,,ii  #aag? ,,congress  #a/ ,session    
,s4 #bcjd  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #bd1 #bjba,mr4   
,durb9 7= himself1 ,mr4 ,grassley1 &    
,mr4 ,k+7 introduc$ ! foll[+ bill2 :i* 0
 read twice & ref]r$ to ! ,committee on 
,f9ance  ,a ,,bill  ,to am5d title ,,xi 
( ! ,social ,security ,act to require t 
direct-to-consum] adv]tisem5ts =        
prescription drugs & biological products
 include an appropriate disclosure (    
pric+ in=mation4  #a4 ,%ort title ,?is  
,act may be cit$ z ! ,drug-,price       
,transp>5cy = ,competition ,act ( #bjba 
or ! ,,dtc ,act ( #bjba4  #b4 ,f9d+s2   
s5se ( ! ,s5ate  7a7 ,f9d+s ,congress   
f9ds ! foll[+3 7#a7 ,direct-to-consum]  
adv]tis+ ( prescription ph>maceuticals  
is legally p]mitt$ 9 only #b develop$   
c\ntries1 ! ,unit$ ,/ates & ,new ,zeal&4
  7#b7 ,9 #bjah1 ph>maceutical ad sp5d+ 
exce$$ #f1jdf1jjj1jjj1 a #d4h p]c5t     
increase ov] #bjag1 result+ 9 ! av]age  
,am]ican see+ #i drug adv]tisem5ts p]   
day4  7#c7 ,! mo/ commonly adv]tis$     

m$ication 9 ! ,unit$ ,/ates has a li/   
price ( m ?an #f1jjj = a "o-mon?'s      
supply4  7#d7 ,a #bjba ,gov]nm5t        
,acc\ntability ,(fice report f\nd t     
two-?irds ( all direct-to-consum] drug  
adv]tis+ betwe5 #bjaf & #bjah 0         
conc5trat$ among #ci br&-"n drugs or    
biological products1 ab\t half ( :i* 7  
rec5tly approv$ by ! ,food & ,drug      
,adm9i/ration4  7#e7 ,accord+ to a #bjaa
 ,congressional ,budget ,(fice report1  
ph>maceutical manufactur]s adv]tise _!  
products directly to consum]s 9 an      
attempt to boo/ dem& = _! products &    
!reby raise ! price t consum]s are will+
 to pay1 increase ! quantity ( drugs    
sold1 or a*ieve "s comb9ation ( ! two4  
7#f7 ,/udies1 includ+ a #bjab sy/ematic 
review publi%$ 9 ! ,annual ,review (    
,public ,heal?1 a #bjje r&omiz$ trial   
publi%$ 9 ! ,j\rnal ( ! ,am]ican ,m$ical
 ,association1 & a #bjjd survey publi%$ 
9 ,heal? ,affairs1 %[ t pati5ts are m   
likely to ask _! doctor = a specific    
m$ication & = ! doctor to write a       

prescription = x1 if a pati5t has se5 an
 adv]tisem5t = su* m$ication1 ev5 if su*
 m$ication is n ! mo/ cl9ically         
appropriate = ! pati5t or if a l[]-co/  
g5]ic m$ication may be available4  7#g7 
,accord+ to a #bjaa ,congressional      
,budget ,(fice report1 ! av]age numb] ( 
prescriptions writt5 = newly approv$    
br&-"n drugs ) direct-to-consum]        
adv]tis+ 0 #i times great] ?an ! av]age 
numb] ( prescriptions writt5 = newly    
approv$ br&-"n drugs )\t                
direct-to-consum] adv]tis+4  7#h7 ,!    
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices is !
 s+le l>ge/ drug pay] 9 ! ,unit$ ,/ates4
 ,betwe5 #bjaf & #bjah1 #eh p]c5t ( !   
#efj1jjj1jjj1jjj 9 ,m$ic>e drug sp5d+ 0 
= adv]tis$ drugs1 & 9 #bjah alone1 ! #bj
 mo/ adv]tis$ drugs on television co/   
,m$ic>e & ,m$icaid a comb9$             
#cd1jjj1jjj1jjj4  7#i7 ,a #bjba         
,gov]nm5t ,acc\ntability ,(fice report  
f\nd t direct-to-consum] adv]tis+ may h 
contribut$ to increases 9 ,m$ic>e       
b5efici>y use & sp5d+ among c]ta9 drugs4

