,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #cff  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #f1 #bjai,mr4 
,durb9 7= himself1 ,ms4 ,h>ris1 ,ms4    
,smi?1 ,ms4 ,klobu*>1 & ,mr4 ,blum5?al7 
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to %ort5 monopoly p]iods =  
prescription drugs t are ! subjects (   
sudd5 price hikes4  #a4 ,%ort title ,?is
 ,act may be cit$ z ! ,=c+ ,limits on   
,abusive & ,tumultu\s ,prices or !      
,,flat ,prices ,act4  #b4 ,r$uc$ m>ket  
exclusivity  7a7 ,p5alty ,if !          
manufactur] ( a prescription drug       
approv$ "u section #eje ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 or lic5s$ "u section    
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb7 increases ! price (
 su* drug z describ$ 9 subsection 7b71  
any rema9+ p]iod ( m>ket exclusivity )  
respect to su* drug %all be r$uc$ z     
foll[s3  7#a7 ,) respect to any price   

increase describ$ 9 subsection 7b71 su* 
m>ket exclusivity %all be r$uc$ by #ahj 
days4  7#b7 ,= e #e p]c5t price increase
 ov] ! #aj p]c5t1 #ah p]c5t1 or #be     
p]c5t1 respectively1 ?re%old price      
increases describ$ 9 subsection 7b71 su*
 m>ket exclusivity %all be r$uc$ = an   
additional #cj days4  7b7 ,price        
increase ,a price increase describ$ 9   
?is subsection is an increase 9 !       
:olesale acquisition co/ 7z def9$ 9     
section #ahdg;,a7c77#f77;,b7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#aciew-#c;a7c77#f77;,b777 ( a           
prescription drug ( m ?an #aj p]c5t ov] 
a #a-ye> p]iod1 m ?an #ah p]c5t ov] a   
#b-ye> p]iod1 or m ?an #be p]c5t ov] a  
#c-ye> p]iod4  7c7 ,report on price     
increase  7#a7 ,9 g5]al ,a drug         
manufactur] t increases ! price ( a     
prescription drug z describ$ 9          
subsection 7b7 %all report su* increase 
to ! ,secret>y ( ,heal? & ,human        
,s]vices 7ref]r$ to 9 ?is section z !   
,secret>y7 )9 #cj days ( meet+ ! crit]ia

 = a price increase "u su* subsection4  
7#b7 ,failure to submit report ,9 ! case
 ( a drug manufactur] t does n submit a 
report requir$ "u p>agraph 7#a7 )9 !    
#cj-;day p]iod describ$ 9 su* p>agraph1 
9 addition to ! p5alty "u subsection    
7a71 ! p]iod ( m>ket exclusivity )      
respect to su* drug %all be r$uc$ by #cj
 days = ea* day aft] ! due date ( !     
report until ! report is submitt$4  7d7 
,waiv] ,! ,secret>y may waive1 or       
decrease1 ! r$uction 9 ! p]iod ( m>ket  
exclusivity t w\ld o!rwise apply "u     
subsection 7a7 ) respect to a           
prescription drug if--  7#a7 !          
manufactur] ( su* drug submits-- 7,a7 a 
report "u subsection 7c77#a72 &  7,b7 an
 application = su* a waiv]1 at su* "t1 9
 su* mann]1 & conta9+ su* in=mation z ! 
,secret>y may require2 &  7#b7 bas$ ^u !
 in=mation 9 su* application1 !         
,secret>y det]m9es t--  7,a7 ! price    
increase is necess>y to enable          
production ( ! drug1 does n unduly      
re/rict pati5t access to ! drug 1 & does

 n negatively impact public heal?2 &    
7,b7 su* waiv] or decrease con/itutes a 
deviation f ! r$uction 9 m>ket          
exclusivity t w\ld o!rwise apply "u     
subsection 7a7 only to ! ext5t necess>y 
to a*ieve drug production objectives4   
7e7 ,p]iod ( m>ket exclusivity ,=       
purposes ( ?is section1 ! t]m p]iod (   
m>ket exclusivity means any p]iod (     
m>ket exclusivity grant$ ) respect to a 
prescription drug "u clause 7ii71 7iii71
 or 7iv7 ( section #eje7;c77#c77;,e7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee7;c77#c77;,e771      
section #eje7;j77#e77;,b77iv7 ( su*     
,act1 clause 7ii71 7iii71 or 7iv7 (     
section #eje7;j77#e77;,f7 ( su* ,act1 or
 p>agraphs 7#f7 or 7#g7 ( section       
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k774