,i  #aag? ,,congress  #b;d ,session  ,h4
 ,r4 #gdgc  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,april #g1 #bjbb,mrs4 
,c>olyn ,b4 ,maloney ( ,new ,york 7=    
h]self1 ,mr4 ,cicill9e1 ,mr4 ,nadl]1    
,mr4 ,wel*1 ,ms4 ,s*ak[sky1 ,ms4 ,port]1
 ,mr4 ,de,saulnier1 & ,mr4 ,rask97      
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ! ,judici>y  ,a ,,bill 
,to prohibit ph>maceutical manufactur]s 
f int]f]+ ) !rapeutically equival5t or  
int]*angeable sub/itution decisions by  
heal? c>e provid]s to limit competition 
f a g5]ic drug or biosimil> biological  
product1 & = o!r purposes4  #a4 ,%ort   
title ,?is ,act may be cit$ z ! ,g5]ic  
,sub/itution ,non9t]f]5ce ,act4  #b4    
,decl>ation ( purposes ,! purposes ( ?is
 ,act are--  7#a7 to enhance competition
 9 ! ph>maceutical m>ket by /opp+       
anticompetitive practices t limit or    
prev5t competition f g5]ic drugs &      
biosimil> biological products1  7#b7 to 
support ! purposes & int5t ( antitru/   
law by prohibit+ anticompetitive        

practices 9 ! ph>maceutical indu/ry t   
h>m consum]s1 &  7#c7 to pres]ve        
physician autonomy4  #c4 ,int]f]5ce )   
provid] sub/itution decisions  7a7      
,prohibition ,x %all be unlawful = a    
ph>maceutical manufactur]--  7#a7 to    
provide any item or s]vice1 or any?+ (  
value1 = ! purpose ( aid+ or assi/+ a   
heal? c>e provid] to reque/ or direct t 
a drug be disp5s$ z writt5 or br& "n    
only :5 a g5]ic drug or biosimil>       
biological product is available1 includ+
 any prescription notepad or            
prescription /amp1 b n includ+ any      
product sample1 or  7#b7 to direct a    
heal? c>e provid] to write disp5se z    
writt51 br& "n only1 or ano!r simil>    
notation or direction on a prescription 
:5 a g5]ic drug or biosimil> biological 
product is available4  7b7 ,limitation  
,no?+ 9 ?is section prev5ts a heal? c>e 
provid] f ex]cis+ ! provid]'s own m$ical
 judgm5t to prescribe any drug or       
biologic product4  7c7 ,civil p5alty    
actions ,if ! ,commission has reason to 

believe t a ph>maceutical manufactur]   
has violat$ or is violat+ ?is ,act1 !   
,f$]al ,trade ,commission may comm5ce a 
civil action to recov] a civil p5alty & 
seek o!r appropriate relief 9 a di/rict 
c\rt ( ! ,unit$ ,/ates aga9/ !          
ph>maceutical manufactur]4 ,except z    
o!rwise provid$ 9 section #af7;a77#b7 ( 
! ,f$]al ,trade ,commission ,act 7#ae   
,u4,s4,c4 #ef7;a77#c771 ! ,commission   
%all h exclusive au?ority to comm5ce or 
def5d1 & sup]vise ! litigation (1 any   
civil action "u p>agraph 7#a7 & any     
appeal ( su* action 9 its own "n by any 
( its attorneys designat$ by x = su*    
purpose1 unless ! ,commission au?orizes 
! ,attorney ,g5]al to d s4 ,!           
,commission %all in=m ! ,attorney ,g5]al
 ( ! ex]cise ( su* au?ority & su*       
ex]cise %all n preclude ! ,attorney     
,g5]al f int]v5+ on behalf ( ! ,unit$   
,/ates 9 su* action & any appeal ( su*  
action z may be o!rwise provid$ by law4 
,! civil p5alty %all be suffici5t to    
det] violations ( ?is section1 b 9 no   

ev5t %all be great] ?an ?ree times !    
gross rev5ues receiv$ = sales ( ! br&-"n
 drug dur+ ! p]iod 9 :i* ! prohibit$    
conduct occurr$4 ,9 det]m9+ ! am\nt ( ! 
civil p5alty1 ! c\rt %all take into     
acc\nt--  7#a7 ! nature1 circum/ances1  
ext5t1 & gravity ( ! violation ) respect
 to ! ph>maceutical manufactur]1  7#b7 !
 degree ( culpability1  7#c7 ! hi/ory ( 
violations1  7#d7 ! ability to pay1 &   
any effect on ! ability to cont9ue do+  
bus9ess1 &  7#e7 o!r matt]s t ju/ice    
requires4  7d7 ,unfair me?od (          
competition ,a violation ( ?is ,act %all
 also con/itute an unfair me?od (       
competition "u section #e7;a77#a7 ( !   
,f$]al ,trade ,commission ,act 7#ae     
,u4,s4,c4 #de7;a77#a774  7e7 ,en=cem5t  
au?ority ,except z o!rwise provid$ 9    
subsection 7c71 ! ,commission %all en=ce
 ?is ,act 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
  7f7 ,actions by /ates  7#a7 ,9 g5]al  
,9 any case 9 :i* ! attorney g5]al ( a  
,/ate has reason to believe t an int]e/ 
( ! resid5ts ( t ,/ate has be5 or is    
?reat5$ or adv]sely affect$ by !        
engagem5t ( a ph>maceutical manufactur] 
9 any conduct describ$ 9 subsection 7a71
 ! ,/ate1 z p>5s patriae1 may br+ a     
civil action on behalf ( ! resid5ts ( ! 
,/ate 9 a di/rict c\rt ( ! ,unit$ ,/ates
 ( appropriate jurisdiction to enjo9 t  
practice1 to obta9 damages1 re/itution1 
or o!r comp5sation on behalf ( resid5ts 
( su* ,/ate1 or to obta9 su* fur!r & o!r
 relief z ! c\rt may deem appropriate4  
7#b7 ,notice ,! ,/ate %all s]ve prior   
writt5 notice ( any civil action "u ?is 
subsection ^u ! ,commission & provide ! 
,commission ) a copy ( its compla9t1    
except t if x is n feasible = ! ,/ate to
 provide su* prior notice1 ! ,/ate %all 
s]ve su* notice imm$iately ^u in/itut+  
su* action4 ,^u receiv+ a notice        
respect+ a civil action1 ! ,commission  

