,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #ejci  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,novemb] #ab1         
#bjai,mr4 ,lip9ski introduc$ ! foll[+   
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce1 & 9 addition to !    
,committee on ,ways & ,means1 = a p]iod 
to be subsequ5tly det]m9$ by ! ,speak]1 
9 ea* case = consid]ation ( su*         
provisions z fall )9 ! jurisdiction ( ! 
committee conc]n$  ,a ,,bill  ,to l[] ! 
prices ( excessively co/ly life-su/a9+  
prescription drugs "u "p ,d ( ! ,m$ic>e 
program by requir+ ! ,secret>y ( ,heal? 
& ,human ,s]vices to negotiate _!       
prices1 & = o!r purposes4  #a4 ,%ort    
title ,?is ,act may be cit$ z !         
,life-,su/a9+ ,prescription ,drug ,price
 ,relief ,act ( #bjai4  #b4             
,id5tification ( excessively pric$      
life-su/a9+ prescription drugs  7a7 ,9  
g5]al ,! ,secret>y1 n lat] ?an #a ye>   
aft] ! date ( enactm5t ( ?is ,act1 %all 
e/abli% a process to conduct a review ( 
all life-su/a9+ prescription drugs1 n   

less frequ5tly ?an once p] cal5d> ye>1  
"u :i* ! ,secret>y det]m9es "u          
subsection 7b7 :e!r ! price ( ea* su*   
drug is excessive4  7b7 ,excessive price
 det]m9ations  7#a7 ,int]national       
ref]5ce price  7,a7 ,9 g5]al ,!         
,secret>y %all det]m9e t any life-su/a9+
 prescription drug = :i* ! dome/ic      
av]age manufactur+ price exce$s #aaj    
p]c5t ( ! av]age price *>g$ = su* drug 9
 ! #e ref]5ce c\ntries to h an excessive
 price4 ,9 assess+ ! ext5t to :i* !     
price is excessive1 ! ,secret>y %all    
consid] ! factors describ$ 9 p>agraph   
7#b74  7,b7 ,ref]5ce ,c\ntries ,9 ?is   
,act1 ! t]m ref]5ce c\ntries means      
,canada1 ! ,unit$ ,k+dom1 ,g]many1      
,france1 & ,japan4  7,c7 ,requirem5t )  
respect to drugs = :i* c]ta9 ref]5ce    
c\ntry in=mation is n available ,!      
,secret>y %all make a det]m9ation "u    
p>agraph 7#a7 = e life-su/a9+           
prescription drug = :i* pric+ in=mation 
is available = at lea/ #c ( ! #e ref]5ce
 c\ntries4  7#b7 ,det]m9ations bas$ on  

o!r factors ,) respect to any           
life-su/a9+ prescription drug t is n    
det]m9$ to h an excessive price by      
op]ation ( p>agraph 7#a7 7includ+ any   
drug = :i* !re is insuffici5t data to   
make su* a det]m9ation "u su* p>agraph71
 ! ,secret>y %all det]m9e t su* drug has
 an excessive price if ! price ( ! drug 
is high] ?an reasonable tak+ into acc\nt
 ! foll[+ factors3  7,a7 ,! size ( !    
affect$ pati5t population4  7,b7 ,! risk
 adju/$ value ( ,f$]al ,gov]nm5t        
subsidies & inve/m5ts relat$ to ! drug4 
7,c7 ,! co/s associat$ ) developm5t ( ! 
drug4  7,d7 ,:e!r ! drug provid$ a      
significant improvem5t 9 heal? outcomes1
 comp>$ to o!r !rapies available at ! "t
 ( its approval4  7,e7 ,! cumulative    
global rev5ues g5]at$ by ! drug4  7,f7  
,:e!r ! dome/ic av]age manufactur] price
 ( ! drug increas$ dur+ any annual qu>t]
 by a p]c5tage t is m ?an ! p]c5tage    
increase 9 ! consum] price index = all  
urban consum]s = ! respective annual    
qu>t]4  7,g7 ,o!r factors ! ,secret>y   

