,i  #aae? ,,congress  #b;d ,session  ,h4
 ,r4 #egci  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #i1 #bjah,ms4    
,de,lauro 7= h]self1 ,mr4 ,doggett1 &   
,ms4 ,moore7 introduc$ ! foll[+ bill2   
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce1 & 9 addition to ! ,committees
 on ,ways & ,means1 & ! ,judici>y1 = 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      
e/abli% )9 ! ,dep>tm5t ( ,heal? & ,human
 ,s]vices ! ,prescription ,drug &       
,m$ical ,device ,price ,review ,bo>d to 
regulate ! prices ( c]ta9 prescription  
drugs & m$ical devices1 & = o!r         
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,prescription ,drug &      
,m$ical ,device ,price ,review ,bo>d    
,act ( #bjah4  #b4 ,e/abli%m5t ,!re is  
e/abli%$ 9 ! ,dep>tm5t ( ,heal? & ,human
 ,s]vices a bo>d to be kn[n z !         
,prescription ,drug & ,m$ical ,device   
,price ,review ,bo>d 79 ?is ,act ref]r$ 

to z ! ,bo>d74  #c4 ,memb]%ip2 /aff  7a7
 ,memb]s ,! ,bo>d %all be compos$ ( #e  
memb]s z foll[s3 7#a7 ,! ,assi/ant      
,secret>y = ,plann+ & ,evaluation ( !   
,dep>tm5t ( ,heal? & ,human ,s]vices 7or
 ! ,assi/ant ,secret>y's designee74     
7#b7 ,! ,adm9i/rator ( ! ,c5t]s =       
,m$ic>e  ,m$icaid ,s]vices 7or !        
,adm9i/rator's designee74  7#c7 ,!      
,assi/ant ,director = ! ,heal? ,s]vices 
,division ( ! ,f$]al ,bureau ( ,prisons 
7or ! ,assi/ant ,director's designee74  
7#d7 ,! ,secret>y ( ,def5se 7or !       
,secret>y's designee74  7#e7 ,!         
,secret>y ( ,vet]ans ,affairs 7or !     
,secret>y's designee74  7#f7 ,!         
,commission] ( ,food & ,drugs 7or !     
,commission]'s designee74  7b7          
,*airp]son ,! ,bo>d %all designate #a   
memb] ( ! ,bo>d to s]ve z ! *airp]son4  
7c7 ,director & /aff  7#a7 ,director ,! 
,bo>d %all h a director :o %all be      
appo9t$ by ! *airp]son ( ! ,bo>d1       
subject to rules prescrib$ by ! ,bo>d4  
7#b7 ,/aff ,! director may appo9t & fix 

! pay ( su* additional p]sonnel z !     
*airp]son consid]s appropriate1 subject 
to rules prescrib$ by ! ,bo>d4  7#c7    
,applicability ( c]ta9 civil s]vice laws
 ,! director & /aff ( ! ,bo>d %all be   
appo9t$ subject to ! provisions ( title 
#e1 ,unit$ ,/ates ,code1 gov]n+         
appo9tm5ts 9 ! competitive s]vice1 &    
%all be paid 9 accordance ) !           
requirem5ts ( *apt] #ea & sub*apt] ,,iii
 ( *apt] #ec ( su* title relat+ to      
classification & ,g5]al ,s*$ule pay     
rates2 except t an individual s appo9t$ 
may n receive pay 9 excess ( ! maximum  
annual rate ( basic pay payable = grade 
,,gs-#ae ( ! ,g5]al ,s*$ule4  7d7       
,assi/ance = ! bo>d ,subject to section 
#g7;g71 9 c>ry+ out ?is ,act1 ! ,bo>d-- 
7#a7 may seek assi/ance f outside exp]ts
 9 ! fields ( consum] advocacy1 m$ic9e1 
ph>macology1 ph>macy1 & prescription    
drug reimbursem5t2 &  7#b7 %all e/abli% 
& ma9ta9 an advisory gr\p & a /akehold] 
gr\p = purposes ( seek+ su* assi/ance4  
7e7 ,initial meet+ ,! ,bo>d %all hold   

