,,ii  #aahth ,,congress  #ast ,session  
,s4 #gge  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,march #ad1         
#bjbc,ms4 ,hassan 7for herself and ,mr4 
,paul7 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
 otherwise7 by a person that has        
submitted or intends to submit an       
abbreviated application under this      
subsection for a drug that is generally 
required by regulation or recommended in

 guidance to contain the same inactive  
ingredients in the same concentration as
 the listed drug referred to or for     
which there is a scientific             
justification that an in vitro approach 
can be used to demonstrate              
bioequivalence based on certain         
qualitative or quantitative criteria    
with respect to an inactive ingredient1 
or on the ,secretary's own initiative   
during the review of an application     
under this subsection for such a drug1  
the ,secretary shall inform the person  
whether such drug is qualitatively and  
quantitatively the same as the listed   
drug4  7ii7 ,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 the 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 required by this            

subparagraph are disclosures authorized 
by law1 including for purposes of       
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