,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #efeg  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,septemb] #ah1 #bjad  
,mr4 ,/iv]s 7= himself & ,mr4 ,wel*7    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to ensure t eligible   
product develop]s h competitive access  
to approv$ drugs & lic5s$ biological    
products1 s z to enable eligible product
 develop]s to develop & te/ new         
products1 & = o!r purposes4  #a4 ,%ort  
title ,?is ,act may be cit$ z ! ,fair   
,access = ,safe & ,timely ,g5]ics ,act (
 #bjad or ! ,,fa/ ,g5]ics ,act ( #bjad4 
#b4 ,f9d+s ,congress f9ds ! foll[+3     
7#a7 ,ref]5ce product lic5se or approval
 hold]s are re/rict+ competitive access 
to ref]5ce products by sponsors seek+ to
 develop drugs1 g5]ic drugs1 &          
biosimil>s "u section #eje7;b7 or       
#eje7;j7 ( ! ,food1 ,drug1 & ,cosmetic  
,act 7#ba ,u4,s4,c4 #cee7;b77#b7 &      
#cee7;j77 & "u section #cea ( ! ,public 

,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb74 ,^! re/rictions are det]r+ &     
delay+ developm5t ( g5]ic drugs &       
biosimil>s by ext5d+ lawful pat5t-bas$  
monopolies beyond _! lawful pat5t life4 
7#b7 ,! en=cem5t provisions set =? 9    
section #eje-a7;f77#h7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee-a7;f77#h77 h n be5 suffici5t to    
prev5t anti-competitive practices t     
int]f]e ) access to ref]5ce products :i*
 is necess>y = ! timely developm5t (    
af=dable g5]ic drugs & biosimil>s4  7#c7
 ,! op9ion 9 ,v]izon ,communications    
,inc4 v4 ,law ,(fices ( ,curtis ,v4     
,tr9ko1 ,,llp1 #edj ,u4,s4 #cih 7#bjjd7 
%\ld n be con/ru$ to impair or b> !     
application ( ! antitru/ laws consi/5t )
 ! provisions ( ?is ,act4  7#d7 ,!re is 
n a regulatory /ructure 9 place t is    
suffici5t to det] or rem$y !            
anti-competitive h>m t results :5 access
 to ref]5ce br& products is re/rict$ to 
sponsors develop+ drugs1 g5]ic drugs1 & 
biosimil>s 9 accordance ) section       

#eje7;b7 or #eje7;j7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77#b7 & #cee7;j771 & section #cea
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bfb71 respectively4  7#e7    
,requir+ lic5se hold]s to comply )      
requirem5ts = competitive access to _!  
products1 & subject+ lic5se hold]s to   
antitru/ liability = fail+ to d s1 w n  
impose obligations on ! c\rts t !y _c   
adequately & reasonably adjudicate4  #c4
 ,competitive access to cov]$ products =
 developm5t purposes  7a7 ,9 g5]al      
,*apt] ,v ( ! ,food ,drug & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cea et seq47 is    
am5d$ by ins]t+ aft] section #eje-a (   
su* ,act 7#ba ,u4,s4,c4 #cee-a7 ! foll[+
 new section3  #eje-b4 ,competitive     
access to cov]$ products = developm5t   
purposes  7a7 ,def9itions ,9 ?is        
section3  7#a7 ,cov]$ product ,! t]m    
cov]$ product means any drug approv$ "u 
section #eje or any biological product t
 is lic5s$ "u section #cea ( ! ,public  
,heal? ,s]vice ,act1 includ+--  7,a7 any

 comb9ation !re(2 &  7,b7 :5 reasonably 
necess>y to demon/rate sam5ess1         
biosimil>ity1 or int]*angeability =     
purposes ( ?is section1 section #eje1 or
 section #cea ( ! ,public ,heal? ,s]vice
 ,act 7z applicable71 any product1      
includ+ any device1 t is m>ket$ or      
int5d$ = use ) su* drug or biological   
product4  7#b7 ,eligible product        
develop] ,! t]m eligible product        
develop] means a p]son t seeks to       
develop an application = ! approval ( a 
drug "u section #eje7;b7 or #eje7;j7 or 
! lic5s+ ( a biological product "u      
section #cea ( ! ,public ,heal? ,s]vice 
,act4  7#c7 ,lic5se hold] ,! t]m lic5se 
hold] means ! hold] ( an application    
approv$ "u section #eje7;b7 or section  
#eje7;j7 or a lic5se "u section #cea ( !
 ,public ,heal? ,s]vice ,act = a cov]$  
product 7includ+ ! hold]'s ag5ts1       
:olesal]s1 di/ributors1 assigns1 &      
corporate affiliates74  7#d7 ,,rems     
product ,! t]m ,,rems product means a   
cov]$ product t--  7,a7 is subject to a 

