,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #bchg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #ca1 #bjai ,mr4  
,van ,holl5 7= himself & ,mr4 ,scott (  
,florida7 introduc$ ! foll[+ bill2 :i* 0
 read twice & ref]r$ to ! ,committee on 
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to e/abli% a process by :i* 
reasonable drug prices may be det]m9$1 &
 = o!r purposes4  #a4 ,%ort title  ,?is 
,act may be cit$ z ! ,we ,protect       
,am]ican ,inve/m5t 9 ,drugs ,act or !   
,we ,,paid ,act4  #b4 ,f9d+s ,congress  
f9ds ! foll[+3 7#a7 ,9 addition to      
spurr+ economic gr[?1 ! ,national       
,in/itutes ( ,heal? supports "s ( ! mo/ 
significant break?r\ghs 9 biom$ical     
innovation1 includ+ "s t are            
comm]cializ$ into new ph>maceutical     
products4  7#b7 ,! ,national ,in/itutes 
( ,heal? fund+ contribut$1 ei!r directly
 or indirectly1 to ! developm5t ( all   
#baj new molecul> entities approv$ by ! 
,food & ,drug ,adm9i/ration betwe5 #bjaj
 & #bjaf1 accord+ to an analysis publi%$

 9 ! ,proce$+s ( ! ,national ,academy ( 
,sci5ces4  7#c7 ,9 fiscal ye> #bjai1    
,congress provid$ #ci1ajj1jjj1jjj 9     
fund+ = ! ,national ,in/itutes ( ,heal?4
  7#d7 ,accord+ to a ,kais] ,family     
,f\ndation heal? track+ poll 9 ,febru>y 
#bjai-- 7,a7 ne>ly #hj p]c5t ( p 9 !    
,unit$ ,/ates say t ! co/ ( prescription
 drugs is unreasonable & only #be p]c5t 
tru/ ph>maceutical companies to price _!
 products fairly2 &  7,b7 "o-f\r? ( p 9 
! ,unit$ ,/ates say x is difficult to   
af=d _! prescription drugs1 & #c 9 #aj  
say !y h n tak5 _! m$ications z         
prescrib$ due to co/s4  7#e7 ,accord+ to
 a ,septemb] #bjah report f ! ,,a>p--   
7,a7 betwe5 #bjaf & #bjag1 retail prices
 = #bfg widely us$ br& "n prescription  
drugs increas$ by #h4d p]c5t aft] #e    
/raight ye>s ( d\ble-digit av]age annual
 price increases2  7,b7 br& "n drug     
prices increas$ #d times fa/] ?an g5]al 
inflation 9 #bjag2 &  7,c7 retail prices
 increas$ 9 #bjag = #hg p]c5t 7#bca (   
#bfg7 ( ! widely us$ br& "n prescription

 drugs review$1 & all b #e su* increases
 exce$$ ! rate ( inflation4  7#f7 ,9    
#bjaf1 prescription drug sp5d+ 9 !      
,unit$ ,/ates 0 #dgg1jjj1jjj1jjj1       
accord+ to an e/imate f ! ,assi/ant     
,secret>y = ,plann+ & ,evaluation ( !   
,dep>tm5t ( ,heal? & ,human ,s]vices4   
7#g7 ,prescription drugs acc\nt = ne>ly 
#a out ( e #e 9 ov]all sp5d+ "u !       
,m$ic>e program1 z well z #ba p]c5t (   
,m$ic>e b5efici>ies' out-(-pocket heal? 
sp5d+1 n includ+ premiums4  7#h7 7,a7 ,a
 drug's li/ price has a significant     
impact on :at payors & pati5ts pay to   
pur*ase prescription drugs4  7,b7 ,9    
prescription drug plans "u ,m$ic>e "p   
,d1 & a gr[+ numb] ( comm]cial heal?    
plans1 s5iors' & o!r b5efici>ies'       
co/-%>+ is bas$ on a p]c5tage ( a drug's
 li/ price4 ,z a result1 high] drug li/ 
prices mean high] out-(-pocket co/s =   
,m$ic>e b5efici>ies = _! retail         
prescriptions4  7,c7 ,= prescription    
drugs cov]$ "u ,m$ic>e "p ,b1           
b5efici>ies are responsible = pay+ #bj  