its initial meet+ n lat] ?an #ij days   
aft] ! date ( ! enactm5t ( ?is ,act4    
#d4 ,report+ requirem5ts  7a7 ,report+  
by manufactur]s ,! ,bo>d %all require   
ea* manufactur] ( a prescription drug or
 m$ical device t is sold 9 ! ,unit$     
,/ates to submit to ! ,bo>d on a p]iodic
 basis1 at a level ( specificity det]m9$
 by ! ,bo>d to be necess>y to make a    
det]m9ation "u section #e1 ! foll[+     
in=mation ) respect to ! report+ p]iod3 
7#a7 ,ea* type ( prescription drug &    
m$ical device t is sold by ! manufactur]
 or an affiliate ( ! manufactur]--  7,a7
 9 ! ,unit$ ,/ates2 or  7,b7 9 a c\ntry 
t is a memb] ( ! ,organization =        
,economic ,co-op]ation & ,developm5t4   
7#b7 ,! price *>g$ by ! manufactur] & ! 
affiliate = ! prescription drug or      
m$ical device 9 ! ,unit$ ,/ates & 9 any 
su* c\ntry1 z applicable4  7#c7 ,! co/s 
( ! manufactur] & ! affiliate to produce
 & m>ket ! prescription drug or m$ical  
device = sale 9 ! ,unit$ ,/ates & 9 any 
su* c\ntry1 z applicable4  7b7 ,report+ 

by ,,cbo ,! ,director ( ! ,congressional
 ,budget ,(fice %all submit an annual   
report to ! ,bo>d on tr5ds 9 ! prices   
*>g$ = prescription drugs & m$ical      
devices4  #e4 ,prohibition aga9/        
excessive price  7a7 ,prohibition       
,beg9n+ on ! effective date ( !         
regulation requir$ by subsection 7b71 ! 
manufactur] ( a prescription drug or    
m$ical device %all n *>ge an excessive  
price1 z det]m9$ pursuant to su*        
regulation1 = su* drug or device4  7b7  
,=mula ,! ,bo>d %all by regulation      
prescribe a =mula = det]m9+ :e!r !      
av]age manufactur] price ( su* drug or  
device ov] an annual qu>t] is an        
excessive price4  7c7 ,det]m9ation (    
excessive price ,if ! ,bo>d det]m9es1 on
 its own initiative or 9 response to a  
petition submitt$ "u subsection 7d71 t !
 manufactur] ( a prescription drug or   
m$ical device *>ges an excessive price =
 su* drug or device 9 violation (       
subsection 7a7--  7#a7 ! ,bo>d %all give
 ! manufactur]-- 7,a7 notice ( su*      

violation2 &  7,b7 subject to subsection
 7d71 a p]iod to correct su* violation2 
&  7#b7 if ! manufactur] fails to       
correct ! violation by ! end ( su*      
p]iod1 ! manufactur] %all be subject to 
section #f ( ?is ,act1 section          
#aibg7;c77#b77;,e7 ( ! ,social ,security
 ,act1 z add$ by subsection 7c7 ( su*   
section #f1 & section #daib ( ! ,int]nal
 ,rev5ue ,code ( #aihf1 z add$ by       
subsection 7d7 ( su* section #f4  7d7   
,petitions ,any p]son may petition !    
,bo>d to make a det]m9ation "u          
subsection 7c7 reg>d+ ! pric+ ( a       
prescription drug or m$ical device4 ,n  
lat] ?an #ij days aft] ! date ( receipt 
( su* a petition1 ! ,bo>d %all--  7#a7  
make a det]m9ation "u subsection 7c7    
reg>d+ su* pric+2 or  7#b7 decl9e to    
make su* a det]m9ation4  7e7 ,cont9u+   
violation ,! ,bo>d %all n be requir$ to 
give a manufactur] an opportunity to    
correct a violation1 z describ$ 9       
subsection 7c77#a77;,b71 be=e !         
manufactur] becomes subject to !        

