,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #ijdj  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #bf1 #bjbf,mr4   
,%]man introduc$ ! foll[+ bill2 :i* 0   
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce1 & 9 addition to ! ,committees 
on ! ,judici>y1 & ,f9ancial ,s]vices1 = 
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% fair prices = prescription      
drugs1 & = o!r purposes4  #a4 ,%ort     
title ,?is ,act may be cit$ z !         
,regulate ! ,price ( ,all ,drugs ,act4  
#b4 ,e/abli%+ ! ,prescription ,drug     
,regulatory ,commission  7a7 ,9 g5]al   
,!re is e/abli%$ ! ,prescription ,drug  
,price ,regulatory ,commission 79 ?is   
section ref]r$ to z ! ,commission74  7b7
 ,duties ( ,commission  7#a7 ,9 g5]al ,n
 lat] ?an ! fair price recomm5dation    
date ) respect to a fair price          
applicability ye>1 ! ,commission %all1 )
 respect to ea* approv$ prescription    

drug1 submit to ! ,secret>y ( ,heal? &  
,human ,s]vices 79 ?is section ref]r$ to
 z ! ,secret>y7 a recomm5dation reg>d+ !
 price t ! ,commission det]m9es to be a 
fair price = su* drug 9 ord] = !        
manufactur] ( su* drug to provide access
 to su* price-- 7,a7 to any fair price  
eligible individual :o is disp5s$ su*   
drug dur+ su* fair price applicability  
ye> 7& to ph>macies1 mail ord] s]vices1 
& o!r disp5s]s1 ) respect to su*        
individuals :o are disp5s$ su* drugs72 &
  7,b7 to any hospital1 physician1 or   
o!r provid] ( s]vices or suppli] t      
furni%es or adm9i/]s su* drug to su* an 
individual dur+ su* ye>4  7#b7 ,fair    
price revisions & waiv]s ,at any "t dur+
 a fair price applicability ye>1 !      
,commission may submit to ! ,secret>y a 
recomm5dation--  7,a7 t ! ,secret>y     
revise ! fair price e/abli%$ = an       
approv$ prescription drug = su* ye> "u  
section #c7;b72 or  7,b7 t ! ,secret>y  
au?orize a tempor>y waiv] ( su* fair    
price "u section #c7;c74  7#c7 ,requir$ 

factors = consid]ation ,9 mak+ a        
recomm5dation "u p>agraph 7#a7 ) respect
 to ! fair price ( an approv$           
prescription drug1 or a recomm5dation "u
 p>agraph 7#b7 ) respect to a revision  
or waiv] ( su* fair price1 ! ,commission
 %all take into acc\nt ! foll[+ factors 
) respect to su* drug3 7,a7 ,! co/s to !
 manufactur] ( produc+ & di/ribut+ ( su*
 drug4  7,b7 ,! co/-effectiv5ess ( !    
drug & its !rapeutic b5efit 7:i* may be 
det]m9$ on ! basis ( quality-adju/$ life
 ye>s1 equal value ( life ye>s ga9$1 or 
su* o!r measure z ! ,commission may     
specify74  7,c7 ,! anticipat$ dem& = !  
drug dur+ ! fair price applicability    
ye>4  7,d7 ,! co/s & risks to !         
manufactur] involv$ 9 rese>*+ & develop+
 su* drug1 & ! return on inve/m5t t w\ld
 provide adequate inc5tive to !         
manufactur] to cont9ue rese>*4  7,e7 ,9 
! case t su* drug is available = pur*ase
 9 #a or m comp>able ref]5ce c\ntries1 !
 av]age price ( su* drug 9 su* c\ntry4  
7,f7 ,su* o!r factors z ! ,secret>y (   