risk evaluation & mitigation /rategy "u 
section #eje-a2 or  7,b7 is deem$ "u    
section #iji7;b7 ( ! ,food & ,drug      
,adm9i/ration ,am5dm5ts ,act ( #bjjg to 
h 9 effect an approv$ risk evaluation & 
mitigation /rategy "u section #eje-a4   
7b7 ,competitive access to cov]$        
products z a condition on approval or   
lic5s+ ,z a condition ( approval or     
lic5sure1 or cont9uation or r5ewal (    
approval or lic5sure1 ( a cov]$ product 
"u section #eje ( ?is ,act or section   
#cea ( ! ,public ,heal? ,s]vice ,act1   
respectively1 ! ,secret>y %all require t
 ! cov]$ product's lic5se hold] n adopt1
 impose1 or en=ce any condition relat+  
to ! sale1 resale1 or di/ribution ( !   
cov]$ product1 includ+ any condition    
adopt$1 impos$1 or en=c$ z an aspect ( a
 risk evaluation & mitigation /rategy   
approv$ by ! ,secret>y1 t re/ricts or   
has ! effect ( re/rict+ ! supply ( su*  
cov]$ product to an eligible product    
develop] = developm5t or te/+ purposes4 
7c7 ,competitive access to cov]$        

products o!r ?an ,,rems products =      
developm5t purposes ,no lic5se hold]    
%all adopt1 impose1 or en=ce any        
condition relat+ to ! sale1 resale1 or  
di/ribution ( a cov]$ product t int]f]es
 ) or re/ricts access to reasonable     
quantities ( a cov]$ product by an      
eligible product develop] = developm5t &
 te/+ purposes1 at comm]cially          
reasonable1 m>ket-bas$ prices1 f !      
lic5se hold] or f any :olesal] or       
specialty di/ributor au?oriz$ by !      
lic5se hold] to comm]cially di/ribute or
 sell ! cov]$ product unless ! lic5se   
hold] g5]ally adopts1 imposes1 or en=ces
 lawful conditions relat+ to ! sale1    
resale1 or di/ribution ( a cov]$        
product1 ) respect to o!r buy]s ( !     
cov]$ product4  7d7 ,competitive access 
to ,,rems products = developm5t purposes
  7#a7 ,prohibit$ use ( ,,rems to       
re/rict access ,) respect to a ,,rems   
product1 no aspect ( a risk evaluation &
 mitigation /rategy "u section #eje-a   
%all prohibit or re/rict1 or be con/ru$ 

or appli$ to prohibit or re/rict1 !     
supply ( su* ,,rems product to an       
eligible product develop] = developm5t &
 te/+ purposes1 at comm]cially          
reasonable1 m>ket-bas$ prices1 f !      
,,rems product's lic5se hold] or f any  
:olesal] or specialty di/ributor        
au?oriz$ by ! lic5se hold] to           
comm]cially di/ribute or sell ! ,,rems  
product4  7#b7 ,s+le1 %>$ sy/em (       
elem5ts to assure safe use ,) respect to
 a ,,rems product1 no lic5se hold] %all 
take any /ep t imp$es--  7,a7 ! prompt  
developm5t ( a s+le1 %>$ sy/em ( elem5ts
 to assure safe use "u section #eje-a2  
or  7,b7 ! entry on comm]cially         
reasonable t]ms ( an eligible product   
develop] into a previ\sly approv$ sy/em 
( elem5ts to assure safe use4  7e7      
,proc$ures = obta9+ access to cov]$     
products  7#a7 ,competitive access      
,not)/&+ any o!r provision ( law1 9 !   
case ( an eligible product develop] t   
has an au?orization to obta9 a cov]$    
product 9 effect "u p>agraph 7#b7 or    