provisions describ$ 9 subsection 7c77#b7
 = su* violation1 if--  7#a7 ! ,bo>d has
 already provid$ su* an opportunity to  
correct to ! manufactur]2 &  7#b7 !     
,bo>d f9ds t ! violation ( subsection   
7a7 is a cont9uation ( an e>li]         
violation ) respect to :i* su* an       
opportunity 0 provid$4  7f7             
,consid]ations ,! =mula requir$ by      
subsection 7a7 %all at a m9imum take    
into consid]ation-- 7#a7 ! av]age       
manufactur] price ( ! prescription drug 
or m$ical device ov] ! respective annual
 qu>t] or qu>t]s2  7#b7 ! av]age        
manufactur] price ( o!r prescription    
drugs or m$ical devices 9 ! same        
!rapeutic class ov] ! same qu>t] or     
qu>t]s2  7#c7 ! av]age price at :i* !   
prescription drug or m$ical device & o!r
 prescription drugs & m$ical devices 9 !
 same !rapeutic class h be5 sold by     
manufactur]s 9 c\ntries o!r ?an ! ,unit$
 ,/ates2  7#d7 ! co/s associat$ )       
produc+ & m>ket+ ! prescription drug or 
m$ical device1 ! value ( ! drug or      

device to pati5ts :]e suffici5t data is 
available to det]m9e su* value1 ! total 
,f$]al inve/m5t 9 ! developm5t ( ! drug 
or device1 ! size ( ! pati5t population 
receiv+ ! drug or device1 & o!r factors 
det]m9ative z to ! true co/ (           
production2 &  7#e7 :e!r ! price ( !    
prescription drug or m$ical device      
increas$ dur+ any annual qu>t] by a     
p]c5tage t is m ?an #b p]c5t great] ?an 
! ,,cpi increase p]c5tage 7z def9$ 9    
section #bae7;i7 ( ! ,social ,security  
,act 7#db ,u4,s4,c4 #dae77 = !          
respective annual qu>t]4  #f4 ,en=cem5t 
provisions  7a7 ,r$uc$ pat5t t]m ,if !  
,bo>d f9ds t ! manufactur] ( a          
prescription drug or m$ical device1 :o  
is also an own] ( a pat5t = su* drug or 
device1 *>g$ an excessive price = su*   
drug or device 9 violation ( section    
#e7;a71 ! ,bo>d may--  7#a7 r$uce ! t]m1
 by n m ?an #e ye>s1 ( any pat5t issu$  
"u title #ce1 ,unit$ ,/ates ,code1      
relat+ to su* drug or device2 or  7#b7  
if ! t]m ( ea* pat5t = su* drug or      

device has expir$1 r$uce ! t]m1 by n m  
?an #e ye>s1 ( ano!r pat5t own$ by !    
pat5t own] relat+ to a prescription drug
 or m$ical device4  7b7 ,civil p5alties 
,if ! ,bo>d det]m9es "u section #e7;c7 t
 a manufactur] ( a prescription drug or 
m$ical device *>g$ an excessive price = 
a prescription drug or m$ical device 9  
violation ( section #e7;a71 ! ,bo>d may 
impose a civil p5alty on ! manufactur] (
 n m ?an #aj p]c5t ( ! manufactur]'s    
gross sales ( ! drug or device dur+ !   
p]iod beg9n+ on ! date on :i* an        
excessive price is fir/ *>g$ & end+ on !
 date on :i* ! manufactur] ceases to    
*>ge an excessive price4  7c7 ,en=cem5t 
?r\gh increas$ ,m$icaid rebates  7#a7 ,9
 g5]al ,section #aibg7;c77#b7 ( !       
,social ,security ,act 7#db ,u4,s4,c4   
#acifr-#h7;c77#b77 is am5d$-- 7,a7 9    
subp>agraph 7,a71 by ins]t+ 1 subject to
 subp>agraph 7,e71 aft] increas$ by2 &  
7,b7 by add+ at ! end ! foll[+ new      
subp>agraph3  7,e7 ,disc\rag+ excessive 
prices  7i7 ,9 g5]al ,9 ! case ( a      