det]m9es appropriate4  7c7 ,petition =  
det]m9ation  7#a7 ,9 g5]al ,any p]son   
may petition ! ,secret>y1 9 accordance )
 section #eec7;e7 ( title #e1 ,unit$    
,/ates ,code1 to make an excessive drug 
price det]m9ation = an applicable drug  
"u subsection 7b77#b74 ,n lat] ?an #ij  
days aft] ! date ( receipt ( su* a      
petition1 subject to p>agraph 7#b71 !   
,secret>y %all--  7,a7 make a           
det]m9ation "u subsection 7b77#b7 reg>d+
 su* drug2 or  7,b7 7i7 decl9e to make  
su* a det]m9ation2 &  7ii7 make public !
 reasons :y ! ,secret>y has decl9$ to   
make su* a det]m9ation4  7#b7 ,exception
 ,! ,secret>y %all n make a det]m9ation 
"u subsection 7b77#b7 = a drug 9        
response to a petition "u ?is section m 
frequ5tly ?an once p] cal5d> ye>4  7#c7 
,public availability ,! ,secret>y %all  
make any petitions submitt$ "u ?is      
subsection1 toge!r ) any docum5tation   
relat$ to ! petitions & ! ,secret>y's   
det]m9ations on su* petitions &         
rationale = su* det]m9ations1 publicly  

available1 includ+ by po/+ su* in=mation
 on ! database "u section #e4  #c4      
,aboli%+ ! prohibition on ,m$ic>e       
negotiation ( drug prices & requir+ !   
,secret>y ( ,heal? & ,human ,s]vices to 
negotiate prices ( life-su/a9+          
prescription drugs furni%$ "u ,"p ,d ( !
 ,m$ic>e program ,section #ahfj;,d-#aa (
 ! ,social ,security ,act 7#db ,u4,s4,c4
 #aciew-#aaa7 is am5d$ by /rik+         
subsection 7i7 & ins]t+ ! foll[+ new    
subsection3  7i7 ,requirem5t ,to        
negotiate prices ) respect to c]ta9     
life-,su/a9+ prescription drugs  7#a7 ,9
 g5]al ,) respect to any life-su/a9+    
prescription drug 7z def9$ 9 section    
#f7d7 ( ! ,life-,su/a9+ ,prescription   
,drug ,price ,relief ,act ( #bjai71 if !
 ,secret>y det]m9es "u section #b ( su* 
,act t ! price ( ! drug is excessive1 ! 
,secret>y %all1 not)/&+ any o!r         
provision ( law1 negotiate )            
manufactur]s1 prescription drug plan    
sponsors1 & ,,ma organizations ! total  
paym5t 7includ+ any disc\nts1 rebates1 &

 o!r price concessions7 t may be made by
 su* sponsors & organizations dur+ a    
negotiat$ price p]iod 7z specifi$ by !  
,secret>y7 = su* drugs ) respect to su* 
drugs furni%$ to individuals :o are     
enroll$ "u a prescription drug plan or  
"u an ,,ma-,,pd plan (f]$ by su* sponsor
 or organization1 respectively4  7#b7   
,price limitation ,9 ! case ( a         
life-su/a9+ prescription drug t is      
negotiat$ by ! ,secret>y pursuant to    
p>agraph 7#a71 ! total paym5t describ$ 9
 su* p>agraph may n exce$ #aaj p]c5t ( !
 av]age price *>g$ = su* drug 9 ! #e    
ref]5ce c\ntries describ$ 9 section     
#b7;b77#a77;,b7 ( su* ,act 79 ?is       
section ref]r$ to z ! int]national      
ref]5ce price74  7#c7 ,en=cem5t  7,a7 ,9
 g5]al ,9 ! case ( a manufactur] ( a    
life-su/a9+ prescription drug = :i* !   
,secret>y has made a det]m9ation        
describ$ 9 p>agraph 7#a7 t fails to ent]
 into a negotiation & agree on a total  
paym5t ) respect to su* drugs z describ$
 9 su* p>agraph )9 #i mon?s ( su*       

