,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #dcih  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #ai1        
#bjai,mr4 ,cicill9e introduc$ ! foll[+  
bill2 :i* 0 ref]r$ to ! ,committee on ! 
,judici>y  ,a ,,bill  ,to am5d ! ,f$]al 
,trade ,commission ,act to prohibit     
anticompetitive behaviors by drug       
product manufactur]s1 & = o!r purposes4 
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,af=dable ,prescriptions = ,pati5ts   
,?r\gh ,promot+ ,competition ,act (     
#bjai4  #b4 ,product hopp+  7a7 ,9 g5]al
 ,! ,f$]al ,trade ,commission ,act 7#ae 
,u4,s4,c4 #da et seq47 is am5d$ by      
ins]t+ aft] section #bf 7#ae ,u4,s4,c4  
#eg;c-#b7 ! foll[+3  #bg4 ,product hopp+
  7a7 ,def9itions ,9 ?is section3 7#a7  
,abbreviat$ new drug application ,! t]m 
abbreviat$ new drug application means an
 application "u subsection 7b77#b7 or   
7j7 ( section #eje ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee74  7#b7 ,biosimil> biological      
product ,! t]m biosimil> biological     

product means a biological product      
lic5s$ "u section #cea7k7 ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k774  7#c7 ,biosimil> biological   
product lic5se application ,! t]m       
biosimil> biological product lic5se     
application means an application        
submitt$ "u section #cea7k7 ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k774  7#d7 ,foll[-on product ,! t]m
 foll[-on product-- 7,a7 means a drug   
approv$ ?r\gh an application or         
supplem5t to an application submitt$ "u 
section #eje7;b7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;c77 or a biological product lic5s$
 ?r\gh an application or supplem5t to an
 application submitt$ "u section        
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a77 = a *ange1    
modification1 or re=mulation to ! same  
manufactur]'s previ\sly approv$ drug or 
biological product t treats ! same      
m$ical condition2 &  7,b7 excludes su*  
an application or supplem5t to an       

application = a *ange1 modification1 or 
re=mulation ( a drug or biological      
product t is reque/$ by ! ,secret>y or  
necess>y to comply ) law1 includ+       
sections #eje;,a & #eje;,b ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee;a1 #cee;c74  7#e7 ,g5]ic 
drug ,! t]m g5]ic drug means a drug     
approv$ "u an application submitt$ "u   
subsection 7b77#b7 or 7j7 ( section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee74  7#f7 ,li/$  
drug ,! t]m li/$ drug means a drug li/$ 
"u section #eje7;j77#g7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#g774  7#g7          
,manufactur] ,! t]m manufactur] means ! 
hold]1 lic5see1 or assignee (-- 7,a7 an 
approv$ application = a drug "u section 
#eje7;c7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c772
 or  7,b7 a biological product lic5se "u
 section #cea7;a7 ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a774  
7#h7 ,ref]5ce product ,! t]m ref]5ce    

product has ! mean+ giv5 ! t]m 9 section
 #cea7;i7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bfb7;i774  7#i7    
,ultimate p>5t entity ,! t]m ultimate   
p>5t entity has ! mean+ giv5 ! t]m 9    
section #hja4a ( title #af1 ,code (     
,f$]al ,regulations1 or any successor   
regulation4  7b7 ,prohibition on product
 hopp+  7#a7 ,prima facie ,except z     
provid$ 9 p>agraph 7#b71 a manufactur] (
 a ref]5ce product or li/$ drug %all be 
consid]$ to h engag$ 9 an unfair me?od (
 competition 9 or affect+ comm]ce 9     
violation ( section #e7;a7 if !         
,commission demon/rates by a            
prepond]ance ( ! evid5ce 9 a proce$+    
initiat$ by ! ,commission "u subsection 
7c77#a77;,a71 or 9 a suit br\ght "u     
subp>agraph 7,b7 or 7,c7 ( subsection   
7c77#a71 t1 dur+ ! p]iod beg9n+ on !    
date on :i* ! manufactur] ( ! ref]5ce   
product or li/$ drug fir/ receives      
notice t an applicant has submitt$ to ! 
,commission] ( ,food & ,drugs an        
abbreviat$ new drug application or      