p]c5t ( ! ,m$ic>e-approv$ am\nt = !     
drug1 & ! "p ,b d$uctible also applies4 
,?is c be a significant burd5 = high-co/
 "p ,b drugs4  7,d7 ,a drug's li/ price 
is a factor 9 det]m9+ ! am\nt ( ! rebate
 paid to ,/ate ,m$icaid plans by !      
drug's manufactur] "u ! ,m$icaid ,drug  
,rebate ,program1 & an increase 9 !     
drug's li/ price may result 9 increas$  
,m$icaid co/s4  7,e7 ,9 ! private heal? 
insurance m>ket1 ph>macy b5efit manag] &
 :olesal] fees are bas$ on a p]c5tage ( 
! li/ price4 ,high] li/ prices increase 
co/s 9 ?is "p ( ! di/ribution *a94  7,f7
 ,f #bjjg ?r\gh #bjag1 enrollm5t 9      
high-d$uctible heal? plans ) a heal?    
sav+s acc\nt 7#d4b p]c5t to #ah4i p]c5t7
 & )\t a heal? sav+s acc\nt 7#aj4f p]c5t
 to #bd4e p]c5t7 increas$ among adults  
betwe5 ages #ah & #fd ) employm5t-bas$  
cov]age1 :ile enrollm5t 9 traditional   
plans decreas$1 accord+ to ! ,c5t]s =   
,disease ,control & ,prev5tion4         
,individuals ) high-d$uctible heal?     
plans pay m out ( pocket = m$ical       

exp5ses until _! d$uctible is met1 mak+ 
high-co/ drugs *all5g+ to af=d4  7,g7 ,a
 l>g] %>e ( prescription drug plans "u  
,m$ic>e "p ,d *>g$ a d$uctible 9 #bjai  
?an 9 #bjah 7#ga p]c5t 9 #bjai1 & #fc   
p]c5t 9 #bjah71 accord+ to ! ,kais]     
,family ,f\ndation4 ,fifty-two p]c5t (  
prescription drug plans w require       
enrollees to satisfy ! /&>d d$uctible ( 
#dae 9 #bjai4  #c4 ,def9itions ,=       
purposes ( ?is ,act3 7#a7 ,applicable   
drug ,! t]m applicable drug means a drug
 7z def9$ 9 section #bja ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba77 t--  7,a7 is approv$ "u
 section #eje7;c7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;c77 or section #cea7;a7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a772  7,b7 is subject to
 section #ejc7;b77#a7 ( su* ,act 7#ba   
,u4,s4,c4 #cec7;b77#a772 &  7,c7 is     
cov]$ by a qualify+ pat5t on ! drug1 on 
a me?od ( us+ su* drug1 or on a me?od or
 ma*9e us$ to manufacture or adm9i/] su*

 drug ) respect to :i* ! drug sponsor   
reta9$ ! title to any subject inv5tion  
"u section #bjb ( title #ce1 ,unit$     
,/ates ,code1 or ent]$ into a lic5s+    
agreem5t aft] ! date ( enactm5t ( ?is   
,act4  7#b7 ,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 decisions 9 matt]s
 relat$ to ! ,drug ,af=dability &       
,access ,committee or ! conduct ( o!r   
activities "u ?is ,act4  7#c7           
,manufactur] li/ price ,! t]m           
manufactur] li/ price means ! national  
price = a prescription drug e/abli%$ by 
! manufactur] or lic5see f\nd 9 a       
catalogue or o!r public s\rce t is !    
price f :i* m>ket disc\nts & price      
concessions are calculat$4  7#d7 ,p]iod 
( m>ket exclusivity ,! t]m p]iod ( m>ket
 exclusivity means any p]iod ( m>ket    
exclusivity grant$ ) respect to a       
prescription drug "u clause 7ii71 7iii71