det]m9ation--  7i7 if su* drug has an   
int]national ref]5ce price1 ! ,secret>y 
%all assess a civil monet>y p5alty equal
 to #b times ! diff]5ce betwe5 ! total  
rev5ue = su* drug f all sales 9 ! ,unit$
 ,/ates made beg9n+ aft] ! date t is #i 
mon?s aft] su* det]m9ation & ! total    
rev5ue = su* drug f all su* sales made  
aft] su* date t w\ld h be5 receiv$ if ! 
manufactur] *>g$ ! int]national ref]5ce 
price = su* drug2 &  7ii7 if su* drug   
has an int]national ref]5ce price1 !    
,secret>y %all assess a civil monet>y   
p5alty equal to #ej p]c5t ( ! rev5ue f  
all ,unit$ ,/ates sales ( ! drug 9 !    
fir/ #ij days aft] ! date t is #i mon?s 
aft] su* det]m9ation1 #ge p]c5t ( !     
value ( all rev5ue f su* sales dur+ !   
foll[+ #ij days1 & #ie p]c5t ( all      
rev5ue f su* sales 9 subsequ5t days     
until su* "t z an agreem5t is rea*$ or  
an int]national ref]5ce price is        
available4  7,b7 ,deposit into tru/ fund
 ,civil monet>y p5alties collect$       
pursuant to subp>agraph 7,a7 %all be    

deposit$ into ! ,f$]al ,hospital        
,insurance ,tru/ ,fund4  4  #d4 ,public 
excessive drug price database  7a7      
,excessive drug price database  7#a7 ,9 
g5]al ,! ,secret>y %all e/abli% & ma9ta9
 a compreh5sive1 up-to-date database (  
life-su/a9+ prescription drugs & !      
excessive price det]m9ations = su* drugs
 "u section #b4  7#b7 ,cont5ts ,!       
database %all include1 at a m9imum1 =   
ea* life-su/a9+ prescription drug1 = !  
applicable cal5d> ye>--  7,a7 ! "n ( !  
drug2  7,b7 ! manufactur]2  7,c7 :e!r ! 
drug 0 det]m9$ "u section #b7;b7 to h an
 excessive price2 &  7,d7 ! numb] (     
petitions ! ,secret>y receiv$ "u section
 #b7;c7 to make an excessive price      
det]m9ation = ! drug1 toge!r ) !        
in=mation describ$ 9 section #b7;c77#c74
  7#c7 ,c]ta9 det]m9ations ,) respect to
 a det]m9ation made "u section          
#b7;b77#a71 ! ,secret>y %all publi% on !
 database su* det]m9ation 9 accordance )
 p>agraph 7#a7 )9 #cj days ( receiv+    
dome/ic & int]national pric+ in=mation f

 manufactur]s "u section #f4  7b7       
,annual reports to ,congress ,n lat] ?an
 #fj days aft] ! fir/ excessive price   
review "u section #b is complete1 &     
annually !reaft]1 ! ,secret>y %all      
submit to ,congress a report describ+ ! 
excessive drug price review = ! prec$+  
ye>4 ,! report %all conta9 summ>y data  
reg>d+--  7#a7 ! total numb] ( drugs t 7
 review$2  7#b7 ! total numb] ( drugs   
det]m9$ to be excessively pric$ "u ea* (
 p>agraphs 7#a7 & 7#b7 ( section #b7;b71
 & ! "n & manufactur] ( ea* su* drug2   
7#c7 ! total numb] ( drugs det]m9$ to be
 excessively pric$1 li/$ by manufactur]2
  7#d7 ! ext5t to :i* ! prices ( ! drugs
 id5tifi$ "u section #b 7 high] ?an     
reasonable1 on av]age2  7#e7 ! total    
numb] ( petitions ! ,secret>y receiv$ "u
 section #b7;c7 to make excessive price 
det]m9ations = drugs2  7#f7 a li/ ( any 
manufactur]s :o fail$ to report         
in=mation z requir$ "u section #f2 &    
7#g7 o!r appropriate in=mation1 z !     
,secret>y det]m9es or z ,congress       

