,,ii  #aae? ,,congress  #a/ ,session    
,s4 #baeg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,novemb] #af1 #bjag    
,mr4 ,durb9 7= himself1 ,mr4 ,k+1 ,mr4  
,br[n1 ,mr4 ,frank51 ,ms4 ,hassan1 &    
,ms4 ,h>ris7 introduc$ ! foll[+ bill2   
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to      
require drug manufactur]s to disclose ! 
prices ( prescription drugs 9 any       
direct-to-consum] adv]tis+ & m>ket+ to  
practition]s ( a drug4  #a4 ,%ort title 
,?is ,act may be cit$ z ! ,drug-,price  
,transp>5cy 9 ,communications ,act4  #b4
 ,f9d+s ,congress f9ds z foll[s3 7#a7   
,direct-to-consum] adv]tis+ (           
prescription ph>maceuticals is legal 9  
only #b develop$ c\ntries1 ! ,unit$     
,/ates & ,new ,zeal&4  7#b7             
,direct-to-consum] adv]tis+ (           
prescription ph>maceuticals is design$  
to cause pati5ts to pressure physicians 
to prescribe c]ta9 m$ications4  7#c7 ,9 
#bjae1 ph>maceutical companies sp5t m   

?an #ajj1jjj1jjj on adv]tis+ ) respect  
to ea* ( #af br&-"n drugs1 prim>ily new 
& exp5sive drugs4  7#d7 ,prescription   
rates ( m$ications adv]tis$ directly to 
consum]s h increas$ by #cd4b p]c5t      
comp>$ to a #e4a p]c5t increase 9 o!r   
ph>maceuticals4  7#e7 ,prescription     
ph>maceuticals co/ m 9 ! ,unit$ ,/ates  
?an !y d 9 any o!r c\ntry4  7#f7 ,!     
,am]ican ,m$ical ,association has pass$ 
resolutions call+ = ! ban (             
direct-to-consum] adv]tis+ (            
prescription ph>maceuticals1 & to       
require price transp>5cy 9 any          
direct-to-consum] adv]tis+4  7#g7 ,!    
am\nt ( sp5d+ by ph>maceutical companies
 9 m>ket+ to heal? c>e provid]s is m ?an
 #d times ! sp5d+ = direct-to-consum]   
adv]tis+4  7#h7 ,heal? c>e provid]s are 
m likely to prescribe a c]ta9 drug if !y
 h receiv$ paym5ts or m>ket+ mat]ials f 
! manufactur] ( t drug4  #c4 ,price     
disclosure requirem5t =                 
direct-to-consum] drug adv]tisem5ts  7a7
 ,9 g5]al ,section #cjc7;g77#a7 ( !     

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #ccc7;g77#a77 is am5d$-- 
7#a7 by /rik+ 7,a7 & ins]t+ 7i72  7#b7  
by /rik+ 7,b7 & ins]t+ 7ii72  7#c7 by   
/rik+ 7#a7 ,) respect & ins]t+ 7#a77;,a7
 ,) respect2  7#d7 by /rik+ ?is p>agraph
 ea* place x appe>s & ins]t+ ?is        
subp>agraph2  7#e7 by /rik+ ,no o!r     
civil monet>y p5alties 9 ?is ,act       
7includ+ ! civil p5alty 9 section       
#cjc7;f77#d77 & ins]t+ ,no civil monet>y
 p5alties 7includ+ ! civil p5alty 9     
section #cjc7;f77#d771 o!r ?an !        
p5alties "u ?is subp>agraph &           
subp>agraph 7,b72 &  7#f7 by add+ at !  
end ! foll[+3  7,b7 ,) respect to a     
p]son :o is a hold] ( an approv$        
application "u section #eje = a drug    
subject to section #ejc7;b7 or "u       
section #cea ( ! ,public ,heal? ,s]vice 
,act1 any su* p]son :o dissem9ates or   
causes ano!r p>ty to dissem9ate a       
direct-to-consum] adv]tisem5t t does n  
include ! :olesale acquisition co/ 7z   
def9$ 9 section #ahdg;,a7c77#f77;,b7 ( !

 ,social ,security ,act7 = a #cj-;day   
supply ( ! drug %all be liable to !     
,unit$ ,/ates = a civil p5alty 9 an     
am\nt n to exce$ #a1jjj1jjj = ! fir/ su*
 violation 9 any #c-ye> p]iod1 & n to   
exce$ #e1jjj1jjj = ea* subsequ5t        
violation 9 any #c-ye> p]iod4 ,=        
purposes ( ?is subp>agraph1 all         
violations "u ?is p>agraph occurr+ 9 a  
s+le day %all be consid]$ "o violation4 
,) respect to adv]tisem5ts t appe> 9    
magaz9es or o!r publications t are      
publi%$ less frequ5tly ?an daily1 ea*   
issue date 7:e!r weekly or mon?ly7 %all 
be treat$ z a s+le day = ! purpose (    
calculat+ ! numb] ( violations "u ?is   
subp>agraph4  4  7b7 ,transf] ( funds ,=
 ea* fiscal ye>1 !re are au?oriz$ to be 
appropriat$1 & are appropriat$1 out (   
any funds n o!rwise obligat$1 to !      
,director ( ! ,national ,in/itutes (    
,heal? = purposes ( c>ry+ out m$ical    
rese>*1 an am\nt equal to ! am\nt       
collect$ 9 p5alties dur+ ! previ\s      
fiscal ye> = violations ( section       