 or 7iv7 ( section #eje7;c77#c77;,e7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee7;c77#c77;,e771      
clause 7ii71 7iii71 or 7iv7 ( section   
#eje7;j77#e77;,f7 ( su* ,act1 section   
#ebg ( su* ,act 7#ba ,u4,s4,c4 #cfj;cc71
 or section #cea7k77#g7 ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k77#g771 & any ext5sion ( su* p]iod
 grant$ "u section #eje;,a or #eje;,e ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cee;a1 #cee;f74  7#e7   
,qualify+ pat5t ,! t]m qualify+ pat5t   
means any pat5t-- 7,a7 held by ! ,f$]al 
,gov]nm5t2 or  7,b7 :i* ! applicant )   
respect to ! pat5t 0 requir$ to disclose
 "u section #bjb7;c77#f7 ( title #ce1   
,unit$ ,/ates ,code1 9 ! application = !
 pat5t4  7#f7 ,secret>y ,! t]m ,secret>y
 means ! ,secret>y ( ,heal? & ,human    
,s]vices4  #d4 ,national ,academy (     
,m$ic9e /udy on det]m9+ a reasonable    
drug price  7a7 ,9 g5]al ,n lat] ?an #fj
 days aft] ! date ( enactm5t ( ?is ,act1
 ! ,secret>y %all seek to ent] into a   

contract ) ! ,national ,academy (       
,m$ic9e 7ref]r$ to 9 ?is section z !    
,academy7 "u :i* ! ,academy agrees to   
/udy--  7#a7 h[ be/ to det]m9e !        
reasonabl5ess ( a drug's manufactur] li/
 price & retail price & develop at lea/ 
#a framework = det]m9+ ! reasonabl5ess (
 a drug's manufactur] li/ price & retail
 price tak+ into consid]ation--  7,a7   
af=dability ( ! drug to pay]s1 pur*as]s1
 & pati5ts across wide m>ket segm5ts 9 a
 mann] t ensures equitable access2  7,b7
 inve/m5t by ! ,national ,in/itutes (   
,heal? or any o!r ,f$]al ,gov]nm5t      
entity 9 ! developm5t ( ! drug2  7,c7   
inclusion ( rese>* fund$ by ! ,national 
,in/itutes ( ,heal? or o!r ,f$]al       
,gov]nm5t entity 9 ! developm5t ( !     
drug2  7,d7 manufactur] rese>* &        
developm5t co/s z %[n on ! manufactur]'s
 ,f$]al tax fil+ "u sections #da & #agd 
( ! ,int]nal ,rev5ue ,code ( #aihf2     
7,e7 inve/m5t & ! rate ( return ne$s = !
 drug manufactur]2  7,f7 m>ket = ! drug2
  7,g7 ! co/ ( production & di/ribution 

( ! drug2  7,h7 ! price ( ! drug 9 o!r  
simil>1 indu/rializ$ c\ntries2  7,i7    
e/imat$ global & dome/ic sales ( ! drug2
  7,j7 gross & net exp5ditures by public
 pay]s = cov]age ( ! drug "u ,f$]al     
heal? programs1 to ! ext5t available2 & 
7,k7 any additional in=mation ! ,academy
 det]m9es appropriate2  7#b7 an         
appropriate timel9e = ! submission (    
in=mation to ! ,drug ,af=dability &     
,access ,committee requir$ "u section   
#f7;a77#b7 to det]m9e ! reasonabl5ess ( 
a drug's manufactur] li/ price & retail 
price2 &  7#c7 an appropriate timel9e = 
! ,drug ,af=dability & ,access          
,committee to det]m9e ! reasonabl5ess ( 
a drug's manufactur] li/ price & retail 
price to be 9 effect ! second ye> aft]  
com+ to m>ket4  7b7 ,report ,any        
contract betwe5 ! ,secret>y & ! ,academy
 "u ?is section %all include a          
requirem5t t ! ,academy submit a report 
on ! results ( ! /udy describ$ 9        
subsection 7a7 to ! ,secret>y1 ! ,drug  
,af=dability & ,access ,committee1 &    

