,i  #aadth ,,congress  #ast ,session    
,h4 ,r4 #bdeb  ,,in ,,the ,,house ,,of  
,,representatives  ,may #ai1 #bjae ,mr4 
,long 7for himself1 ,mr4 ,schrader1 and 
,mr4 ,burgess7 introduced the following 
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act with respect  
to facilitating dissemination of health 
care economic information4  #a4         
,facilitating dissemination of health   
care economic information ,section      
#ejb7;a7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#ceb7;a77 is amended-- 7#a7 by striking 
7a7 ,if its and inserting 7a77#a7 ,if   
its2  7#b7 by striking a formulary      
committee1 or other similar entity1 in  
the course of the committee or the      
entity carrying out its responsibilities
 for the selection of drugs for managed 
care or other similar organizations and 
inserting a payor1 formulary committee1 
or other similar entity with knowledge  

and expertise in the area of health care
 economic analysis1 carrying out its    
responsibilities for the selection of   
drugs for coverage or reimbursement2    
7#c7 by striking directly relates and   
inserting relates2  7#d7 by striking and
 is based on competent and reliable     
scientific evidence4 ,the requirements  
set forth in section #eje7;a7 or in     
section #cea7;a7 of the ,public ,health 
,service ,act shall not apply to health 
care economic information provided to   
such a committee or entity in accordance
 with this paragraph and inserting 1 is 
based on competent and reliable         
scientific evidence1 and includes1 where
 applicable1 a conspicuous and prominent
 statement describing any material      
differences between the health care     
economic information and the labeling   
approved for the drug under section #eje
 or under section #cea of the ,public   
,health ,service ,act4 ,the requirements
 set forth in section #eje7;a7 or in    
subsections 7a7 and 7k7 of section #cea 

of the ,public ,health ,service ,act    
shall not apply to health care economic 
information provided to such a payor1   
committee1 or entity in accordance with 
this paragraph2 and  7#e7 by striking   
,in this paragraph1 the term and all    
that follows and inserting the          
following3  7#b7 7,a7 ,for purposes of  
this paragraph1 the term health care    
economic information means any analysis 
7including the clinical data1 inputs1   
clinical or other assumptions1 methods1 
results1 and other components underlying
 or comprising the analysis7 that       
identifies1 measures1 or describes the  
economic consequences1 which may be     
based on the separate or aggregated     
clinical consequences of the represented
 health outcomes1 of the use of a drug4 
,such analyses may be comparative to the
 use of another drug1 to another health 
care intervention1 or to no             
intervention4  7,b7 ,such term does not 
include any analysis that relates only  
to an indication that is not approved   

under section #eje or under section #cea
 of the ,public ,health ,service ,act   
for such drug4  4