,,ii  #aae? ,,congress  #a/ ,session    
,s4 #aeji  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #bi1 #bjag,mr4   
,hat* 7= himself & ,mr4 ,m55dez7        
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to au?orize an  
ext5sion ( exclusivity p]iods = c]ta9   
drugs t are approv$ = a new indication =
 a r>e disease or condition1 & = o!r    
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,orphan ,products ,ext5sion
 ,n[ ,accel]at+ ,cures & ,treatm5ts ,act
 ( #bjag4  #b4 ,ext5sion ( exclusivity  
p]iods = a drug approv$ = a new         
indication = a r>e disease or condition 
7a7 ,9 g5]al ,! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act is am5d$ by ins]t+ aft]  
section #eje;,f ( su* ,act 7#ba         
,u4,s4,c4 #cee;g7 ! foll[+3  #eje;,g4   
,ext5sion ( exclusivity p]iods = a drug 
approv$ = a new indication = a r>e      
disease or condition  7a7 ,designation  

7#a7 ,9 g5]al ,! ,secret>y %all         
designate a drug z a drug approv$ = a   
new indication to prev5t1 diagnose1 or  
treat a r>e disease or condition =      
purposes ( grant+ ! ext5sions "u        
subsection 7b7 if--  7,a7 prior to      
approval ( an application or supplem5tal
 application = ! new indication1 ! drug 
0 approv$ or lic5s$ "u section #eje7;c7 
( ?is ,act or section #cea7;a7 ( !      
,public ,heal? ,s]vice ,act b 0 n s     
approv$ or lic5s$ = ! new indication2   
7,b7 7i7 ! sponsor ( ! approv$ or lic5s$
 drug files an application or a         
supplem5tal application = approval ( !  
new indication = use ( ! drug to prev5t1
 diagnose1 or treat ! r>e disease or    
condition2 &  7ii7 ! ,secret>y approves 
! application or supplem5tal            
application2 &  7,c7 ! application or   
supplem5tal application = ! new         
indication conta9s ! cons5t ( !         
applicant to public notice "u p>agraph  
7#c7 ) respect to ! designation ( !     
drug4  7#b7 ,revocation ( designation   

7,a7 ,9 g5]al ,except z provid$ 9       
subp>agraph 7,b71 a designation "u      
p>agraph 7#a7 %all n be revok$ = any    
reason4  7,b7 ,exception ,! ,secret>y   
may revoke a designation ( a drug "u    
p>agraph 7#a7 if ! ,secret>y f9ds t !   
application or supplem5tal application  
result+ 9 su* designation conta9$ an    
untrue /atem5t ( mat]ial fact4  7#c7    
,notice to public ,! ,secret>y %all     
provide public notice ( ! designation ( 
a drug "u p>agraph 7#a74  7b7 ,ext5sion 
7#a7 ,9 g5]al ,if ! ,secret>y designates
 a drug z a drug approv$ = a new        
indication = a r>e disease or condition1
 z describ$ 9 subsection 7a77#a7--  7,a7
 7i7 ! #d-1 #e-1 & #g-ye> p]iods        
describ$ 9 subsections 7c77#c77;,e77ii7 
& 7j77#e77;,f77ii7 ( section #eje1 !    
#c-ye> p]iods describ$ 9 clauses 7iii7 &
 7iv7 ( subsection 7c77#c77;,e7 &       
clauses 7iii7 & 7iv7 ( subsection       
7j77#e77;,f7 ( section #eje1 & ! #g-ye> 
p]iod describ$ 9 section #ebg1 z        
applicable1 %all be ext5d$ by #f mon?s2 