,congress4  #e4 ,drug ,af=dability &    
,access ,committee  7a7 ,e/abli%m5t ,!re
 is h]eby au?oriz$ to be e/abli%$ a     
nonpr(it corporation to be kn[n z !     
,drug ,af=dability & ,access ,committee 
7ref]r$ to 9 ?is section z !            
,committee71 :i* is nei!r an ag5cy nor  
e/abli%m5t ( ! ,unit$ ,/ates ,gov]nm5t4 
,! ,committee %all be head$ by an       
,executive ,director4  7b7 ,purpose ,!  
purpose ( ! ,committee is to det]m9e a  
reasonable manufactur] li/ price &      
retail price = ea* applicable drug4  7c7
 ,bo>d ( ,directors  7#a7 ,9 g5]al ,!   
,committee %all h a ,bo>d ( ,directors1 
:i* %all be compos$ ( ex (ficio &       
appo9t$ memb]s 9 accordance ) ?is       
subsection4 ,all appo9t$ memb]s ( !     
,bo>d %all be vot+ memb]s4  7#b7 ,ex    
(ficio memb]s ,! non-vot+ ex (ficio     
memb]s ( ! ,committee %all be ! foll[+  
individuals or _! designees3  7,a7 ,!   
,secret>y ( ,heal? & ,human ,s]vices4   
7,b7 ,! ,director ( ! ,national         
,in/itutes ( ,heal?4  7,c7 ,!           

,commission] ( ,food & ,drugs4  7,d7 ,! 
,director ( ! ,ag5cy = ,heal?c>e ,rese>*
 & ,quality4  7,e7 ,! ,director ( !     
,c5t]s = ,disease ,control & ,prev5tion4
  7,f7 ,! ,adm9i/rator ( ! ,c5t]s =     
,m$ic>e  ,m$icaid ,s]vices4  7,g7 ,!    
,assi/ant ,secret>y = ,plann+ &         
,evaluation4  7#c7 ,appo9t$ memb]s  7,a7
 ,9 g5]al ,t5 additional memb]s %all be 
appo9t$ to ! ,committee by ! ,comptroll]
 ,g5]al ( ! ,unit$ ,/ates n lat] ?an    
#ahj days aft] ! date ( enactm5t ( ?is  
,act4 ,su* memb]s %all include--  7i7 #b
 pati5t & consum] repres5tatives n      
affiliat$ ) any organization t receives 
fund+ f ph>maceutical manufactur]s2     
7ii7 #c provid] repres5tatives1 includ+ 
#a hospital repres5tative & #a ph>maci/ 
repres5tative2  7iii7 #a heal? s]vices  
rese>*]2  7iv7 #a heal? c>e economi/2   
7v7 #a repres5tative ( a sponsor ( a    
heal? plan or heal? insurance cov]age2  
7vi7 #a ph>macy b5efit managem5t s]vices
 repres5tative2 &  7vii7 #a drug        
manufactur] repres5tative4  7,b7        

,duration ( t]ms ,memb]s appo9t$ to !   
,committee "u subp>agraph 7,a7 %all be  
appo9t$ to s]ve #e-ye> t]ms1 :i* %all be
 /agg]$ = ! memb]s fir/ appo9t$4  7,c7  
,t]m limits ,memb]s appo9t$ to !        
,committee "u subp>agraph 7,a7 may n be 
s appo9t$ = m ?an #b t]ms4  7,d7        
,conflicts ( int]e/  7i7 ,9 g5]al ,9    
appo9t+ memb]s "u subp>agraph 7,a71 !   
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all consid] & disclose any pot5tial    
conflicts ( int]e/4 ,memb]s ( ! ,bo>d   
%all recuse !mselves or be recus$ f     
relevant ,committee activities 9 ! case 
:]e ! memb] 7or an imm$iate family memb]
 ( su* memb]7 has a conflict ( int]e/4  
7ii7 ,disclosure ( conflicts ( int]e/   
7,i7 ,9 g5]al ,a conflict ( int]e/ or   
pot5tial conflict ( int]e/ %all be      
disclos$1 z applicable-- 7aa7 by !      
,committee1 9 appo9t+ memb]s to an      
advisory committee & = employm5t z /aff 
on ! ,committee2 &  7bb7 by !           
,comptroll] ,g5]al ( ! ,unit$ ,/ates1 9 
appo9t+ memb]s ( ! ,committee4  7,,ii7  

