,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #ibig  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,novemb] #ae1         
#bjbb,mr4 ,gu?rie 7= himself1 ,ms4      
,e%oo1 ,mr4 ,griffi?1 ,mr4 ,pet]s1 ,mr4 
,burgess1 & ,ms4 ,matsui7 introduc$ !   
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to facilitate ! ex*ange
 ( c]ta9 product in=mation1 & = o!r     
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,pre-,approval ,in=mation  
,ex*ange ,act ( #bjbb4  #b4 ,facilitat+ 
ex*ange ( product in=mation prior to    
approval  7a7 ,9 g5]al ,section #ejb ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #ceb7 is am5d$-- 7#a7 9  
p>agraph 7a7-- 7,a7 by /rik+ drugs =    
cov]age & ins]t+ drugs or devices =     
cov]age2 &  7,b7 by /rik+ drug ea* place
 x appe>s & ins]t+ drug or device1      
respectively2  7#b7 9 p>agraphs 7a77#a7 
& 7a77#b77;,b71 by /rik+ "u section #eje
 or "u section #cea ( ! ,public ,heal?  

,s]vice ,act & ins]t+ "u section #eje1  
#eaj7k71 #eac7;f77#b71 or #eae ( ?is    
,act or section #cea ( ! ,public ,heal? 
,s]vice ,act2  7#c7 9 p>agraph 7a77#a7--
 7,a7 by /rik+ "u section #eje or "u    
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act & ins]t+ "u section #eje1  
#eaj7k71 #eac7;f77#b71 or #eae ( ?is    
,act or section #cea ( ! ,public ,heal? 
,s]vice ,act2 &  7,b7 by /rik+ 9 section
 #eje7;a7 or 9 subsections 7a7 & 7k7 (  
section #cea ( ! ,public ,heal? ,s]vice 
,act & ins]t+ 9 section #eje1 #eaj7k71  
#eac7;f77#b71 or #eae ( ?is ,act or     
section #cea ( ! ,public ,heal? ,s]vice 
,act2 &  7#d7 by add+ at ! end ! foll[+3
  7gg7 7#a7 ,unless its label+ be>s     
adequate directions = use 9 accordance )
 p>agraph 7f71 except t 79 addition to  
drugs or devices t con=m ) exemptions   
pursuant to su* p>agraph7 no drug or    
device %all be deem$ to be misbr&$ "u   
su* p>agraph ?r\gh ! provision ( product
 in=mation 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 or devices = cov]age  
or reimbursem5t if ! product in=mation  
relates to an inve/igational drug or    
device or inve/igational use ( a drug or
 device t is approv$1 cle>$1 grant$     
m>ket+ au?orization1 or lic5s$ "u       
section #eje1 #eaj7k71 #eac7;f77#b71 or 
#eae ( ?is ,act or section #cea ( !     
,public ,heal? ,s]vice ,act 7z          
applicable71 provid$-- 7,a7 ! product   
in=mation includes-- 7i7 a cle> /atem5t 
t ! inve/igational drug or device or    
inve/igational use ( a drug or device   
has n be5 approv$1 cle>$1 grant$ m>ket+ 
au?orization1 or lic5s$ "u section #eje1
 #eaj7k71 #eac7;f77#b71 or #eae ( ?is   
,act or section #cea ( ! ,public ,heal? 
,s]vice ,act 7z applicable7 & t ! safety
 & effectiv5ess ( ! drug or device or   
use has n be5 e/abli%$2  7ii7 in=mation 
relat$ to ! /age ( developm5t ( ! drug  
or device involv$1 su* z-- 7,i7 ! /atus 
( any /udy or /udies 9 :i* !            

inve/igational drug or device or        
inve/igational use is be+ inve/igat$2   
7,,ii7 h[ ! /udy or /udies relate to !  
ov]all plan = ! developm5t ( ! drug or  
device2 &  7,,iii7 :e!r an application1 
prem>ket notification1 or reque/ =      
classification = ! inve/igational drug  
or device or inve/igational use has be5 
submitt$ to ! ,secret>y & :5 su* a      
submission is plann$2  7iii7 9 ! case ( 
in=mation t includes factual            
pres5tations ( results f /udies1 :i*    
%all n be selectively pres5t$1 a        
description (-- 7,i7 all mat]ial aspects
 ( /udy design1 me?odology1 & results2 &
  7,,ii7 all mat]ial limitations relat$ 
to ! /udy design1 me?odology1 & results2
  7iv7 :]e applicable1 a prom95t /atem5t
 disclos+ ! indication or indications = 
:i* ! ,secret>y has approv$1 grant$     
m>ket+ au?orization1 cle>$1 or lic5s$ ! 
product pursuant to section #eje1       
#eaj7k71 #eac7;f77#b71 or #eae ( ?is    
,act or section #cea ( ! ,public ,heal? 
,s]vice ,act1 & a copy ( ! mo/ curr5t   

