,,ii  #aag? ,,congress  #b;d ,session   
,s4 #cegf  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,febru>y #c1 #bjbb,mr4 
,braun 7= himself & ,mr4 ,paul7         
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to all[ sponsors ( c]ta9 new
 drug applications to rely ^u           
inve/igations conduct$ 9 c]ta9 =eign    
c\ntries1 & = o!r purposes4  #a4 ,%ort  
title ,?is ,act may be cit$ z !         
,accel]at$ ,drug ,approval =            
,prescription ,!rapies #b4j ,act or !   
,,adapt #b4j ,act4  #b4 ,drugs approv$ 9
 c]ta9 =eign c\ntries  7a7 ,9 g5]al     
,section #eje ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is 
am5d$-- 7#a7 9 subsection 7b71 by add+  
at ! end ! foll[+3  7#g7 ,an application
 describ$ 9 p>agraph 7#b7 may rely ^u   
inve/igations conduct$ 9 a c\ntry li/$  
"u section #hjb7;b77#a77;,a7 or         
designat$ "u section #hjb7;b77#a77;,b71 
includ+ prem>ket cl9ical & noncl9ical   

inve/igations & po/m>ket surveillance   
/udies1 if ! drug t is ! subject ( su*  
application has be5 approv$ 9 su*       
c\ntry4  2 &  7#b7 9 subsection 7c7--   
7,a7 9 p>agraph 7#a71 by /rik+ ,)9 &    
ins]t+ ,except z provid$ 9 p>agraph     
7#f71 )92 &  7,b7 by add+ at ! end !    
foll[+3  7#f7 7,a7 ,9 ! case ( an       
application t relies on inve/igations   
conduct$ 9 a =eign c\ntry1 z describ$ 9 
subsection 7b77#g71 )9 #ij days aft] !  
fil+ ( su* application "u subsection    
7b71 ! ,secret>y %all approve !         
application if ! ,secret>y det]m9es     
evid5ce t-- 7i7 at ! "t ( application1 !
 drug is au?oriz$ to be m>ket$ 9 a      
c\ntry li/$ "u section #hjb7;b77#a77;,a7
 or designat$ "u section                
#hjb7;b77#a77;,b72  7ii7 ! drug is safe 
& cl9ically effective2  7iii7 !         
manufactur] is capable ( manufactur+ !  
drug safely & consi/5tly1 & c ensure !  
safety ( ! supply *a9 outside ! ,unit$  
,/ates2  7iv7 all relevant ,unit$ ,/ates
 pat5ts or legal p]iods ( exclusivity   

are expir$2  7v7 abs5t reciprocal m>ket+
 approval1 ! drug is n approv$ = m>ket+ 
9 ! ,unit$ ,/ates2  7vi7 ! ,secret>y has
 n1 because ( any conc]n relat+ to      
safety or effectiv5ess1 resc9d$ or      
)drawn any su* approval2 &  7vii7 !     
,secret>y f9ds t none ( ! gr\nds = d5y+ 
approval specifi$ 9 subsection 7d7      
applies4  7,b7 ,limitations ,approval ( 
a drug "u ?is section may1 z ! ,secret>y
 det]m9es appropriate1 be subject to #a 
or bo? ( ! foll[+ requirem5ts3 7i7 ,!   
sponsor conduct appropriate po/approval 
/udies to v]ify & describe ! pr$ict$    
effect ( ! drug on irrev]sible morbidity
 or mortality or ano!r cl9ical b5efit ( 
! drug4  7ii7 ,! sponsor submit copies (
 all promotional mat]ials relat$ to !   
drug dur+ ! preapproval review p]iod &1 
foll[+ approval & = su* p]iod !reaft] z 
! ,secret>y det]m9es to be appropriate1 
at lea/ #cj days prior to ! dissem9ation
 ( ! mat]ials4  7,c7 ,timel9e ,if !     
,secret>y does n approve ! application  
or take su* o!r action )9 su* #ij-;day  

p]iod1 ! application %all be consid]$   
approv$ "u ?is subsection4  7,d7        
,advisory committee  7i7 ,e/abli%m5t ,= 
! purpose ( provid+ exp]t sci5tific     
advice & recomm5dations to ! ,secret>y  
reg>d+ ! approval ( applications        
describ$ 9 subsection 7b77#g71 !        
,secret>y %all e/abli% a /&+ ,=eign     
,drug ,review ,advisory ,committee4     
7ii7 ,memb]%ip ,! /&+ ,=eign ,drug      
,review ,advisory ,committee e/abli%$ "u
 clause 7i7 %all consi/ ( employees ( ! 
,food & ,drug ,adm9i/ration &           
individuals appo9t$ by ! ,secret>y1     
reflect+ a balanc$ composition (        
suffici5t sci5tific exp]tise4 ,!        
,secret>y %all appo9t memb]s :o h div]se
 int]e/s1 education1 tra9+1 exp]i5ce1 & 
exp]tise 9 bioph>macology1 /ati/ics1    
*emi/ry1 legal issues1 e?ics1 & o!r     
appropriate exp]tise p]ta9+ to ! drugs  
"u review1 su* z exp]tise 9 =eign       
regulatory & manufactur+ practices &    
drug developm5t1 & o!r individuals1 z ! 
,secret>y det]m9es appropriate4  7iii7  

,review ( applications ,^u ! fil+ ( an  
application describ$ 9 subsection       
7b77#g7-- 7,i7 ! ,secret>y %all         
imm$iately ref] ! application to !      
,=eign ,drug ,review ,advisory          
,committee = review2 &  7,,ii7 )9 #fj   
days aft] ! receipt by su* advisory     
committee ( su* application1 ! advisory 
committee %all provide ! ,secret>y )    
recomm5dations ) respect to su*         
application4  7,e7 ,publication ( f9al  
decision ,! ,secret>y %all make         
publically available1 on ! website ( !  
,food & ,drug ,adm9i/ration1 ea* f9al   
decision on :e!r to approve an          
application describ$ 9 subsection       
7b77#g71 includ+ ! rationale = !        
decision & ! recomm5dations &           
conclusions ( ! ,=eign ,drug ,review    
,advisory ,committee "u subp>agraph     
7,d77iii74  4  7b7 ,te*nical am5dm5t    
,section #hjb7;b77#a77;,a77i7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #chb7;b77#a77;,a77i77 is am5d$
 by /rik+ or ,s\? ,africa & ins]t+ ,s\? 

,africa1 or ! ,unit$ ,k+dom4