,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #bjbf  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #f1 #bjag,mr4  
,gu?rie introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to improve pati5t 
access to em]g+ m$ication !rapies by    
cl>ify+ ! scope ( p]mitt$ heal? c>e     
economic & sci5tific in=mation          
communications betwe5 bioph>maceutical  
manufactur]s & population heal? decision
 mak]s4  #a4 ,%ort title ,?is ,act may  
be cit$ z ! ,ph>maceutical ,in=mation   
,ex*ange ,act4  #b4 ,facilitat+ ex*ange 
( in=mation prior to approval ,section  
#ejb7;a7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7;a77 
is am5d$--  7#a7 by r$esignat+          
subp>agraph 7#b7 z subp>agraph 7#c72    
7#b7 by ins]t+ aft] subp>agraph 7#a7 !  
foll[+3  7#b7 ,heal? c>e economic       
in=mation or sci5tific in=mation provid$
 to a payor1 =mul>y committee1 or o!r   
simil> entity ) k & exp]tise 9 ! area ( 
heal? c>e economic analysis c>ry+ out   

its responsibilities = ! selection (    
drugs = cov]age1 reimbursem5t1 or o!r   
population-bas$ heal? c>e managem5t1    
%all n be consid]$ false or mislead+ or 
any o!r =m ( misbr&+ "u ?is p>agraph1 or
 a violation ( section #eje ( ?is ,act  
or section #cea ( ! ,public ,heal?      
,s]vice ,act1 or o!rwise prohibit$      
pre-approval promotion ( a drug1 if x is
 bas$ on compet5t & reliable sci5tific  
evid5ce & relates to an inve/igational  
new drug or an inve/igational use ( an  
approv$ drug4 ,9 ord] = in=mation relat+
 to an inve/igational use ( an approv$  
drug to be provid$ pursuant to ?is      
subp>agraph1 !re mu/ h be5 submitt$ to !
 ,secret>y a supplem5tal application =  
approval ( su* use1 or ! /udy or /udies 
ne$$ to support ! submission ( a        
supplem5tal application = su* use mu/ h 
be5 complet$ ) ! int5tion t a           
supplem5tal application w be submitt$ to
 ! ,secret>y = approval ( ! use4 ,=     
purposes ( ?is subp>agraph1 sci5tific   
in=mation includes cl9ical & pre-cl9ical

 data & results relat+ to an unapprov$  
drug !rapy1 or drug indication1 or o!r  
condition ( use be+ inve/igat$ or       
develop$4  2 &  7#c7 9 subp>agraph 7#c71
 z r$esignat$-- 7,a7 by /rik+ 7,a72 &   
7,b7 by /rik+ clause 7,b74