or  7ii7 ! #d- & #ab-ye> p]iods describ$
 9 subp>agraphs 7,a7 & 7,b7 ( section   
#cea7k77#g7 ( ! ,public ,heal? ,s]vice  
,act & ! #g-ye> p]iod describ$ 9 section
 #ebg1 z applicable1 %all be ext5d$ by  
#f mon?s2 &  7,b7 7i7 if ! drug is !    
subject ( a li/$ pat5t = :i* a          
c]tification has be5 submitt$ "u        
subsection 7b77#b77;,a77ii7 or          
7j77#b77;,a77vii77,,ii7 ( section #eje  
or a li/$ pat5t = :i* a c]tification has
 be5 submitt$ "u subsection             
7b77#b77;,a77iii7 or                    
7j77#b77;,a77vii77,,iii7 ( section #eje1
 ! p]iod dur+ :i* an application may n  
be approv$ "u section #eje7;c77#c7 or   
section #eje7;j77#e77;,b7 %all be ext5d$
 by a p]iod ( #f mon?s aft] ! date !    
pat5t expires 7includ+ any pat5t        
ext5sions72 or  7ii7 if ! drug is !     
subject ( a li/$ pat5t = :i* a          
c]tification has be5 submitt$ "u        
subsection 7b77#b77;,a77iv7 or          
7j77#b77;,a77vii77,,iv7 ( section #eje1 
& 9 ! pat5t infr+em5t litigation result+

 f ! c]tification ! c\rt det]m9es t !   
pat5t is valid & w\ld be infr+$1 ! p]iod
 dur+ :i* an application may n be       
approv$ "u section #eje7;c77#c7 or      
section #eje7;j77#e77;,b7 %all be ext5d$
 by a p]iod ( #f mon?s aft] ! date !    
pat5t expires 7includ+ any pat5t        
ext5sions74  7#b7 ,relation to p$iatric 
& qualifi$ infecti\s disease product    
exclusivity ,any ext5sion "u p>agraph   
7#a7 ( a p]iod %all be 9 addition to any
 ext5sion ( ! p]iods "u sections #eje;,a
 & #eje;,e ( ?is ,act & section #cea7m7 
( ! ,public ,heal? ,s]vice ,act1 z      
applicable1 ) respect to ! drug4  7c7   
,limitations ,any ext5sion describ$ 9   
subsection 7b77#a7 %all n apply if !    
drug designat$ "u subsection 7a77#a7 has
 previ\sly receiv$ an ext5sion by       
op]ation ( subsection 7b77#a74  7d7     
,def9ition ,9 ?is section1 ! t]m r>e    
disease or condition has ! mean+ giv5 to
 su* t]m 9 section #ebf7;a77#b74  4  7b7
 ,application ,section #eje;,g ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 z

 add$ by subsection 7a71 applies only ) 
respect to a drug = :i* an application  
or supplem5tal application describ$ 9   
subsection 7a77#a77;,b77i7 ( su* section
 #eje;,g is fir/ approv$ "u section     
#eje7;c7 ( su* ,act 7#ba ,u4,s4,c4      
#cee7;c77 or section #cea7;a7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a77 on or aft] ! date ( 
! enactm5t ( ?is ,act4  7c7 ,con=m+     
am5dm5ts  7#a7 ,relation to p$iatric    
exclusivity = drugs ,section #eje;,a ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee;a7 is am5d$-- 7,a7 9
 subsection 7b71 by add+ at ! end !     
foll[+3  7#c7 ,relation to exclusivity =
 a drug approv$ = a new indication = a  
r>e disease or condition ,not)/&+ !     
ref]5ces 9 p>agraph 7#a7 to ! l5g?s ( ! 
exclusivity p]iods aft] application (   
p$iatric exclusivity1 ! #f-mon?         
ext5sions describ$ 9 p>agraph 7#a7 %all 
be 9 addition to any ext5sions "u       
section #eje;,g4  2 &  7,b7 9 subsection
 7c71 by add+ at ! end ! foll[+3  7#c7  

,relation to exclusivity = a drug       
approv$ = a new indication = a r>e      
disease or condition ,not)/&+ ! ref]5ces
 9 p>agraph 7#a7 to ! l5g?s ( !         
exclusivity p]iods aft] application (   
p$iatric exclusivity1 ! #f-mon?         
ext5sions describ$ 9 p>agraph 7#a7 %all 
be 9 addition to any ext5sions "u       
section #eje;,g4  4  7#b7 ,relation to  
exclusivity = new qualifi$ infecti\s    
disease products t are drugs ,subsection
 7b7 ( section #eje;,e ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee;f7 is am5d$--  7,a7 by am5d+ !     
subsection head+ to read z foll[s3      
,relation to p$iatric exclusivity &     
exclusivity = a drug approv$ = a new    
indication = a r>e disease or           
condition4--2 &  7,b7 by /rik+ any      
ext5sion ( ! p]iod "u section #eje;,a & 
ins]t+ any ext5sion ( ! p]iods "u       
sections #eje;,a & #eje;,g1 z           
applicable14  7#c7 ,relation to p$iatric
 exclusivity = biological products      
,section #cea7m7 ( ! ,public ,heal?     