reque/s4  7c7 ,public availability ,!   
,secret>y %all make ! in=mation 9 !     
database describ$ 9 subsection 7a7 & !  
report 9 subsection 7b7 publicly        
available1 includ+ on ! int]net website 
( ! ,food & ,drug ,adm9i/ration1 9 a    
mann] t is easy to f9d & und]/&4  #e4   
,drug manufactur] report+  7a7 ,9 g5]al 
,ea* manufactur] %all submit to !       
,secret>y1 9 su* =mat z ! ,secret>y may 
require1 an annual report t includes !  
foll[+ in=mation = ea* life-su/a9+      
prescription drug ( ! manufactur]1 )    
respect to ! previ\s cal5d> ye>3  7#a7  
,! av]age manufactur] price ( ! drug 9 !
 ,unit$ ,/ates & 9 ! ref]5ce c\ntries1 =
 ! entire ye>1 & brok5 d[n = ea* qu>t] (
 ! ye>4  7#b7 ,! :olesale acquisition   
co/ ( ! drug 9 ! ,unit$ ,/ates & 9 !    
ref]5ce c\ntries1 = ! entire ye>1 &     
brok5 d[n = ea* qu>t] ( ! ye>4  7#c7    
,cumulative global rev5ues g5]at$ by !  
drug4  7#d7 ,annual net sales rev5ue    
g5]at$ by ! drug 9 ! ,unit$ ,/ates & 9 !
 ref]5ce c\ntries1 = ! entire ye>1 &    

brok5 d[n = ea* qu>t] ( ! ye>4  7#e7    
,total exp5ditures on dome/ic & =eign   
drug rese>* & developm5t relat$ to !    
drug1 itemiz$ by--  7,a7 basic &        
precl9ical rese>*2  7,b7 cl9ical rese>*1
 report$ sep>ately = ea* cl9ical trial2 
7,c7 developm5t ( alt]native dosage =ms 
& /r5g?s = ! drug molecule or           
comb9ations1 includ+ ! molecule2  7,d7  
o!r drug developm5t activities1 su* z   
noncl9ical laboratory /udies & record & 
report ma9t5ance2  7,e7 pursu+ new or   
exp&$ indications = su* drug ?r\gh      
supplem5tal applications "u section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act2 &  7,f7 c>ry+ out po/m>ket        
requirem5ts relat$ to su* drug1 includ+ 
"u section #eje7o77#c7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act4  7#f7 ,total  
exp5ditures on dome/ic & =eign m>ket+ & 
adv]tis+ relat$ to ! drug4  7#g7        
,inve/m5ts 9 human cl9ical trials relat$
 to ! drug1 by ea* trial & ea* ye>1     
includ+ grants1 rese>* contracts1 tax   
cr$its or d$uctions1 & reimbursem5ts f  

public or private heal? plans or        
insurance1 & any o!r public sector      
subsidies or inc5tives1 su* z ! fair    
m>ket value or priority review v\*]s or 
o!r consid]ations4  7#h7 ,! e/imat$ size
 ( ! affect$ pati5t population4  7#i7   
,additional in=mation ! manufactur]     
*ooses to provide relat$ to drug pric+  
decisions1 su* z in=mation relat$ to !  
me?odology us$ to set ! price ( ! drug4 
7#aj7 ,additional in=mation z !         
,secret>y det]m9es necess>y to c>ry out 
?is ,act1 includ+ in=mation = previ\s   
ye>s4  7b7 ,report due date ,applicable 
manufactur]s %all submit ! reports      
describ$ 9 subsection 7a7 n lat] ?an    
,janu>y #ae ( ! ye> foll[+ ! date (     
enactm5t ( ?is ,act1 & ( ea* ye>        
!reaft]4  7c7 ,p5alty = noncompliance   
7#a7 ,9 g5]al ,any manufactur] t fails  
to submit in=mation = a drug z requir$  
by ?is section on a timely basis or t   
kn[+ly provides false in=mation %all be 
liable = a civil monet>y p5alty1 z      
det]m9$ by ! ,secret>y "u p>agraph 7#b71

