o!r provision ( law1 no    
liability %all lie aga9/ a produc]1     
manufactur]1 di/ributor1 prescrib]1     
disp5s]1 possessor1 or us] ( an         
exp]im5tal drug1 biological product1 or 
device = ! production1 manufacture1     
di/ribution1 prescrib+1 disp5s+1        
possession1 or use ( an exp]im5tal drug1
 biological product1 or device t is 9   
compliance ) subsection 7a74  7#b7 ,no  
use ( outcomes ,not)/&+ any o!r         
provision ( law1 ! outcome ( any        
production1 manufacture1 di/ribution1   
prescrib+1 disp5s+1 possession1 or use (
 an exp]im5tal drug1 biological product1
 or device t 0 done 9 compliance )      
subsection 7a7 %all n be us$ 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$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cba74  7#c7 ,exp]im5tal
 drug1 biological product1 or device ,! 
t]m exp]im5tal drug1 biological product1
 or device means a drug1 biological     
product1 or device t-- 7,a7 has         
successfully complet$ 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 or ,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