,,ii  #aaith ,,congress  #ast ,session  
,s4 #acjb  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #c1     
#bjbe,ms4 ,hassan 7for herself1 ,mr4    
,paul1 ,mr4 ,hickenlooper1 and ,mr4     
,lee7 introduced the following bill2    
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
provide for increased transparency in   
generic drug applications4  #a4 ,short  
title ,this ,act may be cited as the    
,increasing ,transparency in ,generic   
,drug ,applications ,act4  #b4          
,increasing transparency in generic drug
 applications  7a7 ,in general ,section 
#eje7;j77#c7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;j77#c77 is amended by adding at  
the end the following3  7,h7 7i7 ,upon  
request 7in controlled correspondence or
 an analogous process7 by a person that 
has submitted or intends to submit an   
abbreviated application under this      
subsection for a drug that is required  

by regulation to contain one or more of 
the same inactive ingredients in the    
same concentrations as the listed drug  
referred to1 or for which the ,secretary
 determines there is a scientific       
justification for an approach that is in
 vitro1 in whole or in part1 to be used 
to demonstrate bioequivalence for a drug
 if such a drug contains one or more of 
the same inactive ingredients in the    
same concentrations as the listed drug  
referred to1 the ,secretary shall inform
 the person whether such drug is        
qualitatively and quantitatively the    
same as the listed drug4 ,the ,secretary
 may also provide such information to   
such a person on the ,secretary's own   
initiative during the review of an      
abbreviated application under this      
subsection for such drug4  7ii7         
,notwithstanding section #cja7;j71 if   
the ,secretary determines that such drug
 is not qualitatively or quantitatively 
the same as the listed drug1 the        
,secretary shall identify and disclose  

to the person-- 7,i7 the ingredient or  
ingredients that cause such drug not to 
be qualitatively or quantitatively the  
same as the listed drug2 and  7,,ii7 for
 any ingredient for which there is an   
identified quantitative deviation1 the  
amount of such deviation4  7iii7 ,if the
 ,secretary determines that such drug is
 qualitatively and quantitatively the   
same as the listed drug1 the ,secretary 
shall not change or rescind such        
determination after the submission of an
 abbreviated application for such drug  
under this subsection unless-- 7,i7 the 
formulation of the listed drug has been 
changed and the ,secretary has          
determined that the prior listed drug   
formulation was withdrawn for reasons of
 safety or effectiveness2 or  7,,ii7 the
 ,secretary makes a written             
determination that the prior            
determination must be changed because an
 error has been identified4  7iv7 ,if   
the ,secretary makes a written          
determination described in clause       

7iii77,,ii71 the ,secretary shall       
provide notice and a copy of the written
 determination to the person making the 
request under clause 7i74  7v7 ,the     
disclosures authorized under clauses 7i7
 and 7ii7 are disclosures authorized by 
law1 including for purposes of section  
#aije of title #ah1 ,united ,states     
,code4 ,this subparagraph shall not     
otherwise be construed to authorize the 
disclosure of nonpublic qualitative or  
quantitative information about the      
ingredients in a listed drug1 or to     
affect the status1 if any1 of such      
information as trade secret or          
confidential commercial information for 
purposes of section #cja7;j7 of this    
,act1 section #eeb of title #e1 ,united 
,states ,code1 or section #aije of title
 #ah1 ,united ,states ,code4  4  7b7    
,guidance  7#a7 ,in general ,not later  
than one year after the date of         
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services shall   
issue draft guidance1 or update         

guidance1 describing how the ,secretary 
will determine whether a drug is        
qualitatively and quantitatively the    
same as the listed drug 7as such terms  
are used in section #eje7;j77#c77;,h7 of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act1 as added by subsection  
7a771 including with respect to         
assessing p,h adjusters4  7#b7 ,process 
,in issuing guidance under this         
subsection1 the ,secretary of ,health   
and ,human ,services shall-- 7,a7       
publish draft guidance2  7,b7 provide a 
period of at least #fj days for comment 
on the draft guidance2 and  7,c7 after  
considering any comments received and   
not later than one year after the close 
of the comment period on the draft      
guidance1 publish final guidance4  7c7  
,applicability ,section                 
#eje7;j77#c77;,h7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act1 as added by 
subsection 7a71 applies beginning on the
 date of enactment of this ,act1        
irrespective of the date on which the   

guidance required by subsection 7b7 is  
finalized4