,heal? & ,human ,s]vices may specify    
?r\gh rulemak+4  7c7 ,memb]s (          
,commission  7#a7 ,9 g5]al ,!           
,commission %all be compos$ ( #ac memb]s
 z foll[s3  7,a7 ,sev5 memb]s appo9t$ by
 ! ,presid5t f individuals :o are n     
(fic]s or employees ( any gov]nm5t4     
7,b7 ,six ex (ficio memb]s appo9t$ by ! 
,secret>y ( ,heal? & ,human ,s]vices f  
ea* ( ! foll[+ ag5cies3  7i7 ,! ,vet]ans
 ,heal? ,adm9i/ration4  7ii7 ,! ,def5se 
,heal? ,ag5cy4  7iii7 ,! ,c5t]s =       
,m$ic>e  ,m$icaid ,s]vices4  7iv7 ,!    
,food & ,drug ,adm9i/ration4  7v7 ,!    
,c5t]s = ,disease ,control & ,prev5tion4
  7vi7 ,! ,f$]al ,trade ,commission4    
7#b7 ,t]ms ,ea* memb] %all be appo9t$ = 
a t]m ( #d ye>s1 except t ! ,secret>y   
may ext5d ! t]m ( any memb] = #a        
additional ye> if ! ,secret>y det]m9es  
su* ext5sion appropriate4  7d7 ,op]ation
 ,9 c>ry+ out ! duties "u subsection    
7b71 ! ,commission is n subject to !    
provisions ( *apt] #aj ( title #e1      
,unit$ ,/ates ,code4  7e7 ,au?orization 

( appropriations ,!re are au?oriz$ to be
 appropriat$ su* sums z may be necess>y 
= ea* fiscal ye> to c>ry out !          
activities ( ! ,commission4  #c4        
,publication ( fair prices  7a7 ,9 g5]al
 ,n lat] ?an ! fair price publication   
date ) respect to a fair price          
applicability ye>1 ! ,secret>y ( ,heal? 
& ,human ,s]vices 79 ?is section ref]r$ 
to z ! ,secret>y7 %all1 ) respect to ea*
 approv$ prescription drug1 e/abli% &   
publi% ! price t ! ,secret>y det]m9es to
 be a fair price = su* drug 9 ord] = !  
manufactur] ( su* drug to provide access
 to su* price--  7#a7 to any fair price 
eligible individual :o is disp5s$ su*   
drug dur+ su* fair price applicability  
ye> 7& to ph>macies1 mail ord] s]vices1 
& o!r disp5s]s1 ) respect to su*        
individuals :o are disp5s$ su* drugs72 &
  7#b7 to hospitals1 physicians1 & o!r  
provid]s ( s]vices & suppli]s t furni%  
or adm9i/] su* drug to su* an individual
 dur+ su* ye>4 ,9 e/abli%+ ! fair price 
= ea* su* drug1 ! ,secret>y %all take   

into acc\nt ! recomm5dations made by !  
,prescription ,drug ,price ,regulatory  
,commission 79 ?is section ref]r$ to z !
 ,commission7 "u section #b7;b77#a7 =   
su* drug & su* ye>4  7b7 ,revisions ,!  
,secret>y may revise ! fair price       
applicable to an approv$ prescription   
drug = a fair price applicability ye>   
aft] ! fair price publication date )    
respect to su* ye> has pass$ if-- 7#a7 !
 ,secret>y has receiv$ a recomm5dation f
 ! ,commission t ! fair price be s      
revis$2  7#b7 9 ! judgm5t ( ! ,secret>y1
 revis+ su* fair price is necess>y to   
acc\nt = significant *anges to-- 7,a7   
supply 7or project$ supply7 or dem& 7or 
project$ dem&7 = su* drug2 or  7,b7 any 
( ! o!r factors describ$ 9 section      
#b7;b77#c7 ) respect to su* drug2 &     
7#c7 ! ,secret>y notifies ! manufactur] 
( su* drug n less ?an #cj days be=e su* 
revis$ fair price goes into effect4  7c7
 ,tempor>y fair price waiv]  7#a7 ,9    
g5]al ,! ,secret>y may au?orize a       
manufactur] ( an approv$ prescription   

drug to provide access to su* drug to a 
fair price eligible individual describ$ 
9 p>agraph 7#a7 ( subsection 7a7 7or to 
a hospital1 physician1 or o!r provid] ( 
s]vices or suppli] describ$ 9 p>agraph  
7#b7 ( su* subsection ) respect to su*  
individual7 at a price 9 excess ( a fair
 price if1 9 ! judgm5t ( ! ,secret>y1   
su* au?orization is necess>y to ma9ta9  
access to su* drug = all fair price     
eligible individuals4  7#b7 ,duration ( 
waiv] ,an au?orization "u ?is subsection
 %all la/ = a p]iod ( #ij days4 ,!      
,secret>y may ext5d su* au?orization =  
#a or m additional #ij-;day p]iods if ! 
,secret>y det]m9es su* ext5sion is      
necess>y4  7d7 ,p5alties = noncompliance
 by a manufactur]  7#a7 ,9 g5]al ,9     
addition to any o!r p5alties prescrib$  
by law1 any manufactur] ( an approv$    
prescription drug t does n provide      
access dur+ a fair price applicability  
ye> to a price t is equal to or less ?an
 ! fair price = su* drug = su* ye> 7or1 
9 ! case t an au?orization "u subsection

