,,ii  #aae? ,,congress  #a/ ,session    
,s4 #big  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #b1 #bjag,ms4 
,coll9s 7= h]self & ,mrs4 ,mc,caskill7  
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to increase competition 9 ! 
ph>maceutical indu/ry4  #a4 ,%ort title 
,?is ,act may be cit$ z ! ,increas+     
,competition 9 ,ph>maceuticals ,act 4   
#b4 ,f9d+s ,congress f9ds ! foll[+3 7#a7
 ,z "p ( ! ,food & ,drug ,adm9i/ration's
 mission to protect ! public heal?1 !   
,food & ,drug ,adm9i/ration approves    
g5]ic drugs t help e/abli% competitive  
m>kets = treatm5ts t improve ! lives (  
millions ( pati5ts 9 ! ,unit$ ,/ates4   
7#b7 ,ris+ heal? c>e co/s1 includ+      
prescription drug co/s1 cont9ue to be a 
major conc]n = pati5ts 9 ! ,unit$       
,/ates4  7#c7 ,eighty-eight p]c5t (     
prescription drugs disp5s$ 9 ! ,unit$   
,/ates1 or ne>ly #i out ( e #aj         
prescriptions disp5s$1 are g5]ic drugs4 

7#d7 ,/udies sugge/ t g5]ic drugs acc\nt
 = only #bh p]c5t ( total prescription  
drug sp5d+ & 7 responsible =            
#a1fhj1jjj1jjj1jjj 9 e/imat$ sav+s ov] !
 p]iod ( #bjje to #bjad4  7#e7 ,increas+
 g5]ic competition c be an effective way
 to help keep prescription drug co/s l[ 
= pati5ts1 ! heal? c>e sy/em1 & ,f$]al &
 ,/ate gov]nm5t4  7#f7 ,despite enactm5t
 ( ! ,g5]ic ,drug ,us] ,fee ,am5dm5ts ( 
#bjab 7#ba ,u4,s4,c4 #cgi;j-#da et      
seq471 :i* 0 e/abli%$ to provide ! ,food
 & ,drug ,adm9i/ration ) indu/ry fund+  
to ensure a m consi/5t timel9e = g5]ic  
drug approvals1 a significant backlog ( 
abbreviat$ new drug applications = g5]ic
 drugs rema9s4  7#g7 ,! sudd51          
aggressive price hikes = a v>iety (     
rec5tly acquir$ (f-pat5t drugs t h be5  
us$ widely = decades1 = :i* !re is no   
g5]ic drug competitor1 also affects     
access to af=dable prescriptions =      
pati5ts & ! ov]all co/ ( heal? c>e 9 !  
,unit$ ,/ates4  7#h7 ,improv+ ! review (
 abbreviat$ new drug applications & !   

approval ( g5]ic drugs w\ld help to     
improve competition & l[] prices =      
pati5ts4  7#i7 ,e/abli%+ a cle>         
timeframe = ! ,food & ,drug             
,adm9i/ration to exp$ite ! review (     
c]ta9 applications = g5]ic drugs w\ld   
also help keep drug prices d[n & improve
 timely access = pati5ts4  ,i ,remov+   
regulatory b>ri]s to competition  #aja4 
,improv+ g5]ic access ,section #eje7;j7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;j77 is am5d$  
by add+ at ! end ! foll[+3  7#aa7 7,a7  
,! ,secret>y %all prioritize ! review1 &
 act n lat] ?an #aej cal5d> days aft] ! 
date ( ! submission ( an application1 on
 an application t has be5 submitt$ =    
review "u ?is subsection1 or on a       
supplem5t to su* an application1 t is = 
a drug t--  7i7 has be5 introduc$ into  
int]/ate comm]ce by n m ?an "o          
manufactur] or sponsor1 z applicable1 9 
! la/ #c mon?s & ) respect to :i*       
t5tative approval "u p>agraph 7#e7 has  
be5 grant$ = n m ?an #b applications2 or

  7ii7 has be5 includ$ on ! li/ "u      
section #ejf;,e4  7,b7 ,! fees pursuant 
to section #gdd;,b7a77#c7 %all be waiv$ 
) respect to an application describ$ 9  
subp>agraph 7,a71 unless su* application
 conta9s a c]tification "u p>agraph     
7#b77;,a77vii77,,iv74  7,c7 ,! ,secret>y
 may exp$ite an inspection or           
re9spection "u section #gjd ( an        
e/abli%m5t t proposes to manufacture a  
drug describ$ 9 subp>agraph 7,a74  4    
#ajb4 ,report+ on p5d+ g5]ic drug       
applications ,n lat] ?an #ij cal5d> days
 aft] ! date ( enactm5t ( ?is ,act1 & e 
#ij cal5d> days !reaft] until ,octob]   
#a1 #bjbb1 ! ,secret>y ( ,heal? & ,human
 ,s]vices %all submit to ! ,committee on
 ,heal?1 ,education1 ,labor1 & ,p5sions 
( ! ,s5ate1 ! ,special ,committee on    
,ag+ ( ! ,s5ate1 & ! ,committee on      
,en]gy & ,comm]ce ( ! ,h\se (           
,repres5tatives a report t provides--   
7#a7 ! numb] ( applications t 7 fil$ "u 
section #eje7;j7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  

