,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #caff  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,janu>y #h1 #bjbj,mr4  
,book] 7= himself1 ,mr4 ,s&]s1 & ,ms4   
,h>ris7 introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to l[] ! co/ ( drugs = all  
,am]icans4  #a4 ,%ort title ,?is ,act   
may be cit$ z ! ,prescription ,drug     
,af=dability & ,access ,act4  #b4       
,e/abli%m5t ( ! ,bureau ( ,prescription 
,drug ,af=dability & ,access  7a7       
,e/abli%m5t  7#a7 ,9 g5]al ,!re is      
e/abli%$ )9 ! ,dep>tm5t ( ,heal? &      
,human ,s]vices an indep5d5t bureau1    
kn[n z ! ,bureau ( ,prescription ,drug  
,af=dability & ,access 79 ?is ,act      
ref]r$ to z ! ,bureau7 to c>ry out !    
duties describ$ 9 ?is section4 ,!       
purposes ( ! ,bureau are to--  7,a7     
atta9 l[] prescription drug co/s =      
pati5ts2  7,b7 decrease gov]nm5t        
exp5ditures on prescription drugs2 &    
7,c7 ensure access to prescription      

drugs4  7#b7 ,executive ag5cy ,! ,bureau
 %all be consid]$ an ,executive ag5cy1 z
 def9$ 9 section #aje ( title #e1 ,unit$
 ,/ates ,code4  7#c7 ,director  7,a7    
,appo9tm5t ,! ,bureau %all be head$ by a
 ,director 79 ?is ,act ref]r$ to z !    
,director7 :o %all be appo9t$ by !      
,presid5t1 by & ) ! advice & cons5t ( ! 
,s5ate4  7,b7 ,qualification ,!         
,presid5t %all nom9ate ! ,director f    
among individuals :o are citiz5s ( !    
,unit$ ,/ates4  7,c7 ,t]m ,! ,director  
%all s]ve = a t]m ( #e ye>s4 ,! t]m ( ! 
fir/ ,director to be appo9t$ %all beg9  
on ! date t is #ahj days aft] ! date (  
enactm5t ( ?is ,act4  7#d7 ,consultation
  7,a7 ,9 g5]al ,9 c>ry+ out ! duties "u
 ?is section1 ! ,bureau %all regul>ly   
consult ) relevant /akehold]s1 includ+  
pati5ts1 repres5tatives ( relevant      
,f$]al ag5cies1 & m$ical & heal? c>e    
f9ance exp]ts4 ,! ,bureau %all h regul> 
public meet+s to solicit input f        
relevant /akehold]s4  7,b7 ,pati5t      
engagem5t  7i7 ,9 g5]al ,! ,director    

%all ensure t pati5ts or organizations  
repres5t+ pati5ts h opportunities to    
mean+fully engage ) ! ,bureau z x       
conducts its "w1 includ+ :ile ! ,bureau 
makes appropriate price det]m9ations "u 
section #c7;d74 ,su* opportunities may  
include hold+ regul> panels1 =ums1 & o!r
 meet+s = pati5t engagem5t4  7ii7       
,petition ,! ,director %all e/abli% a   
process by :i* pati5ts c petition !     
entity & raise conc]ns ab\t ! price ( _!
 prescription drugs4  7,c7 ,consum]     
,advisory ,c\ncil  7i7 ,e/abli%m5t ,!   
,director %all e/abli% a ,consum]       
,advisory ,c\ncil to advise & consult ) 
! ,bureau z x conducts its "w4  7ii7    
,memb]%ip ,! ,c\ncil e/abli%$ "u ?is    
subp>agraph %all be compos$ ( n few] ?an
 #f memb]s appo9t$ by ! ,director4 ,9   
appo9t+ memb]s to ! ,c\ncil1 ! ,director
 %all ensure t at lea/ half ( ! memb]s (
 ! ,c\ncil are pati5ts or organizations 
repres5t+ pati5ts1 p>ticul>ly ^? :o h   
be5 significantly impact$ by high pric$ 
m$ications4 ,! ,director %all also seek 