biosimil> biological product lic5se     
application & end+ on ! date t is #ahj  
days aft] ! date on :i* t g5]ic drug or 
biosimil> biological product is fir/    
m>ket$1 ! manufactur] engag$ 9 ei!r ( ! 
foll[+ actions3  7,a7 ,! manufactur]    
engag$ 9 a h>d swit*1 :i* %all be       
e/abli%$ by demon/rat+ t ! manufactur]  
engag$ 9 ei!r ( ! foll[+ actions3  7i7  
,^u ! reque/ ( ! manufactur] ( ! li/$   
drug or ref]5ce product1 ! ,commission] 
( ,food & ,drugs )drew ! approval ( !   
application = ! li/$ drug or ref]5ce    
product or plac$ ! li/$ drug or ref]5ce 
product on ! discont9u$ products li/ & !
 manufactur] m>ket$ or sold a foll[-on  
product4  7ii7  7,i7 ,! manufactur] ( ! 
li/$ drug or ref]5ce product-- 7aa7     
ann\nc$ )drawal (1 discont9uance ( !    
manufacture (1 or int5t to )draw !      
application ) respect to ! drug or      
ref]5ce product 9 a mann] t imp$es      
competition f a g5]ic drug or a         
biosimil> biological product1 z e/abli%$
 by objective circum/ances2 or  7bb7    

de/roy$ ! inv5tory ( ! li/$ drug or     
ref]5ce product 9 a mann] t imp$es      
competition f a g5]ic drug or a         
biosimil> biological product1 :i* may be
 e/abli%$ by objective circum/ances2 &  
7,,ii7 m>ket$ or sold a foll[-on        
product4  7,b7 ,! manufactur] engag$ 9 a
 s(t swit*1 :i* %all be e/abli%$ by     
demon/rat+ t ! manufactur] engag$ 9 bo? 
( ! foll[+ actions3  7i7 ,! manufactur] 
took actions ) respect to ! li/$ drug or
 ref]5ce product o!r ?an ^? describ$ 9  
subp>agraph 7,a7 t unfairly disadvantage
 ! li/$ drug or ref]5ce product relative
 to ! foll[-on product describ$ 9 clause
 7ii7 9 a mann] t imp$es competition f a
 g5]ic drug or a biosimil> biological   
product t is highly simil> to1 & has no 
cl9ically mean+ful diff]5ce ) respect to
 safety1 purity1 & pot5cy f1 ! ref]5ce  
product1 :i* may be e/abli%$ by         
objective circum/ances4  7ii7 ,!        
manufactur] m>ket$ or sold a foll[-on   
product4  7#b7 ,ju/ification  7,a7 ,9   
g5]al ,subject to p>agraph 7#c71 !      

actions describ$ 9 p>agraph 7#a7 by a   
manufactur] ( a li/$ drug or ref]5ce    
product %all n be consid]$ to be an     
unfair me?od ( competition 9 or affect+ 
comm]ce if--  7i7 ! manufactur]         
demon/rates to ! ,commission or a       
di/rict c\rt ( ! ,unit$ ,/ates1 z       
applicable1 by a prepond]ance ( !       
evid5ce 9 a proce$+ initiat$ by !       
,commission "u subsection 7c77#a77;,a71 
or 9 a suit br\ght "u subp>agraph 7,b7  
or 7,c7 ( subsection 7c77#a71 t--  7,i7 
! manufactur] w\ld h tak5 ! actions     
reg>dless ( :e!r a g5]ic drug t ref]5ces
 ! li/$ drug or biosimil> biological    
product t ref]5ces ! ref]5ce product _h 
already ent]$ ! m>ket2 &  7,,ii7  7aa7 )
 respect to a h>d swit* "u p>agraph     
7#a77;,a71 ! manufactur] took ! action =
 reasons relat+ to ! safety risk to     
pati5ts ( ! li/$ drug or ref]5ce        
product2  7bb7 ) respect to an action   
describ$ 9 item 7aa7 or 7bb7 ( p>agraph 
7#a77;,a77ii77,i71 !re is a supply      
disruption t-- 7,,aa7 is outside ( !    