manufactur] ( a s+le s\rce drug or an   
innovator multiple s\rce drug ) a rebate
 agreem5t "u ?is section1 if !          
,prescription ,drug & ,m$ical ,device   
,price ,review ,bo>d e/abli%$ "u section
 #b ( ! ,prescription ,drug & ,m$ical   
,device ,price ,review ,bo>d ,act (     
#bjah det]m9es "u section #e7;a7 ( su*  
,act t su* manufactur] *>g$1 ) respect  
to a #cj-;day p]iod1 an excessive price 
= su* drug1 & ! ,bo>d det]m9es "u clause
 7ii7 to apply an increas$ am\nt        
describ$ 9 su* clause ) respect to su*  
manufactur] & drug1 ! am\nt ( ! rebate  
det]m9$ "u subp>agraph 7,a7 = su*       
manufactur] & drug %all be1 subject to  
subp>agraph 7,d71 increas$ by su* am\nt 
= ! #d rebate p]iods foll[+ su* #cj-;day
 p]iod4  7ii7 ,increas$ am\nt           
det]m9ation ,= purposes ( clause 7i71 if
 ! ,bo>d describ$ 9 su* clause makes su*
 a det]m9ation "u su* section #e7;a71 ) 
respect to a manufactur] & drug describ$
 9 su* clause1 ! ,bo>d may det]m9e an   
increas$ am\nt to apply ) respect to su*

 manufactur] & drug & rebate p]iod      
describ$ 9 su* clause4 ,su* increas$    
am\nt may n exce$ ! rebate am\nt t w\ld 
o!rwise be appli$ to su* manufactur] &  
drug "u ?is section = su* rebate p]iod1 
)\t reg>d to ?is subp>agraph4  4  7#b7  
,effective date ,?is subsection & !     
am5dm5ts made by ?is subsection %all    
apply ) respect to rebate agreem5ts     
ent]$ into aft] ! date t is #fj days    
aft] ! date ( ! enactm5t ( ?is ,act4    
7d7 ,tax on excess prescription drug &  
m$ical device pr(its  7#a7 ,det]m9ation 
( am\nt ,if ! ,bo>d det]m9es "u section 
#e7;a7 t a manufactur]1 produc]1 or     
import] ( a prescription drug or m$ical 
device *>g$ an excessive price = su*    
prescription drug or m$ical device dur+ 
a taxable ye>1 ! ,bo>d may det]m9e "u   
?is p>agraph a reasonable price = su*   
drug or device = su* taxable ye>4  7#b7 
,imposition ( tax  7,a7 ,9 g5]al ,!     
,int]nal ,rev5ue ,code ( #aihf is am5d$ 
by ins]t+ aft] section #daia ! foll[+   
new section3  #daib4 ,excessive         

prescription drug & m$ical device price 
7a7 ,9 g5]al ,!re is h]eby impos$ on !  
sale ( any prescription drug or m$ical  
device by ! manufactur]1 produc]1 or    
import] a tax equal to ! diff]5ce betwe5
 ! price at :i* su* drug or device is s 
sold & ! reasonable price det]m9$ by !  
,prescription ,drug & ,m$ical ,device   
,price ,review ,bo>d "u section         
#f7;d77#a7 ( ! ,prescription ,drug &    
,m$ical ,device ,price ,review ,bo>d    
,act ( #bjah = su* drug or device = !   
taxable ye> = sales aft] ! det]m9ation4 
7b7 ,prescription ,drug or ,m$ical      
,device ,= purposes ( ?is section1 ! t]m
 prescription drug or m$ical device     
means any prescription drug 7z def9$ 9  
section #ijjh ( ! ,pati5t ,protection & 
,af=dable ,c>e ,act7 or device 7z def9$ 
9 section #bja7;h7 ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act7 int5d$ =       
humans4  4  7,b7 ,cl]ical am5dm5t ,!    
table ( p>ts = *apt] #cb ( su* ,code is 
am5d$-- 7i7 9 ! item relat+ to sub*apt] 
,e1 by /rik+ ,m$ical & ins]t+ ,drugs &  

m$ical1 &  7ii7 by ins]t+ aft] ! item   
relat+ to section #daia ! foll[+ new    
item3  ,sec4 #daib4 ,excessive          
prescription drug & m$ical device price4
  4  7#c7 ,effective date ,?is          
subsection & ! am5dm5ts made by ?is     
subsection %all apply ) respect to sales
 aft] ,decemb] #ca1 #bjah4  7e7 ,safe & 
af=dable drugs f approv$ c\ntries ,*apt]
 ,,viii ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cha et   
seq47 is am5d$ by add+ at ! end !       
foll[+3  #haj4 ,importation by          
individuals ( prescription drugs1 &     
devices1 f an approv$ c\ntry if         
manufactur]s are *>g+ an excessive price
 = comp>able products 9 ! ,unit$ ,/ates 
7a7 ,9 g5]al ,not)/&+ any o!r provision 
( ?is ,act1 n lat] ?an #ahj days aft] ! 
date ( enactm5t ( ?is section1 !        
,prescription ,drug & ,m$ical ,device   
,price ,review ,bo>d 79 ?is section     
ref]r$ to z ! ,bo>d7 %all promulgate    
regulations p]mitt+ individuals to      
safely import f an approv$ c\ntry into !