to appo9t memb]s to ! ,c\ncil :o are    
exp]ts 9 relevant areas1 includ+ m$ic9e 
& heal? c>e f9ance4  7iii7 ,meet+s ,!   
,consum] ,advisory ,c\ncil %all meet f  
"t to "t at ! call ( ! ,director b %all 
meet at lea/ twice a ye>4  7#e7         
,employm5t condition  7,a7 ,9 g5]al ,an 
individual :o has a conflict ( int]e/   
%all n be appo9t$ to be a memb] (1 or   
employ$ by1 ! ,bureau1 includ+ !        
,consum] ,advisory ,c\ncil e/abli%$ "u  
p>agraph 7#d77;,c74  7,b7 ,disclosure   
,individuals "u consid]ation = employm5t
 by1 or appo9tm5t to1 ! ,bureau1 includ+
 ! ,consum] ,advisory ,c\ncil1 mu/      
disclose any pot5tial conflict ( int]e/1
 includ+ ! type1 nature1 & magnitude ( !
 int]e/s involv$4  7b7 ,duties ,!       
,bureau %all c>ry out ! foll[+ duties3  
7#a7 ,c>ry out ! provisions ( section   
#c4  7#b7 ,submit ! annual reports "u   
subsection 7c74  7#c7 ,any o!r duty t ! 
,director det]m9es appropriate4  7c7    
,annual report+  7#a7 ,9 g5]al ,n lat]  
?an ,janu>y #a1 #bjba1 & annually       

!reaft]1 ! ,director %all submit to     
,congress a report on ! activities ( !  
,bureau4  7#b7 ,cont5ts ,ea* report "u  
p>agraph 7#a7 %all conta9 ! foll[+3 7,a7
 ,a description ( ! activities ( !      
,bureau1 includ+--  7i7 ! total e/imat$ 
sav+s a*iev$ by ! ,bureau s9ce ! mo/    
rec5t report2  7ii7 ! disaggregat$ sav+s
 a*iev$ s9ce ! mo/ rec5t report1 includ+
 by ea* !rapeutic class ( prescription  
drugs2  7iii7 a summ>y ( ! in=mation    
submitt$ by prescription drug           
manufactur]s z requir$ "u section #c2 & 
7iv7 ! impact ( ! ,bureau's "w on pati5t
 af=dability & access to prescription   
drugs4  7,b7 ,recomm5dations = su*      
legislation & adm9i/rative action z !   
,bureau det]m9es appropriate4  7,c7 ,a  
copy ( ea* report submitt$ by drug      
manufactur]s z requir$ "u section #c4   
7,d7 ,o!r items t ! ,bureau det]m9es    
appropriate4  7d7 ,fund+ ,!re are       
appropriat$1 f am\nts 9 ! ,treasury n   
o!rwise appropriat$1 #ej1jjj1jjj =      
fiscal ye> #bjbj & ea* subsequ5t fiscal 

ye> to c>ry out ! activities ( !        
,bureau4 ,am\nts appropriat$ "u ! prec$+
 s5t5ce %all rema9 available until      
exp5d$4  #c4 ,prescription drug consum] 
price protections  7a7 ,review ( prices 
7#a7 ,9 g5]al ,! ,bureau %all conduct   
reviews ( ! prices ( prescription drugs 
to ensure t ! :olesale acquisition co/ (
 ea* su* drug is appropriate4  7#b7     
,in=mation on prescription drugs approv$
 z ( enactm5t  7,a7 ,manufactur]        
submission ,) respect to any            
prescription drug t1 z ( ! date (       
enactm5t ( ?is ,act1 has 9 effect an    
application approv$ "u section #eje ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 or section #cea ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb71 ea* manufactur]1 n lat]
 ?an #ahj days aft] su* date ( enactm5t1
 %all provide to ! ,bureau ! foll[+     
in=mation3  7i7 ,! "n ( ! prescription  
drug4  7ii7 ,a description ( !          
prescription drug & its approv$         
indications4  7iii7 ,! numb] (          