  7#aj7 ,! ,am]ican ,m$ical ,association
 has pass$ resolutions support+ !       
requirem5t = price transp>5cy 9 any     
direct-to-consum] adv]tis+1 /at+ t su*  
adv]tisem5ts on _! own inflate dem& =   
new & m exp5sive drugs1 ev5 :5 ^! drugs 
may n be appropriate4  7#aa7 ,a #bjai   
/udy publi%$ 9 ! ,j\rnal ( ! ,am]ican   
,m$ical ,association f\nd t heal? c>e   
consum]s dramatically und]e/imate _!    
out-(-pocket co/s = c]ta9 exp5sive      
m$ications1 b once !y le>n ! :olesale   
acquisition co/ 79 ?is section ref]r$ to
 z ! ,,wac7 ( ! product1 !y are f> bett]
 able to approximate _! out-(-pocket    
co/s4  7#ab7 ,approximately half (      
,am]icans h high-d$uctible heal? plans1 
"u :i* !y (t5 pay ! li/ price ( a drug  
until _! insurance d$uctible is met4    
,all ( ! top ,m$ic>e prescription drug  
plans use co9surance r ?an fix$-doll>   
copaym5ts = m$ications on nonpref]r$    
drug ti]s1 expos+ b5efici>ies to ,,wac  
prices4  7#ac7 ,section #aai ( division 
,,cc ( ! ,consolidat$ ,appropriations   

,act1 #bjba 7,public ,law #aaf-bfj7     
requires ! ,secret>y ( ,heal? & ,human  
,s]vices to increase ! use ( real-"t    
b5efit tools to l[] b5efici>y co/s4     
,h[ev]1 !re /ill rema9s a lack (        
available pric+ tools s pati5ts may n   
le>n ( _! m$ication's co/ until aft] be+
 giv5 a prescription = ! m$ication4 ,a  
#bjac /udy publi%$ 9 ,! ,oncologi/ f\nd 
t "o-qu>t] ( all canc] pati5ts *ose n to
 fill a prescription due to co/4  7#ad7 
,! ,f$]al ,gov]nm5t already ex]cises its
 au?ority to ov]see c]ta9 aspects (     
direct-to-consum] drug adv]tis+1 includ+
 requir$ disclosures ( in=mation relat$ 
to side effects1 contra9dications1 &    
effectiv5ess4  7b7 ,s5se ( ,congress ,x 
is ! s5se ( ,congress t-- 7#a7 a lack ( 
transp>5cy 9 pric+ = ph>maceuticals has 
l$ to a lack ( competition = su*        
ph>maceuticals1 z evid5c$ by a f9d+ by !
 ,dep>tm5t ( ,heal? & ,human ,s]vices t 
,consum]s ( ph>maceuticals are curr5tly 
miss+ in=mation t consum]s ( o!r        
products c m readily access1 namely !   

li/ price ( ! product1 :i* acts z a po9t
 ( comp>ison :5 judg+ ! reasonabl5ess ( 
prices (f]$ = pot5tial sub/itute        
products 7#hd ,f$4 ,reg4 #bjgce72  7#b7 
9 an age :]e price in=mation is         
ubiquit\s1 ! prices ( ph>maceuticals    
rema9 %r\d$ 9 secrecy & limit$ to ^? :o 
subscribe to exp5sive drug price report+
 s]vices1 :i* typically include         
ph>maceutical manufactur]s or o!r heal? 
c>e indu/ry entities & n ! g5]al public2
  7#c7 great] insight & transp>5cy into 
drug prices w help consum]s "k if !y c  
af=d to complete a c\rse ( !rapy be=e   
decid+ to initiate t c\rse ( !rapy2     
7#d7 price %opp+ is ! m>k ( rational    
economic behavior1 & m>kets op]ate m    
effici5tly :5 consum]s h relevant       
in=mation ab\t a product1 includ+ its   
price1 be=e mak+ an in=m$ decision ab\t 
:e!r to buy t product2  7#e7 provid+    
consum]s ) basic price in=mation may    
result 9 ! selection ( less] co/        
alt]natives1 all else be+ equal relative
 to ! pati5t's c>e1 & is integral to    