,mann] ( disclosure ,conflicts ( int]e/s
 %all be disclos$ z soon z practicable  
on ! int]net websites ( ! ,committee & (
 ! ,gov]nm5t ,acc\ntability ,(fice4 ,!  
in=mation s disclos$ %all include !     
type1 nature1 & magnitude ( ! int]e/s ( 
! individual involv$1 except to ! ext5t 
t ! individual recuses himself or h]self
 f p>ticipat+ 9 ! consid]ation (        
activity 9 :i* ! pot5tial conflict      
exi/s4  7,e7 ,confid5tiality ,!         
,committee %all ma9ta9 ! confid5tiality 
( any in=mation provid$ to ! ,committee 
"u ?is section t is a trade secret or   
confid5tial in=mation4  7,f7 ,vacancies 
,vacancies on ! ,bo>d %all be fill$ 9 ! 
same mann] z ! orig9al appo9tm5t 0 made4
 ,any vacancy 9 ! memb]%ip ( ! ,bo>d    
%all n affect ! p[] ( ! rema9+ memb]s to
 execute ! duties ( ! ,bo>d4  7,g7      
,comp5sation ,:ile s]v+ on ! bus9ess ( !
 ,committee 7includ+ travel "t71 a memb]
 ( ! ,committee %all be entitl$ to      
comp5sation at ! p] diem equival5t ( !  
rate provid$ = level ,,iv ( ! ,executive

 ,s*$ule "u section #ecae ( title #e1   
,unit$ ,/ates ,code1 & :ile s s]v+ away 
f home & ! memb]'s regul> place (       
bus9ess1 a memb] may be all[$ travel    
exp5ses1 z au?oriz$ by ! ,*airman ( !   
,committee4  7,h7 ,no ,f$]al employees  
,no employee ( ! ,f$]al ,gov]nm5t %all  
be an appo9t$ memb] ( ! ,committee4  7d7
 ,executive director  7#a7 ,appo9tm5t ,!
 ,bo>d %all appo9t an ,executive        
,director :o %all s]ve at ! pleasure ( !
 ,bo>d4 ,! ,executive ,director %all be 
responsible = ! day-to-day op]ations ( !
 ,committee & %all h su* specific duties
 & responsibilities z ! ,bo>d %all      
prescribe1 includ+ to id5tify1 recruit1 
& hire /aff4  7#b7 ,comp5sation ,!      
comp5sation ( ! ,executive ,director    
%all be fix$ by ! ,bo>d4  7#c7          
,conflicts ( int]e/ & confid5tiality ,! 
,executive ,director & all /aff ( !     
,committee %all be subject to ! same    
conflict ( int]e/ & confid5tiality      
requirem5ts z ! ,bo>d memb]s1 z describ$
 9 subp>agraphs 7,d7 & 7,e7 ( subsection

 7c77#c74  7e7 ,initial meet+ ,! initial
 meet+ ( ! ,committee %all take place )9
 #fj days ( all memb]s be+ appo9t$4 ,9 !
 initial meet+1 ! ,committee %all--     
7#a7 incorporate ! ,committee2  7#b7    
designate a ,*air2 &  7#c7 appo9t !     
,executive ,director4  7f7 ,duties &    
au?orities ,! duties & au?orities ( !   
,committee are z foll[s3  7#a7          
,adm9i/rative duties ,! ,committee %all 
e/abli% adm9i/rative guidel9es = !      
,committee1 includ+-- 7,a7 e/abli%+     
bylaws = ! ,committee t are publi%$ 9 ! 
,f$]al ,regi/] & made available = public
 comm5t2  7,b7 e/abli%+ policies = !    
selection ( (fic]s1 employees1 ag5ts1 & 
contractors ( ! ,committee2  7,c7       
e/abli%+ policies t w\ld subject all    
employees1 fell[s1 & tra9ees ( !        
,committee to ! conflict ( int]e/ /&>ds 
"u subsection 7c77#c77;,d72  7,d7       
specify+ a process = annual ,bo>d review
 ( ! op]ations ( ! ,committee2  7,e7    
e/abli%+ specific duties ( ! ,executive 
,director2  7,f7 evaluat+ ! p]=mance ( !

