,,ii  #aae? ,,congress  #b;d ,session   
,s4 #ceai  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #bg1 #bjah   
,mr4 ,hat* 7= himself & ,mr4 ,b5net7    
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to e/abli% a process = !    
,food & ,drug ,adm9i/ration to det]m9e  
:e!r to modify ! label+ ( drugs ^:      
label+ may be outdat$1 includ+ drugs )  
accept$ uses t are n reflect$ 9 !       
approv$ label+4  #a4 ,%ort title  ,?is  
,act may be cit$ z ! ,mak+ ,objective   
,drug ,evid5ce ,revisions = ,new ,label+
 ,act or ! ,,mod]n ,label+ ,act4  #b4   
,process to update label+ = drugs )     
outdat$ label+ ,*apt] ,v ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cea et seq47 is am5d$ by     
ins]t+ aft] section #ejc;,c ! foll[+3   
#ejc;,d4 ,process to update label+ =    
drugs ) outdat$ label+  7a7 ,def9itions 
,= purposes ( ?is section3 7#a7 ,! t]m  
cov]$ drug means a drug approv$ "u      

section #eje7;c7--  7,a7 = :i* all      
pat5ts & exclusivity p]iods "u ?is *apt]
 h expir$2  7,b7 = :i* ! approval ( !   
label has be5 )drawn2 &  7,c7 ^: label+ 
pot5tially %\ld be modifi$ because--    
7i7 "s aspects ( ! label+ ( ! drug may  
be outdat$ accord+ to evid5ce t1 s9ce ! 
date on :i* ! drug 0 s approv$1 has     
become available reg>d+ ! conditions (  
use reflect$ 9 ! approv$ label+2  7ii7  
!re is a relevant accept$ use 9 cl9ical 
practice t is n reflect$ 9 ! approv$    
label+2 or  7iii7 ! label+ ( su* drug   
does n reflect curr5t legal & regulatory
 requirem5ts4  7#b7 ,! t]m exclusivity  
p]iod1 ) respect to a drug approv$ "u   
section #eje7;c71 means ! p]iod by :i* !
 effective date ( ! approval ( an       
application = a diff]5t drug product    
c\ld be delay$1 or ! diff]5t drug       
product c\ld o!rwise be impact$1 "u     
clause 7ii71 7iii71 or 7iv7 ( section   
#eje7;c77#c77;,e71 clause 7ii71 7iii71  
or 7iv7 ( section #eje7;j77#e77;,f71 or 
section #eje;,a1 #eje;,e1 or #ebg4  7#c7

 ,! t]m g5]ic v]sion means a drug       
approv$ "u section #eje7;j71 ^: ref]5ce 
drug is a cov]$ drug4  7#d7 ,! t]m      
relevant accept$ use means a use = a    
drug 9 cl9ical practice t is support$ by
 evid5ce t c\ld meet ! /&>ds = approval 
"u section #eje4  7#e7 ,! t]m select$   
drug means a cov]$ drug = :i* !         
,secret>y has det]m9$ ?r\gh ! process "u
 subsection 7c7 t ! label+ %\ld be      
updat$ because aspects ( su* label+ are 
outdat$ accord+ to evid5ce t has become 
available reg>d+ ! conditions ( use     
reflect$ 9 ! approv$ label+ or to       
reflect "o or m relevant accept$ uses4  
7b7 ,id5tification ( cov]$ drug c&idates
 = revision ,! ,secret>y may consid]    
requir+ *anges to ! label+ ( drugs :]e  
su* updates w\ld b5efit ! public heal?4 
,to assi/ 9 decid+ :e!r to require      
label+ *anges = cov]$ drugs1 ! ,secret>y
 may d "o or bo? ( ! foll[+3  7#a7 ,ent]
 into coop]ative agreem5ts or contracts 
) public or private entities to review !
 available evid5ce conc]n+ su* drugs4   

7#b7 ,seek public input conc]n+ su*     
drugs1 includ+ input on :e!r !re is a   
relevant accept$ use 9 cl9ical practice 
t is n reflect$ 9 ! approv$ label+ ( su*
 drugs or :e!r aspects ( ! label+ ( su* 
drugs is outdat$ accord+ to evid5ce t   
has become available reg>d+ ! conditions
 ( use reflect$ 9 ! approv$ label+ by-- 
7,a7 hold+ public meet+s2  7,b7 op5+ a  
public docket = ! submission ( public   
comm5ts2 or  7,c7 o!r means1 z !        
,secret>y det]m9es appropriate4  7c7    
,selection ( drugs = updat+ ,if !       
,secret>y det]m9es1 ) respect to a cov]$
 drug1 t ! available evid5ce is         
suffici5t to meet ! /&>ds "u section    
#eje = add+ in=mation to ! label+ or    
modify+ in=mation 9 ! label+ reg>d+ !   
use ( ! cov]$ drug1 ! ,secret>y may     
initiate ! process "u subsection 7d74   
7d7 ,initiation ( ! process ( updat+ ,if
 ! ,secret>y det]m9es t label+ *anges   
are appropriate = a select$ drug        
pursuant to subsection 7c71 ! ,secret>y 
%all provide notice to ! hold]s (       

