,,ib ,union ,calendar ,no4 #dgj #aafth  
,,congress  #b;d ,session  ,h4 ,r4 #dgab
 ,report ,no4 #aaf-egb ,,in ,,the       
,,house ,,of ,,representatives  ,october
 #ag1 #bjai,ms4 ,dean 7for herself1 ,mr4
 ,veasey1 ,mr4 ,carter of ,georgia1 and 
,mr4 ,mc,kinley7 introduced the         
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,november #af1 #bjbj;,additional        
sponsors3 ,mr4 ,tonko1 ,mr4 ,kim1 ,mr4  
,soto1 and ,mr4 ,taylor  ,november #af1 
#bjbj,reported with an amendment2       
committed to the ,committee of the      
,whole ,house on the ,state of the      
,union and ordered to be printed,strike 
out all after the enacting clause and   
insert the part printed in italic,for   
text of introduced bill1 see copy of    
bill as introduced on ,october #ag1     
#bjai  ,a ,,bill  ,to amend the ,federal
 ,food1 ,drug1 and ,cosmetic ,act with  
respect to limitations on exclusive     
approval or licensure of orphan drugs1  
and for other purposes4  #a4 ,short     

title ,this ,act may be cited as the    
,fairness in ,orphan ,drug ,exclusivity 
,act4  #b4 ,limitations on exclusive    
approval or licensure of orphan drugs   
7a7 ,in general ,section #ebg of the    
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;cc7 is         
amended-- 7#a7 in subsection 7a71 by    
striking ,except as provided in         
subsection 7b7 and inserting ,except as 
provided in subsection 7b7 or 7f72 and  
7#b7 by adding at the end the following3
  7f7 ,limitations on exclusive         
approval1 certification1 or license     
7#a7 ,in general ,for a drug designated 
under section #ebf for a rare disease or
 condition pursuant to the criteria set 
forth in subsection 7a77#b77;,b7 of such
 section1 the ,secretary shall not      
grant1 recognize1 or apply exclusive    
approval or licensure under subsection  
7a71 and1 if such exclusive approval or 
licensure has been granted1 recognized1 
or applied1 shall revoke such exclusive 
approval or licensure1 unless the       

sponsor of the application for such drug
 demonstrates-- 7,a7 with respect to an 
application approved or a license issued
 after the date of enactment of this    
subsection1 upon such approval or       
issuance1 that there is no reasonable   
expectation at the time of such approval
 or issuance that the cost of developing
 and making available in the ,united    
,states such drug for such disease or   
condition will be recovered from sales  
in the ,united ,states of such drug1    
taking into account all sales made or   
reasonably expected to be made within   
#ab years of first marketing the drug2  
or  7,b7 with respect to an application 
approved or a license issued on or prior
 to the date of enactment of this       
subsection1 not later than #fj days     
after such date of enactment1 that there
 was no reasonable expectation at the   
time of such approval or issuance that  
the cost of developing and making       
available in the ,united ,states such   
drug for such disease or condition would

 be recovered from sales in the ,united 
,states of such drug1 taking into       
account all sales made or reasonably    
expected to be made within #ab years of 
first marketing the drug4  7#b7         
,considerations ,for purposes of        
subparagraphs 7,a7 and 7,b7 of paragraph
 7#a71 the ,secretary and the sponsor of
 the application for the drug designated
 for a rare disease or condition        
described in such paragraph shall       
consider sales from all drugs that--    
7,a7 are developed or marketed by the   
same sponsor or manufacturer of the drug
 7or a licensor1 predecessor in         
interest1 or other related entity to the
 sponsor or manufacturer72 and  7,b7 are
 covered by the same designation under  
section #ebf4  7#c7 ,criteria ,no drug  
designated under section #ebf for a rare
 disease or condition pursuant to the   
criteria set forth in subsection        
7a77#b77;,b7 of such section shall be   
eligible for exclusive approval or      
licensure under this section unless it  

met such criteria under such subsection 
on the date on which the drug was       
approved or licensed4  4  7b7 ,rule of  
construction ,the amendments made in    
subsection 7a7 shall apply to any drug  
that has been or is hereafter designated
 under section #ebf of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cfj;bb7 for a rare disease or
 condition pursuant to the criteria     
under subsection 7a77#b77;,b7 of such   
section regardless of-- 7#a7 the date on
 which such drug is designated or       
becomes the subject of a designation    
request under such section2  7#b7 the   
date on which such drug is approved     
under section #eje of such ,act 7#ba    
,u4,s4,c4 #cee7 or licensed under       
section #cea of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bfb7 or   
becomes the subject of an application   
for such approval or licensure2 and     
7#c7 the date on which such drug is     
granted exclusive approval or licensure 
under section #ebg of the ,federal      

,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cfj;cc7 or becomes the       
subject of a request for such exclusive 
approval or licensure4  ,november #af1  
#bjbj,reported with an amendment2       
committed to the ,committee of the      
,whole ,house on the ,state of the      
,union and ordered to be printed