Running Head: DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 1

Direct-t-Cn!u"er Mar#eting $ Pre!cri%tin Medicatin:

A Di!cu!!in $ Regu&atr' Standard! and Ad(erti!ing Practice! in t)e United State!
Anna A&&i!n
Uni(er!it' $ San Franci!c
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION *
Intrductin
T)e "!t %r"inent $r" $ )ea&t) c""unicatin in t)e United State! de! nt )a%%en at t)e
dctr+! $$ice, Direct-t-cn!u"er -DTC. ad(erti!ing $ %)ar"aceutica& drug! )a! gr/n
dra"atica&&' during t)e %a!t !e(era& decade!0 !ur%a!!ing )ea&t) de%art"ent!0 "edica& 1urna&!
and dctr+! ad(ice t 2ec"e t)e "!t a2undant $r" $ )ea&t) c""unicatin e3%erienced 2'
"an' A"erican! -4ent&a0 *511., Fr !"e0 %ri"ari&' %)ar"aceutica& c"%anie!0 t)i! $reed"
$ e3%re!!in i! a 2n t 2u!ine!!0 and a 1u!ti$ia2&e e3%re!!in $ t)eir Fir!t A"end"ent rig)t!,
Fr t)er!0 t)ere i! dee% cntr(er!' a2ut DTC ad(erti!ing+! ri!# t %atient+! !a$et'0
(er"edicatin0 and t)e dctr-%atient re&atin!)i%,
T)e Fd and Drug Ad"ini!tratin /a! granted !tatutr' aut)rit' (er %re!cri%tin drug
&a2e&ing and ad(erti!ing in 167*0 2ut DTC ad(erti!ing /a! nt %er"itted unti& 1689 -:HO0
*556., T g(ern t)e!e ad!0 $ur genera& regu&atin! /ere i!!ued0 ;ad! "u!t -1. nt 2e $a&!e r
"i!&eading0 -*. %re!ent a +$air 2a&ance+ $ in$r"atin de!cri2ing 2t) t)e ri!#! and 2ene$it! $ a
drug0 -<. inc&ude $act! t)at are +"ateria&+ t t)e %rduct=! ad(erti!ed u!e!0 and ->. inc&ude a +2rie$
!u""ar'+ t)at "entin! e(er' ri!# de!cri2ed in t)e %rduct=! &a2e&ing -4ent&a0 *511.? At t)eir
ince%tin0 t)e!e ru&e! /ere en$rced t "a#e it i"%ractica& t 2radca!t ad(erti!e"ent! $r
%)ar"aceutica&!, T)e ti"e in(&(ed t !u$$icient&' e3%&ain %tentia& ri!#! and !ide-e$$ect! "ade
2u'ing air ti"e %r)i2iti(e&' e3%en!i(e, H/e(er0 t)e FDA ea!ed u% n t)e ru&e! in 166@0
%r"%ting an e3%&!in $ ad! "ar#eting drug! $r erecti&e di!$unctin0 2&d %re!!ure0 and
e(er't)ing in 2et/een -:HO0 *556.,
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION <
T)e United State! and Ne/ Aea&and are t)e n&' t/ cuntrie! t)at a&&/ %re!cri%tin drug! t
2e "ar#eted direct&' t t)e cn!u"er rat)er t)an t t)e %re!cri2ing %)'!ician -:HO0 *556., But0
/)i&e t)e United State! 2a!t! a %%u&atin $ <1<,6 "i&&in %e%&e0 Ne/ Aea&and+! %%u&atin i!
1u!t under >,9 "i&&in %e%&e -:r&d Ban#0 *51*., :)i&e n t)e !ur$ace0 Ne/ Aea&and and t)e
United State! "a' a%%ear !i"i&ar in t)eir ad(erti!ing %ractice!0 t)e United State! i! uniCue in t)e
!iDe $ it! %)ar"aceutica& indu!tr'0 a! /e&& a! t)e FDA+! regu&ating %/er,
:)i&e t)e United State! and Ne/ Aea&and are t)e n&' indu!tria&iDed cuntrie! t a&&/ DTC
ad(erti!ing0 t)ere are t)er cuntrie! t)at a&&/ DTC ad(erti!ing in !"e $r", Canada0 $r
e3a"%&e0 de! nt a&&/ %)ar"aceutica&! t 2e "ar#eted t cn!u"er!0 2ut t)e' d a&&/
;re"inder ad!? and di!ea!e a/arene!! ad(erti!ing, Re"inder ad! are a&&/ed t !a' t)e drug+!
na"e0 2ut nt it! intended u!e, T)e idea 2e)ind t)i! t'%e $ ad(erti!e"ent i! t re"ind %e%&e t
re$i&& t)eir %re!cri%tin!, H/e(er0 it i! $ten a!!u"ed t)at %e%&e d nt re$i&& t)eir %re!cri%tin!
2ecau!e t)e' $rgt0 /)en it rea&it'0 it i! $ten 2ecau!e t)e' $e&t &i#e t)e' did nt need r /ant
t)e "edicatin -4ent&a0 *511.,
Di!ea!e a/arene!! ad(erti!ing i! &ega& in "!t cuntrie!0 and !er(e! a! a %u2&ic !er(ice
annunce"ent -4ent&a0 *511., T)e %ur%!e $ t)e!e ad! are t encurage %e%&e e3%eriencing
!'"%t"! t !ee a dctr, T)e!e ad(erti!e"ent! are $ten ca&&ed0 ;)e&%-!ee#ing ad!? 2ecau!e
t)e' encurage %e%&e t !ee# "edica& attentin, T)i! t'%e $ ad(erti!ing %r)i2it! t)e "entin
$ an' drug 2rand!0 and in!tead $cu! n e3%&aining t)e 2ene$it! $ an entire c&a!! $ drug!, Fr
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION >
t)i! rea!n0 t)e' "a#e u% a (er' !"a&& %rtin $ DTC ad(erti!ing in t)e United State! -4ent&a0
*511 .,
De!cri%tin $ t)e Pr2&e"
Artic&e 16 $ t)e Uni(er!a& Dec&aratin $ Hu"an Rig)t! and t)e Fir!t A"end"ent $ t)e United
State!+ Bi&& $ Rig)t! guarantee! $reed" $ !%eec) and $reed" $ e3%re!!in t a&& indi(idua&!,
T)e United State+! cr%rate %er!n)d recgniDe! cr%ratin! a! indi(idua&! in t)e e'e! $
t)e &a/0 "eaning t)at %)ar"aceutica& c"%anie! are guaranteed t)e !a"e $reed" $ !%eec) a!
an' !ing&e indi(idua&, Fr t)i! rea!n0 "a#er! $ %)ar"aceutica& c"%anie! a!!ert t)at DTC
ad(erti!e"ent i! a $r" $ e3%re!!in underta#en 2' t)eir cr%ratin!0 and i! t)ere$re
%rtected 2' t)e Fir!t A"end"ent, H/e(er0 critic! $ DTC ad(erti!ing c&ai" t)at 2' u%)&ding
%)ar"aceutica& c"%anie! in$ringed $reed" $ e3%re!!in0 t)eir ad(erti!ing %ractice!