,s]vice ,act 7#db ,u4,s4,c4 #bfb7m77 is 
am5d$ by add+ at ! end ! foll[+3  7#e7  
,relation to exclusivity = a biological 
product approv$ = a new indication = a  
r>e disease or condition ,not)/&+ !     
ref]5ces 9 p>agraphs 7#b77;,a71         
7#b77;,b71 7#c77;,a71 & 7#c77;,b7 to !  
l5g?s ( ! exclusivity p]iods aft]       
application ( p$iatric exclusivity1 !   
#f-mon? ext5sions describ$ 9 su*        
p>agraphs %all be 9 addition to any     
ext5sions "u section #eje;,g4  4  #c4   
,orphan drugs  7a7 ,9 g5]al ,section    
#ebg ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7  
is am5d$-- 7#a7 9 subsection 7a71 9 !   
matt] foll[+ p>agraph 7#b71 by /rik+ su*
 drug = su* disease or condition &      
ins]t+ ! same drug = ! same disease or  
condition2  7#b7 9 subsection 7b7-- 7,a7
 9 ! matt] prec$+ p>agraph 7#a71 by     
/rik+ ,if an application & all t foll[s 
?r\gh su* lic5se if & ins]t+ ,dur+ !    
#g-ye> p]iod describ$ 9 subsection 7a7 =
 an approv$ application "u section #eje 

or lic5se "u section #cea ( ! ,public   
,heal? ,s]vice ,act1 ! ,secret>y may    
approve an application or issue a lic5se
 = a drug t is o!rwise ! same1 z det]m9$
 by ! ,secret>y1 z ! already approv$    
drug = ! same r>e disease or condition  
if2  7,b7 9 p>agraph 7#a71 by /rik+     
notice & all t foll[s ?r\gh assure &    
ins]t+ ( exclusive approval or lic5sure 
notice & opportunity = ! submission (   
views1 t dur+ su* p]iod ! hold] ( !     
exclusive approval or lic5sure _c       
ensure2 &  7,c7 9 p>agraph 7#b71 by     
/rik+ su* hold] provides & ins]t+ !     
hold] provides2 &  7#c7 by add+ at ! end
 ! foll[+3  7c7 ,condition ( cl9ical    
sup]iority  7#a7 ,9 g5]al ,if a sponsor 
( a drug t is designat$ "u section #ebf 
& is o!rwise ! same1 z det]m9$ by !     
,secret>y1 z an already approv$ or      
lic5s$ drug is seek+ exclusive approval 
or exclusive lic5sure describ$ 9        
subsection 7a7 = ! same r>e disease or  
condition z ! already approv$ drug1 !   
,secret>y %all require su* sponsor1 z a 

condition ( su* exclusive approval or   
lic5sure1 to demon/rate t su* drug is   
cl9ically sup]ior to any already approv$
 or lic5s$ drug t is ! same drug4  7#b7 
,def9ition ,= purposes ( p>agraph 7#a71 
! t]m cl9ically sup]ior ) respect to a  
drug means t ! drug provides a          
significant !rapeutic advantage ov] &   
above an already approv$ or lic5s$ drug 
9 t]ms ( great] efficacy1 great] safety1
 or by provid+ a major contribution to  
pati5t c>e4  7d7 ,regulations ,!        
,secret>y may promulgate regulations = !
 implem5tation ( subsection 7c74 ,beg9n+
 on ! date ( enactm5t ( ! ,orphan       
,products ,ext5sion ,n[ ,accel]at+      
,cures & ,treatm5ts ,act ( #bjag1 until 
su* "t z ! ,secret>y promulgates        
regulations 9 accordance ) ?is          
subsection1 ! ,secret>y may apply any   
def9itions set =? 9 regulations t 7     
promulgat$ prior to su* date ( enactm5t1
 to ! ext5t su* def9itions are n        
inconsi/5t ) ! t]ms ( ?is section1 z    
am5d$ by su* ,act4  7e7 ,demon/ration ( 