individuals 9 ! ,unit$ ,/ates & globally
 = :i* su* prescription drug is         
cl9ically indicat$4  7iv7 ,a li/ (      
pat5ts t claim ! prescription drug1 a   
use ( ! prescription drug1 a =m ( !     
prescription drug1 a me?od ( use ( !    
prescription drug1 or a me?od (         
manufacture ( ! prescription drug4  7v7 
,a li/ ( gov]nm5t-grant$ exclusivities t
 prohibit ! submission or approval ( a  
prescription drug & ! date t ea* su*    
gov]nm5t-grant$ exclusivity 0 grant$4   
7vi7 ,! date on :i* ! prescription drug 
0 approv$ "u su* section #eje or su*    
section #cea ( ! ,public ,heal? ,s]vice 
,act4  7vii7 ,! total exp5ditures ( !   
manufactur] on-- 7,i7 dome/ic & =eign   
rese>* & developm5t1 includ+ an itemiz$ 
description (--  7aa7 cl9ical rese>*1   
includ+ ! co/ ( ea* cl9ical trial       
associat$ ) ! prescription drug1 report$
 sep>ately = ea* cl9ical trial2  7bb7 ! 
developm5t ( alt]native dosage =ms &    
/r5g?s = ! prescription drug molecule or
 comb9ations1 includ+ ! molecule2  7cc7 

o!r prescription drug developm5t        
activities1 su* z noncl9ical laboratory 
/udies & record & report ma9t5ance2     
7dd7 pursu+ new or exp&$ indications =  
su* prescription drug ?r\gh supplem5tal 
applications "u su* section #eje or su* 
section #cea2  7ee7 c>ry+ out po/m>ket  
requirem5ts relat$ to su* prescription  
drug1 includ+ "u subsection 7o7 ( su*   
section #eje or su* section #cea2  7ff7 
c>ry+ out risk evaluation & mitigation  
/rategies 9 accordance ) section #eje-a 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee-a7 or su*      
section #cea2 &  7gg7 m>ket+ rese>*2    
7,,ii7 ! acquisition ( prescription drug
 compon5ts & packag+1 9 total & p] unit 
sold1 brok5 out by s\rce & co/ &        
id5tify+ specific co/s t reflect int]nal
 transf]s )9 ! manufactur]'s company2   
7,,iii7 o!r acquisitions relat+ to !    
prescription drug1 includ+ = ! pur*ase (
 pat5ts & lic5s+ or acquisition ( any   
corporate entity own+ any rights to !   
drug dur+ or aft] developm5t ( !        

prescription drug2  7,,iv7 ! co/ (      
manufactur+ ! prescription drug2  7,v7  
m>ket+1 adv]tis+1 & educat+ = !         
promotion ( a prescription drug1 includ+
 a breakd[n ( am\nts aim$ at consum]s1  
prescrib]s1 manag$ c>e organizations1 & 
o!rs1 irrespective ( :e!r a prescription
 drug is m5tion$ 9 m>ket+1 adv]tis+1 or 
educat+2 &  7,,vi7 pati5t assi/ance &   
co-pay programs t ! manufactur] sponsors
 or contributes to4  7viii7 ,! gross    
rev5ue1 net rev5ue1 gross pr(it1 & net  
pr(it ( ! manufactur] ) respect to su*  
prescription drug4  7ix7 ,! total numb] 
( units ( su* prescription drug t 7 sold
 9 int]/ate comm]ce4  7x7 ,pric+        
in=mation ) respect to ! sale ( su*     
prescription drug1 includ+--  7,i7 !    
curr5t :olesale acquisition co/2  7,,ii7
 ! introductory :olesale acquisition    
co/2  7,,iii7 ! net av]age price realiz$
 by ph>macy b5efit manag]s = su*        
prescription drug provid$ to individuals
 9 ! ,unit$ ,/ates1 aft] acc\nt+ = any  
rebates or o!r paym5ts f ! manufactur]  

