,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #ihe  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,febru>y #e1 #bjai    
,mr4 ,wel* 7= himself1 ,mr4 ,mc,kinley1 
& ,mr4 ,cicill9e7 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 ( #bjai or ! ,,fa/ 
,g5]ics ,act ( #bjai4  #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;b77#b7 or #eje7;j7 ( !    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;b77#b7 & #cee7;j77 & "u 

section #cea7k7 ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bfb7k774   
,^! re/rictions are det]r+ & delay+     
developm5t ( drugs1 g5]ic drugs1 &      
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$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee-a7;f77#h77 h n be5 suffici5t to    
prev5t anti-competitive practices t     
int]f]e ) access to ref]5ce products :i*
 is necess>y = ! timely developm5t (    
af=dable drugs1 g5]ic drugs1 &          
biosimil>s4  7#c7 ,!re is n a regulatory
 /ructure 9 place t is suffici5t to det]
 or rem$y ! anti-competitive h>m t      
results :5-- 7,a7 access to ref]5ce     
products is re/rict$ to sponsors        
develop+ drugs1 g5]ic drugs1 or         
biosimil>s 9 accordance ) section       
#eje7;b77#b7 or #eje7;j7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;b77#b7 or #cee7;j771 &  
section #cea7k7 ( ! ,public ,heal?      

,s]vice ,act 7#db ,u4,s4,c4 #bfb7k771   
respectively2 or  7,b7 lic5se hold]s    
imp$e ! prompt negotiation & developm5t 
( a s+le1 %>$ sy/em ( elem5ts to assure 
safe use & support+ agreem5ts "u section
 #eje-a7;i77#a77;,b7 ( su* ,act 7#ba    
,u4,s4,c4 #cee-a7;i77#a77;,b771 on      
comm]cially reasonable t]ms4  7#d7      
,requir+ lic5se hold]s to comply )      
requirem5ts = competitive access to _!  
products1 & = ! negotiation & developm5t
 ( s+le1 %>$ sy/ems ( elem5ts to assure 
safe use "u section #eje-a7;i77#a77;,b7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4                     
#cee-a7;i77#a77;,b771 & subject+ lic5se 
hold]s to liability = fail+ to d s1 w n 
impose obligations on ! c\rts t !y _c   
adequately & reasonably adjudicate4  #c4
 ,competitive access to cov]$ products =
 developm5t purposes  7a7 ,9 g5]al      
,*apt] ,v ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cea et   
seq47 is am5d$ 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-- 7,a7 means--  7i7 any  
drug approv$ "u section #eje or         
biological product lic5s$ "u section    
#cea ( ! ,public ,heal? ,s]vice ,act2   
7ii7 any comb9ation !re(2 or  7iii7 :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 product2 &  7,b7 
excludes any drug or biological product 
:i* ! ,secret>y has det]m9$ to be       
curr5tly 9 %ortage & t appe>s on ! drug 
%ortage li/ 9 effect "u section #ejf;,e1
 unless ! %ortage w n be promptly       
resolv$--  7i7 z demon/rat$ by ! fact t 
! drug or biological product has be5 9  
%ortage = m ?an #f mon?s2 or  7ii7 z    

o!rwise det]m9$ by ! ,secret>y4  7#b7   
,eligible product develop] ,! t]m       
eligible product develop] means a p]son 
t seeks to develop a product = approval 
pursuant to an application "u section   
#eje7;b77#b7 or #eje7;j7 or = lic5s+    
pursuant to an application "u section   
#cea7k7 ( ! ,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 
( ?is ,act or "u section #cea ( !       
,public ,heal? ,s]vice ,act = a cov]$   
product 7includ+ ! hold]'s ag5ts1       
:olesal]s1 di/ributors1 assigns1        
corporate affiliates1 & contractors74   
7#d7 ,,rems ,! t]m ,,rems means a risk  
evaluation & mitigation /rategy "u      
section #eje-a4  7#e7 ,,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   
7#f7 ,,rems impact+ product di/ribution 
,! t]m ,,rems impact+ product           
di/ribution means a ,,rems t conta9s    
elem5ts to assure safe use t impact !   
di/ribution ( ! product subject to !    
,,rems4  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       
con/rue or apply any condition or       
re/riction relat+ to ! sale1 resale1 or 
di/ribution ( ! cov]$ product1 includ+  
any condition or re/riction adopt$1     
impos$1 or en=c$ z an aspect ( a risk   
evaluation & mitigation /rategy1 9 a way
 t re/ricts or has ! effect ( re/rict+ !
 supply ( su* cov]$ product to an       
eligible product develop] = developm5t  

