,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #cghi  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,june #e1 #bjbe,mr4   
,taylor 7= himself & ,ms4 ,s*ak[sky7    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce1 & 9 
addition to ! ,committee on ,ways &     
,means1 = a p]iod to be subsequ5tly     
det]m9$ by ! ,speak]1 9 ea* case =      
consid]ation ( su* provisions z fall )9 
! jurisdiction ( ! committee conc]n$  ,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 = ,consum]s ,act ( #bjbe or 
! ,,dtc ,act ( #bjbe4  #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 9 #bjbj _h a
 li/ price ( m ?an #f1jjj = a "o-mon?   
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    
biologicals1 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$ication1 & ! doctor is m likely to    
write a prescription = x1 if a pati5t   
has se5 an adv]tisem5t = su* m$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+ tools1 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 &     
biologicals include an appropriate      
disclosure ( pric+ in=mation  7a7       
,requirem5t  7#a7 ,9 g5]al ,subject to  
p>agraph 7#b71 n lat] ?an ,july #a1     
#bjbf1 ! ,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 & t is requir$ to      
include ! in=mation relat+ to side      
effects1 contra9dications1 &            
effectiv5ess describ$ 9 section         
#bjb4a7;e77#a7 ( title #ba1 ,code (     
,f$]al ,regulations 7or any successor   
regulation7 also include an appropriate 
disclosure ( pric+ in=mation1 z describ$
 9 subsection 7b71 ) respect to su*     

prescription drug or biological product4
  7#b7 ,exemption ,! requirem5t "u      
p>agraph 7#a7 %all n apply to a         
prescription drug or biological product 
= :i* ! :olesale acquisition co/ = a    
#cj-;day supply ( 7or1 if applicable1 a 
typical c\rse ( treatm5t z set =? 9 !   
approv$ label = ! prim>y indication     
address$ 9 ! adv]tisem5t =7 su*         
prescription drug or biological product 
is less ?an #ce4  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  
cle>ly & conspicu\sly disclose !        
:olesale acquisition co/ = a #cj-;day   
supply ( 7or1 if applicable1 a typical  
c\rse ( treatm5t =7 su* prescription    
drug or biological product2 &  7#b7 may 
expla9 t a consum] may pay a diff]5t    
am\nt = su* prescription drug or        
biological product ?an su* :olesale     
acquisition co/ dep5d+ on ! heal?       

insurance cov]age ( ! consum]4  7c7     
,rulemak+ ,n lat] ?an #a ye> aft] ! date
 ( enactm5t ( ?is section1 ! ,secret>y  
%all promulgate f9al regulations to c>ry
 out ?is section1 includ+ e/abli%+      
requirem5ts =--  7#a7 ! visual & audio  
compon5ts1 ) respect to ea* m$ium (     
direct-to-consum] adv]tisem5t1 to       
communicate ! :olesale acquisition co/ (
 ! adv]tis$ prescription drug or        
biological product2 &  7#b7 ! am\nt ( "t
 = a manufactur] to update any          
direct-to-consum] adv]tisem5t to reflect
 any *ange to ! :olesale acquisition co/
 ( ! adv]tis$ prescription drug or      
biological product4  7d7 ,sanctions ,any
 manufactur] ( a prescription drug or   
biological product1 or an ag5t ( su*    
manufactur]1 t violates ! requirem5t (  
?is section may be subject to a civil   
money p5alty ( n m ?an #ajj1jjj = ea*   
su* violation4 ,! provisions ( section  
#aabh;,a 7o!r ?an subsections 7a7 & 7b77
 %all apply to civil money p5alties "u !
 prec$+ s5t5ce 9 ! same mann] z !y apply

 to a p5alty or proce$+ "u section      
#aabh;,a7a74  7e7 ,public report+ ,9    
ord] to en=ce ! requirem5t "u ?is       
section1 ! ,secret>y may use in=mation  
report$ ab\t manufactur]s t fail to     
comply ) su* requirem5t4  7f7           
,def9itions ,9 ?is section3 7#a7        
,biological product ,! t]m biological   
product means any biological product 7z 
def9$ 9 section #cea7;i7 ( ! ,public    
,heal? ,s]vice ,act7 t is lic5s$ by !   
,food & ,drug ,adm9i/ration pursuant to 
section #cea & is subject to !          
requirem5ts ( section #ejc7;b77#a7 ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act4  
7#b7 ,prescription drug ,! t]m          
prescription drug means any drug 7z     
def9$ 9 section #bja7;g7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act7 t has   
be5 approv$ by ! ,food & ,drug          
,adm9i/ration pursuant to section #eje (
 su* ,act & is subject to ! requirem5ts 
( section #ejc7;b77#a7 ( su* ,act4  7#c7
 ,:olesale acquisition co/ ,! t]m       
:olesale acquisition co/ has ! mean+    

giv5 su* t]m 9 section                  
#ahdg;,a7c77#f77;,b74  7g7 ,au?orization
 ( appropriations ,!re are au?oriz$ to  
be appropriat$ su* sums z may be        
necess>y = ! purposes ( c>ry+ out ?is   
section4  4