1e%ardiDe %atient!+ rig)t t "a#e in$r"ed "edica& deci!in!,
Deter"ining t)e e$$ect $ DTC ad(erti!ing i! nt !traig)t$r/ard, E"%irica& data i! "i3ed0 and
t)ere i! an in)erent di!tru!t $ DTC ad(erti!ing due t /ide!%read 2an! in t)e (a!t "a1rit' $
cuntrie!, It i! ea!' t a!!u"e DTC ad(erti!ing de! )ar" 1u!t 2ecau!e it i! ut&a/ed in a&& 2ut
t/ cuntrie!, :)en tr'ing t deter"ine t)e e$$ect! $ DTC ad(erti!ing0 it i! i"%rtant t
cn!ider )/ t)e $&&/ing $actr! are a$$ected: -1. "edicatin !ee#ing 2e)a(ir 0 -*. cn!u"er
under!tanding $ t)e %rduct0 -<. ad)erence t %re!cri2er in!tructin and ->. t)e dctr-%atient
re&atin!)i%,
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 9
Medicatin See#ing Be)a(ir
:)i&e %atient! cannt c)!e t u!e %re!cri%tin "edicatin /it)ut $ir!t cn!u&ting a dctr0 a
%atient+! de!ire $r "edicatin /i&& in$&uence /)et)er nt nt t)e' c)!e t !%ea# t a dctr0 a!
/e&& a! t)e r&e t)e' %&a' in c)!ing t)eir "edicatin, Bet/een 1666 and *5550 t/ 'ear! a$ter
DTC ad(erti!ing 2egan t !%i#e0 t)e !a&e $ %re!cri%tin "edicatin 2egan t !%i#e a! /e&&
-Berndt E Dn)ue *55>., T)e!e !i"u&taneu! !%i#e! cu&d indicate t)at increa!ed ad(erti!ing
increa!ed t)e !a&e $ %re!cri%tin "ediatin -Berndt E Dn)ue *55>., I$ !uc) i! t)e ca!e0 t)ere
i! a c&ear indicatin t)at %atient! are a2&e t dri(e a dctr+! c)ice t %re!cri2e "edicatin0
de!%ite t)eir ina2i&it' t %re!cri2e it $r t)e"!e&(e!,
:)i&e DTC ad(erti!ing i! 2e&ie(ed t increa!e t)e !a&e $ %re!cri%tin "edicatin0 it i! unc&ear
/et)er t)at increa!e i! due t)e %atient+! increa!ed a/arene!! $ t)eir rea& need!0 r a $a2ricatin
$ need! due t dece%ti(e ad(erti!ing, DTC ad(erti!e"ent! n&' "entin incidence *9 %ercent $
t)e ti"e0 and d/n%&a' t)e !e(erit' $ !'"%t"! and !ide-e$$ect! -4ent&a0 *511 ., E3c&uding
incidence rate!0 and d/n%&a'ing !e(erit' $ !'"%t"!0 "a' &ead %atient! t "i!ta#e nr"a&
)ea&t) ccurrence! and !"et)ing t)at reCuire! "edicatin, In a !ur(e' $ %)'!ician!0 it /a!
$und t)at /)en a %atient a%%rac)ed t)eir dctr reCue!ting "edicatin0 dctr! 2e&ie(ed t)at
%)ar"aceutica& treat"ent i! nt nece!!ar' 1* %ercent $ t)e ti"e, In t)e!e ca!e!0 dctr! 2e&ie(ed
nn "edicina& treat"ent0 !uc) a! &i$e!t'&e c)ange!0 /u&d 2e "re a%%r%riate, One !tud' $und
t)at >5 %ercent $ dctr! )ad a %atient a!# $r an ad(erti!ed drug ne t $i(e ti"e! %er /ee#
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 7
-4ent&a0 *511.,
In a "ar#et!can $ antide%re!!ant!0 it /a! $und t)at /)i&e DTC ad(erti!ing didn+t )a(e a
!tatica&&' !igni$icant in$&uence n t)e 2rand $ antide%re!!ant 2ug)t0 it did increa!e a %atient+!
&i#e&i)d t !ee# antide%re!!ant! -Berndt E Dn)ue *55>., It i! %!!i2&e t)at %atient! !ee#
antide%re!!ant! a$ter !eeing an ad 2ecau!e t)e' /ere nt a/are t)at t)eir !'"%t"! /ere
!'"%t"! $ de%re!!in, In !uc) an in!tance0 t)e ad(erti!e"ent /u&d 2e ding a !er(ice t t)e
%atient, It i! a&! %!!i2&e t)at ad(erti!e"ent! decrea!e t)e !tig"a a!!ciated /it) i&&ne!! and
!ee#ing )e&%, H/e(er0 $r a&& t)e %tentia& gd in DTC ad(erti!e"ent!0 t)ere are a&! ri!#!, I$
an ad(erti!e"ent "ade an i&&ne!! !ee" &i#e a c""n ccurrence0 r ne t)at /a! ea!i&' treated
/it) "edicatin0 cn!u"er! cu&d !ee# "edicatin $r nr"a& "d r )ea&t) $&uctuatin!,
:)en re(ie/ing %re!cri2ing %ractice! $ antide%re!!ant!0 t)ere are "an' %atient! /) $i&&
%re!cri%tin! /it)ut e(idence $ a diagn!ed cnditin, O$ t)e %atient! /) $i&&ed at &ea!t ne
%re!cri%tin0 19 %ercent )ad a diagn!i! $ "a1r de%re!!in0 1> %ercent )ad an ut-%atient (i!it
$r an3iet'0 and !i3 %ercent )ad a diagn!i! $ de%re!!in /)i&e 2eing treated $r an3iet', A $u&&
98 %ercent $ antide%re!!ant u!er! )ad n diagn!i! $ de%re!!in r an3iet' -Berndt E
Dn)ue *55>., T)i! cu&d indicate t)at antide%re!!ant! are u!ed t treat cnditin! ut!ide t)e
!c%e $ t)eir intended u!e0 r are u!ed te"%rari&' 2' %atient! /) dn+t )a(e an nging
cnditin,
Gegra%)ica&&' and ecn"ica&&' !i"i&ar &catin! in t)e United State! and Canada can 2e
c"%ared t 2etter under!tand t)e e$$ect $ DTC ad(erti!ing n a %atient+! de!ire $r "edicatin,
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION @
Since DTC ad(erti!ing i! i&&ega& in Canada0 it can 2e u!ed a! a ;2a!e &ine? $r %re!cri%tin
reCue!t!, :)en t)e!e &catin! /ere c"%ared0 %atient! in t)e United State! /ere t/ice a! &i#e&'
a! %atient! in Canada t reCue!t a "edicatin t)at i! ad(erti!ed direct&' t t)e cn!u"er
-:e&&ingtn0 *515., T)i! !)/! a !igni$icant increa!e in "edicatin !ee#ing 2e)a(ir a"ng
%atient! /) e3%erienced DTC ad(erti!ing, Patient! /) are nt e3%!ed t !uc) ad(erti!e"ent!
are &e!! &i#e&' t reCue!t "edicatin t)an t)!e /) are,
Cn!u"er Under!tanding $ t)e Prduct
Accrding t FDA guide&ine!0 DTC ad(erti!ing "u!t %re!ent a ;$air 2a&ance? $ in$r"atin
de!cri2ing 2t) t)e ri!#! and 2ene$it! $ a drug, H/e(er0 in *55@ t)e Furna& $ Hea&t)
C""unicatin $und t)at t)e a(erage DTC drug c""ercia& !%ent "re ti"e ad(erti!ing t)e
2ene$it! t)an it did di!cu!!ing t)e ri!#! -4ent&a0 *511., Since FDA guide&ine! d nt direct&'
de$ine t)e "eaning $ ;$air 2a&ance? it i! %en t inter%retatin0 and %)ar"aceutica& c"%anie!
are nt reCuired t !%end eCua& ti"e di!cu!!ing t)e ri!#! $ t)eir %rduct0 n&' a ;$air? a"unt $
ti"e, Di!ci%&inar' actin 2' t)e FDA indicate! t)at t)i! i! a %r2&e" c""n t DTC
ad(erti!ing, Bet/een 166@ t *5570 8> %ercent $ t)e regu&atr' &etter! !ent $r DTC drug
ad(erti!ing &i!ted "ini"iDing ri!#!0 e3aggerating 2ene$it!0 r 2t) a! t)e (i&atin -4ent&a0
*511.,
E(en /)en DTC ad(erti!e"ent! ad)ere t t)e guide&ine! i!!ued 2' t)e FDA0 (i!ua& "e!!age!