%all h ! "r to-- 7,a7 int]v5e 9 su*     
action1  7,b7 ^u s int]v5+1 to be he>d  
on all matt]s aris+ !re91 &  7,c7 to    
file petitions = appeal4  7#c7          
,con/ruction ,= purposes ( br++ a civil 
action "u ?is subsection1 no?+ 9 ?is    
,act %all prev5t an attorney g5]al f    
ex]cis+ ! p[]s conf]r$ on ! attorney    
g5]al by ! laws ( su* ,/ate to conduct  
inve/igations1 or to adm9i/] oa?s or    
affirmations1 or to compel ! att5dance (
 witnesses or ! production ( docum5t>y &
 o!r evid5ce4  7#d7 ,actions by         
commission ,:5ev] a civil action has be5
 in/itut$ by or on behalf ( !           
,commission = violation ( ?is ,act1 no  
,/ate may1 dur+ ! p5d5cy ( su* action   
in/itut$ by or on behalf ( !            
,commission1 in/itute a civil action "u 
?is subsection aga9/ any def5dant nam$ 9
 ! compla9t 9 su* action = violation (  
?is ,act4  7#e7 ,v5ue2 s]vice ( process 
,any civil action br\ght "u ?is         
subsection 9 a di/rict c\rt ( ! ,unit$  
,/ates may be br\ght 9 ! di/rict 9 :i* !

 def5dant is f\nd1 is an inhabitant1 or 
transacts bus9ess or :]ev] v5ue is prop]
 "u section #acia ( title #bh4 ,process 
9 su* an action may be s]v$ 9 any       
di/rict 9 :i* ! def5dant is an          
inhabitant or 9 :i* ! def5dant may be   
f\nd4  7g7 ,def9itions ,9 ?is section3  
7#a7 ,antitru/ laws ,! t]m antitru/ laws
 has ! mean+ giv5 ! t]m 9 subsection 7a7
 ( ! #a/ section ( ! ,clayton ,act 7#ae 
,u4,s4,c4 #ab7;a774  7#b7 ,biosimil>    
biological product ,! t]m biosimil>     
biological product means a biological   
product lic5s$ "u section #cea7k7 ( !   
,public ,heal? ,s]vice ,act4  7#c7 ,br& 
"n drug ,! t]m br& "n drug means a drug 
approv$ or lic5s$ "u section #eje7;c7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
or section #cea7;a7 ( ! ,public ,heal?  
,s]vice ,act4  7#d7 ,g5]ic drug ,! t]m  
g5]ic drug means a drug approv$ "u      
section #eje7;j7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act4  7#e7 ,heal?   
c>e provid] ,! t]m heal? c>e provid]    
means any individual or entity1 includ+ 

any ph>macy1 t p>ticipates 9 any ,f$]al 
heal? c>e program 7z def9$ 9 section    
#aabh;,b7f77 ( ! ,social ,security ,act4
  7#f7 ,ph>maceutical manufactur] ,! t]m
 ph>maceutical manufactur] means ! hold]
 (--  7,a7 an application approv$ "u    
section #eje7;c7 or #eje7;j7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act1 or  7,b7
 a lic5se "u section #cea7;a7 or #cea7k7
 ( ! ,public ,heal? ,s]vice ,act4  7h7  
,rule ( con/ruction ,except to ! ext5t  
?is ,act e/abli%es an additional basis =
 liability en=c$ z provid$ h]e91 no?+ 9 
?is ,act %all modify1 impair1 limit1 or 
sup]s$e ! applicability ( ! antitru/    
laws1 z def9$ 9 subsection 7a7 ( ! #a/  
section ( ! ,clayton ,act 7#ae ,u4,s4,c4
 #ab7;a771 & ( section #e7;a7 ( ! ,f$]al
 ,trade ,commission ,act 7#ae ,u4,s4,c4 
#de7;a774 ,no?+ 9 ?is ,act %all be      
con/ru$ to limit ! au?ority ( ! ,f$]al  
,trade ,commission "u any o!r provision 
( law4  7i7 ,sev]ability ,if any        
provision ( ?is ,act1 or ! application (
 su* provision1 to any p]son or         

circum/ance is held to be               
uncon/itutional1 ! rema9d] ( ?is ,act1 &
 ! application ( ! rema9+ provisions (  
?is ,act1 to any p]son or circum/ance   
%all n be affect$4