to ! ph>macy b5efit manag] & f ! ph>macy
 b5efit manag] to ! manufactur]2  7,,iv7
 ! li/ price ( su* prescription drug    
*>g$ to pur*as]s 9 ea* applicable       
prescription drug ref]5ce c\ntry2  7,v7 
! net price ( su* prescription drug1    
aft] acc\nt+ = disc\nts1 rebates1 or o!r
 f9ancial consid]ations1 *>g$ to        
pur*as]s 9 ea* applicable prescription  
drug ref]5ce c\ntry2  7,,vi7 a          
description ( all price *anges ( !      
prescription drug s9ce ! introductory   
:olesale acquisition co/2 &  7,,vii7 !  
av]age net price ( su* prescription drug
 = ea* ye> s9ce fir/ be+ sold 9 ! ,unit$
 ,/ates4  7xi7 ,any ,f$]al b5efits &    
am\nts & p]iods ( impact = ea* su*      
b5efit receiv$ by ! manufactur] )       
respect to ! prescription drug1 includ+ 
tax cr$its1 ,f$]al grants1 pat5t        
applications t b5efitt$ f su* grants1   
pat5t ext5sions1 exclusivity p]iods1 &  
waiv]s ( fees4  7xii7 ,! p]c5tage (     
rese>* & developm5t exp5ditures describ$
 9 ?is section t 7 d]iv$ f ,f$]al funds4

  7xiii7 ,executive comp5sation = ! *ief
 executive (fic]1 *ief f9ancial (fic]1 &
 ! ?ree o!r mo/ highly comp5sat$        
executive (fic]s1 includ+ bonuses1 paid 
by su* manufactur]1 & /ock options      
affiliat$ ) ! manufactur] t 7 (f]$ to or
 accru$ by su* (fic]s4  7xiv7 ,o!r      
in=mation z ! ,director may require4    
7,b7 ,bureau review priorities ,9       
review+ submissions "u subp>agraph 7,a71
 ! ,bureau %all prioritize prescription 
drugs t meet any ( ! foll[+ crit]ia3    
7i7 ,9 ! top #ej? p]c5tile ( net sp5d+  
on prescription drugs "u any ,f$]al     
program1 includ+ ! ,m$ic>e program "u   
title ,,xviii ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #acie et seq47 or !     
,m$icaid program "u title ,,xix ( su*   
,act 7#db ,u4,s4,c4 #acif et seq474     
7ii7 ,9 ! top #ej? p]c5tile (           
utilization "u any ,f$]al program1      
includ+ su* ,m$ic>e program or su*      
,m$icaid program4  7iii7 ,exp]i5c$ an   
increase 9 ! :olesale acquisition co/ ( 
#be p]c5t or m ov] ! prec$+ #c ye>s4    

7iv7 ,o!r qualifications1 z det]m9$ by !
 ,director4  7#c7 ,in=mation on         
prescription drugs approv$ aft] enactm5t
 ,) respect to any prescription drug    
approv$ "u section #eje ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 or section #cea ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7 aft] ! date ( enactm5t (
 ?is ,act1 ea* manufactur]1 n lat] ?an  
#de days prior to introduc+ su*         
prescription drug into int]/ate comm]ce 
9 ! ,unit$ ,/ates1 %all provide to !    
,bureau ! foll[+ in=mation3  7,a7 ,!    
in=mation describ$ 9 ! foll[+ provisions
 ( p>agraph 7#b77;,a73 7i7 ,clauses 7i7 
?r\gh 7vi74  7ii7 ,subclauses 7,i7 ?r\gh
 7,,iv7 ( clause 7vii74  7iii7 ,clauses 
7xi7 ?r\gh 7xiv74  7,b7 ,pric+ in=mation
 ) respect to ! sale ( su* prescription 
drug1 includ+-- 7i7 ! plann$            
introductory :olesale acquisition co/2  
7ii7 ! li/ price ( su* prescription drug
 *>g$ or plann$ to be *>g$ to pur*as]s 9
 ea* applicable prescription drug       