#cee7;j77 prior to ,octob] #a1 #bjae1 t 
are p5d+ at ! "t ! report is submitt$2  
7#b7 ! av]age & m$ian total "t su*      
applications h be5 p5d+2  7#c7 ! numb] (
 su* applications t conta9 c]tifications
 "u section #eje7;j77#b77;,a77vii77,,iv7
 ( su* ,act2 &  7#d7 ! numb] ( su*      
applications t are subject to priority  
review4  ,,ii ,inc5tiviz+ competition   
#bja4 ,g5]ic priority review v\*] ,*apt]
 ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cea et seq47 is   
am5d$ by ins]t+ aft] section #ejf;,g !  
foll[+3  #ejf;,h4 ,g5]ic priority review
 v\*]  7a7 ,def9itions ,9 ?is section3  
7#a7 ,! t]m priority review ) respect to
 an application "u section #eje7;j7     
means review & action by ! ,secret>y on 
su* application by ! ,secret>y n lat]   
?an #aej cal5d> days aft] su*           
application has be5 submitt$ = review4  
7#b7 ,! t]m priority review v\*] means a
 v\*] = priority review = an application
 "u section #eje7;j74 ,su* v\*] %all be 
aw>d$ ^u ! approval ( ! application     

describ$ 9 #eje7;j77#aa77;,a71 unless   
su* application conta9s a c]tification  
"u subclauses 7,,iii7 & 7,,iv7 ( section
 #eje7;j77#b77;,a77vii74  7b7 ,g5]ic    
,priority ,review ,v\*]s1 9 g5]al ,!    
,secret>y %all aw>d a priority review   
v\*] to ! sponsor ( an application      
describ$ 9 #eje7;j77#aa77;,a7 ^u        
approval by ! ,secret>y ( su*           
application4  7c7 ,transf]ability  7#a7 
,9 g5]al ,! recipi5t ( a priority review
 v\*] "u subsection 7a7 may transf]     
7includ+ by sale7 ! entitlem5t to su*   
v\*]4 ,!re is no limit on ! numb] (     
times a priority review v\*] may be     
transf]r$ be=e su* v\*] is us$4  7#b7   
,notification to ! ,secret>y ,ea* p]son 
to :om a v\*] is transf]r$ %all notify !
 ,secret>y ( su* *ange 9 own]%ip ( su*  
v\*] n lat] ?an #cj cal5d> days aft] su*
 transf]4  7d7 ,notification ,! sponsor 
%all notify ! ,secret>y n lat] ?an #cj  
cal5d> days prior to ! submission ( a   
human drug application t is int5d$ to be
 ! subject ( a priority review v\*]1    

except 9 ! case ( su* an application t 0
 p5d+ z ( ,octob] #a1 #bjae1 9 :i* case 
! sponsor ( su* p5d+ application %all   
notify ! ,secret>y n lat] ?an #cj days  
aft] ! date on :i* su* v\*] is aw>d$4   
7e7 ,fees ,! sponsor ( an application t 
is ! subject ( a priority review v\*]   
%all be subject to ! fees requir$ "u    
section #gdd;,a4  7f7 ,cl>ification     
,no?+ 9 ?is section affects any p]iod ( 
exclusivity "u ?is ,act or ! protection 
( any pat5t4  7g7 ,revocation ,!        
,secret>y may revoke any priority review
 v\*] aw>d$ "u subsection 7b7 if ! drug 
= :i* su* v\*] 0 aw>d$ is n m>ket$ 9 !  
,unit$ ,/ates )9 ! #cfe-;day p]iod      
beg9n+ on ! date ( ! approval ( su*     
drug4  7h7 ,sunset ,! au?ority ( !      
,secret>y to c>ry out ! g5]ic priority  
review v\*] program "u ?is section %all 
t]m9ate on ,octob] #a1 #bjbb4  4  #bjb4 
,tropical disease product application   
,section #ebd7;a77#d77;,a7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfjn7a77#d77;,a77 is am5d$-- 