cl9ical sup]iority /&>d ,to assi/       
sponsors 9 demon/rat+ cl9ical sup]iority
 z describ$ 9 subsection 7c71 !         
,secret>y--  7#a7 ^u ! designation ( any
 drug "u section #ebf1 %all notify !    
sponsor ( su* drug 9 writ+ ( ! basis = !
 designation1 includ+1 z applicable1 any
 plausible hypo!sis (f]$ by ! sponsor & 
reli$ ^u by ! ,secret>y t ! drug is     
cl9ically sup]ior to a previ\sly approv$
 drug2 &  7#b7 ^u grant+ exclusive      
approval or lic5sure "u subsection 7a7  
on ! basis ( a demon/ration ( cl9ical   
sup]iority z describ$ 9 subsection 7c71 
%all publi% a summ>y ( ! cl9ical        
sup]iority f9d+s4  4  7b7 ,rule (       
,con/ruction ,no?+ 9 ! am5dm5ts made by 
subsection 7a7 %all affect any          
det]m9ation "u sections #ebf & #ebg ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bb1 #cfj;cc7 made   
prior to ! date ( enactm5t ( ! ,orphan  
,products ,ext5sion ,n[ ,accel]at+      
,cures & ,treatm5ts ,act ( #bjag4  #d4  
,p$iatric in=mation add$ to label+      

,section #eje;,a7o7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;a7o77 is am5d$-- 7#a7 9 !          
subsection head+1 by /rik+ ,"u ,section 
#eje7;j72  7#b7 9 p>agraph 7#a7-- 7,a7  
by /rik+ "u section #eje7;j7 & ins]t+ "u
 subsection 7b77#b7 or 7j7 ( section    
#eje2 &  7,b7 by /rik+ or by exclusivity
 "u clause 7iii7 or 7iv7 ( section      
#eje7;j77#e77;,f7 & ins]t+ 1 or by      
exclusivity "u clause 7iii7 or 7iv7 (   
section #eje7;j77#e77;,f71 clauses 7iii7
 & 7iv7 ( section #eje7;c77#c77;,e71 or 
section #ebg7;a71 or by an ext5sion (   
su* exclusivity "u ?is section or       
section #eje;,e2  7#c7 9 p>agraph 7#b71 
9 ! matt] prec$+ subp>agraph 7,a7-- 7,a7
 by ins]t+ clauses 7iii7 & 7iv7 (       
section #eje7;c77#c77;,e71 or section   
#ebg1 aft] section #eje7;j77#e77;,f712 &
  7,b7 by /rik+ drug approv$ "u section 
#eje7;j7 & ins]t+ drug approv$ pursuant 
to an application submitt$ "u subsection
 7b77#b7 or 7j7 ( section #eje2 &  7#d7 
by am5d+ p>agraph 7#c7 to read z foll[s3

  7#c7 ,pres]vation ( p$iatric          
exclusivity & o!r provisions ,?is       
subsection does n affect-- 7,a7 !       
availability or scope ( exclusivity "u--
  7i7 ?is section2  7ii7 section #eje = 
p$iatric =mulations2 or  7iii7 section  
#ebg2  7,b7 ! "q ( ! eligibility =      
approval ( any application "u subsection
 7b77#b7 or 7j7 ( section #eje t omits  
any o!r conditions ( approval entitl$ to
 exclusivity "u--  7i7 clause 7iii7 or  
7iv7 ( section #eje7;j77#e77;,f72  7ii7 
clause 7iii7 or 7iv7 ( section          
#eje7;c77#c77;,e72 or  7iii7 section    
#ebg2 or  7,c7 except z expressly       
provid$ 9 p>agraphs 7#a7 & 7#b71 !      
op]ation ( section #eje or section #ebg4
  4