,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #bdee  ,,in ,,the ,,house ,,of  
,,representatives  ,may #a1 #bjai,mr4   
,joyce of ,pennsylvania 7for himself and
 ,mr4 ,brindisi7 introduced the         
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend the ,federal ,food1
 ,drug1 and ,cosmetic ,act with respect 
to citizen petitions4  #a4 ,short title 
,this ,act may be cited as the ,ensuring
 ,timely ,access to ,generics ,act of   
#bjai4  #b4 ,citizen petitions ,section 
#eje7q77#a7 of the ,federal ,food1      
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7q77#a77 is amended--  7#a7 in     
subparagraph 7,e7-- 7,a7 by striking ,if
 the ,secretary and inserting the       
following3  7i7 ,in general ,if the     
,secretary  2  7,b7 by striking the     
second sentence and inserting the       
following3  7ii7 ,factors ,in           
determining whether a petition was      
submitted with the primary purpose of   
delaying the approval of an application1

 the ,secretary shall consider--  7,i7  
whether it appears1 based on the date   
that relevant information relied upon in
 the petition became known to the       
petitioner 7or reasonably should have   
been known to the petitioner71 as       
certified by the petitioner in          
accordance with subparagraph 7,h71 that 
the petitioner has taken an unreasonable
 length of time to submit the petition2 
7,,ii7 whether the petitioner has       
submitted multiple or serial petitions  
raising issues that reasonably could    
have been known to the petitioner at the
 time of submission of the earlier      
petition or petitions2  7,,iii7 whether 
the petition was submitted close in time
 to a known first date upon which an    
application under subsection 7b77#b7 of 
this section or section #cea7k7 of the  
,public ,health ,service ,act could be  
approved2  7,,iv7 whether the petition  
was submitted without any data or       
information in support of the scientific
 positions set forth in the petition2   

7,v7 whether the petition raises the    
same or substantially similar issues as 
a prior petition to which the ,secretary
 has responded substantively already1   
particularly if the subsequent          
submission follows the earlier response 
closely in time2  7,,vi7 whether the    
petition concerns standards for approval
 of a drug for which the ,secretary has 
provided an opportunity for public      
input1 such as draft or final           
product-specific guidance applicable to 
the drug1 and the petitioner has not    
provided comment other than through the 
petition2  7,,vii7 whether the petition 
requests that other applicants meet     
standards for testing1 data1 or labeling
 for a drug that are more onerous or    
rigorous than the standards applicable  
to1 as applicable1 the listed drug1     
reference product1 or petitioner's      
version of the same drug2  7,,viii7 the 
history of the petitioner with the ,food
 and ,drug ,administration1 such as     
whether the petitioner has a history of 

submitting petitions that the ,secretary
 has determined were submitted with the 
primary purpose of delay2 and  7,,ix7   
other relevant considerations1 as the   
,secretary may describe in guidance4  2 
and  7,c7 by adding at the end the      
following3  7iii7 ,public availability  
,the ,secretary shall publish on the    
internet website of the ,food and ,drug 
,administration a list of any petitions 
that the ,secretary determines were     
submitted for the primary purpose of    
delaying the approval of an application4
  7iv7 ,referral to the ,federal ,trade 
,commission ,the ,secretary shall       
establish procedures for referring to   
the ,federal ,trade ,commission any     
petition or supplement to a petition    
that the ,secretary determines was      
submitted with the primary purpose of   
delaying approval of an application4    
,such procedures shall include          
notification to the petitioner and an   
opportunity for the petitioner to       
respond to the ,secretary prior to      

referral to the ,federal ,trade         
,commission4  2 and  7#b7 by adding at  
the end the following3  7,j7 ,timeline  
for submitting petitions ,the ,secretary
 may establish a time period after the  
relevant information relied upon in a   
petition became known to the petitioner 
7or reasonably should have been known to
 a petitioner71 as certified by the     
petitioner in accordance with           
subparagraph 7,h71 and any petition that
 is submitted after such time period has
 passed shall be summarily denied4  4