or te/+ purposes4  7c7 ,competitive     
access = developm5t purposes to products
 ) ,,rems impact+ product di/ribution ,)
 respect to a product subject to a      
,,rems impact+ product di/ribution1 no  
aspect ( su* a ,,rems %all be con/ru$ or
 appli$ by ! ,,rems product's lic5se    
hold] 9 a way t prohibits or re/ricts ! 
supply1 at comm]cially reasonable1      
m>ket-bas$ prices1 ( su* ,,rems product 
f ! ,,rems product's lic5se hold] to an 
eligible product develop] ) an          
applicable individual cov]$ product     
au?orization obta9$ pursuant to         
subsection 7e7 = developm5t & te/+      
purposes4  7d7 ,s+le1 %>$ sy/em (       
elem5ts ,to assure safe use ,:]e an     
eligible product develop] seeks approval
 ( an application "u #eje7;j7 ref]5c+ a 
,,rems product ^: ,,rems includes       
elem5ts to assure safe use--  7#a7 no   
lic5se hold] %all take any /ep t        
imp$es-- 7,a7 ! prompt developm5t on    
comm]cially reasonable t]ms ( a s+le1   
%>$ sy/em ( elem5ts to assure safe use  

"u section #eje-a2 or  7,b7 ! prompt    
entry on comm]cially reasonable t]ms (  
an eligible product develop] into a     
previ\sly approv$ sy/em ( elem5ts to    
assure safe use2 &  7#b7 lic5se hold]s  
%all negotiate 9 good fai? t[>ds !      
prompt developm5t ( 7or entry into7 a   
s+le1 %>$ sy/em ( elem5ts to assure safe
 use "u section #eje-a7;i7 on           
comm]cially reasonable t]ms4  7e7       
,proc$ures = obta9+ access to cov]$     
products  7#a7 ,competitive access to   
products n subject to ,,rems impact+    
product di/ribution ,not)/&+ any o!r    
provision ( law1 a lic5se hold] t       
receives a reque/ f an eligible product 
develop] or its ag5t = suffici5t        
supplies ( a cov]$ product 7t is n      
subject to a ,,rems impact+ product     
di/ribution7 to conduct te/+ necess>y to
 support an application "u section      
#eje7;b77#b7 or #eje7;j7 or "u section  
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7or o!rwise meet ! requirem5ts =        
approval ( su* an application7 %all     

provide to ! eligible product develop]  
or its ag5t ! quantity reque/$ )9 #cj   
days ( receipt ( ! reque/ at a          
nondiscrim9atory1 comm]cially           
reasonable1 m>ket-bas$ price = :i* su*  
cov]$ product has be5 previ\sly sold by 
! lic5se hold] to ?ird p>ties 9 ! op5   
m>ket4  7#b7 ,competitive access to     
products subject to ,,rems impact+      
product di/ribution3 individual cov]$   
product au?orization ,any eligible      
product develop] may seek an            
au?orization to obta9 an individual     
cov]$ product subject to a ,,rems       
impact+ product di/ribution = developm5t
 & te/+ purposes by mak+ a writt5 reque/
 to ! ,secret>y4 ,)9 #abj 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 developm5t &
 te/+ t involves human cl9ical trials if

