,,ii  #aai? ,,congress  #a/ ,session    
,s4 #feb  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #bj1 #bjbe,mr4
 ,durb9 7= himself & ,mr4 ,m>%all7      
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to provide = ! regulation ( 
c]ta9 communications reg>d+ prescription
 drugs4  #a4 ,%ort title ,?is ,act may  
be cit$ z ! ,protect+ ,pati5ts f        
,deceptive ,drug ,ads ,act4  #b4        
,regulation ( c]ta9 communications      
reg>d+ prescription drugs  7a7          
,regulation ( communications  7#a7 ,9   
g5]al ,section #cjc ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ccc7 is am5d$ by add+ at ! end !       
foll[+3  7h7 7#a7 ,9 ! case ( a social  
m$ia influ5c] or heal? c>e provid] :o   
makes false or mislead+ communications  
reg>d+ a drug approv$ "u section #eje or
 lic5s$ "u section #cea ( ! ,public     
,heal? ,s]vice ,act1 & subject to       
section #ejc7;b71 or comp\nd$ 9         

accordance ) section #ejc;,a or #ejc;,b1
 %all be liable to ! ,unit$ ,/ates = a  
civil p5alty 9 an am\nt describ$ 9      
p>agraph 7g77#a71 9 accordance ) a      
process simil> to ! process describ$ 9  
p>agraph 7g77#b74  7#b7 ,= purposes (   
?is p>agraph-- 7,a7 ! t]m false or      
mislead+ communications-- 7i7 means     
adv]tisem5ts or promotional             
communications on a social m$ia plat=m f
 :i* !re is a f9ancial b5efit to ! p]son
 engag+ 9 su* communications reg>d+ su* 
drug-- 7,i7 7aa7 t are made kn[+ly or   
recklessly2 &  7bb7 conta9 a false or   
inaccurate /atem5t or mat]ial omission (
 fact reg>d+ a drug describ$ 9          
subp>agraph 7#a72 or  7,,ii7 fail to    
include in=mation 9 brief summ>y relat+ 
to side effects1 contra9dications1 &    
effectiv5ess ( ! drug 9 ! same mann] &  
to ! same ext5t z su* in=mation is      
requir$ 9 prescription drug adv]tisem5ts
 pursuant to section #ejb7n72 &  7ii7   
does n include-- 7,i7 /atem5ts t take   
place 9 ! c\rse ( bona fide pati5t c>e  

or m$ical rese>* t are made by          
pr(essionals engag$ 9 su* pati5t c>e or 
m$ical rese>*2 or  7,,ii7 /atem5ts t    
describe ! p]son's own exp]i5ce1 op9ion1
 or value judgm5t2 &  7,b7 ! t]m social 
m$ia influ5c] means a private individual
 :o has p]ceiv$ cr$ibility or popul>ity 
& :o expresses _! op9ions1 beliefs1     
f9d+s1 recomm5dations1 or exp]i5ce on   
social m$ia plat=ms to an audi5ce1      
includ+ 9 a mann] convey+ tru/ or       
exp]tise on a topic1 = ! purpose to     
promot+ or adv]tis+ c]ta9 in=mation or  
products or induc+ behavior by !        
audi5ce4  4  7#b7 ,guidance ,n lat] ?an 
#ahj days aft] ! date ( enactm5t ( ?is  
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices 7ref]r$ to 9 ?is section z !   
,secret>y7 %all issue guidance on h[ !  
,secret>y w adm9i/] p>agraph 7h7 (      
section #cjc ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #ccc71 z  
add$ by p>agraph 7#a71 includ+ ) respect
 to ! factors t w be consid]$ 9 det]m9+ 
:e!r a communication is false or        

mislead+ communication1 z def9$ 9 su*   
p>agraph 7h71 includ+-- 7,a7 ! v>i\s    
types ( /atem5ts or omission ( facts    
reg>d+ a prescription drug t w\ld       
con/itute false or mislead+1 su* z      
/atem5ts or omissions relat$ to safety1 
efficacy1 approv$ or unapprov$ uses1    
directions = use f ! label approv$ by ! 
,food & ,drug ,adm9i/ration1 sci5tific  
in=mation1 or o!r simil> attributes2    
7,b7 :e!r ! inclusion ( ! in=mation 9   
brief summ>y describ$ 9 p>agraph        
7h77#b77;,a77i77,,iii7 ( section #cjc ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #ccc71 z add$ by p>agraph
 7#a71 alone is suffici5t 9 ea*         
circum/ance to avoid su* a det]m9ation2 
7,c7 actions tak5 by ! social m$ia      
influ5c]1 heal? c>e provid]1 or o!r     
p]son to demon/rate compliance ) su*    
p>agraph 7h72 &  7,d7 *>act]i/ics       
specific to v>i\s social m$ia plat=ms1 &
 ! spe$ ( dissem9ation ( ! cont5t on su*
 plat=m4  7#c7 ,additional requirem5ts =
 teleheal? provid]s  7,a7 ,9 g5]al      

