,,ii  #aafth ,,congress  #ast ,session  
,s4 #bajc  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,july #aa1     
#bjai ,mr4 ,durbin 7for himself1 ,mr4   
,cramer1 and ,ms4 ,smith7 introduced the
 following bill2 which was read twice   
and referred to the ,committee on       
,health1 ,education1 ,labor1 and        
,pensions  ,a ,,bill  ,to improve access
 to affordable insulin4  #a4 ,short     
title  ,this ,act may be cited as the   
,affordable ,insulin ,approvals ,now    
,act4  #b4 ,deemed approval under       
section #cea ,section #gjjb7;e77#d7 of  
the ,biologics ,price ,competition and  
,innovation ,act of #bjji 7,public ,law 
#aaa-adh7 is amended--  7#a7 by striking
 ,an amended and inserting the          
following3  7,a7 ,in general ,an amended
  2 and  7#b7 by adding at the end the  
following3  7,b7 ,treatment of certain  
pending applications ,with respect to an
 application for an insulin biological  
product submitted under subsection      
7b77#b7 or 7j7 of section #eje of the   

,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7 with a filing 
date that is not later than ,december   
#ca1 #bjai1 until the ,secretary makes a
 determination on final approval with   
respect to such application1 the        
,secretary shall continue to review and 
approve 7as appropriate7 such           
application under such section #eje1    
even if such review and approval process
 continues after ,march #bc1 #bjbj4 ,for
 purposes of completing the review and  
approval process for such an            
application1 any listed drug referenced 
in the application shall be treated as a
 listed drug under section #eje7;j77#g7 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act1 even if such listed drug
 is deemed licensed under section #cea  
of the ,public ,health ,service ,act    
during such review and approval process4
 ,effective on the later of ,march #bc1 
#bjbj1 or the date of approval under    
subsection 7c7 or 7j7 of section #eje of
 the ,federal ,food1 ,drug1 and         

,cosmetic ,act of any such application1 
such approved application shall be      
deemed to be a license for the          
biological product under section #cea of
 the ,public ,health ,service ,act4  4