 ,unit$ ,/ates prescription drugs1 &    
devices1 t are comp>able to prescription
 drugs1 & devices1 = :i* ! ,bo>d makes a
 f9al det]m9ation t ! manufactur] is    
*>g+ or has *>g$ an excessive price 9   
violation ( section #e7;a7 ( !          
,prescription ,drug & ,m$ical ,device   
,price ,review ,bo>d ,act ( #bjah4  7b7 
,comp>able def9$ ,= purposes ( ?is      
section1 ! t]m comp>able means-- 7#a7 ) 
respect to a drug1 hav+ ! same active   
+r$i5t or +r$i5ts1 r\te ( adm9i/ration1 
dosage =m1 & /r5g?2 &  7#b7 ) respect to
 a device1 be+ sub/antially equival5t4  
7c7 ,assurance ( safety ,= purposes (   
?is section1 ! t]m approv$ c\ntry means 
a c\ntry t is det]m9$ by ! ,secret>y to 
h 9 effect /&>ds to ensure ! safety (   
prescription drugs1 & ( devices1 t are  
at lea/ z protective z ! /&>ds          
applicable "u ,f$]al law 9 ! ,unit$     
,/ates4  4  #g4 ,au?ority  7a7 ,obta9+  
(ficial data ,! *airp]son ( ! ,bo>d may 
secure directly f any ,f$]al ag5cy      
in=mation necess>y to enable ! ,bo>d to 

c>ry out its duties4 ,^u reque/ ( !     
*airp]son1 ! head ( ! ag5cy %all furni% 
su* in=mation to ! ,bo>d to ! ext5t su* 
in=mation is n prohibit$ f disclosure by
 law4  7b7 ,mails ,! ,bo>d may use !    
,unit$ ,/ates mails 9 ! same mann] & "u 
! same conditions z o!r ,f$]al ag5cies4 
7c7 ,adm9i/rative support s]vices ,^u ! 
reque/ ( ! *airp]son ( ! ,bo>d1 !       
,adm9i/rator ( ,g5]al ,s]vices %all     
provide to ! ,bo>d1 on a reimbursable   
basis1 ! adm9i/rative support s]vices   
necess>y = ! ,bo>d to c>ry out its      
duties4  7d7 ,contract au?ority ,! ,bo>d
 may contract ) & comp5sate gov]nm5t &  
private ag5cies or p]sons = ! purpose ( 
conduct+ rese>*1 surveys1 & o!r s]vices 
necess>y to enable ! ,bo>d to c>ry out  
its duties4  7e7 ,inve/igations ,! ,bo>d
 may make su* inve/igations z x consid]s
 necess>y to det]m9e :e!r !re is or may 
be a violation ( any regulation         
promulgat$ "u ?is ,act & may require or 
p]mit any p]son to file ) x a /atem5t 9 
writ+1 "u oa? or o!rwise z ! ,bo>d %all 

det]m9e1 z to all ! facts & circum/ances
 conc]n+ ! matt] to be inve/igat$4  7f7 
,subpo5a p[]  7#a7 ,9 g5]al ,! ,bo>d may
 issue subpo5as requir+ ! att5dance &   
te/imony ( witnesses & ! production (   
any evid5ce relat+ to any matt] "u      
inve/igation by ! ,bo>d4 ,! att5dance ( 
witnesses & ! production ( evid5ce may  
be requir$ f any place )9 ! ,unit$      
,/ates at any designat$ place ( he>+ )9 
! ,unit$ ,/ates4  7#b7 ,failure to obey 
a subpo5a ,if a p]son refuses to obey a 
subpo5a issu$ "u p>agraph 7#a71 ! ,bo>d 
may apply to a ,unit$ ,/ates di/rict    
c\rt = an ord] requir+ t p]son to appe> 
be=e ! ,bo>d to give te/imony1 produce  
evid5ce1 or bo?1 relat+ to ! matt] "u   
inve/igation4 ,! application may be made
 )9 ! judicial di/rict :]e ! he>+ is    
conduct$ or :]e t p]son is f\nd1        
resides1 or transacts bus9ess4 ,any     
failure to obey ! ord] ( ! c\rt may be  
puni%$ by ! c\rt z civil contempt4  7#c7
 ,s]vice ( subpo5as ,! subpo5as ( !     
,bo>d %all be s]v$ 9 ! mann] provid$ =  

