,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #ahig  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #ai1 #bjai ,mr4  
,b5net 7= himself & ,mr4 ,enzi7         
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to e/abli% a process =      
updat+ ! label+ ( c]ta9 drugs ) outdat$ 
label+4  #a4 ,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* !re are  
no unexpir$ pat5ts includ$ 9 ! li/ "u   
section #eje7;j77#g7 & no unexpir$ p]iod
 ( m>ket exclusivity2  7,b7 = :i* !     
approval ( ! application has be5 )drawn 
= reasons o!r ?an safety or             
effectiv5ess2 &  7,c7 = :i*1 ) respect  

to ! label+-- 7i7 new sci5tific evid5ce 
is available reg>d+ ! conditions ( use (
 ! drug2  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    
p]iod ( m>ket exclusivity1 ) respect to 
a drug approv$ "u section #eje7;c71     
means any p]iod ( m>ket exclusivity "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;j7 ^: 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
 sci5tific evid5ce t appe>s to !        
,secret>y to 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 *ang$4  7b7      

,id5tification ( cov]$ drugs ,!         
,secret>y may id5tify cov]$ drugs = :i* 
label+ updates w\ld provide a public    
heal? b5efit4 ,to assi/ 9 id5tify+ 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  
sci5tific 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 new sci5tific evid5ce is 
available reg>d+ ! conditions ( use =   
su* drug1 by--  7,a7 hold+ "o or m      
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 sci5tific evid5ce meets !     
/&>ds "u section #eje = add+ or modify+ 
in=mation to ! label+ or provid+        

supplem5tal in=mation to ! 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 sci5tific evid5ce meets !    
/&>ds "u section #eje = add+ or modify+ 
in=mation or provid+ supplem5tal        
in=mation to ! label+ ( ! cov]$ drug    
pursuant to subsection 7c72  7#b7       
provides a cle> /atem5t reg>d+ !        
additional1 modifi$1 or supplem5tal     
in=mation = su* label+1 accord+ to !    
det]m9ation by ! ,secret>y 7includ+1 z  
applicable1 modifications to add !      
relevant accept$ 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 ( cov]$ 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 = a g5]ic v]sion ( 
! select$ drug %all--  7#a7 agree to    
*ange ! approv$ label+ to reflect !     
additional1 modifi$1 or supplem5tal     
in=mation ! ,secret>y has det]m9$ to be 
appropriate2 or  7#b7 notify ! ,secret>y
 t ! hold] ( ! approv$ application does 
n believe t ! reque/$ label+ *anges are 
w>rant$ & submit a /atem5t detail+ !    
reasons :y su* *anges are n w>rant$4    
7f7 ,review ( application hold]'s       
response  7#a7 ,9 g5]al ,^u receipt ( ! 
application hold]'s response1 !         
,secret>y %all promptly review ea*      
/atem5t receiv$ "u subsection 7e77#b7 & 
det]m9e :i* label+ *anges pursuant to ! 
,secret>y's notice "u subsection 7d7 are
 appropriate1 if any4 ,if ! ,secret>y   
disagrees ) ! reasons :y su* label+     
*anges are n w>rant$1 ! ,secret>y %all  

provide opportunity = discussions ) !   
application hold]s to rea* agreem5t on  
:e!r ! label+ = ! cov]$ drug %\ld be    
updat$ to reflect curr5t sci5tific      
evid5ce1 & if s1 ! cont5t ( su* label+  
*anges4  7#b7 ,*anges to label+ ,aft]   
consid]+ all responses f ! hold] ( an   
approv$ application "u p>agraph 7#a7 or 
7#b7 ( subsection 7e71 & any discussion 
"u p>agraph 7#a71 ! ,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 7f77#b71 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 any label+ *ange    
requir$ "u ?is section1 ! g5]ic v]sion  
%all be deem$ to h ! same conditions (  
use & ! same label+ z a ref]5ce drug =  
purposes ( clauses 7i7 & 7v7 ( section  
#eje7;j77#b77;,a74 ,any label+ *ange s  
requir$ %all n h any legal effect = !   
applicant t is diff]5t ?an ! legal      
effect t w\ld h result$ if a supplem5tal
 application _h be5 submitt$ & approv$  
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*
 ! label+ *anges ord]$ by ! ,secret>y "u
 subsection 7d77#b7 are requir$ = a     
class ( cov]$ drugs1 su* label+ *anges  
%all be made = g5]ic v]sions ( su* drug 
9 t class4  7j7 ,rules ( con/ruction    
7#a7 ,approval /&>ds ,?is section %all n
 be con/ru$ z alt]+ ! applicability ( ! 
/&>ds = approval ( an application "u    

section #eje4 ,no ord] %all be issu$ "u 
?is subsection unless ! evid5ce support+
 ! *ang$ label+ meets ! /&>ds = approval
 applicable to any *ange to label+ "u   
section #eje4  7#b7 ,removal ( in=mation
 ,no?+ 9 ?is section %all be con/ru$ to 
give ! ,secret>y additional au?ority to 
remove approv$ indications = drugs1 o!r 
?an ! au?ority to remove c]ta9          
indications f ! labels ( c]ta9 cov]$    
drugs1 z describ$ 9 ?is section4  7k7   
,reports ,n lat] ?an #d ye>s aft] ! date
 ( ! enactm5t ( ?is section & 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--  7#a7 describes ! actions ( !
 ,secret>y "u ?is section1 includ+--    
7,a7 ! numb] ( cov]$ drugs & description
 ( ! types ( drugs ! ,secret>y has      
select$ = label+ *anges & ! rationale = 
su* recomm5d$ *anges2 &  7,b7 ! numb] ( 
times ! ,secret>y ent]$ into discussions

 conc]n+ a disagreem5t ) an application 
hold] or hold]s & a summ>y ( ! decision 
reg>d+ a label+ *ange1 if any2 &  7#b7  
includes any recomm5dations ( !         
,secret>y = modify+ ! program "u ?is    
section4  4