provid+ adequate competition 9 ! m>ket2 
7#f7 ! ,,wac is a factual1 objective1 & 
uncontrov]sial def9ition = ! li/ price (
 a m$ication1 9 t x is def9$ 9 /atute1  
reflects an und]/ood place 9 ! supply   
*a91 & is at ! sole discretion ( !      
manufactur] to set2  7#g7 !re is a      
gov]nm5tal int]e/ 9 ensur+ t consum]s :o
 seek to pur*ase ph>maceuticals =       
purposes ( promot+ _! heal? & safety    
und]/& ! objective li/ price ( any      
ph>maceutical t !y are enc\rag$ ?r\gh   
adv]tisem5ts to pur*ase1 :i* all[s      
consum]s to make in=m$ pur*as+          
decisions2 &  7#h7 !re is a gov]nm5tal  
int]e/ 9 mitigat+ wa/eful exp5ditures & 
promot+ ! effici5t adm9i/ration ( !     
,m$ic>e program by sl[+ ! gr[? ( ,f$]al 
sp5d+ on prescription drugs4  #c4       
,requirem5t t direct-to-consum]         
adv]tisem5ts = prescription drugs &     
biological products include an          
appropriate disclosure ( pric+ in=mation
 ,"p ,a ( title ,,xi ( ! ,social        
,security ,act is am5d$ by add+ at ! end

 ! foll[+ new section3  #aaej;,d4       
,requirem5t t direct-to-consum]         
adv]tisem5ts = prescription drugs &     
biological products include an          
appropriate disclosure ( pric+ in=mation
  7a7 ,9 g5]al ,! ,secret>y %all require
 t ea* direct-to-consum] adv]tisem5t = a
 prescription drug or biological product
 = :i* paym5t is available "u title     
,,xviii or ,,xix includes an appropriate
 disclosure ( pric+ in=mation ) respect 
to ! drug or product4  7b7 ,appropriate 
disclosure ( pric+ in=mation ,= !       
purposes ( subsection 7a71 an           
appropriate disclosure ( pric+          
in=mation1 ) respect to a prescription  
drug or biological product-- 7#a7 %all  
include a disclosure ( ! :olesale       
acquisition co/ 7z def9$ 9 section      
#ahdg;,a7c77#f77;,b77 = a #cj-;day      
supply ( 7or1 if applicable1 a typical  
c\rse ( treatm5t =7 su* drug or product2
  7#b7 %all be pres5t$ cle>ly &         
conspicu\sly1 z appropriate = ! m$ium ( 
! adv]tisem5t2 &  7#c7 may include      

additional qualitative or quantitative  
in=mation reg>d+ ! price ( su* drug or  
product expla9+ t c]ta9 pati5ts may pay 
a diff]5t am\nt dep5d+ on _! insurance  
cov]age4  7c7 ,en=cem5t ,any p]son :o   
violates ! requirem5t ( ?is section may 
be subject to a civil money p5alty ( n m
 ?an #ajj1jjj = ea* su* violation or to 
ano!r en=cem5t me*anism det]m9$ by !    
,secret>y4 ,any civil money p5alty %all 
be impos$ & collect$ 9 ! same mann] z   
civil money p5alties "u subsection 7a7 (
 section #aabh;,a are impos$ & collect$ 
"u t section4  7d7 ,regulations ,!      
,secret>y1 act+ ?r\gh ! ,adm9i/rator ( !
 ,c5t]s = ,m$ic>e  ,m$icaid ,s]vices1   
%all promulgate regulations to c>ry out 
?is section4 ,su* regulations %all      
det]m9e ! compon5ts ( ! requirem5t "u   
?is section1 includ+ ! =ms ( adv]tis+1 !
 mann] ( disclosure1 ! appropriate      
sanctions1 & ! appropriate disclosure ( 
pric+ in=mation4  4