 7c7 is 9 effect ) respect to su*       
manufactur] & drug1 a price t is equal  
to or less ?an ! price au?oriz$ "u su*  
subsection7-- 7,a7 to a fair price      
eligible individual :o is disp5s$ su*   
drug dur+ su* fair price applicability  
ye> 7& to ph>macies1 mail ord] s]vices1 
& o!r disp5s]s1 ) respect to su*        
individuals :o are disp5s$ su* drugs72  
or  7,b7 to a hospital1 physician1 or   
o!r provid] ( s]vices or suppli] t      
furni%$ or adm9i/]$ su* drug to su* an  
individual dur+ su* ye>2  %all be       
subject to a civil p5alty1 = ea* ye> & =
 ea* drug = :i* ! violation occurs1     
equal to #aj times ! am\nt equal to !   
product ( ! numb] ( units ( su* drug s  
furni%$1 disp5s$1 or adm9i/]$ dur+ su*  
ye> & ! diff]5ce betwe5 ! price = su*   
drug made available = su* ye> by su*    
manufactur] ) respect to su* individual 
or hospital1 physician1 provid] (       
s]vices1 or suppli] & ! fair price = su*
 drug = su* ye> 7or ! price au?oriz$ "u 
subsection 7c71 z applicable74  7#b7    

,application ,! provisions ( section    
#aabh;,a ( ! ,social ,security ,act 7#db
 ,u4,s4,c4 #acbj;a-#g7 7o!r ?an         
subsections 7a7 & 7b77 %all apply to a  
civil monet>y p5alty "u ?is section 9 ! 
same mann] z su* provisions apply to a  
p5alty or proce$+ "u section            
#aabh;,a7a74  #d4 ,fair prices =        
prescription drugs requir$  7a7         
,prohibition ,section #cja ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act is am5d$ 
by add+ at ! end ! foll[+3  7jjj7       
,sell+1 or (f]+ = sale1 a drug 7or      
biological product7 at a price t exce$s 
! fair price publi%$ "u section #c ( !  
,regulate ! ,price ( ,all ,drugs ,act4  
4  7b7 ,en=cem5t by ,f$]al ,trade       
,commission  7#a7 ,unfair or deceptive  
acts or practices ,a violation ( section
 #cja7;jjj7 ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act or a regulation          
promulgat$ "u su* subsection %all be    
treat$ z a violation ( a regulation "u  
section #ah7;a77#a77;,b7 ( ! ,f$]al     
,trade ,commission ,act 7#ae ,u4,s4,c4  

#eg;a7a77#a77;,b77 reg>d+ unfair or     
deceptive acts or practices4  7#b7 ,p[]s
 ( ,commission ,! ,f$]al ,trade         
,commission %all en=ce subsection 7jjj7 
( su* section #cja & any regulation     
promulgat$ "u su* subsection 9 ! same   
mann]1 by ! same means1 & ) ! same      
jurisdiction1 p[]s1 & duties z ?\gh all 
applicable t]ms & provisions ( ! ,f$]al 
,trade ,commission ,act 7#ae ,u4,s4,c4  
#da et seq47 7 incorporat$ into & made a
 "p ( ?is section4 ,any p]son :o        
violates su* subsection or a regulation 
promulgat$ "u su* subsection %all be    
subject to ! p5alties & entitl$ to !    
privileges & immunities provid$ 9 !     
,f$]al ,trade ,commission ,act4  7c7    
,actions by ,/ates  7#a7 ,9 g5]al ,9 any
 case 9 :i* ! attorney g5]al ( a ,/ate1 
or an (ficial or ag5cy ( a ,/ate1 has   
reason to believe t an int]e/ ( !       
resid5ts ( su* ,/ate has be5 or is      
?reat5$ or adv]sely affect$ by an act or
 practice 9 violation ( subsection 7jjj7
 ( su* section #cja or a regulation     