$ten cn$&ict /it) (er2a& "e!!age!, Fr e3a"%&e0 /)en !ide-e$$ect! are (er2a&&' !%#en /)i&e a
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 8
1'$u& i"age i! !)/n0 it i! t)e i"age t)at cn!u"er! are "re &i#e&' t re"e"2er, Additina&&'0
i$ t)e (i!ua& i"age i! unre&ated t t)e (er2a& "e!!age0 cn!u"er! are "re &i#e&' t "i!inter%ret
t)e drug+! intended u!e, :)en dctr! /ere a!#ed a2ut %atient! !ee#ing ad(erti!ed
%)ar"aceutica&!0 t)e' re%rted t)at t)e "edicatin t)e %atient a!#ed $r /a! ina%%r%riate $r
t)eir cnditin @> %ercent $ t)e ti"e -4ent&a0 *511., T)i! "a' !%ea# t DTC ad(erti!ing
ina2i&it' t c&ear&' e3%&ain )/ and /)en drug! !)u&d 2e u!ed,
:)i&e DTC ad(erti!ing )a! 2een credited /it) increa!ing a cn!u"er+! under!tanding $ "edica&
cnditin!0 !tudie! )a(e 2een "i3ed, A !ur(e' 2' t)e Henr' F, Kai!er Fa"i&' Fundatin $und
t)at a$ter /atc)ing a %)ar"aceutica& ad(erti!e"ent0 @5 %ercent $ %artici%ant! !aid t)at t)e'
&earned &itt&e r nt)ing a2ut t)e cnditin t)e drug /a! !u%%!ed t treat -:e&&ingtn0 *515.,
Since "an' DTC ad(erti!e"ent! re&' n e"tina& a%%ea&!0 rat)er t)an e"%irica& data0 it cu&d
2e t)at %atient! /) !ee# treat"ent 2a!ed n ad(erti!e"ent! "a' nt 2e ding ! 2ecau!e $ a
2etter under!tanding $ t)e "edica& cnditin, In!tead0 t)e' cu&d !ee# "edicatin t e3%erience
t)e gd $ee&ing! !)/n in t)e c""ercia&,
T)e Au!tra&ian Medica& A!!ciatin !u%%rt! a 2an n DTC ad(erti!e"ent! 2ecau!e t)e' 2e&ie(e
it cu&d c"%r"i!e a %atient+! in$r"ed cn!ent0 and t)eir rig)t t $air and 2a&anced educatina&
"ateria& -:e&&ingtn0 *515., O%%nent! $ t)e AMA !a' t)at t)e!e cncern! are t %aterna&i!tic,
H/e(er0 in t)e United State! DTC ad(erti!ing i! t)e "!t c""n $r" $ )ea&t)
c""unicatin, In!tead $ re&'ing n un2ia!ed in$r"atin t "a#e an in$r"ed deci!in0 t)e
2runt $ a %atient+! in$r"atin cu&d 2e "ar#eting ca"%aign! created 2' t)e %)ar"aceutica&
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 6
c"%anie!,
Ad)erence t Pre!cri2er In!tructin
Pr%nent! $ DTC ad(erting $ten argue t)at ;!u$$icient&' in$r"ati(e? ad(erti!e"ent! cu&d
en)ance %atient )ea&t)0 a! t)e' /u&d ;!er(e a! a re"inder and a %r"%t t c"%&iance
-:e&&ingtn0 *515.,? A! /it) "an' a!%ect! $ DTC ad(erti!ing0 t)e e"%irica& e(idence t 2&!ter
t)e!e c&ai"! are !cant and (aried at 2e!t, But0 de!%ite uncertain e(idence0 t)e idea $ u!ing DTC
ad(erti!ing t increa!e treat"ent ad)erence i! %%u&ar, DTC ad(erti!e"ent=! r&e in c"%&iance
)a! 2een di!cu!!ed at !e(era& !enate )earing!0 and )a! 2een $eatured in t)e %%u&ar %re!!
-:!in!#a0 *559., T)ere i! certain&' a "ti(e $r increa!ing %atient c"%&iance t %re!cri2ed
"edicatin, Nn-c"%&iance i! e!ti"ated t c!t %)ar"aceutica& c"%anie! 19 t *5 2i&&in
annua&&'0 and i! re!%n!i2&e $r 1*90555 %re"ature deat)! natin/ide -:!in!#a0 *559.,
:)i&e ad(erti!e"ent! %ri"ari&' ai" t recruit u!er! t a %rduct0 t)ere i! !"e e(idence t
!ugge!t t)at !eeing an ad(erti!e"ent "a' increa!e an e3i!ting %atient+! &i#e&i)d t cntinue
ta#ing t)eir "edicatin, One !ur(e' re(ea&ed t)at ;t)ree $ ten %atient! a&read' ta#ing a %rduct
c&ai"ed t)at t)e' /ere "re &i#e&' t ta#e t)eir %re!cri2ed "edicine a$ter !eeing it ad(erti!ed
-:!in!#a0 *559.,? It "a' 2e t)at !eeing an ad(erti!e"ent re"inded %atient! t ta#e t)eir
"edicatin, It i! a&! %!!i2&e t)at )earing t)e &ng ter" 2ene$it! $ t)e "edicatin )e&%ed
%atient! acce%t un%&ea!ant !ide-e$$ect! t)at di!curaged t)e" $r" cntinuing treat"ent,
:)et)er r nt t)i! c""it"ent t $&&/ t)eir treat"ent regi"en /a! te"%rar' r "re
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 15
&a!ting )a! nt 2e te!ted, T)e rene/ed c""it"ent t cntinue "edicatin "a' nt &a!t &ng
a$ter t)e c""ercia& i! (er,
T)ere i! indirect crre&atin 2et/een DTC ad(erti!ing0 "edicatin !ee#ing 2e)a(ir and
"edicatin c"%&iance, A *551 !e&$-re%rted !ur(e' $und t)at %atient! /) a!#ed $r
"edicatin /ere "re &i#e&' t 2e n drug t)era%' !i3 "nt)! a$ter t)e "edicatin /a!
%re!cri2ed -:!in!#a0 *559., Since t)ere i! e(idence t !ugge!t %atient! are "re &i#e&' t
reCue!t "edicatin a$ter !eeing ad(erti!e"ent!0 it /u&d a&! !tand t rea!n t)at ad(erti!e"ent!
increa!ed c"%&iance0 !ince t)e' encurage %atient! t a!# $r "edicatin0 rat)er t)an /aiting
$r it t 2e %re!cri2ed,
It i! a&! %!!i2&e0 t)at /)i&e DTC ad(erti!ing de! i"%r(e c"%&iance0 it de!n+t nece!!ari&'
i"%r(e t)e !%n!ring c"%an'+! 2tt" &ine, T)e c!t e$$ecti(ene!! $ DTC ad(erti!ing i!
genera&&' cn!idered t 2e Cuite %r, An ad(erti!e"ent+! return rate i! e!ti"ated t 2e 17 cent!
n t)e d&&ar -:!in!#a0 *559., :)i&e DTC ad(erti!ing de! increa!e a %atient+! &i#e&i)d t
u!e %re!cri%tin "edicatin0 it de!n+t nece!!ari&' i"%r(e t)e (ie/er! &i#e&i)d t u!e t)at
%articu&ar "edicatin, In!tead0 DTC ad(erti!ing increa!e! t)e !a&e $ an entire c&a!! $
"edicatin, Fr e3a"%&e0 a ca"%aign ad(erti!ing an antide%re!!ant /i&& increa!e t)e !a&e $ a&&
antide%re!!ant!0 nt 1u!t t)e ne 2eing ad(erti!ed -4ent&a0 *511., T)ere i! a !i"i&ar !%i&&(er
e$$ect /it) "edicatin c"%&iance, An ad(erti!e"ent $r an antide%re!!ant /i&& increa!e %atient+!
