,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #cbga  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,febru>y #aa1 #bjbj,mr4
 ,cassidy 7= himself1 ,ms4 ,baldw91 &   
,mrs4 ,%ahe57 introduc$ ! foll[+ bill2  
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
) respect to limitations on exclusive   
approval or lic5sure ( orphan drugs1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,fairness 9 ,orphan
 ,drug ,exclusivity ,act4  #b4          
,limitations on exclusive approval or   
lic5sure ( orphan drugs  7a7 ,9 g5]al   
,section #ebg ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 
is am5d$-- 7#a7 9 subsection 7a71 by    
/rik+ ,except z provid$ 9 subsection 7b7
 & ins]t+ ,except z provid$ 9 subsection
 7b7 or 7f72 &  7#b7 by add+ at ! end ! 
foll[+3  7f7 ,limitations on exclusive  
approval1 c]tification1 or lic5se  7#a7 
,9 g5]al ,= a drug designat$ "u section 

#ebf = a r>e disease or condition       
pursuant to ! crit]ia set =? 9          
subsection 7a77#b77;,b7 ( su* section1 !
 ,secret>y %all n grant1 recognize1 or  
apply exclusive approval or lic5sure "u 
subsection 7a71 &1 if su* exclusive     
approval or lic5sure has be5 grant$1    
recogniz$1 or appli$1 %all revoke su*   
exclusive approval or lic5sure1 unless !
 sponsor ( ! application = su* drug     
demon/rates-- 7,a7 ) respect to an      
application approv$ or a lic5se issu$   
aft] ! date ( enactm5t ( ?is subsection1
 ^u su* approval or issuance1 t !re is  
no reasonable expectation at ! "t ( su* 
approval or issuance t ! co/ ( develop+ 
& mak+ available 9 ! ,unit$ ,/ates su*  
drug = su* disease or condition w be    
recov]$ f sales 9 ! ,unit$ ,/ates ( su* 
drug1 tak+ into acc\nt all sales made or
 reasonably expect$ to be made )\t a "t 
limitation2 or  7,b7 ) respect to an    
application approv$ or a lic5se issu$ on
 or prior to ! date ( enactm5t ( ?is    
subsection1 n lat] ?an #fj days aft] su*

 date ( enactm5t1 t !re 0 no reasonable 
expectation at ! "t ( su* approval or   
issuance t ! co/ ( develop+ & mak+      
available 9 ! ,unit$ ,/ates su* drug =  
su* disease or condition w\ld be recov]$
 f sales 9 ! ,unit$ ,/ates ( su* drug1  
tak+ into acc\nt all sales made or      
reasonably expect$ to be made )\t a "t  
limitation4  7#b7 ,consid]ations ,=     
purposes ( subp>agraphs 7,a7 & 7,b7 (   
p>agraph 7#a71 ! ,secret>y & ! sponsor (
 ! application = ! drug designat$ = a   
r>e disease or condition describ$ 9 su* 
p>agraph %all consid] sales f all drugs 
t-- 7,a7 are develop$ or m>ket$ by !    
same sponsor or manufactur] ( ! drug 7or
 a lic5sor1 pr$ecessor 9 int]e/1 or o!r 
relat$ entity to ! sponsor or           
manufactur]72 &  7,b7 are cov]$ by !    
same designation "u section #ebf4  7#c7 
,crit]ia ,no drug designat$ "u section  
#ebf = a r>e disease or condition       
pursuant to ! crit]ia set =? 9          
subsection 7a77#b77;,b7 ( su* section   
%all be eligible = exclusive approval or

 lic5sure "u ?is section unless x met   
su* crit]ia "u su* subsection on ! date 
on :i* ! drug 0 approv$ or lic5s$4  4   
7b7 ,rule ( con/ruction ,! am5dm5ts made
 9 subsection 7a7 %all apply to any drug
 t has be5 or is h]eaft] designat$ "u   
section #ebf ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bb7 =
 a r>e disease or condition pursuant to 
! crit]ia "u subsection 7a77#b77;,b7 (  
su* section reg>dless (-- 7#a7 ! date on
 :i* su* drug is designat$ or becomes ! 
subject ( a designation reque/ "u su*   
section2  7#b7 ! date on :i* su* drug is
 approv$ "u section #eje ( su* ,act 7#ba
 ,u4,s4,c4 #cee7 or lic5s$ "u section   
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb7 or becomes !       
subject ( an application = su* approval 
or lic5sure2 &  7#c7 ! date on :i* su*  
drug is grant$ exclusive approval or    
lic5sure "u section #ebg ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;cc7 or becomes ! subject 
( a reque/ = su* exclusive approval or  

lic5sure4