,,ii  #aaith ,,congress  #b;d ,session  
,s4 #cgaf  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,january #bh1  
#bjbf,ms4 ,baldwin introduced the       
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to set forth limitations on    
exclusive approval or licensure of drugs
 designated for rare diseases or        
conditions4  #a4 ,short title ,this ,act
 may be cited as the ,retaining ,access 
and ,restoring ,exclusivity ,act or the 
,,rare ,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 in 
the matter following paragraph 7#b71 by 
striking same disease or condition and  
inserting same approved use or          
indication within such rare disease or  
condition2  7#b7 in subsection 7b7--    
7,a7 in the matter preceding paragraph  

7#a71 by striking same rare disease or  
condition and inserting same approved   
use or indication for which such #g-year
 period applies to such already approved
 or licensed drug2 and  7,b7 in         
paragraph 7#a71 by inserting 1 relating 
to the approved use or indication1 after
 the needs2  7#c7 in subsection 7c77#a71
 by striking same rare disease or       
condition as the already approved drug  
and inserting same use or indication for
 which the already approved or licensed 
drug was approved or licensed2 and  7#d7
 by adding at the end the following3    
7f7 ,approved use or indication defined 
,in this section1 the term approved use 
or indication means the use or          
indication approved under section #eje  
of this ,act or licensed under section  
#cea of the ,public ,health ,service    
,act for a drug designated under section
 #ebf for a rare disease or condition4  
4  7b7 ,application of amendments ,the  
amendments made by subsection 7a7 shall 
apply with respect to any drug          

designated under section #ebf of the    
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;bb71 regardless
 of the date on which the drug was so   
designated1 and regardless of the date  
on which the drug was 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 #bfb74