c"%&iance /it) a&& antide%re!!ant!0 nt 1u!t t)e "edicatin ad(erti!ed in t)e c""ercia&,
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 11
In "an' /a'!0 DTC ad(erti!ing can 2e u!ed t increa!ing %atient c"%&iance0 and "a' 2e a
2n t %u2&ic )ea&t), H/e(er0 it i! nt a gd /a' t increa!e !a&e!, T)i! /u&d indicate t)at i$
"ne' /ere t 2e in(e!ted in %u2&ic !er(ice annunce"ent!0 rat)er t)an traditina& ad!0
%)ar"aceutica& c"%anie! /u&d e3%erience t)e !a"e return n in(e!t"ent t)an i$ t)e' )ad
de!igned a %r"tina& ad(erti!e"ent t)e"!e&(e!,
T)e Dctr-Patient Re&atin!)i%
DTC ad(erti!ing )a! 2een credited /it) "a#ing in$r"ed cn!u"er! a! /e&& a! "i!in$r"ed
cn!u"er!, In an era /)en %atient! 2egan 2eing "re acti(e %artici%ant! in t)eir "edica&
deci!in!0 it i! nt ea!' t tea!e ut /)ere ne $actr! end! and ant)er 2eing!, T)e increa!e in
rate! $ c)rnic i&&ne!!0 t)e %atient!+ rig)t and /"en+! rig)t "(e"ent0 and /ide!%read u!e $
t)e internet )a(e a&& a$$ected t)e /a' %atient! interact /it) t)eir dctr! -Arne' E Ge/in0 *51<.,
In t)e United State!0 "an' argue t)at DTC ad(erti!ing )a! %&a'ed a r&e a! /e&&, T)e e3tent $
DTC ad(erti!ing=! in$&uence i! di$$icu&t t deter"ine,
DTC ad(erti!ing )a! genera&&' 2een (ie/ed $a(ra2&' 2' %atient!0 2ut t)at /ide!%read a%%r(a&
i! n t)e dec&ine, In 166*0 87 %ercent $ cn!u"er! !aid DTC ad(erti!ing ;H"adeI t)e" "re
a/are $ ne/ drug!0? in *55*0 a$$ir"ati(e %artici%ant re!%n!e! dr%%ed t @@ %ercent -Arne' E
Ge/in0 *51<., E(en "re dra"atic0 i! t)e decrea!e in cn!u"er $a(r /)en it ca"e t t)e
dctr-%atient re&atin!)i%, In 166*0 7* %ercent $ %atient! !aid ;DTC ad(erti!ing )e&%HedI t)e"
)a(e 2etter di!cu!!in! /it) t)eir dctr! -Arne' E Ge/in0 *51<.,? In *55*0 n&' >< %ercent $
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 1*
%atient! agreed /it) t)e !tate"ent -Arne' E Ge/in0 *51<., T)i! dra"atic dec&ine in DTC
ad(erti!ing+! %%u&arit' cu&d indicate t)at0 $r "an' %atient!0 t)e n(e&t' $ DTC ad(erti!ing i!
!tarting t /ear $$0 and %atient! are 2ec"ing $ru!trated /)ere t)e' /ere nce a%%reciati(e, Jet
de!%ite increa!ing negati(it' $r" cn!u"er!0 it i! c&ear t)at DTC ad(erti!ing )a! an e$$ect n
t)e /a' %atient! ta&# t t)eir dctr!0 and t)at "an' %atient! u!e DTC ad(erti!ing a! %re%aratr'
"ateria& t 1u"% !tart cn(er!atin! /it) t)eir "edica& %r(ider!,
Fr t)e "!t %art0 it a%%ear! t)at dctr! are %en t di!cu!!ing ad(erti!ed "edicatin! /it) t)eir
%atient!, :)en a!#ed0 n&' 15 %ercent $ dctr! !aid t)e' )ad a negati(e e3%erience /)en a
%atient a!#ed a2ut a "edicatin t)e' )ad !een ad(erti!ed, :)i&e t)e "a1rit' $ dctr!0 77
%ercent0 re%rted neutra& encunter! /)en a!#ed a2ut !%eci$ic "edicatin!0 *> %ercent !aid t)e'
)ad a %!iti(e encunter /it) t)e %atient -Arne' E Ge/in0 *51<., H/e(er0 de!%ite t)eir
/i&&ingne!! t di!cu!! "edicatin0 /)en (icing t)eir cncern a2ut DTC ad(erti!ing0 >1
%ercent $ dctr! re%rted t)at t)e' )ad t !%end ti"e crrecting %atient "i!cnce%tin! -Arne'
E Ge/in0 *51<., During t)e !a"e !ur(e'0 *6 %ercent $ dctr! re%rted t)at t)eir %atient! )ad
a!#ed a2ut "edicatin /)en "edicatin /a! nt nece!!ar' -Arne' E Ge/in0 *51<., T)i! "a'
indicate t)at /)i&e DTC ad(erti!ing de! !%ar# cn(er!atin! 2et/een %atient! and %r(ider!0
t)e in$r"atin t)e %atient i! recei(ing i! nt nece!!ari&' re&ia2&e0 and de!n+t i"%r(e t)eir
under!tanding $ t)e "edicatin r $ t)e under&'ing cnditin,
:)i&e %)'!ician re!%n!e! t DTC ad(erti!ing /ere &arge&' neutra&0 <* %ercent re!%nded t)at
t)e' 2e&ie(ed r ;!trng 2e&ie(ed? t)at DTC ad(erti!ing "ade ;%atient! &e!! cn$ident in Ht)e
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 1<
%)'!ician=!I 1udg"ent -Arne' E Ge/in0 *51<.,? T)i! du2t can a&! 2e e3tra%&ated $r"
%re!cri%tin data, :)i&e 79 %ercent $ dctr! re%rted t)at t)e' didn+t $ee& an' %re!!ure t
%re!cri2e a "edicatin t acc""date a %atient0 t)e "edicatin t)e %atient reCue!ted /a!
%re!cri2ed 9< %ercent $ t)e ti"e, T)e %atient gt t)eir reCue!ted "edicatin "re t)an )a&$ $
t)e ti"e0 de!%ite t)e $act t)at t)e reCue!ted drug /a! nt t)e %)'!ician=! $ir!t c)ice 7* %ercent
$ t)e ti"e -Arne' E Ge/in0 *51<., T)i! "ean! t)at /)i&e dctr! "a' re%rt n %re!!ure t
%re!cri2e "edicatin t acc""date a %atient0 t)e' are (erru&ed 2' t)eir %atient at &ea!t nine
%ercent $ t)e ti"e,
P&ic' Sugge!tin! and Di!cu!!in
In a !erie! $ ca!e! t)at 2egan in t)e 16@5!0 t)e United State! Su%re"e Curt "ade it c&ear t)at
2anning DTC ad(erti!ing /a! nt a rea&i!tic ga&, C""ercia& !%eec) i! a $r" $ e3%re!!in
%rtected under t)e Fir!t A"end"ent, T)ere$re0 e&i"inating DTC ad(erti!ing i! a (i&atin $
t)e Fir!t A"end"ent -4ent&a0 *511., H/e(er0 t)ere are certain circu"!tance! in /)ic)
c""ercia& !%eec) "a' 2e 2anned, T)e Centra& Hud!n te!t ut&ine! t)e circu"!tance! in /)ic)
!uc) a 2an can 2e ac)ie(ed, T)e te!t ;e3a"ine! /)et)er t)e ad(erti!ing i! "i!&eading0 /)et)er
2anning it direct&' ad(ance! a !u2!tantia& g(ern"ent intere!t -e,g,0 %re!er(ing %u2&ic )ea&t).0
and /)et)er t)e g(ern"ent=! intere!t cu&d 2e ac)ie(ed t)rug) a &e!! re!tricti(e rute0 !uc) a!
