,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #fifc  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #g1 #bjbb,mr4    
,pallone introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act to /r5g!n
 requirem5ts = po/approval /udies =     
drugs approv$ us+ accel]at$ approval1 & 
= o!r purposes4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,accel]at$         
,approval ,integrity ,act ( #bjbb4  #b4 
,po/approval /udies requir$ = accel]at$ 
approval drugs  7a7 ,9 g5]al ,section   
#ejf7;c7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77 
is am5d$-- 7#a7 9 p>agraph 7#b7-- 7,a7 9
 ! matt] prec$+ subp>agraph 7,a71 by    
/rik+ may be subject to #a or bo? ( &   
ins]t+ %all be subject to2  7,b7 by     
am5d+ subp>agraph 7,a7 to read z foll[s3
  7,a7 ,po/approval /udies  7i7 ,9 g5]al
 ,! sponsor ( a product approv$ "u      
accel]at$ approval %all-- 7,i7 conduct  
appropriate1 adequate1 & well-controll$ 

po/approval /udies to v]ify & describe !
 pr$ict$ effect on irrev]sible morbidity
 or mortality or o!r cl9ical b5efit2 &  
7,,ii7 submit reports on su* /udies 9   
accordance ) section #ejf;,b4  7ii7     
,agreem5t ,! ,secret>y & ! sponsor %all 
ent] into an agreem5t reg>d+ ! requir$  
conduct ( su* /udies prior to !         
,secret>y approv+ a product "u accel]at$
 approval4 ,su* agreem5t may include    
requirem5ts reg>d+ enrollm5t t>gets1    
/udy protocol1 & mile/ones1 includ+ !   
t>get date ( /udy completion4  7iii7    
,/udies begun be=e approval ,! ,secret>y
 may-- 7,i7 require su* /udies to be    
und]way prior to approval2 &  7,,ii7    
refuse to approve a product "u accel]at$
 approval until su* /udies are und]way4 
2 &  7,c7 9 subp>agraph 7,b71 by /rik+  
7,b7 ,t ! sponsor & ins]t+ ! foll[+3    
7,b7 ,promotional mat]ials ,! sponsor ( 
a product approv$ "u accel]at$ approval 
%all  2 &  7#b7 by /rik+ p>agraph 7#c7 &
 ins]t+ ! foll[+3  7#c7 ,exp$it$ )drawal
 ( approval  7,a7 ,9 g5]al ,! ,secret>y 

may )draw approval ( a product approv$  
"u accel]at$ approval us+ exp$it$       
proc$ures describ$ 9 subp>agraph 7,b71  
if-- 7i7 ! sponsor fails to conduct any 
requir$ po/approval /udy ( ! product )  
due dilig5ce2  7ii7 ! sponsor fails to  
a*ieve agre$ ^u enrollm5t t>gets1       
mile/ones1 or timely /udy completion2   
7iii7 ! sponsor fails to submit reports 
9 accordance ) section #ejf;,b2  7iv7 a 
/udy requir$ to v]ify & describe !      
pr$ict$ effect on irrev]sible morbidity 
or mortality or o!r cl9ical b5efit ( !  
product fails to v]ify & describe su*   
effect or b5efit2  7v7 o!r evid5ce      
demon/rates t ! product is n %[n to be  
safe or effective "u ! conditions ( use2
 or  7vi7 ! sponsor dissem9ates false or
 mislead+ promotional mat]ials ) respect
 to ! product4  7,b7 ,exp$it$ proc$ures 
describ$ ,exp$it$ proc$ures describ$ 9  
?is subp>agraph-- 7i7 %all consi/ (--   
7,i7 provid+ ! sponsor due notice & an  
opportunity = writt5 appeal to !        
,commission] ( ,food & ,drugs2 &  7,,ii7

 an opportunity = public comm5t on !    
notice propos+ to )draw approval2 &     
7ii7 may include1 at ! ,secret>y's      
discretion1 conv5+ & consult+ an        
advisory committee4  7,c7 ,automatic    
expiration ,! approval ( a product      
approv$ "u accel]at$ approval aft] !    
date ( enactm5t ( ! ,accel]at$ ,approval
 ,integrity ,act ( #bjbb %all           
automatically expire #a ye> aft] any    
t>get date ( /udy completion includ$ 9  
an agreem5t describ$ 9 clause 7ii7 (    
p>agraph 7#b77;,a71 & 9 no case lat] ?an
 #e ye>s aft] ! date on :i* ! product is
 approv$1 unless-- 7i7 a /udy requir$ to
 v]ify & describe ! pr$ict$ effect on   
irrev]sible morbidity or mortality or   
o!r cl9ical b5efit ( ! product has      
v]ifi$ t pr$ict$ effect2 or  7ii7 !     
,secret>y has det]m9$ t adequate        
progress has be5 made on completion (   
po/approval /udies requir$ "u p>agraph  
7#b77;,a74  7#d7 ,label+  7,a7 ,9 g5]al 
,subject to subp>agraph 7,b71 ! label = 
a product approv$ "u accel]at$ approval 

%all include-- 7i7 a /atem5t indicat+ t 
! product 0 approv$ "u accel]at$        
approval2  7ii7 a /atem5t indicat+ t    
cont9u$ approval ( ! product is subject 
to po/m>ket+ /udies to v]ify cl9ical    
b5efit2  7iii7 id5tification ( ! cl9ical
 endpo9t t is "u /udy & any kn[n        
limitations ( t surrogate or int]m$iate 
endpo9t 9 det]m9+ cl9ical b5efit2  7iv7 
a succ9ct description ( ! product & any 
unc]ta9ty ab\t anticipat$ cl9ical b5efit
 & a discussion ( available evid5ce )   
respect to su* cl9ical b5efit2 &  7v7   
any o!r in=mation requir$ by ! ,secret>y
 9 ! ord] approv+ ! product4  7,b7      
,applicability ,! label+ requirem5ts (  
subp>agraph 7,a7 %all apply only to     
products approv$ "u accel]at$ approval =
 :i* ! pr$ict$ effect on irrev]sible    
morbidity or mortality or o!r cl9ical   
b5efit has n be5 v]ifi$4  4  7b7        
,reports ( po/m>ket+ /udies ,section    
#ejf;,b7a7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;b7a77
 is am5d$-- 7#a7 by r$esignat+ p>agraph 

7#b7 z p>agraph 7#c72 &  7#b7 by ins]t+ 
aft] p>agraph 7#a7 ! foll[+3  7#b7      
,accel]at$ approval ,not)/&+ p>agraph   
7#a71 a sponsor ( a drug approv$ "u     
accel]at$ approval %all submit to !     
,secret>y a report ( ! progress ( any   
/udy requir$ "u section #ejf7;c71       
includ+ progress t[>d any agre$ ^u      
enrollm5t t>gets1 mile/ones1 & o!r      
in=mation z requir$ by ! ,secret>y1 n   
lat] ?an #ij days aft] ! approval ( su* 
drug & n less frequ5tly ?an e #ij days  
!reaft]1 until ! /udy is complet$ or    
t]m9at$4  4  7c7 ,en=cem5t ,section #cja
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cca7 is am5d$ by   
ins]t+ aft] p>agraph 7eee7 ! foll[+3    
7fff7 ,! failure ( a sponsor ( a product
 approv$ "u accel]at$ approval pursuant 
to section #ejf7;c7-- 7#a7 to conduct ) 
due dilig5ce any po/approval /udy       
requir$ "u section #ejf7;c7 ) respect to
 su* product2 or  7#b7 to submit timely 
reports ) respect to su* product 9      
accordance ) section #ejf;,b7a77#b74  4