7#c71 no lic5se hold] %all adopt1       
impose1 or en=ce any o!r condition      
relat+ to ! sale1 resale1 or di/ribution
 ( su* cov]$ product t int]f]es ) or    
re/ricts access to reasonable quantities
 ( ! cov]$ product by ! eligible product
 develop] = developm5t & te/+ purposes1 
at comm]cially reasonable1 m>ket-bas$   
prices1 f ! lic5se hold] or f any       
:olesal] or specialty di/ributor        
au?oriz$ by ! lic5se hold] to           
comm]cially di/ribute or sell ! cov]$   
product1 unless ! lic5se hold] g5]ally  
adopts1 imposes1 or en=ces lawful       
conditions relat+ to ! sale1 resale1 or 
di/ribution ( a cov]$ product1 ) respect
 to o!r buy]s ( ! cov]$ product4  7#b7  
,g5]al cov]$ products au?orization ,any 
eligible product develop] may seek a    
g5]al cov]$ products au?orization1      
au?oriz+ ! eligible product develop] to 
obta9 any cov]$ product = ! purposes (  
developm5t & te/+1 by mak+ a writt5     
reque/ to ! ,secret>y4 ,)9 #fj days aft]
 receiv+ su* a reque/1 ! ,secret>y %all1

 by writt5 notice1 issue su*            
au?orization if--  7,a7 ! eligible      
product develop] holds "o or m approv$  
applications or lic5ses = a cov]$       
product or1 9 ! abs5ce ( su* approvals  
or lic5sures1 o!rwise e/abli%es t !     
eligible product develop] c comply ) !  
requirem5ts ( ?is ,act & o!r applicable 
law = ! developm5t & te/+ ( cov]$       
products2 &  7,b7 ! ,secret>y does n f9d
 t ! eligible product develop] has      
mat]ially fail$ to comply ) !           
requirem5ts ( ?is ,act or o!r applicable
 law = ! developm5t & te/+ ( cov]$      
products4  7#c7 ,individual cov]$       
product au?orization ,any eligible      
product develop] may seek an            
au?orization to obta9 an individual     
cov]$ product = developm5t & te/+       
purposes by mak+ a writt5 reque/ to !   
,secret>y4 ,)9 #fj days ( receiv+ su* a 
reque/1 ! ,secret>y %all1 by writt5     
notice1 issue su* au?orization =        
purposes (--  7,a7 developm5t & te/+ t  
does n involve human cl9ical trials1 if 

! eligible product develop] has agre$ to
 comply ) any conditions ! ,secret>y    
det]m9es necess>y2 or  7,b7 te/+ t      
involves human cl9ical trials if !      
eligible product develop] has submitt$ a
 protocol = te/+ t includes protections 
t w provide an assurance ( safety       
comp>able to ! assurance ( safety       
provid$ by any di/ribution re/rictions  
gov]n+ ! approval or lic5sure ( ! cov]$ 
product or ! lic5se hold]'s di/ribution 
( ! cov]$ product4  7#d7 ,failure by    
,secret>y to take f9al action ,if !     
#fj-;day p]iod ref]r$ to 9 p>agraph 7#b7
 or 7#c7 expires )\t ! ,secret>y hav+   
tak5 f9al action on ! reque/ =          
au?orization1 ! ,secret>y %all be deem$ 
to h issu$1 by writt5 notice1 ! reque/$ 
au?orization4  7#e7  7,a7 ,process =    
obta9+ product pursuant to an           
au?orization ,if an eligible product    
develop] is unable1 = purposes (        
developm5t & te/+1 to obta9 reasonable  
quantities ( a cov]$ product            
comm]cially1 ei!r f ! lic5se hold] or f 

any :olesal] or specialty di/ributor    
au?oriz$ by ! lic5se hold] to           
comm]cially di/ribute or sell ! cov]$   
product1 any eligible product develop] t
 has obta9$ au?orization to d s1 9      
accordance ) p>agraph 7#b7 or 7#c71 %all
 be entitl$ to obta9 su* reasonable     
quantities ( su* cov]$ product at ! same
 comm]cially reasonable1 m>ket bas$     
price on :i* su* reasonable quantities (
 su* cov]$ product h be5 previ\sly sold 
by ! lic5se hold] to ?ird p>ties 9 ! op5
 m>ket4 ,su* eligible product develop]  
%all initiate its acquisition ( su*     
cov]$ product by provid+ a writt5 reque/
 = specific quantities ( su* cov]$      
product ei!r--  7i7 to any :olesal] or  
specialty di/ributor au?oriz$ by !      
lic5se hold] to comm]cially di/ribute or
 sell ! cov]$ product2 or  7ii7 9 ! ev5t
 no su* :olesal] or specialty di/ributor
 has be5 designat$ = su* purpose by !   
lic5se hold]1 to ! ,secret>y4  7,b7     
,reque/ cont5ts ,su* reque/ %all include
 a /atem5t reg>d+ ! quantity ( cov]$    