2' adding a !%ecia& &a2e&,? I$ t)e a$re"entined criteria are "et0 t)en c""ercia& !%eec) "a'
2e deter"ined a )aDard0 and i! e&igi2&e $r !i&encing -4ent&a0 *511.,
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 1>
T)ere are !trng argu"ent! t 2e "ade $r t)e "i!&eading nature $ DTC ad(erti!ing, Dece%ti(e
!tati!tic!0 "i!!ing r a22re(iated ri!#!0 and cn$&icting i"age! a&& "a#e DTC ad(erti!ing
categrica&&' "i!&eading, Banning DTC ad(erti!ing cu&d a&! 2e cn!idered %rtecti(e $ t)e
%u2&ic+! )ea&t), Merc#+! drug0 4i330 /a! a%%r(ed 2' t)e FDA in 1666, B' *55*0 a nu"2er $
e%ide"i&gica& !tudie! $und t)at 4i33 increa!ed t)e ri!# $ !eriu! crnar' )eart di!ea!e
/)en c"%ared t t)er drug! in t)e !a"e c&a!!, Jet Merc# cntinued t aggre!!i(e&' "ar#et
4i33 unti& Se%te"2er $ *55> /)en t)e drug /a! %u&&ed $r" t)e !)e&(e!, In *5570 Merc#
ad"itted t)at t)e' "ade "ade an ;errr in inter%retatin in a crucia& !tati!tica& te!t and agreed t
ne $ t)e &arge!t ci(i& &itigatin !ett&e"ent! $r c&a!! actin &a/!uit!? in t)at 'ear -:e&&ingtn0
*515., Merc# /a! a/are $ t)eir errr 2e$re *55>0 2ut cntinued t !%end (er 155 "i&&in
d&&ar! a 'ear in DTC ad(erti!ing $ 4i33 -:e&&ingtn0 *515., :)i&e t)i! "a' 2e a !ingu&ar
e3a"%&e $r" ne c"%an'0 it !%ea#! t t)e )ar" t)at can c"e $r" aggre!!i(e %)ar"aceutica&
ad(erti!ing t)at de! nt cater t t)e intere!t $ t)e %atient!,
De!%ite !"e atte"%t! at regu&atin0 it re"ain! unc&ear i$ t)e g(ern"ent+! intere!t cu&d 2e
ac)ie(ed t)rug) a &e!! re!tricti(e rute0 t)u! !ati!$'ing t)e t)ird reCuire"ent $ t)e Centra&
Hud!n te!t, :)en DTC ad(erti!e"ent! $ $i(e "a1r %)ar"aceutica& c"%anie! /ere $&&/ed
(er a $ur 'ear %erid0 cn!i!tent FDA (i&atin! /ere $und acr!! t)e 2ard0 de!%ite t)e
c"%anie!+ %&edge! t %arta#e in re!%n!i2&e ad(erti!ing %ractice! -Arn&d E Oa#&e'0 *51<., In
re!%n!e0 P)RMA created 19 Guiding Princi%&e! in an atte"%t t !e&$ regu&ate, H/e(er0 /)en
t)e!e %rinci%&e! /ere (i&ated0 $$ending c"%anie! /eren+t %ena&iDed 2' t)e indu!tr'0 and /ere
a&&/ed t cntinue /)i&e P)RMA turned a 2&ind e'e -Arn&d E Oa#&e'0 *51<., Critic! &a2e&ed
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 19
P)RMA+! guide&ine! a! ;a crdinated e$$rt 2' t)e indu!tr' t %re(ent un/anted $edera&
regu&atin -Arn&d E Oa#&e'0 *51<.,? Regu&ating a "u&ti-2i&&in d&&ar indu!tr' t)at i! acti(e&'
a(iding in-)u!e and $edera& atte"%t! at regu&atin /u&d 2e an e3%en!i(e and near&'
i"%!!i2&e ta!#,
Ba!ed n t)e !iDe0 %&itica& %/er and un/i&&ingne!! $ t)e %)ar"aceutica& indu!tr'0 e3%anding
current FDA guide&ine! /i&& nt 2e !u$$icient t %rtect t)e %u2&ic $r" irre!%n!i2&e ad(erti!ing
%ractice!, T)ere$re0 a 2an $ t)e "!t )ar"$u& c&a!! $ DTC ad(erti!e"ent0 %rduct-c&ai" ad!0
i! %r%!ed, Prduct-c&ai" ad! are t)e "!t c""n $r" $ DTC ad(erti!e"ent0 a! t)e'
direct&' "ar#et a !%eci$ic drug t cn!u"er!, T)e intentin $ t)i! 2an /u&d nt 2e t undercut
t)e %)ar"aceutica& indu!tr'=! rig)t t c""ercia& e3%re!!in0 r t e&i"inate DTC ad(erti!e"ent
entire&'0 2ut rat)er t redirect $und! t/ard! "re %rducti(e0 !a$e0 and ecn"ica& $r"! $
ad(erti!e"ent,
:)i&e t)ere i! a 2d' $ e(idence0 2t) $r and again!t DTC ad(erti!ing0 t)ere i! &itt&e e(idence
t)at DTC ad(erti!ing actua&&' increa!e! !a&e! !%eci$ic t t)e drug ad(erti!ed, Rat)er t)an
increa!ing !a&e! $ t)e !%eci$ic drug0 e(idence !ugge!t! t)at ad(erti!ing increa!e! t)e re(enue $
an entire c&a!! $ drug!, A! %re(iu!&' !tated0 i$ an antide%re!!ant /a! "ar#eted0 it /u&d
increa!e t)e !a&e $ a&& antide%re!!ant!0 nt 1u!t t)e drug 2eing ad(erti!ed, T)i! cu&d indicate
t)at ad(erti!ing %r"%t! cn!u"er! t ta&# t t)eir dctr a2ut "edicatin0 2ut !ince dctr!
