,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #bchg  ,,in ,,the ,,house ,,of  
,,representatives  ,april #bi1 #bjai,mr4
 ,levin of ,michigan 7for himself and   
,mr4 ,rooney of ,florida7 introduced the
 following bill2 which was referred to  
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend subsection 7q7 of  
section #eje of the ,federal ,food1     
,drug1 and ,cosmetic ,act to clarify the
 process for denying certain petitions  
whose primary purpose is to delay the   
approval of an application submitted    
under subsection 7b77#b7 or 7j7 of such 
section #eje1 and for other purposes4   
#a4 ,short title ,this ,act may be cited
 as the ,stop ,the ,overuse of          
,petitions and ,get ,affordable         
,medicines to ,enter ,soon ,act of #bjai
 or the ,,stop ,,games ,act of #bjai4   
#b4 ,denial of petitions whose primary  
purpose is to delay approval of certain 
applications  7a7 ,in general           
,subparagraph 7,e7 of section           
#eje7q77#a7 of the ,federal ,food1      

,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7q77#a77 is amended to read as     
follows3  7,e7 ,denial based on intent  
to delay  7i7 ,in general ,if the       
,secretary determines that a petition or
 a supplement to the petition was       
submitted with the primary purpose of   
delaying the approval of an application 
or the petition does not on its face    
raise valid scientific or regulatory    
issues1 the ,secretary may deny the     
petition at any point based on such     
determination4  7ii7 ,factors ,the      
,secretary may issue guidance to        
describe the factors that will be used  
to determine under this subparagraph    
whether a petition is submitted with the
 primary purpose of delaying the        
approval of an application4 ,such       
factors shall include the following3    
7,i7 ,submission of a petition where 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 that the petitioner has   
taken an unreasonable length of time to 
submit the petition4  7,,ii7 ,submission
 of 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   
petitions4  7,,iii7 ,submission of a    
petition close in time to a known1 first
 date upon which an application under   
subsection 7b77#b7 or 7j7 of this       
section or under section #cea7k7 of the 
,public ,health ,service ,act could be  
approved 7such as submission close in   
time to the expiration of a blocking    
patent or exclusivity74  7,,iv7         
,submission of a petition without any   
data or information in support of the   
scientific positions set forth in the   
petition4  7,v7 ,submission of a        
petition raising the same or            
substantially similar issues as a prior 
petition to which the ,food and ,drug   
,administration has already             
substantively responded1 particularly   

where the subsequent submission closely 
follows in time the earlier response4   
7,,vi7 ,submission of a petition        
concerning standards for approval of a  
drug product for which-- 7aa7 the ,food 
and ,drug ,administration has provided  
an opportunity for public input 7such as
 when the ,food and ,drug               
,administration has issued draft or     
final product-specific guidance         
applicable to the drug product72 and    
7bb7 the petitioner has not provided    
comment other than through the petition4
  7,,vii7 ,submission of a petition     
requesting that other applicants must   
meet standards for testing1 data1 or    
labeling for their products that are    
more onerous or rigorous than the       
standards applicable to the applicable  
listed drug or the petitioner's version 
of the same product4  7,,viii7 ,other   
relevant considerations1 including the  
history of the petitioner with the ,food
 and ,drug ,administration 7such as     
whether the petitioner has a history of 

submitting petitions which the ,food and
 ,drug ,administration has determined   
were submitted with the primary purpose 
of delay74  7iii7 ,referral to ,,ftc ,if
 the ,secretary determines that a       
petition has been submitted with the    
primary purpose of delaying the approval
 of an application1 as described in     
clause 7i71 the ,secretary shall refer  
the matter to the ,federal ,trade       
,commission4  4  7b7 ,deadline for      
submission of petitions  7#a7 ,deadline 
,clause 7i7 of section #eje7q77#a77;,a7 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7q77#a77;,a77 is amended to read as 
follows3  7i7 the request is in writing1
 is a petition submitted to the         
,secretary pursuant to section #aj4cj1  
#aj4ca1 or #aj4ce of title #ba1 ,code of
 ,federal ,regulations 7or any successor
 regulations71 and is submitted not     
later than #fj days after the           
information upon which the petition is  
based first became known to the party on

 whose behalf the petition is submitted2
 and  4  7#b7 ,certification ,section   
#eje7q77#a77;,h7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7q77#a77 is amended by striking ,i 
further certify that the information    
upon which ,i have based the action     
requested herein first became known to  
the party on whose behalf this petition 
is submitted on or about the following  
date3 4 and inserting ,i further certify
 that the information upon which ,i have
 based the action requested herein first
 became known to the party on whose     
behalf this petition is submitted on or 
about 1 which date was not more than #fj
 days before the date of submitting this
 petition44  7c7 ,reporting to ,congress
 ,section #eje7q77#c7 of the ,federal   
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7q77#c77 is amended-- 7#a7
 in the matter before subparagraph 7,a71
 by striking specifies2  7#b7 in        
subparagraphs 7,a71 7,b71 7,c71 and     
7,d71 by striking the number and        

inserting specifies the number2  7#c7 in
 subparagraph 7,c71 by striking and at  
the end2  7#d7 in subparagraph 7,d71 by 
striking the period at the end and      
inserting 2 and2 and  7#e7 by adding at 
the end the following3  7,e7  7i7 lists 
each petition submitted during such     
period and1 for each1 identifies the    
petitioner2  7ii7 quantifies the time   
and resources expended on each such     
petition2  7iii7 states the timing of   
the petition relative to the expiration 
date of the patents specified in the    
pending application in the certification
 under subsection 7b77#b77;,a7 or       
7j77#b77;,a77vii71 as applicable2  7iv7 
quantifies the delay1 if any1 caused by 
any such petition on the approval of any
 application submitted under subsection 
7b77#b7 or 7j71 including a description 
of how any such delay is calculated and 
an estimate of when any delayed approval
 would have been granted absent the     
petition2 and  7v7 in cases in which a  
pending application and a petition with 

respect to such pending application are 
disposed of on the same or nearly the   
same date1 states when the ,food and    
,drug ,administration would have        
disposed of the pending application     
absent the petition4  4