 9 addition to any o!r p5alty "u o!r    
applicable provisions ( law4  7#b7      
,am\nt ( p5alty ,! am\nt ( a civil      
p5alty "u p>agraph 7#a7 %all be equal to
 ! product (-- 7,a7 an am\nt1 z det]m9$ 
appropriate by ! ,secret>y1 :i* is--    
7i7 n less ?an #j4e p]c5t ( ! gross     
rev5ues f sales = ! previ\s cal5d> ye> (
 ! drug = :i* ! in=mation 0 n submitt$2 
&  7ii7 n great] ?an #a p]c5t ( ! gross 
rev5ues f sales = ! previ\s cal5d> ye> (
 su* drug2 &  7,b7 ! numb] ( days 9 !   
p]iod betwe5-- 7i7 ! report due date "u 
subsection 7b72 &  7ii7 ! date on :i* ! 
,secret>y receives ! in=mation requir$  
to be report$ by ! manufactur] "u ?is   
section4  7#c7 ,use ( civil p5alty ,!   
,secret>y %all collect ! civil p5alties 
"u ?is subsection & %all use su* funds  
to support competitive rese>* grant     
programs ( ! ,national ,in/itutes (     
,heal?4  #f4 ,def9itions ,= ! purposes (
 ?is ,act3 7#a7 ,av]age manufactur]     
price  7,a7 ,9 g5]al ,! t]m av]age      
manufactur] price1 ) respect to a drug1 

subject to subp>agraph 7,b71 has ! mean+
 giv5 su* t]m 9 section #aibg7k77#a7 ( !
 ,social ,security ,act 7#db ,u4,s4,c4  
#acifr-#h7k77#a772 or ) respect to a    
drug = :i* !re is no av]age manufactur] 
price z s def9$1 su* t]m %all mean !    
:olesale acquisition co/ 7z def9$ 9     
section #ahdg;,a7c77#f77;,b7 ( ! ,social
 ,security ,act 7#db ,u4,s4,c4          
#aciew-#c;a7c77#f77;,b77 ( ! drug4  7,b7
 ,application to ref]5ce c\ntries ,)    
respect to ref]5ce c\ntries1 ! t]m      
av]age manufactur] price1 z def9$ 9     
subp>agraph 7,a71 %all be det]m9$ bas$  
on ! price ( ! drug 9 ! applicable      
ref]5ce c\ntry4  7#b7 ,biosimil>        
biological product ,! t]m biosimil>     
biological product means a biological   
product lic5s$ pursuant to an           
application "u section #cea7k7 ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k774  7#c7 ,g5]ic drug ,!
 t]m g5]ic drug means a drug approv$    
pursuant to an application "u section   
7b77#b7 or 7j7 ( ! ,f$]al ,food1 ,drug1 

& ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74  
7#d7 ,life-su/a9+ prescription drug ,!  
t]m life-su/a9+ prescription drug means 
a drug t is-- 7,a7 approv$ "u subsection
 7c7 or 7j7 ( section #eje ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 or a biological product 
lic5s$ "u subsection 7a7 or 7k7 (       
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb72  7,b7 subject
 to section #ejc7;b77#a7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cec7;b77#a772 &  7,c7        
life-su/a9+ 7z su* t]m is def9$ 9       
regulation pursuant to section #ejf;,c (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cef;c774  7#e7         
,manufactur] ,! t]m manufactur] means ! 
hold] ( an application approv$ "u       
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or (
 a lic5se issu$ "u section #cea ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb74  7#f7 ,secret>y ,! t]m 
,secret>y means ! ,secret>y ( ,heal? &  

,human ,s]vices4