,section #ejb7n7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ceb7n77 is am5d$ by add+ at ! end !    
foll[+3 ,= purposes ( ?is p>agraph1     
manufactur]1 pack]1 or di/ributor       
includes a p]son :o issues or causes to 
be issu$ an adv]tisem5t or o!r          
descriptive pr9t$ matt] ) respect to a  
specific drug subject to section        
#ejc7;b77#a7 or comp\nd$ 9 accordance ) 
section #ejc;,a or #ejc;,b1 & :o        
directly or indirectly (f]s to br+      
toge!r a pot5tial pati5t & a prescrib]  
or disp5s] ?r\gh use ( electronic       
in=mation & telecommunication           
te*nologies to engage 9 prescrib+ or    
disp5s+ ( any drug subject to section   
#ejc7;b77#a74 ,no?+ 9 ?is p>agraph %all 
apply to a private communication betwe5 
a practition] lic5s$ by law to prescribe
 or disp5se a prescription drug 7or an  
individual "u ! direct sup]vision ( su* 
a practition]7 & an individual pati5t or
 _! repres5tative44  7,b7 ,regulations  
,n lat] ?an #a ye> aft] ! date (        

enactm5t ( ?is ,act1 ! ,secret>y %all   
update ! regulations promulgat$ to c>ry 
out section #ejb7n7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ceb7n77 9 accordance ) ! am5dm5ts made 
by subp>agraph 7,a74  7#d7 ,rule (      
con/ruction ,no?+ 9 ?is subsection1     
includ+ ! am5dm5ts made by ?is          
subsection1 precludes a drug manufactur]
 f tak+ any corrective action to        
mitigate ! pot5tial = pati5t h>m f false
 or mislead+ communications describ$ 9  
p>agraph 7h77#b77;,a7 ( section #cjc ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cec71 z add$ by p>agraph
 7#a74  7#e7 ,effective date ,! am5dm5ts
 made by p>agraphs 7#a7 & 7#c7 %all take
 effect #ahj days aft] ! date on :i* !  
regulations describ$ 9 p>agraph         
7#c77;,b7 are f9aliz$4  7b7 ,report+    
requirem5t  7#a7 ,9 g5]al ,any paym5t   
describ$ 9 p>agraph 7#b7 ) respect to ! 
promotion (1 or communications reg>d+1 a
 cov]$ drug %all be treat$ z a paym5t f 
an applicable manufactur] to a cov]$    

recipi5t = purposes ( section #aabh;,g (
 ! ,social ,security ,act 7#db ,u4,s4,c4
 #acbj;a-#g;h71 & %all be report$ to !  
,secret>y ( ,heal? & ,human ,s]vices by 
! drug manufactur] or heal? c>e provid] 
mak+ ! paym5t & made publicly available 
by ! ,secret>y 9 accordance ) su*       
section #aabh;,g4  7#b7 ,paym5ts        
describ$ ,a paym5t describ$ 9 ?is       
p>agraph is-- 7,a7 a paym5t by a drug   
manufactur] to a heal? c>e provid]1     
includ+ a teleheal? company or o!r      
simil> entity1 or social m$ia influ5c]2 
or  7,b7 a paym5t by a heal? c>e        
provid]1 includ+ a teleheal? provid] or 
o!r simil> entity1 to a social m$ia     
influ5c]4  7#c7 ,def9itions ,9 ?is      
subsection-- 7,a7 ! t]ms applicable     
manufactur] & cov]$ recipi5t h ! mean+s 
giv5 su* t]ms 9 section #aabh;,g7e7 ( ! 
,social ,security ,act 7#db ,u4,s4,c4   
#acbj;a-#g;h72 &  7,b7 ! t]m cov]$ drug 
means any drug1 includ+ a biological    
product 7z def9$ 9 section #cea7;i7 ( ! 
,public ,heal? ,s]vice ,act 7#db        

,u4,s4,c4 #bfb7;i7771 = :i* paym5t is   
available "u title ,,xviii ( ! ,social  
,security ,act 7#db ,u4,s4,c4 #acie et  
seq47 or a ,/ate plan "u title ,,xix or 
,,xxi ( su* ,act 7#db ,u4,s4,c4 #acif et
 seq42 #db ,u4,s4,c4 #acig;aa et seq47  
7or a waiv] ( su* a plan74  7c7 ,m>ket  
surveillance ( prescription drug        
adv]tis+ or promotion  7#a7 ,9 g5]al ,! 
,secret>y may conduct m>ket surveillance
 activities reg>d+ any promotion (      
prescription drugs on social m$ia       
plat=ms4 ,! activities "u ?is section   
may include-- 7,a7 activities1 c>ri$ out
 directly or by contract1 relat+ to--   
7i7 aggregat+ & analysis ( public       
communications 7:i* may involve ! use ( 
artificial intellig5ce applications71   
includ+ to e/abli% any relation%ip      
betwe5 a manufactur] ( a prescription   
drug & individuals engag+ 9             
communications ab\t su* drug2  7ii7     
analytical tools to review submissions (
 promotional communications2  7iii7     
engagem5t ) repres5tatives ( social m$ia