 ,executive ,director2 &  7,g7 c>ry+ out
 o!r necess>y activities reg>d+ !       
function+ ( ! ,committee4  7#b7         
,process1 me?odology1 & timel9e =       
det]m9+ reasonable prices  7,a7 ,9 g5]al
 ,n lat] ?an #b ye>s aft] receipt ( !   
report ( ! ,national ,academy ( ,m$ic9e 
"u section #d1 ! ,committee %all--  7i7 
outl9e ! process & me?odology by :i* !  
,committee w det]m9e1 bas$ on su*       
report1 :e!r ! manufactur] li/ price &  
retail price is reasonable = ea*        
applicable drug2  7ii7 outl9e ! timel9e 
"u :i* ! manufactur]1 bas$ on su*       
report1 is requir$ to submit ! in=mation
 requir$ "u section #f7;a77#b7 to !     
,committee2  7iii7 outl9e ! timel9e "u  
:i* ! ,committee is requir$ to det]m9e1 
bas$ on su* report1 :e!r ! manufactur]  
li/ price & retail price is reasonable =
 ea* applicable drug2 &  7iv7 publi% su*
 propos$ process1 me?odology1 & timel9e 
on ! int]net website ( ! ,committee4    
7,b7 ,public input ,n lat] ?an #fj days 
aft] publication ( ! propos$ process1   

me?odology1 & timel9e "u subp>agraph    
7,a71 ! ,committee %all hold a m9imum ( 
#b public /akehold] meet+s to solicit   
fe$back on su* propos$ process1         
me?odology1 & timel9e4  7,c7            
,publication ( f9al process1 me?odology1
 & timel9e ,n lat] ?an #cj mon?s aft]   
receipt ( ! report "u section #d1 !     
,committee %all publi% a f9al process1  
me?odology1 & timel9e on ! ,committee's 
int]net website4  7,d7 ,updates to      
process1 me?odology1 & timel9e ,!       
,committee may make *anges & updates to 
! f9al process1 me?odology1 & timel9e z 
necess>y4 ,any su* *anges or updates    
%all be publi%$ on ! int]net website ( !
 ,committee4  7#c7 ,issuance (          
reasonable pric+ det]m9ation  7,a7      
,det]m9ations ,! ,committee %all issue a
 reasonable pric+ det]m9ation = ea*     
applicable drug t-- 7i7 is bas$ on a    
review ( ! in=mation submitt$ "u section
 #f7;a72 &  7ii7 uses ! process1        
me?odology1 & timel9e develop$ by !     
,committee "u p>agraph 7#b74  7,b7      

,timeframe ,! ,committee %all issue a   
reasonable pric+ det]m9ation "u         
subp>agraph 7,a7 = a drug t1 ^u approval
 ( an application "u section #eje7;b7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cee7;b77 or section     
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a771 w be an      
applicable drug1 tak+ into consid]ation 
! recomm5d$ timeframe "u section        
#d7;a77#b74  7,c7 ,reports to drug      
manufactur]s ,= ea* reasonable pric+    
det]m9ation made "u subp>agraph 7,a71 ! 
,committee %all submit a report 9 writ+ 
to ! applicable drug manufactur] outl9+ 
su* det]m9ation4 ,ea* su* report %all be
 made public1 exclud+ any propriet>y    
in=mation4  7#d7 ,appo9tm5t ( advisory  
committees ,! ,committee may appo9t     
p]man5t or ad hoc advisory committees z 
det]m9$ appropriate to assi/ 9 ! "w ( ! 
,committee4 ,all memb]s ( any su*       
advisory committee %all be subject to ! 
same conflict ( int]e/ requirem5ts z    
,committee memb]s4  7g7 ,annual reports 

,! ,committee %all submit an annual     
report to ,congress & to ! ,secret>y1 & 
%all make ! annual report available to !
 public4 ,ea* su* report %all include-- 
7#a7 a description ( ! activities       
conduct$ "u ?is ,act2  7#b7 ! budget ( !
 ,committee = ! foll[+ ye>2 &  7#c7 any 
o!r relevant in=mation1 includ+         
in=mation on ! memb]%ip ( ! ,bo>d1      
advisory committees1 & ! executive /aff 
( ! ,committee1 any conflicts ( int]e/ )
 respect to su* individuals1 & any      
bylaws adopt$ by ! ,bo>d dur+ ! prec$+  
ye>4  #f4 ,requirem5ts = ent]+ into a   
lic5s+ agreem5t  7a7 ,9 g5]al ,^u reta9+
 ! title to any subject inv5tion "u     
section #bjb ( title #ce1 ,unit$ ,/ates 
,code1 or ent]+ into a p>tial or        
exclusive lic5s+ agreem5t relat+ to an  
applicable drug1 ! drug manufactur] %all
 agree to--  7#a7 beg9n+ "o ye> aft] an 
applicable drug fir/ comes to m>ket1    
limit ! annual price increase on su*    
drug to ! p]c5tage by :i* ! m$ical c>e  
consum] price index detail$ exp5diture  

