,,ii  #aah? ,,congress  #a/ ,session    
,s4 #ebf  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #af1 #bjbc,mr4
 ,wick] 7= himself & ,ms4 ,klobu*>7     
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to /r5g!n ! use (           
pati5t-exp]i5ce data )9 ! b5efit-risk   
framework = approval ( new drugs4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,bett] ,emp[]m5t ,n[ to ,enhance        
,framework & ,improve ,treatm5ts ,act ( 
#bjbc or ! ,,b5efit ,act ( #bjbc4  #b4  
,/r5g!n+ ! use ( pati5t-exp]i5ce data )9
 risk-b5efit framework ,section #efi;,c 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;bbb-#h;c7 is   
am5d$-- 7#a7 9 subsection 7a77#a7-- 7,a7
 9 subp>agraph 7,a71 by /rik+ 2 & &     
ins]t+ a semicolon2  7,b7 9 subp>agraph 
7,b71 by /rik+ ! p]iod & ins]t+ 2 &2 &  
7,c7 by add+ at ! end ! foll[+3  7,c7 z 
"p ( ! risk-b5efit assessm5t framework 9
 ! new drug approval process describ$ 9 

section #eje7;d71 consid]+ pati5t       
exp]i5ce data submitt$ by ! m$ical      
product sponsor or ano!r p>ty4  2 &     
7#b7 9 subsection 7b77#a71 by ins]t+ 1  
includ+ a description ( h[ su* data &   
in=mation 7 consid]$ 9 ! risk-b5efit    
assessm5t describ$ 9 section #eje7;d7   
be=e ! p]iod at ! end4