,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #bedb  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #a1 #bjbe,mr4  
,davis ( ,nor? ,c>ol9a 7= himself & ,mr4
 ,pflug]7 introduc$ ! foll[+ bill2 :i* 0
 ref]r$ to ! ,committee on ,en]gy &     
,comm]ce1 & 9 addition to ! ,committee  
on ,ways & ,means1 = a p]iod to be      
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,a ,,bill  ,to am5d titles     
,,xviii & ,,xix ( ! ,social ,security   
,act to provide t priority rese>* drugs 
%all n be treat$ z l9e ext5sions ( exi/+
 drugs = purposes ( calculat+           
manufactur] rebates "u ! ,m$ic>e &      
,m$icaid programs1 & = o!r purposes4    
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,old ,drugs1 ,new ,cures ,act4  #b4   
,priority rese>* drugs  7a7 ,9 g5]al    
,section #aibg7;c77#b77;,c7 ( ! ,social 
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7;c77#b77;,c77 is am5d$ by     
ins]t+ ! foll[+ new clause be=e ! flu%  

matt] at ! end3  7iv7 ,priority rese>*  
drug  7,i7 ,reque/ = designation ,n lat]
 ?an #ij days foll[+ ! date ( enactm5t (
 ?is clause1 ! ,secret>y %all e/abli% & 
make effective a process = ! manufactur]
 ( a cov]$ outpati5t drug to reque/ t ! 
,secret>y designate ! drug z a priority 
rese>* drug4  7,,ii7 ,designation ,n    
lat] ?an #fj cal5d> days aft] ! receipt 
( a reque/ "u subclause 7,i71 !         
,secret>y %all designate a cov]$        
outpati5t drug z a priority rese>* drug 
s long z x meets ! foll[+ crit]ia3  7aa7
 ,z ( ! date ( submission ( su* reque/1 
at lea/ #aj ye>s h elaps$ s9ce ! date ! 
drug 0 approv$ "u section #eje7;c7 ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act or
 section #cea7;a7 ( ! ,public ,heal?    
,s]vice ,act4  7bb7 ,! manufactur] ( !  
drug is inve/igat+ su* drug "u section  
#eje7;i7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act or section #cea7;a77#c7 (
 ! ,public ,heal? ,s]vice ,act = a new  
indication t w\ld address a significant 
unmet m$ical ne$ because !re is no      

alt]native drug approv$ "u section #eje 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act or lic5s$ "u section #cea ( !      
,public ,heal? ,s]vice ,act = su*       
indication on ! date t ! reque/ "u      
subclause 7,i7 0 submitt$ to !          
,secret>y4  7cc7 ,! new indication      
describ$ 9 item 7bb7 is = a disease or  
condition t has a high preval5ce among  
b5efici>ies ( ,f$]al heal? c>e programs4
 ,= purposes ( ?is clause1 a disease or 
condition has a high preval5ce among    
b5efici>ies ( ,f$]al heal? c>e programs 
if at lea/ #cc p]c5t ( claims 9 !       
population t>get$ by ! new indication   
dur+ ! prior cal5d> ye> 7 paid = "u--   
7,,aa7 a ,/ate plan "u ?is title or a   
,/ate *ild heal? plan "u title ,,xxi2   
7,,bb7 "p ,d ( title ,,xviii ) respect  
to an individual :o is eligible =       
subsidies "u section #ahfj;,d-#ad2      
7,,cc7 ! drug disc\nt program "u section
 #cdj;,b ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bef;b2 or 7,,dd7 a     
heal? c>e program adm9i/]$ by !         

,dep>tm5t ( ,vet]ans ,affairs4  4  7b7  
,exclusion ( priority rese>* drugs f    
,m$icaid def9ition ( l9e ext5sion ,!    
flu% matt] at ! end ( section           
#aibg7;c77#b77;,c7 ( ! ,social ,security
 ,act 7#db ,u4,s4,c4                    
#acifr-#h7;c77#b77;,c77 is am5d$ by     
ins]t+ a priority rese>* drug 7z        
designat$ "u clause 7iv77 or aft] does n
 include4  7c7 ,exclusion ( priority    
rese>* drugs f ,m$icaid be/ price       
special rule = select$ drugs ,section   
#aibg7;c77#a77;,c77ii77,v7 ( ! ,social  
,security ,act 7#db ,u4,s4,c4           
#acifr-#h7;c77#a77;,c77ii77,v77 is am5d$
 by ins]t+ unless su* drug is also      
designat$ z a priority rese>* drug "u   
p>agraph 7#b77;,c77iv7 dur+ su* p]iod   
be=e ! p]iod4  7d7 ,exclusion ( priority
 rese>* drugs f ,m$ic>e def9ition ( l9e 
ext5sion ,section                       
#ahfj;,d-#ad;,b7b77#e77;,b77ii7 ( !     
,social ,security ,act 7#db ,u4,s4,c4   
#aciew-#aad;b7b77#e77;,b77ii77 is am5d$ 
by ins]t+ a priority rese>* drug 7z     

designat$ "u section                    
#aibg7;c77#b77;,c77iv77 or aft] does n  
include4