)a(e %re!cri2ing %/er0 %atient! "a' r "a' nt end u% ta#ing t)e drug t)e' !a/ ad(erti!ed
-4ent&&a0 *511.,
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 17
:)i&e !"e e!ti"ate! %&ace t)e return rate $ DTC ad(erti!ing at 17 cent! n t)e d&&ar0 t)er
!urce! %redict t)at DTC ad(erti!ing n&' increa!e! re(enue 2' 1> %ercent -P)ar"a&t0 *511.,
T)i! "de!t return n in(e!t"ent i! certain&' nt t)e %)ar"aceutica& c"%anie!+ %ri"ar' /a' t
2ring in re(enue, On t)e cntrar'0 DTC ad(erti!ing )a! t)e %tentia& t cau!e a gd dea& $
)ar" t cn!u"er! /it)ut ding "uc) gd $r t)e indu!tr', Ba!ed n t)e "de!t return! $
DTC ad(erti!ing0 t)ere /u&d nt 2e "uc) ri!# t t)e c"%anie! i$ ad(erti!ing %ractice! /ere
a&tered, In!tead $ ad(erti!ing a !ing&e 2rand $ drug0 it /u&d "a#e "re $i!ca& !en!e0 and 2e
!a$er $r t)e cn!u"er0 i$ di!ea!e a/arene!! ad(erti!e"ent! 2eca"e t)e nr"0 rat)er t)an
%rduct-c&ai" ad, Since ad(erti!ing de! nt actua&&' increa!e !a&e! $ t)e drug 2eing ad(erti!ed0
ca"%aign! t)at $cu!ed n t)e 2ene$it! $ a c&a!! $ "edicatin "a' actua&&' 2e "re c!t-
e$$ecti(e t)an i$ eac) c"%an' /ere t "ar#et eac) drug !e%arate&', A genera& ad(erti!e"ent
di!cu!!ing t)e (a&ue $ a /)&e c&a!! $ drug! /u&d increa!e !a&e! acr!! t)e 2ard0 and /u&d
e&i"inate "an' $ t)e %r2&e"! current&' e3%erienced in DTC ad(erti!ing,
Di!ea!e a/arene!! ad! are )e&d t t)e !a"e FDA !tandard! a! %rduct-c&ai" ad!0 2ut are una2&e
t na"e an' drug !%eci$ica&&', Ad(erti!e"ent! identit' c""n !ide-e$$ect! /it)in t)e c&a!! $
drug0 and encurage t)e cn!u"er t !%ea# t t)eir dctr a2ut t)e 2ene$it! $ %!!i2&e
"edicatin, An ad(erti!ing ca"%aign uti&iDing di!ea!e a/arene!! ad! /u&d "aintain "an' $
t)e 2ene$it! $ %rduct-c&ai" ad!0 /)i&e e&i"inating !"e $ t)e )aDard! and %re!er(ing t)e
%)ar"aceutica& indu!tr'+! rig)t t ad(erti!e, T)ere i! a&! rea!n t 2e&ie(e %)ar"aceutica&
c"%anie!+ %r$it "argin! /u&d 2e una$$ected 2' t)e !/itc),
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 1@
Current&'0 ne $ t)e 2igge!t cncern! !urrunding DTC ad(erti!ing i! t)at it %re!!ure! dctr!
t %re!cri2e an ina%%r%riate drug0 and cau!e! %atient! t %re$er t)e ad(erti!ed drug (er t)e ne
t)eir dctr !ugge!t!, S/itc)ing t an a/arene!! ca"%aign "de& /u&d !ti&& !%ar# cn(er!atin
2et/een %atient and dctr0 /it)ut adding !"e $ t)e %re!!ure t %re!cri2e a %articu&ar 2rand
na"e drug, Dctr! cu&d t)an di!cu!! t)e !ide e$$ect! $ t)e drug t)e' end u% %re!cri2ing0
/it)ut %atient! 2eing cn$u!ed 2' cn$&icting i"age! n te&e(i!in,
:)i&e !uc) a !&utin "a' !&(e !"e i!!ue! in DTC ad(erti!ing0 it /u&d nt 2e a2&e t !&(e
t)e" a&&, H/e(er0 nt)ing !)rt $ a $u&& 2an n DTC ad(erti!ing /u&d 2e a2&e t d !, I$ a
c"%&ete 2an /ere t c"e int %&a'0 it /u&d e&i"inate t)e %tentia& 2ene$it! $ DTC
ad(erti!ing 1u!t a! it /u&d "itigate %tentia& ri!#!, I$ di!ea!e a/arene!! ad! /ere u!ed in!tead0
t)e g&a"riDatin $ "edicatin /u&d %r2a2&' cntinue t 2e an i!!ue0 and %atient! /) are
nt in need $ "edicatin "a' !ti&& cntinue t !ee# it0 2ut "an' $ t)e 2ene$it!0 !uc) a! !%ar#ing
a/arene!! and cn(er!atin0 /u&d 2e %re!er(ed,
:)i&e an ad(erti!e"ent ca"%aign $cu!ed n di!ea!e a/arene!! /u&d idea&&' increa!e %atient
under!tanding0 it /u&d !ti&& 2e i"%rtant t en!ure t)at %atient! under!tand t)e !%eci$ic ri!#!
a!!ciated /it) t)e drug t)e' c)!e /it) t)eir dctr, H/e(er0 2' re"(ing !"e $ t)e "!t
di!tracting and "ani%u&ati(e e&e"ent! $r" DTC ad(erti!ing0 %atient! and dctr! /u&d nce
again 2e in c)arge $ t)eir c)ice $ "edicatin0 and /u&d 2e a2&e t )a(e %rducti(e
cn!er(atin! arund DTC ad(erti!ing,
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 18
:)i&e !/itc)ing t di!ea!e a/arene!! ad(erti!e"ent! /u&d 2e t)e "!t e$$ecti(e !&utin0 t)ere
i! ant)er0 &e!! re!tricti(e /a' t !&(e !"e $ t)e "!t dire %r2&e"! $acing DTC ad(erti!ing,
Be$re a ne/ drug i! a%%r(ed $r )u"an cn!u"%tin0 it ge! t)rug) a rigru! !erie! $ te!t!,
H/e(er0 e(en t)e "!t !tringent te!ting i! nt $&%r$, Hu"an errr0 te!ting 2ia!0 and rand"
c)ance a&& can e$$ect t)e utc"e $ a te!t, :)i&e rare0 /)en "i!ta#e! are "ade t)e
cn!eCuence! are dire, I$ %)ar"aceutica& drug! are t 2e "ar#eted t cn!u"er!0 t)e !a$et' $
t)!e drug! !)u&d 2e a! a!!ured a! %!!i2&e, Un&i#e dctr!0 cn!u"er! are nt a&/a'! trained
t accurate&' a!!e!! t)e !a$et' $ a %rduct, DTC ad(erti!ing ta#e! !"e $ t)e cntr& a/a'
$r" dctr!0 and %ut! it in t)e )and! $ t)e cn!u"er, I$ DTC ad(erti!ing i! nt curtai&ed0 and i$
c"%anie! are a&&/ed t "ar#et !%eci$ic drug! t t)e cn!u"er0 t)e drug! t)e' "ar#et !)u&d
)a(e a %r(en trac# recrd and !a$et' and e$$ecti(ene!!, Fr t)i! rea!n0 a t/ 'ear )&d !)u&d
2e %&aced n a&& ne/ drug! 2e$re t)e' are a&&/ed t 2e "ar#eted direct&' t cn!u"er!, A$ter
FDA a%%r(a&0 a t/ 'ear /aiting %erid /i&& a&&/ dctr! t %re!cri2e t)e drug a! t)e' !ee $it0
2ut a&! en!ure t)e' are nt %re!!ured t %re!cri2e ne/ "edicatin! 2ecau!e a %atient &i#ed t)e
/a' it /a! ad(erti!ed,
Bt) $ t)e %r%!ed !&utin! /u&d "ini"a&&' in$ringe u%n t)e %)ar"aceutica& c"%anie!+
rig)t t $reed" $ e3%re!!in, Bt) !&utin! /u&d )a(e "ini"a&0 i$ an' i"%act n t)e
c"%anie!+ %r$it "argin, H/e(er0 t)e!e c)ange! /u&d g a &ng /a' t/ard %rtecting
%atient=! !a$et' and )ea&t), A! t)e current FDA ru&e! !tand0 %)ar"aceutica& c"%anie! )a(e a
great dea& $ &ee/a' t ad(erti!e %rduct!, T)e FDA de! nt need t a%%r(e ad(erti!e"ent!