7#a7 9 clause 7i71 by /rik+ &2  7#b7 9  
clause 7ii71 by add+ & aft] ! semicolon2
 &  7#c7 by add+ at ! end ! foll[+3     
7iii7 t conta9s reports ( new cl9ical   
inve/igations 7o!r ?an bioavailability  
/udies7 ess5tial to ! approval ( !      
application & conduct$ or sponsor$ by ! 
applicant2  4  ,,iii ,/udy on ,,rems    
#cja4 ,/udy on ,,rems  7a7 ,9 g5]al ,!  
,comptroll] ,g5]al %all conduct a review
 ( ! implem5tation & effectiv5ess (     
section #eje-a ( ! ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7   
7ref]r$ to 9 ?is section z ! ,,rems     
program71 :i* section--  7#a7 au?orizes 
! ,secret>y ( ,heal? & ,human ,s]vices  
to require a risk evaluation &          
mitigation /rategy 7ref]r$ to 9 ?is     
section z ,,rems72 &  7#b7 codifies &   
exp&s regulations issu$ by ! ,food &    
,drug ,adm9i/ration "u :i* ! ,food &    
,drug ,adm9i/ration may impose          
re/rictions on di/ribution necess>y to  
ensure a drug is safely us$4  7b7       
,cont5ts ( /udy ,9 conduct+ ! review "u 

subsection 7a71 ! ,comptroll] ,g5]al    
%all exam9e ea* relevant elem5t describ$
 9 subsection 7c7 ) respect to ea* ( !  
foll[+ categories3  7#a7 ,new drug      
applications "u subsection 7b7 ( section
 #eje ( ! ,f$]al ,food1 ,drug1 &        
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b774
  7#b7 ,abbreviat$ new drug applications
 "u subsection 7j7 ( su* section4  7#c7 
,applications = ! lic5se ( a biological 
product "u section #cea ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb74  7#d7 ,s+le1 %>$ sy/em ,,rems1 z 
describ$ 9 section #eje-a7;i7 ( ! ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee-a7;i774  7#e7 ,controll$ sub/ances 
z def9$ 9 section #ajb ( ! ,controll$   
,sub/ances ,act 7#ba ,u4,s4,c4 #hjb74   
7#f7 ,r,i,s,k,m,a,ps or o!r risk        
managem5t processes employ$ by ! ,food &
 ,drug ,adm9i/ration4  7c7 ,elem5ts "u  
review ,9 conduct+ ! review "u          
subsection 7a71 ! ,comptroll] ,g5]al    
%all exam9e ea* ( ! foll[+ elem5ts )    
respect to ea* relevant category        

describ$ 9 subsection 7b74  7#a7 ,= ea* 
type ( application1 & by ye>1 ! numb] ( 
,,rems requir$1 submitt$1 volunt>ily    
submitt$1 modifi$1 add$1 approv$1 or    
remov$1 & :e!r ^? ,,rems includ$ elem5ts
 to assure safe use1 su* z re/rict$     
di/ribution4  7#b7 ,= ea* type (        
application1 ! numb] ( ,,rems 9 effect  
at ! "t ( ! review & ! numb] ( ye>s t   
ea* su* ,,rems has be5 9 effect at su*  
"t4  7#c7 ,if & h[ ! ,,rems program has 
improv$ drug safety1 z comp>$ to ! "t   
be=e ! ,,rems program became effective1 
& h[ ! ,food & ,drug ,adm9i/ration      
tracks su* improvem5ts4  7#d7 ,! burd5s 
associat$ ) ,,rems1 includ+ burd5s on   
pati5ts1 heal? c>e provid]s1 g5]ic drug 
manufactur]s1 & br& drug manufactur]s4  
7#e7 ,9 ! case ( a ,,rems program = a   
drug conta9+ a controll$ sub/ance1 !    
coord9ation betwe5 ! ,food & ,drug      
,adm9i/ration & ! ,drug ,en=cem5t       
,adm9i/ration4  7#f7 ,! impact (        
additional risk mitigation /rategies1   
includ+ non-,,rems re/rict$ di/ribution 

sy/ems1 impos$ by companies outside (   
:at is requir$ "u ! ,,rems program4     
7#g7 ,! /&>ds & policies appli$ by !    
,food & ,drug ,adm9i/ration to require1 
modify1 add1 or remove1 a ,,rems1 & h[  
^? /&>ds & policies h *ang$ s9ce !      
,,rems program became effective4  7d7   
,report ,n lat] ?an ,may #a1 #bjah1 !   
,comptroll] ,g5]al %all submit a report 
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions ( ! ,s5ate1 !        
,special ,committee on ,ag+ ( ! ,s5ate1 
& ! ,committee on ,en]gy & ,comm]ce ( ! 
,h\se ( ,repres5tatives1 conta9+ !      
results ( ! review describ$ 9 ?is       
section4