control ( ! manufactur]2 7,,bb7 prev5ts 
! production or di/ribution ( !         
applicable li/$ drug or ref]5ce product2
 & 7,,cc7 _c be rem$i$ by reasonable    
ef=ts2 or  7cc7 ) respect to a s(t swit*
 "u p>agraph 7#a77;,b71 ! manufactur] _h
 legitimate pro-competitive reasons1    
ap>t f ! f9ancial effects ( r$uc$       
competition1 to take ! action4  7,b7    
,rule ( con/ruction ,no?+ 9 subp>agraph 
7,a7 may be con/ru$ to limit ! in=mation
 t ! ,commission may o!rwise obta9 9 any
 proce$+ or action in/itut$ ) respect to
 a violation ( ?is section4  7#c7       
,response ,) respect to a ju/ification  
(f]$ by a manufactur] "u p>agraph 7#b71 
! ,commission may-- 7,a7 rebut any      
evid5ce pres5t$ by a manufactur] dur+ t 
ju/ification2 or  7,b7 e/abli% by a     
prepond]ance ( ! evid5ce t1 on balance1 
! pro-competitive b5efits f ! conduct   
describ$ 9 subp>agraph 7,a7 or 7,b7 (   
p>agraph 7#a71 z applicable1 d n        
outweigh any anticompetitive effects ( !
 conduct1 ev5 9 consid]ation ( !        

ju/ification s (f]$4  7c7 ,en=cem5t     
7#a7 ,9 g5]al ,if ! ,commission has     
reason to believe t any manufactur] has 
violat$1 is violat+1 or is ab\t to      
violate ?is section1 ! ,commission may  
take any ( ! foll[+ actions3  7,a7      
,in/itute a proce$+-- 7i7 t1 except z   
provid$ 9 p>agraph 7#b71 complies ) !   
requirem5ts "u section #e7;b72 &  7ii7 9
 :i* ! ,commission may impose on !      
manufactur] any p5alty t ! ,commission  
may impose = a violation ( section #e4  
7,b7 ,9 ! same mann] & to ! same ext5t z
 provid$ 9 section #ac7;b71 br+ suit 9 a
 di/rict c\rt ( ! ,unit$ ,/ates to      
tempor>ily enjo9 ! action ( !           
manufactur]4  7,c7 ,br+ suit 9 a di/rict
 c\rt ( ! ,unit$ ,/ates1 9 :i* !        
,commission may seek-- 7i7 to p]man5tly 
enjo9 ! action ( ! manufactur]2  7ii7   
any ( ! rem$ies describ$ 9 p>agraph     
7#c72 &  7iii7 any o!r equitable rem$y1 
includ+ ancill>y equitable relief4  7#b7
 ,judicial review  7,a7 ,9 g5]al        
,not)/&+ any provision ( section #e1 any