ref]5ce c\ntry2 &  7iii7 ! net price (  
su* prescription drug1 aft] acc\nt+ =   
disc\nts1 rebates1 or o!r f9ancial      
consid]ations1 *>g$ or plann$ to be *>g$
 to pur*as]s 9 ea* applicable           
prescription drug ref]5ce c\ntry1 z     
def9$ 9 ?is ,act4  7,c7 ,! e/imat$      
annual pr(it & rev5ue t w be g5]at$ by !
 prescription drug1 bo? dome/ically &   
globally4  7,d7 ,o!r in=mation z !      
,director may require4  7b7 ,review (   
c]ta9 price increases  7#a7 ,9 g5]al ,! 
,bureau %all conduct a review ( ! price 
( a prescription drug = :i* a submission
 is requir$ "u p>agraph 7#b74  7#b7     
,notification ( int5tion to increase    
price ,if a manufactur] int5ds to       
increase ! :olesale acquisition co/ ( a 
prescription drug by m ?an ! p]c5tage by
 :i* ! ,consum] ,price ,index = ,all    
,urban ,consum]s = t ye> exce$s su*     
index = ! prec$+ cal5d> ye>1 su*        
manufactur]1 n lat] ?an #fj days be=e ! 
price increase takes effect1 %all submit
 to ! ,bureau ! foll[+ in=mation3  7,a7 

,! in=mation describ$ 9 subsection      
7a77#b77;,a74  7,b7 ,! plann$ increase 9
 ! :olesale acquisition co/ & ! plann$  
date ! increase w g into effect4  7,c7  
,a ju/ification ( ! plann$ increase 9   
:olesale acquisition co/4  7,d7 ,any o!r
 in=mation z ! ,secret>y may require4   
7c7 ,rev5ue b5*m>k review  7#a7 ,9 g5]al
 ,! ,bureau %all conduct a review ( a   
prescription drug :5 rev5ue = su*       
prescription drug surpasses ! rev5ue    
b5*m>k 9 ord] to ensure t ! :olesale    
acquisition co/ ( ! prescription drug   
rema9s appropriate4  7#b7 ,requir$      
submission ,n lat] ?an #fj days be=e !  
manufactur] ( a prescription drug       
anticipates ! global rev5ue = su* drug w
 surpass ! rev5ue b5*m>k1 ! manufactur] 
%all submit to ! ,bureau ! in=mation    
outl9$ 9 subsection 7a77#b77;,a74  7#c7 
,rev5ue b5*m>k  7,a7 ,9 g5]al ,subject  
to subp>agraph 7,b71 = purposes ( ?is   
subsection1 ! rev5ue b5*m>k is          
#e1jjj1jjj1jjj 9 global rev5ue4  7,b7   
,update ,! ,bureau may update ! am\nt ( 

! global b5*m>k ov] "t4  7d7 ,g5]al     
au?ority ,to review  7#a7 ,9 g5]al ,!   
,bureau may at any "t review ! :olesale 
acquisition co/ ( a prescription drug to
 det]m9e if su* price is appropriate1   
includ+ 9 response to a pati5t petition 
z describ$ 9 section                    
7#b77;a77#c77;,b77ii74  7#b7 ,proc$ure  
,! ,bureau %all notify ! manufactur] ( a
 prescription drug x wi%es to review    
pursuant to ! au?ority "u ?is           
subsection1 &1 )9 #de days ( receiv+ su*
 a notification1 ! manufactur] %all     
submit to ! ,bureau in=mation ! ,bureau 
det]m9es necess>y = its review4  7e7    
,appropriate price det]m9ations  7#a7   
,consid]ations ,9 det]m9+ :e!r !        
:olesale acquisition co/ or propos$     
:olesale acquisition co/ ( a            
prescription drug is appropriate1 !     
,bureau %all consid] ! foll[+3  7,a7 ,! 
size ( ! affect$ pati5t population4     
7,b7 ,! !rapeutic b5efits ( !           
prescription drug to pati5ts4  7,c7 ,!  
impact ( ! price on access to !         