product s\ght = developm5t or te/+      
purposes1 & /ate t ei!r--  7i7 !        
eligible product develop] has1 or is    
deem$ to h1 a g5]al cov]$ products      
au?orization "u p>agraph 7#b72 or  7ii7 
! eligible product develop] has1 or is  
deem$ to h1 an au?orization "u p>agraph 
7#c7 to obta9 ! specific cov]$ product4 
7,c7 ,disclosure ( in=mation by         
:olesal]s & specialty di/ributors ,9 !  
ev5t t a reque/ is made to a :olesal] or
 specialty di/ributor "u ?is p>agraph1 !
 :olesal] or specialty di/ributor %all n
 disclose to ! lic5se hold] ( ! cov]$   
product involv$ ! id5tity ( ! eligible  
product develop]1 b may disclose to su* 
lic5se hold]1 only if requir$ to d s by 
! hold]--  7i7 ! fact t a reque/ has be5
 made2  7ii7 ! dates on :i* ! reque/ 0  
made & fulfill$2  7iii7 ! comm]cial t]ms
 on :i* ! reque/ 0 fulfill$2 &  7iv7 !  
quantity ( ! cov]$ product furni%$ by ! 
:olesal] or specialty di/ributor 9      
compliance ) ! reque/4  7,d7 ,disclosure
 pursuant to means specifi$ by ,secret>y

 ,9 ! ev5t t a reque/ is made to !      
,secret>y "u ?is subsection1 !n !       
,secret>y %all1 )9 #e bus9ess days (    
receipt ( ! reque/1 notify ! lic5se     
hold] t a reque/ = su* cov]$ product has
 be5 made1 & ! quantity ( ! cov]$       
product reque/$1 & su* lic5se hold]     
%all1 )9 #cj days aft] receiv+ notice f 
! ,secret>y1 provide ! quantity ( !     
reque/$ cov]$ product1 ?r\gh means      
specifi$ by ! ,secret>y1 at a           
non-discrim9atory1 comm]cially          
reasonable1 m>ket-bas$ price = :i* su*  
cov]$ product has be5 previ\sly sold by 
! lic5se hold] 7or any :olesal] or      
specialty di/ributor au?oriz$ by !      
lic5se hold] to comm]cially di/ribute or
 sell ! cov]$ product7 to ?ird p>ties 9 
! op5 m>ket4 ,! means e/abli%$ by !     
,secret>y "u ?is clause %all n disclose 
to ! lic5se hold] ! id5tity ( ! eligible
 product develop] t has reque/$         
quantities ( ! cov]$ product =          
developm5t & te/+ purposes4  7,e7       
,imm95t haz>d ,at any "t1 ! ,secret>y   

may prohibit1 limit1 or o!rwise susp5d a
 transf] ( a cov]$ product to an        
eligible product develop] if ! ,secret>y
 det]m9es t ! transf] ( su* product to !
 eligible product develop] w\ld pres5t  
an imm95t haz>d to ! public heal?4 ,9   
su* cases1 ! ,secret>y %all specify !   
basis = ! det]m9ation1 includ+ !        
specific in=mation available to !       
,secret>y :i* s]v$ z ! basis = su*      
det]m9ation1 & confirm su* det]m9ation 9
 writ+4  7f7 ,public & private en=cem5t 
7#a7 ,application ( c]ta9 provisions ,= 
purposes ( ?is ,act & ! ,public ,heal?  
,s]vice ,act1 a violation ( a requirem5t
 or prohibition 9 subsection 7b71 7c71  
7d77#a71 7d77#b71 or 7e77#a7 %all be    
treat$ 9 ! case ( a ,,rems product1 z a 
violation ( ! product's risk evaluation 
& mitigation /rategy4  7#b7 ,rem$ies ,an
 eligible product develop] t has        
au?orization = access to a cov]$ product
 f ! ,secret>y "u subsection 7e7 & t is 
aggriev$ by a violation ( subsection    
7b71 7c71 7d77#a71 7d77#b71 or 7e77#a7  