subpo5as issu$ by a ,unit$ ,/ates       
di/rict c\rt "u ! ,f$]al ,rules ( ,civil
 ,proc$ure = ! ,unit$ ,/ates di/rict    
c\rts4  7#d7 ,s]vice ( process ,all     
process ( any c\rt to :i* application is
 made "u p>agraph 7#b7 may be s]v$ 9 !  
judicial di/rict 9 :i* ! p]son requir$  
to be s]v$ resides or may be f\nd4  7#e7
 ,notice ,^u issu+ any subpo5a "u ?is   
subsection1 ! ,bo>d %all give notice (  
su* issuance to ! appropriate committees
 ( ,congress1 includ+ ! ,committee on   
,appropriations ( ! ,h\se (             
,repres5tatives & ! ,committee on       
,appropriations ( ! ,s5ate4  7g7        
,confid5tiality ,no?+ 9 ?is ,act %all be
 con/ru$ z au?oriz+ ! ,bo>d to disclose 
any in=mation t is a trade secret or    
confid5tial in=mation subject to section
 #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates 
,code1 or section #aije ( title #ah1    
,unit$ ,/ates ,code4  #h4 ,regulations  
7a7 ,9 g5]al ,n lat] ?an #a ye> aft] !  
date ( ! initial meet+ held "u section  
#c7;e71 ! ,bo>d %all issue f9al         

regulations to c>ry out ?is ,act4  7b7  
,notice & comm5t requirem5t ,!          
regulations develop$ "u subsection 7a7  
%all be issu$ 9 accordance ) ! notice & 
comm5t proc$ures e/abli%$ "u section    
#eec ( title #e1 ,unit$ ,/ates ,code4   
#i4 ,report to ,f$]al ag5cies ,n lat]   
?an #a ye> aft] ! effective date ( !    
regulations "u section #h & annually    
!reaft]1 ! ,bo>d %all submit to ea*     
,f$]al ag5cy t disp5ses or makes paym5ts
 = ! disp5s+ ( prescription drugs or    
m$ical devices a report conta9+--  7#a7 
a li/ ( ea* prescription drug & m$ical  
device = :i* an excessive price 0 *>g$  
dur+ ! prec$+ cal5d> ye>1 z det]m9$ by !
 ,bo>d "u section #e2  7#b7             
recomm5dations to ! ,f$]al ag5cy aga9/  
disp5s+ or mak+ paym5ts = ! disp5s+ ( ! 
prescription drug or m$ical device2 &   
7#c7 recomm5dations to ! ,f$]al ag5cy to
 sub/itute1 9 place ( any drug or device
 li/$ pursuant to p>agraph 7#a71 a      
simil> prescription drug or m$ical      
device t is n sold at an excessive      

price4  #aj4 ,report to ,congress ,n    
lat] ?an #a ye> aft] ! initial meet+ ( !
 ,bo>d "u section #c7;e71 & annually    
!reaft]1 ! ,bo>d %all submit to !       
,congress a report describ+ ! activities
 ( ! ,bo>d = ! prec$+ ye>4  #aa4        
,def9itions ,9 ?is ,act3 7#a7 ,! t]m    
affiliate means1 ) respect to a         
manufactur]1 any entity t controls1 is  
controll$ by1 or is "u common control ) 
su* manufactur]4  7#b7 ,! t]m av]age    
manufactur] price means ! av]age price  
*>g$ by ! manufactur] ( a prescription  
drug or m$ical device1 z applicable1 =  
sales ( ! drug or device by !           
manufactur] 9 ! ,unit$ ,/ates ov] !     
respective annual qu>t]4  7#c7 ,! t]m   
m$ical device means a device 7z def9$ 9 
section #bja ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cba774   
7#d7 ,! t]m prescription drug means a   
drug 7z def9$ 9 section #bja ( ! ,f$]al 
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