prescription drug1 includ+ = pati5ts :o 
are un9sur$1 & ! associat$ f9ancial     
burd5 on pati5ts t utilize su*          
prescription drug4  7,d7 ,! total annual
 ,f$]al ,gov]nm5t exp5ditures on !      
prescription drug & ! budget>y impact ( 
,f$]al heal? programs provid+ cov]age ( 
! prescription drug4  7,e7 ,!           
risk-adju/$ value ( ,f$]al ,gov]nm5t    
subsidies & inve/m5ts relat$ to !       
prescription drug4  7,f7 ,! co/s        
associat$ ) ! developm5t ( !            
prescription drug4  7,g7 ,! numb] (     
simil>ly effective prescription drugs or
 alt]native treatm5t regim5s = ea*      
approv$ use ( su* prescription drug4    
7,h7 ,:e!r ! prescription drug provid$ a
 significant improvem5t 9 heal?         
outcomes1 comp>$ to o!r !rapies         
available at ! "t ( its approval1 z     
det]m9$ ?r\gh cl9ical effectiv5ess4     
7,i7 ,! curr5t :olesale acquisition co/ 
( comp>able prescription drugs 9 !      
,unit$ ,/ates1 to ! ext5t t ^? prices h 
be5 deem$ appropriate4  7,j7 ,!         

cumulative & expect$ global rev5ue      
g5]at$ by ! prescription drug4  7,k7 ,! 
price ( ! drug 9 o!r c\ntries1 includ+ 9
 ! prescription drug ref]5ce c\ntries4  
7,l7 ,! public heal? b5efit ( ! drug4   
7,m7 ,! in=mation t ! manufactur]       
submits to ! ,bureau z requir$ "u ?is   
section4  7,n7 ,any o!r in=mation1 z !  
,bureau requires4  7#b7 ,special rules  
7,a7 ,int]im appropriate price (        
prescription drugs  7i7 ,9 g5]al ,= ea* 
prescription drug describ$ 9 clause     
7ii71 ! ,bureau %all--  7,i7 e/abli% an 
int]im appropriate price1 :i* %all be ! 
less] (-- 7aa7 ! m$ian li/ price ( !    
prescription drug 9 ! prescription drug 
ref]5ce c\ntries2 or  7bb7 if           
applicable1 ! appropriate price         
det]m9ation made by ! ,bureau2 &  7,,ii7
 direct ! manufactur] to set ! :olesale 
acquisition co/ at a level t does n     
exce$ ! int]im appropriate price4  7ii7 
,applicable drugs ,a prescription drug  
describ$ 9 ?is clause is a prescription 
drug-- 7,i7 t--  7aa7 z ( ! date ( !    

enactm5t ( ?is ,act1 has 9 effect an    
application approv$ "u section #eje7;c7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;c77 or section
 #cea7;a7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bfb7;a772 &  7bb7  
is n a li/$ drug or a ref]5ce product = 
m ?an #b prescription drugs or          
biological products approv$ & curr5tly  
m>ket$ "u section #eje7;j7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77 or "u section       
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k772 or  7,,ii7 )   
respect to :i* ! ,secret>y has au?oriz$ 
"u subsection 7g7 ! use ( any pat5t1    
cl9ical trial data1 or o!r              
gov]nm5t-grant$ exclusivity relat$ to   
su* drug by ano!r sponsor1 until ! date 
t is #a ye> aft] ! date on :i* ano!r    
application = su* drug1 = :i* ! sponsor 
relies ^u a su* au?orization "u         
subsection 7g71 is approv$ "u su*       
section #eje or su* section #cea4  7,b7 
,spike 9 price ,if a manufactur]        

increases ! :olesale acquisition co/ ( a
 prescription drug by m ?an ! p]c5tage  
by :i* ! ,consum] ,price ,index = ,all  
,urban ,consum]s = t ye> exce$s su*     
index = ! prec$+ cal5d> ye>1 su*        
prescription drug %all be deem$ to h a  
:olesale acquisition co/ t is n         
appropriate unless ! ,bureau det]m9es1  
bas$ on ! in=mation submitt$ "u         
p>agraphs 7#b7 & 7#c7 ( subsection 7a7 &
 "u subsection 7b77#b7 & ! consid]ations
 describ$ 9 p>agraph 7#a71 t ! :olesale 
acquisition co/ is appropriate4  7#c7   
,opportunity to comm5t ,prior to mak+ a 
det]m9ation on :e!r ! :olesale          
acquisition co/ ( a prescription drug is
 appropriate1 ! ,bureau %all ensure     
relevant /akehold]s1 includ+ pati5ts1 h 
an opportunity to comm5t4  7f7 ,requir$ 
actions if price is n appropriate  7#a7 
,notice & requirem5t to remit excess ,if
 ! ,bureau det]m9es t ! :olesale        
acquisition co/ ( a prescription drug is
 n appropriate1 ! ,bureau %all notify & 
direct ! manufactur] to l[] ! :olesale  