by a lic5se hold] or any :olesal] or    
specialty di/ributor au?oriz$ by !      
lic5se hold] to comm]cially di/ribute or
 sell ! cov]$ product may sue su* lic5se
 hold] = injunctive relief & treble     
damages 7includ+ co/s & int]e/ ( ! k9d  
describ$ 9 section #d7;a7 ( ! ,clayton  
,act 7#ae ,u4,s4,c4 #ae7;a7774  7g7     
,limitation ( liability ,! hold] ( an   
approv$ application or lic5se = a cov]$ 
product %all n be liable = any claim    
aris+ out ( an eligible product         
develop]'s developm5t or te/+ activities
 conduct$ "u ?is section1 includ+ a     
claim aris+ out ( a failure ( ! eligible
 drug develop] to foll[ adequate        
safegu>ds to assure safe use ( ! cov]$  
product4  7h7 ,reports  7#a7 ,report by 
,,fda ,n lat] ?an #ahj days aft] !      
enactm5t ( ! ,fair ,access = ,safe &    
,timely ,g5]ics ,act ( #bjad1 & annually
 !reaft]1 ! ,secret>y1 act+ ?r\gh !     
,commission] ( ,food & ,drugs1 %all     
submit to ,congress a report t--  7,a7  
id5tifies ea* in/ance ( noncompliance by

 any lic5se hold] ) a requirem5t or     
prohibition 9 subsection 7b71 7c71      
7d77#a71 7d77#b71 or 7e77#a72 &  7,b7   
describes ! actions tak5 by ! ,secret>y 
to rem$y su* noncompliance & to en=ce   
su* requirem5ts & prohibitions1 :e!r by 
assessm5t ( a p5alty or o!rwise4  7#b7  
,report by ,,ftc ,n lat] ?an #bgj days  
aft] ! enactm5t ( ! ,fair ,access =     
,safe & ,timely ,g5]ics ,act ( #bjad1 & 
annually !reaft]1 ! ,f$]al ,trade       
,commission %all submit to ,congress a  
report t--  7,a7 describes ! compla9ts  
receiv$ by ! ,commission p]ta9+ to !    
)hold+ ( competitive access to cov]$    
products1 ! actions tak5 by !           
,commission ) respect to ea* su*        
compla9t1 & ! result ( ea* su*          
,commission action2 &  7,b7 exam9es !   
impact on ! m>ket entry ( compet+ drug  
products1 & ! pric+ & availability ( su*
 products1 9 ! ,unit$ ,/ates result+ f  
noncompliance by lic5se hold]s ) a      
requirem5t or prohibition 9 subsection  
7b71 7c71 7d77#a71 7d77#b71 or 7e77#a74 

4  7b7 ,prohibit$ act ,section #cja ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cca7 is am5d$ by add+ at
 ! end ! foll[+3  7ddd7 ,any violation  
by ! lic5se hold] ( a cov]$ product 7z  
su* t]ms are def9$ 9 section #eje-b7;a7 
7includ+ its contractors1 assigns1 or   
corporate affiliates77 ( a requirem5t or
 prohibition 9 subsection 7b71 7c71     
7d77#a71 7d77#b71 or 7e77#a7 ( section  
#eje-b 7relative to competitive access  
to cov]$ products = developm5t          
purposes74  4  7c7 ,waiv] ( s+le1 %>$   
sy/em requirem5t ,section               
#eje-a7;i77#a77;,b7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee-a7;i77#a77;,b77 is am5d$--  7#a7 9 
clause 7i71 by /rik+ or at ! end2  7#b7 
9 clause 7ii71 by /rik+ ! p]iod at ! end
 & ins]t+ 2 or2 &  7#c7 by add+ at ! end
 ! foll[+3  7iii7 ! applicant = an      
abbreviat$ new drug application c]tifies
 t x attempt$ 9 good fai? to create or  
negotiate entry into a s+le1 %>$ sy/em1 
b 0 unable to f9alize comm]cially       

reasonable t]ms ) ! hold] ( ! li/$ drug 
)9 #abj days1 & su* c]tification        
includes a description ( ! ef=ts made by
 ! applicant = ! abbreviat$ new drug    
application to create or negotiate entry
 into a s+le1 %>$ sy/em4  4  7d7        
,effective date ,?is section & !        
am5dm5ts made by ?is section %all take  
effect ^u enactm5t1 & %all apply to all 
approv$ applications or lic5ses = a     
cov]$ product 7z def9$ 9 section        
#eje-b7;a7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act1 z add$ by ?is section7  
reg>dless ( :e!r ^? applications or     
lic5ses 7 approv$ be=e1 on1 or aft] !   
date ( enactm5t ( ?is ,act4