,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #feh  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #e1 #bjai ,mr4    
,braun introduc$ ! foll[+ bill2 :i* 0   
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to provide = an accel]at$   
approval pa?way = c]ta9 drugs t are     
au?oriz$ to be lawfully m>ket$ 9 o!r    
c\ntries4  #a4 ,%ort title  ,?is ,act   
may be cit$ z ! ,accel]at$ ,drug        
,approval = ,prescription ,!rapies ,act 
or ! ,,adapt ,act4  #b4 ,accel]at$      
approval ( c]ta9 drugs t are au?oriz$ to
 be lawfully m>ket$ 9 o!r c\ntries      
,*apt] ,v ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cea et   
seq47 is am5d$ by ins]t+ aft] section   
#ejf ! foll[+3  #ejf-a4 ,accel]at$      
approval ( c]ta9 drugs t are au?oriz$ to
 be lawfully m>ket$ 9 o!r c\ntries  7a7 
,9 g5]al ,! ,secret>y may approve an    
application = approval = a drug "u      
subsection 7c7 or 7j7 ( section #eje t  
is curr5tly au?oriz$ to be m>ket$ 9 "o  

or m ( ! c\ntries includ$ 9 ! li/ "u    
section #hjb7;b77#a71 ^u a det]m9ation  
by ! ,secret>y t ! sponsor has submitt$ 
evid5ce suffici5t to demon/rate all ( ! 
crit]ia "u subsection 7b77#a74  7b7     
,crit]ia  7#a7 ,9 g5]al ,! ,secret>y may
 approve a drug "u subsection 7a7 only  
if ! ,secret>y det]m9es t !re is evid5ce
 t--  7,a7 at ! "t ( application1 ! drug
 is au?oriz$ to be m>ket$ 9 a c\ntry    
includ$ 9 ! li/ "u section #hjb7;b77#a72
  7,b7 ! drug is safe & cl9ically       
effective & has a satisfactory hi/ory ( 
cl9ical trials & data2  7,c7 !          
manufactur] is capable ( manufactur+ !  
drug safely & consi/5tly1 & c assure !  
safety ( ! supply *a9 outside ! ,unit$  
,/ates2  7,d7 all relevant ,unit$ ,/ates
 pat5ts or legal exclusivities are      
expir$2  7,e7 abs5t reciprocal m>ket+   
approval1 ! drug is n approv$ = m>ket+ 9
 ! ,unit$ ,/ates2  7,f7 ! ,secret>y has 
n1 because ( any conc]n relat+ to safety
 or effectiv5ess1 resc9d$ or )drawn any 
su* approval2 &  7,g7 !re is a public   

heal? or unmet m$ical ne$ = ! drug 9 !  
,unit$ ,/ates4  7#b7 ,limitation        
,approval ( a drug "u ?is section may1 z
 ! ,secret>y det]m9es appropriate1 be   
subject to #a or bo? ( ! foll[+         
requirem5ts3  7,a7 ,! sponsor conduct   
appropriate po/approval /udies to v]ify 
& describe ! pr$ict$ effect on          
irrev]sible morbidity or mortality or   
o!r cl9ical b5efit ( ! drug4  7,b7 ,!   
sponsor submit copies ( all promotional 
mat]ials relat$ to ! product 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  7c7 ,timel9e ,! ,secret>y   
%all make a det]m9ation on an           
application describ$ 9 subsection 7a7 n 
lat] ?an #ahj days aft] ! date (        
submission ( su* application4  4