acquisition co/ to a level t w\ld be    
deem$ appropriate4 ,! ,bureau %all also 
require ! manufactur] to remit ! excess 
rev5ue e>n$ z a result ( ! prescription 
drug hav+ a price t is n appropriate4   
7#b7 ,pati5t rebate ,! ,director ( !    
,bureau %all e/abli% a process to       
di/ribute funds remitt$ "u p>agraph 7#a7
 to pati5ts :o 7 impact$ by !           
prescription drug hav+ a price t is n   
appropriate4  7g7 ,en=cem5t  7#a7 ,9    
g5]al ,if1 )9 #cj days ( receiv+ a      
notice t ! :olesale acquisition co/ ( a 
prescription drug is n appropriate1 !   
manufactur] ( su* prescription drug     
fails to l[] ! :olesale acquisition co/ 
( a prescription drug or fails to remit 
excessive rev5ue e>n$ 9 accordance )    
subsection 7f71 ! ,director %all notify 
! ,secret>y & ! ,secret>y %all au?orize 
! use ( any pat5t1 cl9ical trial data1  
or o!r gov]nm5t-grant$ exclusivity by an
 entity = purposes ( manufactur+ su*    
prescription drug = sale4 ,an entity t  
wi%es to manufacture su* prescription   

drug = sale mu/ agree to--  7,a7 set !  
:olesale acquisition co/ ( su*          
prescription drug at or bel[ ! level t !
 ,bureau det]m9es is appropriate2 &     
7,b7 provide ! prescription drug        
manufactur] ) reasonable comp5sation1   
:i* %all be det]m9$ by ! ,bureau1 bas$  
on ! in=mation submitt$ by ! manufactur]
 "u ?is section includ+--  7i7 !        
risk-adju/$ value ( any ,f$]al ,gov]nm5t
 subsidies & inve/m5ts 9 rese>* &       
developm5t us$ to support ! developm5t (
 su* drug2  7ii7 ! risk-adju/$ value (  
any inve/m5t made by su* manufactur] 9 !
 rese>* & developm5t ( su* drug2  7iii7 
! impact ( ! price1 includ+ lic5se      
comp5sation paym5ts1 on meet+ ! m$ical  
ne$ ( all pati5ts2  7iv7 ! relation%ip  
betwe5 ! price ( su* drug1 includ+      
comp5sation paym5ts & ! heal? b5efits ( 
su* drug2 &  7v7 o!r relevant in=mation 
det]m9$ appropriate by ! ,secret>y1 9   
coord9ation ) ! ,director4  7#b7 ,po/   
lic5s+  7,a7 ,9 g5]al ,any manufactur] (
 a prescription drug t fails to comply )

 ! int]im appropriate price "u          
subsection 7e77#b77;,a77i77,i7 %all be  
subject to a civil monet>y p5alty ( n   
less ?an an am\nt equal to #aej p]c5t ( 
all rev5ues obta9$ by ! manufactur] t   
are 9 excess ( ! expect$ rev5ues at !   
int]im appropriate price4  7,b7         
,proc$ure ,! provisions ( section       
#aabh;,a1 o!r ?an subsections 7a7 & 7b7 
& ! fir/ s5t5ce ( subsection 7c77#a7 (  
su* section1 %all apply to civil monet>y
 p5alties "u ?is p>agraph 9 ! same mann]
 z su* provisions apply to a p5alty or  
proce$+ "u section #aabh;,a4  7,c7      
,transf] to ,national ,in/itutes (      
,heal? ,! civil monet>y p5alties        
collect$ "u ?is p>agraph %all be        
transf]r$ to ! ,national ,in/itutes (   
,heal? to supplem5t activities relat$ to
 ph>maceutical rese>* & developm5t4  7h7
 ,def9itions ,9 ?is ,act3 7#a7 ,conflict
 ( int]e/ ,! t]m conflict ( int]e/ means
 an association1 includ+ a f9ancial or  
p]sonal association1 or pa/ employm5t1 t
 has ! pot5tial to bias or h ! appe>ance

