,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #dajf  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,july #cj1 #bjai,ms4  
,de,lauro 7= h]self1 ,mr4 ,khanna1 &    
,mr4 ,grijalva7 introduc$ ! foll[+ bill2
 :i* 0 ref]r$ to ! ,committee on ,en]gy 
& ,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act to      
re/rict direct-to-consum] drug adv]tis+4
  #a4 ,%ort title ,?is ,act may be cit$ 
z ! ,responsibility 9 ,drug ,adv]tis+   
,act ( #bjai4  #b4 ,direct-to-consum]   
drug adv]tis+ ,! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq47 is am5d$--  7#a7 9 section #cja   
7#ba ,u4,s4,c4 #cca71 by add+ at ! end !
 foll[+3  7fff7 ,! conduct (            
direct-to-consum] adv]tis+ ( a drug 9   
violation ( section #ejf;,j4  2 &  7#b7 
9 *apt] ,v1 by ins]t+ aft] section      
#ejf;,i 7#ba ,u4,s4,c4 #cef;f7 ! foll[+3
  #ejf;,j4 ,direct-to-consum] drug      
adv]tis+  7a7 ,prohibitions  7#a7 ,fir/ 
?ree ye>s  7,a7 ,9 g5]al ,subject to    
subp>agraph 7,b71 no p]son %all conduct 

direct-to-consum] adv]tis+ ( a drug =   
:i* an application is submitt$ "u       
section #eje7;b7 be=e ! end ( ! #c-ye>  
p]iod beg9n+ on ! date ( ! approval (   
su* application4  7,b7 ,waiv] ,!        
,secret>y may waive ! application (     
subp>agraph 7,a7 to a drug dur+ ! ?ird  
ye> ( ! #c-ye> p]iod describ$ 9 su*     
subp>agraph if--  7i7 ! sponsor ( ! drug
 submits an application to ! ,secret>y  
pursuant to subp>agraph 7,c72 &  7ii7 ! 
,secret>y1 aft] consid]+ ! application &
 any accompany+ mat]ials1 det]m9es t    
direct-to-consum] adv]tis+ ( ! drug w\ld
 h an affirmative value to public heal?4
  7,c7 ,application = waiv] ,to seek a  
waiv] "u subp>agraph 7,b71 ! sponsor ( a
 drug %all submit an application to !   
,secret>y at su* "t1 9 su* mann]1 &     
conta9+ su* in=mation z ! ,secret>y may 
require4  7#b7 ,subsequ5t ye>s ,!       
,secret>y may prohibit direct-to-consum]
 adv]tis+ ( a drug dur+ ! p]iod beg9n+  
at ! end ( ! #c-ye> p]iod describ$ 9    
p>agraph 7#a77;,a7 if ! ,secret>y       

det]m9es t ! drug has significant adv]se
 heal? effects bas$ on po/-approval     
/udies1 risk-b5efit analyses1 adv]se    
ev5t reports1 ! sci5tific lit]ature1 any
 cl9ical or obs]vational /udies1 or any 
o!r appropriate res\rce4  7b7           
,regulations ,n lat] ?an #a ye> aft] !  
date ( ! enactm5t ( ?is section1 !      
,secret>y %all revise ! regulations     
promulgat$ "u ?is ,act gov]n+ drug      
adv]tisem5ts to ! ext5t necess>y to     
implem5t ?is section4  7c7 ,rule (      
con/ruction ,?is section %all n be      
con/ru$ to dim9i% ! au?ority ( !        
,secret>y to prohibit or regulate       
direct-to-consum] adv]tis+ ( drugs "u   
o!r provisions ( law4  7d7 ,effective   
date ,?is section applies only ) respect
 to a drug = :i* an application submitt$
 "u section #eje7;b7 is approv$ on or   
aft] ! date t is #a ye> be=e ! date ( ! 
enactm5t ( ?is section4  4