 manufactur] t is subject to a f9al ord]
 ( ! ,commission t is issu$ 9 a proce$+ 
initiat$ "u p>agraph 7#a77;,a7 may1 n   
lat] ?an #cj days aft] ! date on :i* !  
,commission issues ! ord]1 petition =   
review ( ! ord] 9--  7i7 ! ,unit$ ,/ates
 ,c\rt ( ,appeals = ! ,di/rict (        
,columbia ,circuit2 or  7ii7 ! c\rt (   
appeals ( ! ,unit$ ,/ates = ! circuit 9 
:i* ! ultimate p>5t entity ( !          
manufactur] is incorporat$4  7,b7       
,treatm5t ( f9d+s ,9 a review ( an ord] 
issu$ by ! ,commission conduct$ by a    
c\rt ( appeals ( ! ,unit$ ,/ates "u     
subp>agraph 7,a71 ! factual f9d+s ( !   
,commission %all be conclusive if ^?    
facts are support$ by ! evid5ce4  7#c7  
,equitable rem$ies  7,a7 ,disgorgem5t   
7i7 ,9 g5]al ,9 a suit br\ght "u        
p>agraph 7#a77;,c71 ! ,commission may   
seek1 & ! c\rt may ord]1 disgorgem5t (  
any unju/ enri*m5t t a p]son obta9$ z a 
result ( ! violation t gives rise to !  
suit4  7ii7 ,calculation ,any           
disgorgem5t t is ord]$ ) respect to a   

p]son "u clause 7i7 %all be (fset by any
 am\nt ( re/itution ord]$ "u subp>agraph
 7,b74  7iii7 ,limitations p]iod ,!     
,commission may seek disgorgem5t "u ?is 
subp>agraph n lat] ?an #e ye>s aft] !   
late/ date on :i* ! p]son f :i* !       
disgorgem5t is s\ght receives any unju/ 
enri*m5t f ! effects ( ! violation t    
gives rise to ! suit 9 :i* ! ,commission
 seeks ! disgorgem5t4  7,b7 ,re/itution 
7i7 ,9 g5]al ,9 a suit br\ght "u        
p>agraph 7#a77;,c71 ! ,commission may   
seek1 & ! c\rt may ord]1 re/itution )   
respect to ! violation t gives rise to !
 suit4  7ii7 ,limitations p]iod ,!      
,commission may seek re/itution "u ?is  
subp>agraph n lat] ?an #e ye>s aft] !   
late/ date on :i* ! p]son f :i* !       
re/itution is s\ght receives any unju/  
enri*m5t f ! effects ( ! violation t    
gives rise to ! suit 9 :i* ! ,commission
 seeks ! re/itution4  7#d7 ,rules (     
con/ruction ,no?+ 9 ?is subsection may  
be con/ru$ z-- 7,a7 requir+ !           
,commission to br+ a suit seek+ a       

tempor>y injunction "u p>agraph         
7#a77;,b7 be=e br++ a suit seek+ a      
p]man5t injunction "u p>agraph          
7#a77;,c72 or  7,b7 affect+ any o!r     
au?ority ( ! ,commission "u ?is ,act to 
seek relief or obta9 a rem$y ) respect  
to a violation ( ?is ,act4  4  7b7      
,applicability ,section #bg ( ! ,f$]al  
,trade ,commission ,act1 z add$ by      
subsection 7a71 %all apply ) respect to 
any--  7#a7 conduct t occurs on or aft] 
! date ( enactm5t ( ?is ,act2 &  7#b7   
action or proce$+ t is comm5c$ on or    
aft] ! date ( enactm5t ( ?is ,act4  7c7 
,antitru/ laws ,no?+ 9 ?is section1 or !
 am5dm5ts made by ?is section1 %all     
modify1 impair1 limit1 or sup]s$e !     
applicability ( ! antitru/ laws z def9$ 
9 subsection 7a7 ( ! fir/ section ( !   
,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 &
 ( section #e ( ! ,f$]al ,trade         
,commission ,act 7#ae ,u4,s4,c4 #de7 to 
! ext5t t x applies to unfair me?ods (  
competition4  7d7 ,rulemak+ ,! ,f$]al   
,trade ,commission may issue rules "u   

section #eec ( title #e1 ,unit$ ,/ates  
,code1 to c>ry out section #bg ( !      
,f$]al ,trade ,commission ,act1 z add$  
by subsection 7a71 includ+ by def9+ any 
t]ms us$ 9 su* section #bg 7o!r ?an t]ms
 t are def9$ 9 subsection 7a7 ( su*     
section #bg74