category = all urban consum]s = t ye>   
exce$ su* index = ! prec$+ cal5d> ye>2  
7#b7 submit to ! ,drug ,af=dability &   
,access ,committee1 on a good fai?      
timel9e t is consi/5t ) ! recomm5dation 
"u section #e7;f77#b77;,a77ii7--  7,a7 !
 manufactur] li/ price = ! drug2  7,b7 !
 retail price = ! drug2  7,c7 in=mation 
on exp5ditures1 includ+-- 7i7 ! total   
annual exp5ditures ( ! manufactur] on   
mat]ials & manufactur+ = ! drug2  7ii7 !
 total exp5ditures ( ! manufactur] on   
acquir+ pat5ts & lic5s+ = ! drug1       
includ+ expect$ royalty paym5ts2  7iii7 
! total exp5ditures ( ! manufactur] on  
rese>* & developm5t z %[n on !          
manufactur]'s ,f$]al tax returns "u     
sections #da & #agd ( ! ,int]nal ,rev5ue
 ,code ( #aihf2  7iv7 ! am\nt ( !       
manufactur]'s total exp5ditures d]iv$ f 
any ,f$]al fund+ s\rce1 includ+ tax     
d$uctions or cr$its claim$2 &  7v7 total
 expect$ exp5ditures = m>ket+ & adv]tis+
 = ! drug 9 ! fir/ #c ye>s t ! drug is  
on ! m>ket2  7,d7 ! anticipat$ numb] (  

pati5ts :o w be treat$ ) ! drug2  7,e7 a
 copy ( ! application submitt$ "u       
section #eje7;b7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77 or section #cea7;a7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a77 & any subsequ5t     
in=mation or data reque/$ by1 or        
submitt$ to1 ! ,food & ,drug            
,adm9i/ration dur+ ! approval process2  
7,f7 any additional in=mation reque/$ by
 ! ,drug ,af=dability & ,access         
,committee2 &  7,g7 any additional      
in=mation ! manufactur] *ooses to       
provide relat$ to drug pric+ decisions2 
7#c7 submit ! manufactur] li/ price &   
retail price ( an applicable drug to !  
,drug ,af=dability & ,access ,committee 
= a reasonable price det]m9ation2 &     
7#d7 beg9n+ "o ye> aft] an applicable   
drug fir/ comes to m>ket1 n exce$ !     
reasonable price1 z det]m9$ by su*      
,committee1 = ! drug's manufactur] li/  
price4  7b7 ,p5alties  7#a7 ,loss (     
p]iod ( m>ket exclusivity ,9 ! case ( a 

drug manufactur] subject to ?is section 
:o increases ! price ( an applicable    
drug to an am\nt t exce$s ! am\nt "u    
subsection 7a77#a7 or exce$s !          
reasonable price z requir$ "u subsection
 7a77#d71 any p]iod ( m>ket exclusivity 
) respect to ! applicable drug %all be  
deem$ expir$1 effective on ! date ( su* 
price increase or laun* price4  7#b7    
,prohibition on ent]+ into future lic5s+
 agreem5ts ,if a drug manufactur] fails 
to adh]e to ! limit on annual price     
increases "u subsection 7a77#a71 su*    
drug manufactur]1 & its presid5t1 *ief  
executive (fic]1 *ief op]at+ (fic]1 &   
g5]al c\nsel employ$ at ! "t ( !        
violation1 %all be ineligible = future  
lic5s+ agreem5ts = qualify+ pat5t$      
te*nology4  7#c7 ,prohibition on ent]+  
into future lic5s+ agreem5ts ,if a drug 
manufactur] fails to adh]e to !         
reasonable price z requir$ "u subsection
 7a77#d71 ! drug manufactur]1 & its     
presid5t1 *ief executive (fic]1 *ief    
op]at+ (fic]1 & g5]al c\nsel1 %all be   