promulgat$ "u su* subsection1 ! ,/ate1 z
 p>5s patriae1 may br+ a civil action on
 behalf ( ! resid5ts ( ! ,/ate 9 an     
appropriate di/rict c\rt ( ! ,unit$     
,/ates to-- 7,a7 enjo9 su* act or       
practice2  7,b7 en=ce compliance ) su*  
subsection or su* regulation2  7,c7     
obta9 damages1 re/itution1 or o!r       
comp5sation on behalf ( resid5ts ( !    
,/ate2 or  7,d7 obta9 su* o!r legal &   
equitable relief z ! c\rt may consid] to
 be appropriate4  7#b7 ,notice ,be=e    
fil+ an action "u ?is subsection1 !     
attorney g5]al1 (ficial1 or ag5cy ( !   
,/ate involv$ %all provide to ! ,f$]al  
,trade ,commission a writt5 notice ( su*
 action & a copy ( ! compla9t = su*     
action4 ,if ! attorney g5]al1 (ficial1  
or ag5cy det]m9es t x is n feasible to  
provide ! notice describ$ 9 ?is p>agraph
 be=e ! fil+ ( ! action1 ! attorney     
g5]al1 (ficial1 or ag5cy %all provide   
writt5 notice ( ! action & a copy ( !   
compla9t to ! ,f$]al ,trade ,commission 
imm$iately ^u ! fil+ ( ! action4  7#c7  

,au?ority ( ,f$]al ,trade ,commission   
7,a7 ,9 g5]al ,on receiv+ notice "u     
p>agraph 7#b7 ( an action "u ?is        
subsection1 ! ,f$]al ,trade ,commission 
%all h ! "r-- 7i7 to int]v5e 9 ! action2
  7ii7 ^u s int]v5+1 to be he>d on all  
matt]s aris+ !re92 &  7iii7 to file     
petitions = appeal4  7,b7 ,limitation on
 ,/ate action :ile ,f$]al action is p5d+
 ,if ! ,f$]al ,trade ,commission or !   
,attorney ,g5]al ( ! ,unit$ ,/ates has  
in/itut$ a civil action = violation (   
subsection 7jjj7 ( su* section #cja or a
 regulation promulgat$ "u su* subsection
 7ref]r$ to 9 ?is subp>agraph z ! ,f$]al
 action71 no ,/ate attorney g5]al1      
(ficial1 or ag5cy may br+ an action "u  
?is subsection dur+ ! p5d5cy ( ! ,f$]al 
action aga9/ any def5dant nam$ 9 !      
compla9t 9 ! ,f$]al action = any        
violation ( su* subsection or regulation
 alleg$ 9 su* compla9t4  7#d7 ,rule (   
con/ruction ,= purposes ( br++ a civil  
action "u ?is subsection1 no?+ 9 ?is    
,act %all be con/ru$ to prev5t an       

attorney g5]al1 (ficial1 or ag5cy ( a   
,/ate f ex]cis+ ! p[]s conf]r$ on !     
attorney g5]al1 (ficial1 or ag5cy by !  
laws ( su* ,/ate to conduct             
inve/igations1 adm9i/] oa?s &           
affirmations1 or compel ! att5dance (   
witnesses or ! production ( docum5t>y & 
o!r evid5ce4  7d7  ,private "r ( action 
7#a7  ,9 g5]al  ,a p]son injur$ by an   
act or practice 9 violation ( subsection
 7jjj7 ( su* section #cja or a          
regulation promulgat$ "u su* subsection 
may br+ 9 an appropriate di/rict c\rt ( 
! ,unit$ ,/ates--  7,a7 an action to    
enjo9 ! violation2  7,b7 an action to   
recov] ?ree times ! am\nt ( damages =   
actual monet>y loss f ! violation1 or to
 receive up to #ej1jjj 9 damages = ea*  
su* violation1 :i*ev] is great]2 or     
7,c7 bo? su* actions4  7#b7 ,willful or 
kn[+ violations ,if ! c\rt f9ds t !     
def5dant act$ willfully or kn[+ly 9     
committ+ a violation describ$ 9 p>agraph
 7#a71 ! c\rt may1 9 its discretion1    
increase ! am\nt ( ! aw>d to an am\nt   