approv$ applications = a g5]ic v]sion ( 
su* drug t--  7#a7 summ>izes ! f9d+s    
support+ ! det]m9ation ( ! ,secret>y t !
 available evid5ce is suffici5t to meet 
! /&>ds "u section #eje = modify+ !     
label+ ( ! drug pursuant to subsection  
7c72  7#b7 /ates ! modifications to !   
label+ t %\ld be made 9 ord] to reflect 
su* det]m9ation 7includ+1 z applicable1 
modifications to add ! relevant accept$ 
use to ! label+ ( ! drug z an additional
 indication = ! drug72 &  7#c7 /ates    
:e!r ! /atem5t "u p>agraph 7#b7 applies 
to ! select$ drug z a class ( drugs or  
only z to a specific drug product4  7e7 
,response to notification ,)9 #cj days (
 receipt ( notification provid$ by !    
,secret>y pursuant to subsection 7d71 ! 
hold] ( an approv$ application %all--   
7#a7 agree to *ange ! approv$ label+ to 
reflect ! modifications ! ,secret>y has 
det]m9$ are appropriate2 or  7#b7 notify
 ! ,secret>y t ! hold] ( ! approv$      
application does n agree t ! reque/$    
modifications are w>rant$ & submit a    

/atem5t detail+ ! reasons :y su*        
modifications are n w>rant$4  7f7       
,review ( application hold]'s response  
7#a7 ,9 g5]al ,! ,secret>y %all promptly
 review ea* /atem5t receiv$ "u          
subsection 7e77#b7 & det]m9e :i*        
modifications to ! ,secret>y's notice "u
 subsection 7d7 are appropriate1 if any4
  7#b7 ,*anges to label+ ,aft] consid]+ 
a response f a hold] ( an approv$       
application "u p>agraph 7#a7 or 7#b7 (  
subsection 7e71 ! ,secret>y may ord] su*
 hold] to make ! label+ *anges !        
,secret>y det]m9es are appropriate4 ,su*
 hold] ( an approv$ application %all--  
7,a7 update its pap] label+ = ! drug at 
! next pr9t+ ( t label+2  7,b7 update   
any electronic label+ = ! drug )9 #cj   
days2 &  7,c7 submit ! revis$ label+    
?r\gh ! =m1 ,supplem5t--,*anges ,be+    
,effect$4  7g7 ,violation ,if ! hold] ( 
an approv$ application = ! g5]ic v]sion 
( ! select$ drug does n comply ) !      
requirem5ts ( subsection 7f71 su* g5]ic 
v]sion ( ! select$ drug %all be deem$ to

 be misbr&$ "u section #ejb4  7h7       
,limitations2 g5]ic drugs  7#a7 ,9 g5]al
 ,) respect to ! modification ( ! label+
 s\ght ?r\gh a supplem5tal application  
pursuant to subsection 7f77#b77;,c7 !   
manufactur] ( any g5]ic v]sion %all1 by 
reason ( ! /atem5t ( ! ,secret>y "u     
subsection 7d77#b71 be deem$ to h ! same
 conditions ( use & ! same label+ z a   
ref]5ce drug = purposes ( clauses 7i7 & 
7v7 ( section #eje7;j77#b77;,a74 ,!     
approval ( a supplem5tal application    
%all n h any legal effects = ! applicant
 t are diff]5t ?an ! legal effects t    
w\ld h result$ if ! supplem5tal         
application _h be5 submitt$ to con=m !  
label+ ( ! g5]ic v]sion to a *ange 9 !  
label+ ( ! ref]5ce drug4  7#b7          
,supplem5tal applications ,*anges to    
label+ made 9 accordance ) ?is p>agraph 
%all n be eligible = an exclusivity     
p]iod "u ?is ,act4  7i7 ,drug product   
classes ,9 ! case ( a select$ drug = :i*
 ! /atem5t ( ! ,secret>y "u subsection  
7d77#b7 applies to ! select$ drug z a   

class ( drugs1 a supplem5tal application
 pursuant to subsection 7f77#b77;,c7 may
 be submitt$ = ea* su* drug product4    
7j7 ,rule ( con/ruction ,?is section    
%all n be con/ru$ z alt]+ !             
applicability ( any sub/antive approval 
/&>d "u section #eje4  7k7 ,reports ,n  
lat] ?an #d ye>s aft] ! date ( !        
enactm5t ( ! ,mak+ ,objective ,drug     
,evid5ce ,revisions = ,new ,label+ ,act 
& e #d ye>s !reaft]1 ! ,secret>y %all   
prep>e & submit to ! ,committee on      
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives1 a 
report t describes ! actions ( !        
,secret>y "u ?is section & t provides   
any recomm5dations ( ! ,secret>y =      
modify+ ! program "u ?is section1       
includ+ any recomm5dations on :e!r !    
program %\ld apply to a broad] scope (  
drugs4 ,ea* report "u ?is subsection    
%all be made publicly available on !    
,int]net website ( ! ,food & ,drug      
,adm9i/ration4  4