 plat=ms on /rategies & opportunities to
 address false or mislead+ promotion (  
prescription drugs1 includ+ ?r\gh me?ods
 ( te*nology or functionality to id5tify
 & assess false or mislead+             
communications2 &  7iv7 develop+ &      
dissem9at+ public fac+ communications & 
educational mat]ials & programs =       
prescription drug manufactur]s1 social  
m$ia plat=ms1 & ! public1 :i* may       
include communications & educational    
mat]ials & programs reg>d+ ! ,bad ,ad   
program ( ! ,food & ,drug ,adm9i/ration2
  7,b7 hir+ additional /aff = ! ,(fice (
 ,prescription ,drug ,promotion ( !     
,c5t] = ,drug ,evaluation & ,rese>* & ! 
,adv]tis+ & ,promotional ,label+ ,bran* 
( ! ,c5t] = ,biologics ,evaluation &    
,rese>* = ! review ( adv]tis+ or        
promotion ( prescription drugs on       
digital plat=ms1 su* z social m$ia1 &   
su* o!r purposes z ! ,secret>y det]m9es 
appropriate2 &  7,c7 e/abli%+ a task    
=ce1 jo9tly ) ! ,f$]al ,trade           
,commission1 to coord9ate & enhance     

communication betwe5 ! ,f$]al ,trade    
,commission & ! ,food & ,drug           
,adm9i/ration relat$ to monitor+ (1 &   
compliance activities relat+ to1        
prescription drug adv]tis+ or promotion4
  7#b7 ,rule ( con/ruction ,no?+ 9      
p>agraph 7#a7 %all be con/ru$ to affect 
! au?ority ( ! ,secret>y to c>ry out    
activities describ$ 9 su* p>agraph      
pursuant to o!r provisions ( law4  7#c7 
,,fda notice to manufactur]s ,!         
,secret>y may e/abli% a process =       
provid+ in=mation to ! hold] ( an       
approv$ application ( a prescription    
drug "u section #eje ( ?is ,act or      
section #cea ( ! ,public ,heal? ,s]vice 
,act = ! purpose ( notify+ su* hold] (  
in/ances ( communications by heal? c>e  
provid]s or social m$ia influ5c]s t fail
 to include in=mation 9 brief summ>y    
relat+ to side effects1                 
contra9dications1 & effectiv5ess ( !    
drug 9 ! same mann] & to ! same ext5t z 
su* in=mation is requir$ 9 prescription 
drug adv]tisem5ts pursuant to section   

#ejb7n7 ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7n774 
7#d7 ,report+ ,! ,secret>y %all-- 7,a7 n
 lat] ?an #b ye>s aft] ! date ( enactm5t
 ( ?is ,act1 submit to ,congress a      
report on ! activities c>ri$ out "u ?is 
subsection2  7,b7 n lat] ?an #d ye>s    
aft] ! date ( enactm5t ( ?is ,act1      
submit to ,congress1 & make publicly    
available1 a report on ! activities     
c>ri$ out "u ?is subsection2 &  7,c7    
make publicly available on ! website ( !
 ,food & ,drug ,adm9i/ration notice (   
all en=cem5t actions tak5 "u p>agraph   
7h7 ( section #cjc ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ccc71 z add$ by subsection 7a74  7#e7  
,au?orization ( appropriations ,to c>ry 
out ?is subsection1 !re are au?oriz$ to 
be appropriat$ #ae1jjj1jjj = ea* (      
fiscal ye>s #bjbe ?r\gh #bjbi4  7d7     
,social m$ia influ5c] ,9 ?is section1 ! 
t]m social m$ia influ5c] has ! mean+    
giv5 su* t]m 9 p>agraph 7h7 ( section   
#cjc ( ! ,f$]al ,food1 ,drug1 &         

,cosmetic ,act 7#ba ,u4,s4,c4 #ccc71 z  
add$ by subsection 7a74  7e7            
,sev]ability ,if any provision ( ?is    
,act or ( any am5dm5t made by ?is ,act1 
or ! application ( su* provision or     
am5dm5t to any p]son or circum/ance1 is 
held to be invalid1 ! rema9d] ( !       
provisions ( ?is ,act & ( ! am5dm5ts    
made by ?is ,act & ! rema9d] ( !        
provisions ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq471 & ! application ( any su*        
provision or am5dm5t to o!r p]sons n    
simil>ly situat$ or to o!r circum/ances1
 %all n be affect$4