,,ii  #aafth ,,congress  #ast ,session  
,s4 #cff  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,february #f1       
#bjai,mr4 ,durbin 7for himself1 ,ms4    
,harris1 ,ms4 ,smith1 ,ms4 ,klobuchar1  
and ,mr4 ,blumenthal7 introduced the    
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to shorten monopoly periods for
 prescription drugs that are the        
subjects of sudden price hikes4  #a4    
,short title ,this ,act may be cited as 
the ,forcing ,limits on ,abusive and    
,tumultuous ,prices or the ,,flat       
,prices ,act4  #b4 ,reduced market      
exclusivity  7a7 ,penalty ,if the       
manufacturer of a prescription drug     
approved under section #eje of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7 or licensed   
under section #cea of the ,public       
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7 increases the price of such drug  
as described in subsection 7b71 any     

remaining period of market exclusivity  
with respect to such drug shall be      
reduced as follows3  7#a7 ,with respect 
to any price increase described in      
subsection 7b71 such market exclusivity 
shall be reduced by #ahj days4  7#b7    
,for every #e percent price increase    
over the #aj percent1 #ah percent1 or   
#be percent1 respectively1 threshold    
price increases described in subsection 
7b71 such market exclusivity shall be   
reduced for an additional #cj days4  7b7
 ,price increase ,a price increase      
described in this subsection is an      
increase in the wholesale acquisition   
cost 7as defined in section             
#ahdg;,a7c77#f77;,b7 of the ,social     
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7c77#f77;,b777 of a          
prescription drug of more than #aj      
percent over a #a-year period1 more than
 #ah percent over a #b-year period1 or  
more than #be percent over a #c-year    
period4  7c7 ,report on price increase  
7#a7 ,in general ,a drug manufacturer   

that increases the price of a           
prescription drug as described in       
subsection 7b7 shall report such        
increase to the ,secretary of ,health   
and ,human ,services 7referred to in    
this section as the ,secretary7 within  
#cj days of meeting the criteria for a  
price increase under such subsection4   
7#b7 ,failure to submit report ,in the  
case of a drug manufacturer that does   
not submit a report required under      
paragraph 7#a7 within the #cj-;day      
period described in such paragraph1 in  
addition to the penalty under subsection
 7a71 the period of market exclusivity  
with respect to such drug shall be      
reduced by #cj days for each day after  
the due date of the report until the    
report is submitted4  7d7 ,waiver ,the  
,secretary may waive1 or decrease1 the  
reduction in the period of market       
exclusivity that would otherwise apply  
under subsection 7a7 with respect to a  
prescription drug if--  7#a7 the        
manufacturer of such drug submits-- 7,a7

 a report under subsection 7c77#a72 and 
7,b7 an application for such a waiver1  
at such time1 in such manner1 and       
containing such information as the      
,secretary may require2 and  7#b7 based 
upon the information in such            
application1 the ,secretary determines  
that--  7,a7 the price increase is      
necessary to enable production of the   
drug1 does not unduly restrict patient  
access to the drug 1 and does not       
negatively impact public health2 and    
7,b7 such waiver or decrease constitutes
 a deviation from the reduction in      
market exclusivity that would otherwise 
apply under subsection 7a7 only to the  
extent necessary to achieve drug        
production objectives4  7e7 ,period of  
market exclusivity ,for purposes of this
 section1 the term period of market     
exclusivity means any period of market  
exclusivity granted with respect to a   
prescription drug under clause 7ii71    
7iii71 or 7iv7 of section               
#eje7;c77#c77;,e7 of the ,federal ,food1

 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cee7;c77#c77;,e771 section   
#eje7;j77#e77;,b77iv7 of such ,act1     
clause 7ii71 7iii71 or 7iv7 of section  
#eje7;j77#e77;,f7 of such ,act1 or      
paragraphs 7#f7 or 7#g7 of section      
#cea7k7 of the ,public ,health ,service 
,act 7#db ,u4,s4,c4 #bfb7k774