,,ii  #aacth ,,congress  #ast ,session  
,s4 #aabh  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,june #aa1     
#bjac ,mr4 ,toomey 7for himself1 ,mr4   
,casey1 and ,mr4 ,crapo7 introduced the 
following bill2 which was read twice and
 referred to the ,committee on ,finance 
,a ,,bill  ,to clarify the orphan drug  
exception to the annual fee on branded  
prescription pharmaceutical             
manufacturers and importers4  #a4 ,short
 title ,this ,act may be cited as the   
,preserving ,access to ,orphan ,drugs   
,act of #bjac4  #b4 ,clarification of   
orphan drug exception to annual fee on  
branded prescription pharmaceutical     
manufacturers and importers  7a7 ,in    
general ,paragraph 7#c7 of section      
#ijjh7;e7 of the ,patient ,protection   
and ,affordable ,care ,act 7#bf         
,u4,s4,c4 #djja note prec42 ,public ,law
 #aaa-adh7 is amended to read as        
follows3  7#c7 ,exclusion of orphan drug
 sales  7,a7 ,in general ,the term      
branded prescription drug sales shall   

not include sales of any drug or        
biological product--  7i7 with respect  
to which a credit was allowed for any   
taxable year under section #de;,c of the
 ,internal ,revenue ,code of #aihf2 or  
7ii7 which is approved or licensed by   
the ,food and ,drug ,administration for 
marketing solely for one or more rare   
diseases or conditions4  7,b7           
,limitation ,subparagraph 7,a7 shall not
 apply with respect to any drug or      
biological product after the date on    
which the drug or biological product is 
approved or licensed by the ,food and   
,drug ,administration for marketing for 
any indication other than the treatment 
of a rare disease or condition4  7,c7   
,rare disease or condition ,in this     
paragraph1 the term rare disease or     
condition has the meaning given such    
term under section #de;,c7d77#a7 of the 
,internal ,revenue ,code of #aihf1      
except that in the case of any drug or  
biological product that has not been    
designated under section #ebf of the    

,federal ,food1 ,drug and ,cosmetic ,act
 for a particular indication1           
determinations under such section       
#de;,c7d77#a7 shall be made on the basis
 of the facts and circumstances as of   
the date such drug or biological product
 is approved or licensed by the ,food   
and ,drug ,administration for marketing 
for the treatment of such disease or    
condition4  4  7b7 ,effective date ,the 
amendment made by this section shall    
take effect as if included in section   
#ijjh of the ,patient ,protection and   
,affordable ,care ,act 7#bf ,u4,s4,c4   
#djja note prec42 ,public ,law          
#aaa-adh74