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION 16
2e$re t)e' are aired0 t)e' d nt need /r# t)e /it) c"%anie! t "a#e !uita2&e
ad(erti!e"ent!0 nr d t)e' %re(ent dangeru! drug! $r" 2eing ad(erti!ed -FDA0 *51*., :)i&e
t)e FDA de! reCuire drug c"%anie! t di!cu!! at &ea!t ne intended u!e $ t)e drug0 and
%re!ent t)e "!t c""n !ide e$$ect!0 drug c"%anie! are nt reCuired t di!cu!! c!t $ t)e
"edicatin0 nr are t)e' reCuired t di!c&!e /)at 2e)a(ira& c)ange! "a' render "edicatin
unnece!!ar' -FDA0 *51*., An increa!e in regu&atr' %&icie! /u&d )e&% "itigate "an' $ t)e
ri!#! %!ed 2' current0 (er&' %er"i!!i(e FDA regu&atin!,
:)' i! Current FDA Mnitring In!u$$icientK
I$ t)e FDA /ere a2&e t !u$$icient&' i"%&e"ent t)eir current %&icie!0 $urt)er !te%! t/ard
regu&atin "a' nt 2e nece!!ar', H/e(er0 current di!ci%&inar' "ea!ure! "!t c""n&' c"e
in t)e $r" $ a &etter a!#ing t)e c"%an' t !t% airing t)eir ina%%r%riate ad(erti!e"ent, :)i&e
t)e!e &etter! cntain n $urt)er %uni!)"ent0 t)e' d a&ert t)e c"%an' $ t)e FDA+! intentin t
%ur!ue t)e "atter i$ t)e c"%an' de! nt re!%nd /it)in 1> da'!, H/e(er0 a! t)e 2urden $
DTC ad(erti!ing gr/!0 "nitring i! 2ec"ing an increa!ing&' ti"e cn!u"ing ta!#0 and an
a&read' in!u$$icient !'!te" i! 2ec"ing 2gged d/n,
In rare circu"!tance!0 !uc) a! ne t)at endanger! t)e %u2&ic )ea&t)0 t)e FDA /i&& reCuire t)e
c"%an' t %rint a retractin $ t)eir %re(iu! ad(erti!e"ent, C"%ared t t)er in$ractin! t)at
endanger t)e %u2&ic )ea&t)0 %rinting a retractin i! nt "uc) $ a deterrent, Irnica&&'0 !e&&ing
%re!cri%tin drug! n t)e !treet carrie! a %uni!)"ent $ u% t 19 'ear! in 1ai&, I$ a drug c"%an'
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION *5
!e&&! t)eir %re!cri%tin! t)rug) "i!&eading ad(erti!e"ent!0 t)e' get a !trng&' /rded &e$ter,
:)i&e t)e FDA de! )a(e t)e %/er t !eiDe a c"%an'+! drug0 r ta#e t)e" t curt $r gr!!
(i&atin!0 t)!e actin! are re(er!ed $r t)e "!t $&agrant0 and cri"ina&0 di!regard $r )u"an
!a$et', :)i&e a !"a&& in$ringe"ent "a' nt !ee" t endanger t)e %u2&ic )ea&t)0 t)e a(erage
%er!n !ee! nine DTC ad(erti!e"ent! a da' -4ent&&a0 *511., Eac) !"a&& in$ractin cu&d add u%
t a 2ig "i!cnce%tin /)en t)e cn!u"er i! inundated /it) t)e", In *5510 t)e FDA t# an
a(erage $ t/ /ee#! a$ter t)e ad(erti!e"ent aired t i!!ue a /arning &etter t t)e c"%an', B'
*5590 t)e a(erage ti"e 1u"%ed t $urt) "nt)! -S)a/0 *558., B' t)i! ti"e t)e $$ending
ad(erti!e"ent cu&d )a(e a&read' run it! cur!e0 and an' atte"%t t curtai& it /u&d a&read' 2e in
(ain,
Rat)er t)an i"%!ing tig)ter regu&atin! n %)ar"aceutica& c"%anie!0 t)ere i! e(idence t
!ugge!t t)at t)e FDA i! actua&&' &e!! a2&e t regu&ate t)en in /a! in t)e ear&' 'ear! $ DTC
ad(erti!ing, In 166@0 1>* regu&atr' &etter! /ere !ent ut -S)a/0 *558., H/e(er0 in *55* it /a!
decided t)at 2e$re regu&atr' &etter! cu&d 2e !ent ut0 t)e' )ad t 2e re(ie/ed 2' t)e FDA+!
O$$ice $ C)ie$ Cun!e&, In *5570 n&' *1 regu&atr' &etter! /ere i!!ued -S)a/0 *558., T)i!
!igni$icant dr% in regu&atin %r2a2&' )a! "re t d /it) interna& 2ureaucrac' t)an it de!
/it) %)ar"aceutica& c"%anie!+ /i&&ingne!! t %&a' 2' t)e ru&e!,
E(en i$ &etter! cu&d 2e !ent ut i""ediate&'0 t)e FDA /u&d nt )a(e t)e !ta$$ t %rce!! t)e",
In *55* t)e entire re(ie/ c""ittee0 c)arged /it) (er!eeing a&& 2radca!ted and %rinted
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION *1
ad(erti!e"ent!0 cn!i!ted $ $i(e %e%&e, T)ere /ere *>8 ad(erti!e"ent! 2radca!ted in t)at
'ear0 and an un#n/n nu"2er $ %rint ad(erti!e"ent! -S)a/0 *558., H/e(er0 /)i&e t)e 2urden
$ re(ie/ "a' )a(e 2een )ea(' in *55*0 t)e nu"2er $ DTC ad(erti!e"ent! 2a&&ned t "re
t)an 190555 in *557 -S)a/0 *558., S)c#ing&'0 t)e entire re(ie/ c""ittee !ti&& cn!i!ted $
&e!! t)an )a&$ a dDen !ta$$ "e"2er!, A! it !tand!0 n&' <9 %ercent $ DTC ad(erti!e"ent! n
te&e(i!in are e(er re(ie/ed 2' t)e FDA -S)a/0 *558.,
E$$rt! t 2&!ter t)e FDA+! regu&atr' %/er! ca"e in *55@ /)en Pre!ident Bu!) re!igned t)e
Pre!cri%tin Drug U!er Fee Act t g int e$$ect in *558 t *51*, T)i! act aut)riDed t)e FDA t
c&&ect $ee! $r" %)ar"aceutica& c"%anie! t)at cu&d t)en 2e u!ed 2' t)e FDA t )ire "uc)
needed !ta$$ "e"2er!, Fr t)e $ir!t in$ringe"ent $ ad(erti!ing regu&atin!0 t)e FDA cu&d
c)arge t)e c"%an' u% t *950555 d&&ar!0 $r eac) !u2-!eCuentia& in$ractin t)e FDA cu&d
c)arge t)e c"%an' u% t 9550555 d&&ar! -S)a/0 *558.,
:)i&e t)e Pre!cri%tin Drug U!er Fee Act /ent int e$$ect in *5580 it &a!ted &e!! t)an 19 da'!,
On Fanuar' 190 *558 t)e FDA annunced t)at t)e' cu&d nt cntinue t)e %rgra" due t a &ac#
$ $und! a&&cated 2' Cngre!! -S)a/0 *558., Ba!ed n t)e FDA+! &ac# $ $und!0 !ta$$ "e"2er!0
and in!u$$icient di!ci%&inar' %/er!0 t)ere i! a !trng ca!e t)at tig)ter regu&atin! "eet t)e t)ird
reCuire"ent $ t)e Centra& Hud!n te!t, A! it !tand!0 t)e g(ern"ent=! intere!t cu&d nt 2e
ac)ie(ed t)rug) a &e!! re!tricti(e rute t)an t)e %r%!ed !&utin!, Atte"%t! t i"%&e"ent
e$$ecti(e0 2ut &e!! re!tricti(e !&utin! )a(e 2een ine$$ecti(e, Se&$-regu&atin0 increa!ed
(er!ig)t0 and a !'!te" $ $ine! )a(e a&& %r(ed $ruit&e!!, On&' a $ractin $ DTC ad(erti!e"ent!
