,,ii  #aahth ,,congress  #ast ,session  
,s4 #aaad  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,march #cj1    
#bjbc,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 period4  #a4      
,short title ,this ,act may be cited as 
the ,expanding ,access to ,low-,cost    
,generics ,act of #bjbc4  #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,i7-- 7,a7 by inserting  
and subclause 7,,iii7 after subparagraph
 7,d72 and  7,b7 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     
described in subclause 7,,iii7 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    
,the applicant of such application has  
submitted a certification to the        
abbreviated new drug application that   
there are no conditions that would      
prevent the applicant from commercial   
marketing within #ge days after the date
 of approval and that the applicant     
intends to so market the drug4  7cc7 ,at
 least #cc months have passed since the 
date of submission of an application for
 the drug by at least one first         
applicant4  7dd7 ,approval of an        
application for the drug submitted by at
 least one first applicant is not       
precluded under clause 7iii74  7ee7 ,no 
application for the drug submitted by   
any first applicant is effectively      
approved on the date that the conditions
 under items 7aa71 7bb71 7cc71 and 7dd7 
are all met and maintained4  4  7b7     
,special approval status rule for       

certain subsequent applicants ,section  
#eje7;j77#e77;,d7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cee 7j77#e77;,d77 is amended 
at the end by adding the following3  7v7
 ,special approval status rule for      
certain subsequent applicants ,an       
application that is approved pursuant to
 subclause 7,,iii7 of subparagraph      
7,b77iv7 is deemed to be tentatively    
approved and to no longer have an       
effective approval pursuant to such     
subclause 7,,iii7 on the date that is   
#gf days after the date on which the    
approval has been made effective        
pursuant to such subclause 7,,iii7 if   
the applicant fails to commercially     
market such drug within the #ge-;day    
period after the date on which the      
approval is made effective4 ,if the     
applicant of an application approved    
pursuant to such subclause 7,,iii7      
submits a notification that it can no   
longer commence commercial marketing    
within #ge days after the date of       

approval1 as required under subparagraph
 7,b77iv77,,iii77bb71 its application is
 deemed to be tentatively approved and  
to no longer be effectively approved on 
the date that such a notification is    
received4 ,if an applicant does not     
commence commercial marketing within the
 #ge-;day period1 it shall not be       
eligible for a subsequent effective     
approval for the application under      
subclause 7,,iii7 of subparagraph       
7,b77iv7 unless1 in addition to meeting 
each of the conditions in such subclause
 7,,iii71 it submits a certification to 
its abbreviated new drug application    
that an event that could not have been  
reasonably foreseen by the applicant    
prevented it from commencing commercial 
marketing and that it has fully resolved
 this issue4 ,the applicant shall submit
 notification to the abbreviated new    
drug application confirming that such   
applicant has commenced commercial      
marketing of the drug not later than one
 business day after commencing such     

marketing4  4  7c7 ,applicability ,the  
amendments made by subsections 7a7 and  
7b7 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    
#eje7;j7 was made before such date of   
enactment4