 ! eligible product develop] has--  7i7 
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]$ 
product2 or  7ii7 o!rwise satisfi$ !    
,secret>y t su* protections w be        
provid$4  7#c7  7,a7 ,process = obta9+  
product pursuant to an au?orization  7i7
 ,an eligible product develop] %all be  
entitl$ to obta91 f ! lic5se hold] ( a  
cov]$ product subject to a ,,rems       
impact+ di/ribution1 suffici5t          
quantities ( ! cov]$ product = purposes 
( developm5t & te/+ necess>y to support 
an application "u section #eje7;b77#b7  
or #eje7;j7 or "u section #cea7k7 ( !   
,public ,heal? ,s]vice ,act1 or o!rwise 
meet ! requirem5ts = approval ( su*     
application1 if ! eligible product      
develop] has obta9$ an applicable       
au?orization "u p>agraph 7#b74  7ii7    
,ea* lic5se hold] %all publicly         
designate at lea/ "o :olesal] or        

specialty di/ributor to receive &       
fulfill reque/s = cov]$ products        
submitt$ pursuant to p>agraph 7#a7 or   
clause 7i7 ( ?is p>agraph4  7iii7 ,an   
eligible product develop] %all initiate 
its acquisition ( a cov]$ product "u    
clause 7i7 by provid+ or hav+ its ag5t  
provide a writt5 reque/ = specific      
quantities ( su* cov]$ product to !     
lic5se hold]4  7,b7 ,reque/ cont5ts &   
response ,a reque/ "u subp>agraph       
7,a77iii7 %all include a /atem5t reg>d+ 
! quantity ( cov]$ product s\ght =      
developm5t or te/+ purposes1 & /ate t ! 
eligible product develop] has an        
au?orization "u p>agraph 7#b7 to obta9 !
 specific cov]$ product4 ,)9 #cj days ( 
receiv+ su* a reque/1 ! :olesal] or     
specialty di/ributor %all provide !     
reque/$ quantity ( ! cov]$ product at a 
nondiscrim9atory1 comm]cially           
reasonable1 m>ket-bas$ price = :i* su*  
cov]$ product has be5 previ\sly sold by 
! lic5se hold] to ?ird p>ties 9 ! op5   
m>ket4  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]-- 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 ,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   
,en=cem5t  7#a7 ,rem$ies ,an eligible   
product develop] t is aggriev$ by a     
violation ( subsection 7b71 7c71 7d71   
7e77#a7 or 7e77#c7 by a lic5se hold] may
 sue su* lic5se hold] 9 a c\rt (        
compet5t jurisdiction = injunctive      
relief & treble damages 7includ+ co/s & 
int]e/ ( ! k9d describ$ 9 section #d7;a7
 ( ! ,clayton ,act 7#ae ,u4,s4,c4       
#ae7;a7774  7#b7 ,rule ( con/ruction    
7,a7 ,pres]vation ( antitru/ laws ,no?+ 
9 ?is ,act1 or ! am5dm5ts made by ?is   
,act1 %all be con/ru$ to modify1        
sup]s$e1 or impair ! op]ation ( !       
antitru/ laws4  7,b7 ,def9ition ,=      
purposes ( p>agraph 7#a71 ! t]m antitru/
 laws %all h ! mean+ giv5 su* t]m 9     
subsection 7a7 ( ! #a/ section ( !      
,clayton ,act 7#ae ,u4,s4,c4 #ab71      
except t su* t]m %all include section #e
 ( ! ,f$]al ,trade ,commission ,act 7#ae
 ,u4,s4,c4 #de7 to ! ext5t t su*        
subsection applies to unfair me?ods (   
competition4  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 failure 
to foll[ adequate safegu>ds to assure   
safe use ( ! cov]$ product dur+         
developm5t or te/+ activities conduct$  
"u ?is section4  4  7b7 ,waiv] ( s+le1  
%>$ sy/em requirem5t ,section           
#eje-a7;i77#a77;,c7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee-a7;i77#a77;,c77 is am5d$-- 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 ins]t+ aft]  
clause 7ii7 ! 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  7c7 ,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