equal to n m ?an #c times ! am\nt       
available "u p>agraph 7#a77;,b74  7#c7  
,co/s & attorney's fees  ,! c\rt %all   
aw>d to a prevail+ pla9tiff 9 an action 
"u ?is subsection ! co/s ( su* action & 
reasonable attorney's fees1 z det]m9$ by
 ! c\rt4  7#d7  ,limitation  ,an action 
may be comm5c$ "u ?is subsection n lat] 
?an #e ye>s aft] ! date on :i* ! p]son  
fir/ discov]$ or _h a reasonable        
opportunity to discov] ! violation4     
7#e7  ,nonexclusive rem$y  ,! rem$y     
provid$ by ?is subsection %all be 9     
addition to any o!r rem$ies available to
 ! p]son4  #e4 ,m>*-9 rights = pat5t ,if
 ! own] ( a pat5t sells a drug 9 !      
,unit$ ,/ates above ! fair price publi%$
 pursuant to section #c or does n sell  
an adequate quantity to meet pati5t dem&
 ( a drug 9 ! ,unit$ ,/ates at ! fair   
price publi%$ pursuant to section #c1 ! 
,secret>y ( ,heal? & ,human ,s]vices may
 ass]t ! "r to claim f ! own] ( any     
pat5t = su* drug a nonexclusive1        
p>tially exclusive1 or exclusive lic5se 

9 any field ( use1 ^u t]ms t are        
reasonable "u ! circum/ances4  #f4 ,use 
( ! ,def5se ,production ,act ,!         
,presid5t may use ! au?orities "u title 
,i1 title ,,iii1 & title ,,vii ( !      
,def5se ,production ,act ( #aiej to     
increase ! dome/ic supply ( a drug if ! 
,commission has det]m9$ t--  7#a7 !re   
are inadequate facilities or means (    
production 9 ! ,unit$ ,/ates to produce 
an am\nt ( su* drug t w\ld satisfy      
pati5t dem& = su* drug2 &  7#b7 =eign   
supplies ( su* drug _c be reliably &    
su/a9ability import$ into ! ,unit$      
,/ates 9 su* quantities z are necess>y =
 su* drug to be pur*as$ at ! fair price 
e/abli%$ = su* drug "u section #c4  #g4 
,def9itions ,9 ?is ,act1 ! foll[+       
def9itions apply3 7#a7 ,approv$         
prescription drug ,! t]m approv$        
prescription drug means--  7,a7 a drug  
:i* may be disp5s$ only ^u prescription 
& t is describ$ 9 subp>agraph 7,a77i71  
7,a77ii71 or 7,a77iii7 ( section        
#aibg7k77#b7 ( ! ,social ,security ,act 

7#db ,u4,s4,c4 #acifr-#h7k77#b772  7,b7 
a biological product describ$ 9 clauses 
7i7 ?r\gh 7iii7 ( subp>agraph 7,b7 ( su*
 section2  7,c7 insul9 describ$ 9       
subp>agraph 7,c7 ( su* section & m$ical 
supplies associat$ ) ! injection (      
insul9 7z def9$ 9 regulations ( !       
,secret>y72 or  7,d7 a vacc9e lic5s$ "u 
section #cea ( ! ,public ,heal? ,s]vice 
,act4  7#b7 ,comp>able ref]5ce c\ntry ,!
 t]m comp>able ref]5ce c\ntry means any 
( ! foll[+ c\ntries3 7,a7 ,canada4  7,b7
 ,france4  7,c7 ,g]many4  7,d7 ,italy4  
7,e7 ,japan4  7,f7 ,! ,unit$ ,k+dom4    
7#c7 ,fair price applicability ye> ,!   
t]m fair price applicability ye> means a
 ye> 7beg9n+ ) #bjbg74  7#d7 ,fair price
 eligible individual ,! t]m fair price  
eligible individual means1 ) respect to 
an approv$ prescription drug1 an        
individual :o is locat$ 9 ! ,unit$      
,/ates at ! "t su* drug is furni%$ or   
adm9i/]$ to su* individual4  7#e7 ,fair 
price publication date ,! t]m fair price
 publication date means1 ) respect to a 

fair price applicability ye>1 ,july #a (
 ! prec$+ ye>4  7#f7 ,fair price        
recomm5dation date ,! t]m fair price    
recomm5dation date means1 ) respect to a
 fair price applicability ye>1 ,may #a (
 ! prec$+ ye>4