,,ii  #aagth ,,congress  #ast ,session  
,s4 #biaj  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,september #cj1
 #bjba,ms4 ,smith 7for herself and ,mr4 
,braun7 introduced the following bill2  
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act with respect to the      
#ahj-;day exclusivity period1 and for   
other purposes4  #a4 ,short title ,this 
,act may be cited as the ,expanding     
,access to ,low-,cost ,generics ,act of 
#bjba4  #b4 #ahj-;day exclusivity period
  7a7 ,in general ,section              
#eje7;j77#e77;,b77iv7 of the ,federal   
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7;j77#e77;,b77iv77 is     
amended-- 7#a7 in subclause 7,i71 by    
inserting before the period at the end  
the following3 or an applicant whose    
application was approved pursuant to    
subclause 7,,iii74 ,if an applicant     
described in subclause 7,,iii7 is       

eligible for effective approval on the  
same day a tentatively approved first   
applicant who has requested final       
approval is determined by the ,secretary
 to be eligible for effective approval  
by meeting all the approval requirements
 of this subsection1 such applicant may 
not receive effective approval until    
#ahj days after the first applicant     
begins commercial marketing of the      
drug42 and  7#b7 by adding at the end   
the following new subclause3  7,,iii7   
,applicant approval ,the ,secretary may 
approve an application containing a     
certification described in paragraph    
7#b77;,a77vii77,,iv7 that is for a drug 
for which a first applicant has         
submitted an application containing such
 a certification1 notwithstanding the   
eligibility of a first applicant for the
 #ahj-;day exclusivity period described 
in subclause 7,,ii77aa71 if each of the 
following conditions is met3 7aa7 ,the  
approval of such application could be   
made effective1 but for the eligibility 

of a first applicant for #ahj-;day      
exclusivity under this clause4  7bb7 ,at
 least #cj months have passed since the 
date of submission of an application for
 the drug by at least one first         
applicant4  7cc7 ,approval of an        
application for the drug submitted by at
 least one first applicant is not       
precluded under clause 7iii74  7dd7 ,no 
application for the drug submitted by   
any first applicant is effectively      
approved on the date that the conditions
 under items 7aa71 7bb71 and 7cc7 are   
all met1 regardless of whether such     
application is subsequently approved4  4
  7b7 ,applicability ,the amendments    
made by subsection 7a7 shall apply only 
with respect to an application filed    
under section #eje7;j7 of the ,federal  
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7;j77 after the date of   
enactment of this ,act that identifies a
 listed drug for which no certification 
under paragraph 7#b77;,a77vii77,,iv7 of 
such section was made before such date  

of enactment4