#cjc7;g77#a77;,b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act4  7c7           
,regulations ,! ,secret>y ( ,heal? &    
,human ,s]vices1 act+ ?r\gh !           
,commission] ( ,food & ,drugs1 %all     
promulgate regulations to c>ry out      
subp>agraph 7,b7 ( section #cjc7;g77#a7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #ccc7;g77#a771 z    
add$ by subsection 7a74 ,su* regulations
 %all include provisions sett+ =?--     
7#a7 a reasonable am\nt ( "t a          
manufactur] has to update any           
direct-to-consum] adv]tis+ ( a drug 9   
accordance ) su* subp>agraph 7,b7 aft] a
 *ange to ! :olesale acquisition co/ ( !
 drug2 &  7#b7 ! specific mann] 9 :i* ! 
:olesale acquisition co/ ( a drug is    
requir$ to be conspicu\sly disclos$ 9   
su* direct-to-consum] adv]tisem5ts 9    
ord] to communicate su* s+le price      
metric to ! public1 :i* %all include    
visual & audio 7z applicable7 compon5ts 
( ! adv]tisem5t1 & :i* may include a    
brief qualitative explanation ( r$uc$   

co/ availability = c]ta9 consum]s1 su* z
 ?r\gh insurance co/-%>+ arrangem5ts or 
pati5t assi/ance programs4  #d4 ,drug   
manufactur] duty to disclose drug prices
 to practition]s  7a7 ,duty ,to disclose
 ,:5ev] a drug manufactur]1 includ+ any 
repres5tative ( ! manufactur]1          
communicates ) a heal? c>e practition]  
ab\t a drug manufactur$ by ! drug       
manufactur]1 includ+ ?r\gh promotional1 
educational1 or m>ket+ communications1  
meet+s or paid ev5ts1 & ! provision (   
goods1 gifts1 & samples1 ! drug         
manufactur] %all disclose to !          
practition] ! :olesale acquisition co/  
7z def9$ 9 section #ahdg;,a7c77#f77;,b7 
( ! ,social ,security ,act 7#db         
,u4,s4,c4 #aciew-#c;a7c77#f77;,b777 = a 
#cj-;day supply ( ! drug1 :i* may       
include a brief qualitative explanation 
( r$uc$ co/ availability = c]ta9        
consum]s t is consi/5t ) ! regulations  
describ$ 9 section #c7;c77#b74  7b7     
,en=cem5t by ,f$]al ,trade ,commission  
7#a7 ,unfair or deceptive acts or       

practices ,a violation ( subsection 7a7 
by a p]son ) respect to :om !           
,commission is emp[]$ "u section        
#e7;a77#b7 ( ! ,f$]al ,trade ,commission
 ,act 7#ae ,u4,s4,c4 #de7;a77#b77 %all  
be treat$ z a violation ( a rule def9+  
an unfair or deceptive act or practice  
prescrib$ "u section #ah7;a77#a77;,b7 ( 
! ,f$]al ,trade ,commission ,act 7#ae   
,u4,s4,c4 #eg;a7a77#a77;,b774  7#b7     
,p[]s ( ,f$]al ,trade ,commission  7,a7 
,9 g5]al ,! ,f$]al ,trade ,commission   
%all en=ce ?is section 9 ! same mann]1  
by ! same means1 & ) ! same             
jurisdiction1 p[]s1 & duties z ?\gh all 
applicable t]ms & provisions ( ! ,f$]al 
,trade ,commission ,act 7#ae ,u4,s4,c4  
#da et seq47 7 incorporat$ into & made a
 "p ( ?is ,act4  7,b7 ,privileges &     
immunities ,any p]son :o violates ?is   
section %all be subject to ! p5alties & 
entitl$ to ! privileges & immunities    
provid$ 9 ! ,f$]al ,trade ,commission   
,act 7#ae ,u4,s4,c4 #da et seq474  7c7  
,rulemak+ ,! ,f$]al ,trade ,commission  

%all promulgate 9 accordance ) section  
#eec ( title #e1 ,unit$ ,/ates ,code1   
su* rules z may be necess>y to c>ry out 
?is section4  7d7 ,sav+s provision ,no?+
 9 ?is section %all be con/ru$ to limit1
 impair1 or sup]s$e ! op]ation ( !      
,f$]al ,trade ,commission ,act or any   
o!r provision ( ,f$]al law4