 ( bias+ an individual's decisions4     
7#b7 ,excess rev5ue ,! t]m excess rev5ue
 means ! diff]5ce betwe5 a prescription 
drug's :olesale acquisition co/ at ! "t 
( ! ,bureau review "u ?is section & !   
maximum :olesale acquisition price = !  
prescription drugs t ! ,bureau det]m9es 
to be appropriate4  7#c7                
,gov]nm5t-grant$ exclusivity ,! t]m     
gov]nm5t-grant$ exclusivity means       
prohibitions on ! submission or         
effective approval ( prescription drug  
applications grant$ "u any ( ! foll[+3  
7,a7 ,clauses 7ii7 ?r\gh 7v7 ( section  
#eje7;c77#c77;,e7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;c77#c77;,e774  7,b7 ,section      
#eje7;j77#e77;,b77iv7 ( su* ,act 7#ba   
,u4,s4,c4 #cee7;j77#e77;,b77iv77 or     
clause 7ii71 7iii71 or 7iv7 ( section   
#eje7;j77#e77;,f7 ( su* ,act4  7,c7     
,section #eje;,a ( su* ,act 7#ba        
,u4,s4,c4 #cee;a74  7,d7 ,section       
#eje;,e ( su* ,act 7#ba ,u4,s4,c4       
#cee;f74  7,e7 ,section #ebg ( su* ,act 

7#ba ,u4,s4,c4 #cfj;cc74  7,f7 ,section 
#cea7k77#g7 ( su* ,act 7#db ,u4,s4,c4   
#bfb7k77#g774  7,g7 ,any o!r provision (
 law t provides = exclusivity 7or       
ext5sion ( exclusivity7 ) respect to a  
drug4  7#d7 ,li/$ drug ,! t]m li/$ drug 
means a drug li/$ "u section            
#eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;j77#g774  7#e7 ,manufactur] ,! t]m
 manufactur]1 ) respect to a            
prescription drug1 means an entity t--  
7,a7 is ! hold] ( ! approv$ application 
"u section #eje ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7  
or "u section #cea ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bfb72 &    
7,b7 is responsible = sett+ ! price ( ! 
prescription drug4  7#f7 ,prescription  
drug ,! t]m prescription drug means any 
drug subject to section #eje ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act or       
section #cea ( ! ,public ,heal? ,s]vice 
,act & to section #ejc7;b77#b7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   

7#ba ,u4,s4,c4 #cec7;b77#b774  7#g7     
,prescription drug ref]5ce c\ntry ,! t]m
 prescription drug ref]5ce c\ntry means 
,japan1 ,g]many1 ! ,unit$ ,k+dom1       
,france1 ,italy1 ,canada1 ,au/ralia1    
,spa91 ! ,ne!rl&s1 ,switz]l&1 & ,sw$54  
7#h7 ,ref]5ce product ,! t]m ref]5ce    
product has ! mean+ giv5 ! t]m 9 section
 #cea7;i7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bfb7;i774  7#i7    
,secret>y ,! t]m ,secret>y means !      
,secret>y ( ,heal? & ,human ,s]vices4   
7#aj7 ,:olesale acquisition co/ ,! t]m  
:olesale acquisition co/ has ! mean+    
giv5 t t]m 9 section                    
#ahdg;,a7c77#f77;,b7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7c77#f77;,b774  #d4 ,repeal (
 ,m$ic>e's non9t]f]5ce clause ,section  
#ahfj;,d-#aa ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$ by 
/rik+ subsection 7i74