,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #agjc  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #bc1 #bjag,mr4   
,griffi? introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act ) respect
 to det]m9+ ! int5d$ use ( drugs &      
devices4  #a4 ,%ort title ,?is ,act may 
be cit$ z ! ,m$ical ,product            
,communications ,act ( #bjag4  #b4      
,communications reg>d+ int5d$ uses (    
drugs & devices2 sci5tific ex*ange ,!   
,f$]al ,food1 ,drug1 & ,cosmetic ,act is
 am5d$ by ins]t+ aft] section #bja ( su*
 ,act 7#ba ,u4,s4,c4 #cba7 ! foll[+3    
#bja;,a4 ,int5d$ uses ( drugs & devices 
7a7 ,int5d$ use ,= purposes ( ?is ,act1 
includ+ sections #cja7;d71 #ejb7;f77#a71
 #eje1 #eaj1 & #eae & = purposes (      
section #cea ( ! ,public ,heal? ,s]vice 
,act1 ! int5d$ use ( a drug1 biological 
product1 or device--  7#a7 %all be      
det]m9$ by ref]5ce to ! objective int5t 
( ! manufactur] & sponsor ( su* drug1   

biological product1 or device1 or p]sons
 act+ on ! manufactur]'s or sponsor's   
behalf1 z demon/rat$ by /atem5ts conta9$
 9 label+1 adv]tis+1 or analog\s oral   
/atem5ts2 &  7#b7 %all n be det]m9$ by  
ref]5ce to-- 7,a7 actual or con/ructive 
k ( ! manufactur] or sponsor t su* drug1
 biological product1 or device w be us$ 
9 a mann] t v>ies f ! use approv$ =     
m>ket+ "u section #eje1 #eaj1 or #eae ( 
?is ,act or section #cea ( ! ,public    
,heal? ,s]vice ,act2 or  7,b7 sci5tific 
ex*ange z describ$ 9 subsection 7b74    
7b7 ,sci5tific ex*ange  7#a7 ,9 g5]al ,=
 purposes ( ?is ,act1 includ+ sections  
#cja7;d71 #ejb7;f77#a71 #eje1 #eaj7k71 &
 #eae & = purposes ( section #cea ( !   
,public ,heal? ,s]vice ,act1 ! sci5tific
 ex*ange ( in=mation ab\t a drug1       
biological product1 or device1 z        
describ$ 9 p>agraph 7#b71 %all n        
con/itute label+1 adv]tis+1 or evid5ce (
 a new int5d$ use4  7#b7 ,requirem5ts = 
sci5tific ex*ange ,a communication by a 
manufactur] or sponsor1 or a p]son act+ 

on behalf ( a manufactur] or sponsor1   
ab\t ! manufactur]'s or sponsor's drug1 
biological product1 or device1 or use ( 
su* drug1 biological product1 or device1
 t has n be5 approv$ = m>ket+ "u section
 #eje1 #eaj1 or #eae ( ?is ,act or      
section #cea ( ! ,public ,heal? ,s]vice 
,act1 ab\t a device or use ( su* device 
t has n be5 approv$ or cle>$ = m>ket+ "u
 section #eaj or #eae ( ?is ,act1 or    
ab\t in=mation t is n includ$ 9 ! drug1 
biological product1 or device label+1   
con/itutes sci5tific ex*ange :5--  7,a7 
! communication is support$ by          
sci5tifically appropriate & /ati/ically 
s\nd data1 /udies1 or analyses2  7,b7 ! 
communication includes a conspicu\s &   
prom95t /atem5t t ! drug1 biological    
product1 or device1 or use ( su* drug1  
biological product1 or device1 t is !   
subject ( ! communication1 has n be5    
approv$ = m>ket+ "u section #eje1 #eaj1 
or #eae ( ?is ,act or section #cea ( !  
,public ,heal? ,s]vice ,act1 or t su*   
communication includes in=mation t is n 

conta9$ 9 ! drug1 biological product1 or
 device label+1 z applicable2 &  7,c7 = 
communications relat+ to a drug1        
biological product1 or device t has n   
be5 approv$ = m>ket+ "u section #eje1   
#eaj1 or #eae ( ?is ,act or section #cea
 ( ! ,public ,heal? ,s]vice ,act1 or    
relat+ to a use ( a drug1 biological    
product1 or device t has n be5 s        
approv$1 ! manufactur] & sponsor make no
 claims t su* product or use has be5    
demon/rat$ to be safe or effective4     
7#c7 ,sci5tific ex*ange describ$ ,!     
sci5tific ex*ange ( in=mation "u        
p>agraph 7#b7 may include-- 7,a7        
dissem9ation ( sci5tific f9d+s 9        
sci5tific or lay m$ia2  7,b7 publication
 ( results ( sci5tific /udies2  7,c7    
lett]s to ! editor 9 def5se ( public    
*all5ges2  7,d7 communications at       
sci5tific or m$ical conf]5ces or meet+s2
  7,e7 dissem9ation ( m$ical or         
sci5tific publications1 ref]5ce texts1  
or cl9ical practice guidel9es2  7,f7    
communication1 bo? proactive & reactive1

 ( in=mation reg>d+ a manufactur]'s     
rese>* & developm5t ef=ts2  7,g7        
communication1 bo? proactive & reactive1
 ( sci5tific1 m$ical1 or te*nical       
in=mation or f9d+s1 includ+             
communication ( su* in=mation by        
p]sonnel 9 sci5tific1 m$ical1 or cl9ical
 developm5t dep>tm5ts ( manufactur]s2 & 
7,h7 communication1 bo? proactive &     
reactive1 ( heal? c>e economic & heal?  
outcomes in=mation1 includ+             
communication ( su* in=mation deliv]$ by
 or on behalf ( ! heal? c>e economic or 
heal? outcomes dep>tm5ts ( manufactur]s 
to an individual1 gr\p ( individuals1 or
 entity responsible = contribut+ t[>d1  
advis+1 or facilitat+ decisionmak+      
relat$ to heal? c>e res\rce or          
utilization managem5t1 includ+ decisions
 ab\t ! selection ( drugs1 biological   
products1 or devices = a population (   
pati5ts4  7#d7 ,rule ( con/ruction ,no?+
 9 ?is subsection %all be con/ru$-- 7,a7
 to au?orize ! ,secret>y to require t a 
manufactur] or sponsor submit an        

application1 c]tification1 or o!r su*   
submission1 or to seek ! ,secret>y's    
review or approval1 be=e1 dur+1 or      
subsequ5t to engag+ 9 sci5tific ex*ange2
 or  7,b7 to limit ! ability (          
manufactur]s or sponsors to engage 9    
communications or activities t prop]ly  
con/itute sci5tific ex*ange z t t]m is  
describ$ 9 p>agraph 7#b7 b t are n      
specifi$ 9 p>agraph 7#c74  4