requir$ label+2 &  7v7 updat$ in=mation1
 if previ\sly communicat$ in=mation     
becomes mat]ially outdat$ z a result (  
significant *anges or z a result ( new  
in=mation reg>d+ ! product or its review
 /atus2 &  7,b7 ! product in=mation does
 n include-- 7i7 in=mation t repres5ts t
 an unapprov$ product-- 7,i7 has be5    
approv$1 cle>$1 grant$ m>ket+           
au?orization1 or lic5s$ "u section #eje1
 #eaj7k71 #eac7;f77#b71 or #eae ( ?is   
,act or section #cea ( ! ,public ,heal? 
,s]vice ,act 7z applicable72 or  7,,ii7 
has o!rwise be5 det]m9$ to be safe or   
effective = ! purpose or purposes = :i* 
! drug or device is be+ /udi$2 or  7ii7 
in=mation t repres5ts t an unapprov$ use
 ( a drug or device t has be5 s approv$1
 grant$ m>ket+ au?orization1 cle>$1 or  
lic5s$-- 7,i7 is s approv$1 grant$      
m>ket+ au?orization1 cle>$1 or lic5s$2  
or  7,,ii7 t ! product is safe or       
effective = ! use or uses = :i* ! drug  
or device is be+ /udi$4  7#b7 ,=        
purposes ( ?is p>agraph1 ! t]m product  

in=mation includes-- 7,a7 in=mation     
describ+ ! drug or device 7su* z drug   
class1 device description1 & features72 
7,b7 in=mation ab\t ! indication or     
indications be+ inve/igat$2  7,c7 !     
anticipat$ timel9e = a possible         
approval1 cle>ance1 m>ket+ au?orization1
 or lic5sure pursuant to section #eje1  
#eaj7k71 #eac1 or #eae ( ?is ,act or    
section #cea ( ! ,public ,heal? ,s]vice 
,act2  7,d7 drug or device pric+        
in=mation2  7,e7 pati5t utilization     
projections2  7,f7 product-relat$       
programs or s]vices2 &  7,g7 factual    
pres5tations ( results f /udies t d n   
*>act]ize or make conclusions reg>d+    
safety or efficacy4  4  7b7 ,,gao /udy &
 report ,beg9n+ on ! date t is #e ye>s &
 #f mon?s aft] ! date ( enactm5t ( ?is  
,act1 ! ,comptroll] ,g5]al ( ! ,unit$   
,/ates %all conduct a /udy on !         
provision & use ( in=mation pursuant to 
section #ejb7;gg7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act1 z add$ by ?is  
subsection 7a71 betwe5 manufactur]s (   

drugs & devices 7z def9$ 9 section #bja 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cba77 & entities   
describ$ 9 su* section #ejb7;gg74 ,su*  
/udy %all include an analysis ( !       
foll[+3 7#a7 ,! types ( in=mation       
communicat$ betwe5 su* manufactur]s &   
payors4  7#b7 ,! mann] ( communication  
betwe5 su* manufactur]s & payors4  7#c7 
7,a7 ,:e!r su* manufactur]s file an     
application = approval1 m>ket+          
au?orization1 cle>ance1 or lic5s+ ( a   
new drug or device or ! new use ( a drug
 or device t is ! subject (             
communication betwe5 su* manufactur]s & 
payors "u section #ejb7;gg7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act1 z add$  
by subsection 7a74  7,b7 ,h[ frequ5tly !
 ,food & ,drug ,adm9i/ration approves1  
grants m>ket+ au?orization1 cle>s1 or   
lic5ses ! new drug or device or new use4
  7,c7 ,! timeframe betwe5 ! initial    
communications p]mitt$ "u section       
#ejb7;gg7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act1 z add$ by subsection    

7a71 reg>d+ an inve/igational drug or   
device or inve/igational use1 & !       
initial m>ket+ ( su* drug or device4