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION **
are e(er regu&ated0 and t)e ne! t)at are are $ten $&agged &ng a$ter t)e'+re $ini!)ed airing, Curt
)earing! )ard&' e(er ccur0 and t)e %r"i!ed retractin $ "i!&eading ad(erti!e"ent! are $e/
and $ar 2et/een,
Cnc&u!in
DTC ad(erti!ing i! a %)en"enn in t)e United State!0 and ne !urrunded 2' a great dea& $
cntr(er!', T)ere i! a 2d' $ e(idence t)at DTC ad(erti!ing 2t) )e&%! and )urt! t)e genera&
%%u&atin, H/e(er0 "an' $ t)e !tudie! indicating 2ene$it! t cn!u"er! re&' n !e&$ re%rted
data, In t)er /rd!0 /e are re&'ing n cn!u"er! t)e"!e&(e! t re%rt t)e 2ene$it! $
ad(erti!ing, One cu&d !a' t)at an' data gat)ered $r" t)e cn!u"er n&' %r(e! t)at
ad(erti!ing i! an e$$ecti(e t& $r !e&&ing a %rduct, Cn!u"er! "a' 2e&ie(e t)e' are "re
a/are $ di!ea!e!0 and t)e "edicatin! u!ed t treat t)e"0 /)en in rea&it' t)e' n&' #n/ ne
!ide $ t)e !tr'0 t)e !ide t)at %)ar"aceutica& c"%anie! !%ent "i&&in! $ d&&ar! de(e&%ing,
T "a#e !und "edica& deci!in!0 %atient! and dctr! "u!t /r# tget)er, Patient! need t
under!tand /)at ri!#! t)e' are /i&&ing t ta#e0 and dctr! "u!t "a#e !ure t)eir %atient
under!tand! t)e ri!#! and t)e 2ene$it! $ "edicatin, DTC ad(erti!e"ent i! t)e unnece!!ar'0 and
"ani%u&ati(e e&e%)ant in t)e r",

:)i&e "an' %atient! are #n/&edga2&e enug) t cnduct inde%endent re!earc) $ t)eir /n0
DTC ad(erti!e"ent "a#e! t)at "re di$$icu&t a! /e&&, It can 2e )ard t deter"ine t)e di$$erence
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION *<
2et/een a re&ia2&e artic&e and a !tud' %aid $r 2' t)e drug c"%an', E(en re&ia2&e /e2!ite! t)at
%r(ide a 2a&ance $ data "a' a&! )a(e ad(erti!e"ent! %aid $r 2' t)e drug c"%an',
Di!cerning re&ia2&e e(idence !"eti"e! reCuire! a dee% in(e!tigatin int t)e !urce!, Nt a&&
%atient! /i&& )a(e t)e under!tanding0 ti"e0 r %atience t cnduct !uc) a !earc), Patient! /) are
!cared "a' 2e "re &i#e&' t $a&& %re' t (er&' %ti"i!tic ad(erti!e"ent! t)at te&& t)e" t)eir
cnditin i! ea!i&' treata2&e /it) a nce-a-da' %i&&,
B' a&&/ing drug c"%anie! t retain t)e $u&& 2ene$it $ t)eir Fir!t A"end"ent Rig)t!0 /e are
1e%ardiDing %atient+! rig)t! t "a#e inde%endent "edica& deci!in!, Cncern (er 2ec"ing t
%aterna&i!tic )a! cau!ed a %&itica& c&i"ate t)at $a(r! c"%anie! (er %e%&e, I$ c"%anie! are
gi(en t)e !a"e rig)t! a! %e%&e0 t)e' !)u&d 2e )e&% t t)e !a"e !tandard!0 and !)u&d nt 2e
a&&/ed t inter$ere /it) a %atient+! "edica& deci!in,
T)ere i! a /a' t gi(e %atient! autn"' /)i&e %re!er(ing %)ar"aceutica& c"%anie!+ rig)t! t
$reed" $ e3%re!!in, A c"%r"i!e t)at a&&/ed %)ar"aceutica& c"%anie! t ad(erti!e a
c&a!! $ %re!cri%tin "edicatin0 /it)ut !a'ing an' 2rand na"e!0 /u&d increa!e t)eir
%re!cri%tin !a&e! /it)ut inter$ering /it) dctr!+ and %atient!+ "edica& deci!in!, Or0 i$ t)at i!
i"%!!i2&e0 i"%&e"enting a t/ 'ear ad(erti!ing )&d n %re!cri%tin "edicatin /u&d a&&/
t)e e$$ect! $ t)e drug t 2e "re t)rug)&' a!!e!!ed 2e$re it /a! aggre!!i(e&' !&d t
cn!u"er!,
Ba!ed n t)e e(idence a(ai&a2&e0 t)ere i! rea!n t 2e&ie(e t)at c)anging DTC ad(erti!ing t
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION *>
e3c&u!i(e&' c&a!! 2a!ed ad(erti!e"ent! /u&d %rtect t)e %u2&ic )ea&t) /it) ut actua&&'
da"aging c"%anie!+ %r$it!, A&& e!ti"ate! indicate t)at t)ere i! a (er' %r return n DTC
ad(erti!ing, I$ c&a!! 2a!ed ad(erti!ing /a! u!ed0 %)ar"aceutica& c"%anie! cu&d c"2ine t)eir
ad(erti!ing 2udget!0 !%end &e!! "ne'0 /)i&e increa!ing t)eir !a&e!, Since 2rand !%eci$ic
ad(erti!e"ent! increa!e t)e !a&e $ a %re!cri%tin=! /)&e c&a!!0 rat)er t)at t)e %re!cri%tin it!
!e&$0 t)ere i! e(er' rea!n t 2e&ie(e t)at a c%erati(e a%%rac) /u&d 2e t)e "!t e$$ecti(e,
Re$erence!
Arney, J., & Lewin, B. (2013). Models of physicianpaien relaionships in
phar!ace"ical direc#o#cons"!er ad$erisin% and cons"!er
iner$iews. Qualitative Health Research, 23(&).
Arnold, '., & (a)ley, J. (2013). *he poliics and srae%y of ind"sry self#
re%"laion+ *he phar!ace"ical ind"sry,s principles for ehical direc#o#
cons"!er ad$erisin% as a decepi$e -loc)in% srae%y. Journal of Health
Politics, Policy and Law, 38(3).
Bernd, .., & 'onoh"e, J. (2013). ./ecs of direc#o#cons"!er ad$erisin% on
!edicaion choice+ *he case of anidepressans. Journal of Public Policy &
Maretin!, 23(2).
DIRECT-TO-CONSUMER MARKETING OF PERSCRIPTION MEDICATION *9
0il$er!an, .. (2011, J"ne 02). "#$ advertisin! and di%inishin! returns.
1erie$ed fro! hp+22www.phar!ali$e.co!2dc#ad$erisin%#and#
di!inishin%#re"rns.
3enola, 4. (2011). 'irec#o#cons"!er phar!ace"ical ad$erisin%.
Phar%acy and #hera&eutics, 3'(10).
5ellin%on, A. (2010). o -an or no o -an+ direc#o#cons"!er ad$erisin%
and h"!an ri%hs analysis. (ustralasian Medical Journal, 3(12).
5orld 6ealh (r%ani7aion. (2008). 'irec#o#cons"!er ad$erisin% "nder
9re. )ulletin of the *orld Health +r!ani,ation, 8-(:),
*he 5orld Ban). (2013). ;op"laion (oal). #he *orld )an .rou&, 1erie$ed
fro! hp+22daa.world-an).or%2indicaor20;.;(;.*(*L
5osins)a, M. J. (200<). 'irec#o#cons"!er ad$erisin% and dr"% herapy
co!pliance. Journal of Maretin! Research, /2(3),