,,ib ,union ,cal5d> ,no4 #egh #aaf?     
,,congress  #b;d ,session  ,h4 ,r4 #eacc
 ,report ,no4 #aaf-fie ,,9 ,,! ,,h\se   
,,( ,,repres5tatives  ,novemb] #ah1     
#bjai,mr4 ,cicill9e 7= himself1 ,mr4    
,coll9s ( ,georgia1 ,mr4 ,nadl]1 & ,mr4 
,s5s5br5n]7 introduc$ ! foll[+ bill2 :i*
 0 ref]r$ to ! ,committee on ! ,judici>y
  ,decemb] #bd1 #bjbj;,additional       
sponsors3 ,mrs4 ,mc,bath & ,mr4 ,cl9e   
,decemb] #bd1 #bjbj,report$ f !         
,committee on ! ,judici>y2 committ$ to !
 ,committee ( ! ,:ole ,h\se on ! ,/ate (
 ! ,union & ord]$ to be pr9t$  ,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 or a 
relat$ indication2  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$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee;a1 #cee;c72  7,c7        
excludes su* an application or supplem5t
 to an application submitt$ "u section  
#eje7;b7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 
t has be5 grant$ ,new ,*emical ,entity  
exclusivity 7#ba ,u4,s4,c4              
#cee7;c77#c77;,e77ii77 by ! ,food &     
,drug ,adm9i/ration2 &  7,d7 excludes   
su* an application or supplem5t submitt$

 "u section #cea7;a7 ( ! ,public ,heal? 
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 t 
has be5 grant$ exclusivity pursuant to  
section #cea7k77#g7 ( su* ,act 7#db     
,u4,s4,c4 #bfb7k77#g774  7#e7           
,commission ,! t]m ,commission means !  
,f$]al ,trade ,commission  7#f7         
,disadvantage ,! t]m disadvantage means 
to imp$e ! li/$ drug or ref]5ce         
product's ability to compete on ! m]its 
) ! foll[-on product4 ,?is t]m excludes 
actions t consi/ solely (-- 7,a7        
tru?ful1 non-mislead+ promotional       
m>ket+2 or  7,b7 ceas+ promotional      
m>ket+ = ! li/$ drug or ref]5ce product4
  7#g7 ,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$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee74    
7#h7 ,li/$ 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#i7     
,manufactur] ,! t]m manufactur] means ! 

hold]1 lic5see1 or assignee (-- 7,a7 an 
approv$ application = a drug "u section 
#eje7;c7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c772
 or  7,b7 a biological product lic5se "u
 section #cea7;a7 ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a774  
7#aj7 ,ref]5ce product ,! t]m ref]5ce   
product has ! mean+ giv5 ! t]m 9 section
 #cea7;i7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bfb7;i774  7#aa7   
,ultimate p>5t entity ,! t]m ultimate   
p>5t entity has ! mean+ giv5 ! t]m 9    
section #hja4a ( title #af1 ,code (     
,f$]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 ( ! ,f$]al   
,trade ,commission ,act if compla9t     
c\nsel or ! ,commission demon/rates by a
 prepond]ance ( ! evid5ce 9 a proce$+   

initiat$ by ! ,commission "u subsection 
7c77#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 !     
e>li] ( #ahj days aft] ! date on :i* t  
g5]ic drug or biosimil> biological      
product or ano!r g5]ic drug or biosimil>
 biological product ref]5c+ ! li/$ drug 
or ref]5ce product is fir/ m>ket$ or #c 
ye>s aft] ! date on :i* ! foll[-on      
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 ( ! actions   
describ$ 9 clause 7i7 or 7ii73 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/2 & 
7,i7 ! manufactur] m>ket$ or sold a     
foll[-on product4  7ii7 7,i7 ,!         
manufactur] ( ! li/$ drug or ref]5ce    
product-- 7aa7 )drew1 discont9u$ !      
manufacture (1 or )drew ! application ) 
respect to1 or ann\nc$ )drawal (1       
discont9uance ( ! manufacture (1 or     
)drawal ( ! application ) respect to1 ! 
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/ances1 unless su*  
actions 7 tak5 by ! manufactur] pursuant
 to a reque/ ( ! ,commission] ( ,food & 
,drugs2 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 "o or m 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$es competition f ei!r a g5]ic drug  
or a biosimil> biological product1 :i*  
may be e/abli%$ 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#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;,a77i71 ! 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 
compla9t c\nsel or ! ,commission1 z     
applicable1 w prevail 9 its case if x   
e/abli%es by a prepond]ance ( ! evid5ce 
t-- 7,a7 ! conduct describ$ 9 subsection
 7b77#a7 is n reasonably necess>y to    
address or a*ieve ! ju/ifications claim$
 "u p>agraph 7#b77;,a77,,ii77aa-cc71 or 
su* ju/ifications c\ld be reasonably    
address$ or a*iev$ ?r\gh less           
anticompetitive means2 or  7,b7 !       
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]$4  7c7 ,en=cem5t     
7#a7 ,en=cem5t by ! ,f$]al ,trade       
,commission ,except z provid$ 9 p>agraph
 7#b71 ! ,commission %all en=ce ?is     

section 9 ! same mann]1 by ! same means1
 & ) ! same jurisdiction1 p[]s1 duties1 
& rem$ies provid$ = by all applicable   
t]ms & provisions ( ! ,f$]al ,trade     
,commission ,act 7#ae ,u4,s4,c4 #de et  
seq474  7#b7 ,judicial review  7,a7 ,9  
g5]al ,not)/&+ any provision ( section  
#e ( ! ,f$]al ,trade ,commission ,act1  
any manufactur] t is subject to a f9al  
ord] ( ! ,commission t is issu$ 9 a     
proce$+ initiat$ "u p>agraph 7#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  

,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  ,decemb] #bd1            
#bjbj;,committ$ to ! ,committee ( !     
,:ole ,h\se on ! ,/ate ( ! ,union &     
ord]$ to be pr9t$