ineligible = future lic5s+ agreem5ts =  
qualify+ pat5t$ te*nology4  7#d7        
,failure to submit in=mation or submitt+
 false in=mation to ! ,drug ,af=dability
 & ,access ,committee ,any manufactur] t
 fails to submit in=mation requir$ "u   
subsection 7a77#b7 to be submitt$ to !  
,drug ,af=dability & ,access ,committee1
 or :o submits false in=mation to su*   
,committee %all be subject to a civil   
monet>y p5alty ( #ejj1jjj & if a        
violation is n correct$ )9 #cj days     
foll[+ notification ( su* violation1    
#a1jjj1jjj = ea* day t ! violation      
cont9ues aft] su* p]iod until !         
violation is correct$4  7#e7 ,excessive 
price 9 ! fir/ ye> ( laun* ,if a drug   
manufactur]'s laun* price 9 ! fir/ ye> =
 an applicable drug is at lea/ #ej p]c5t
 high] ?an ! reasonable price z requir$ 
"u subsection 7a77#d7 to be 9 effect = !
 second ye>1 ! drug manufactur] %all be 
subject to a civil monet>y p5alty ( !   
co/ ( ! drug 9 excess ( #ej p]c5t       
multipli$ by ! numb] ( doses ( ! drug   

sold 9 ! ,unit$ ,/ates 9 ! fir/ ye> on !
 m>ket4  7#f7 ,di/ribution ( paym5ts to 
! national in/itutes ( heal?  7,a7 ,9   
g5]al ,ea* fiscal ye>1 !re %all be      
transf]r$1 out ( funds 9 ! ,treasury n  
o!rwise obligat$1 to ! ,director ( !    
,national ,in/itutes ( ,heal?1 an am\nt 
equal to ! am\nt collect$ 9 civil       
p5alties "u ?is subsection dur+ !       
previ\s fiscal ye>1 unless ! am\nt      
o!rwise appropriat$ to ! ,national      
,in/itutes ( ,heal? = ! fiscal ye> 9 :i*
 su* transf] w\ld occur is less ?an !   
am\nt s appropriat$ = ! previ\s fiscal  
ye>4  7,b7 ,delay$ di/ribution ,if1 9   
accordance ) clause 7i71 ! ,secret>y ( !
 ,treasury does n transf] am\nts "u su* 
clause dur+ any portion ( a fiscal ye>1 
&1 at a lat] date 9 su* fiscal ye>1 !   
appropriations to ! ,national ,in/itutes
 ( ,heal? becomes equal to or great] ?an
 ! am\nt ( appropriations = ! previ\s   
fiscal ye>1 su* ,secret>y %all transf]  
su* am\nt at any "t 9 su* fiscal ye>4   
#g4 ,prop] disclosure ( gov]nm5t support

  7a7 ,def9itions ,9 ?is section-- 7#a7 
! t]m contractor--  7,a7 has ! mean+    
giv5 ! t]m 9 section #bja ( title #ce1  
,unit$ ,/ates ,code2 &  7,b7 includes an
 assignee ( a contractor to ! ext5t t ! 
assignee is ! entity t files an         
application describ$ 9 section          
#bjb7;c77#f72  7#b7 ! t]m cov]$         
contractor means a contractor t-- 7,a7  
is a p>ty to a fund+ agreem5t t conta9s 
an appropriate provision to effectuate !
 requirem5t "u section #bjb7;c77#f72 &  
7,b7 files a ,unit$ ,/ates pat5t        
application ) respect to a subject      
inv5tion t ! contractor conceiv$ or fir/
 actually r$uc$ to practice 9 ! p]=mance
 ( "w "u ! fund+ agreem5t describ$ 9    
subp>agraph 7,a72  7#c7 ! t]m cov]$     
pat5tee means ! pat5tee ) respect to a  
pat5t issu+ f an application describ$ 9 
p>agraph 7#b77;,b72  7#d7 ! t]m drug has
 ! mean+ giv5 t t]m 9 section #bja ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act2  
7#e7 ! t]ms fund+ agreem5t & subject    
inv5tion h ! mean+s giv5 ! t]ms 9       

section #bja ( title #ce1 ,unit$ ,/ates 
,code2  7#f7 ! t]m pat5tee has ! mean+  
giv5 ! t]m 9 section #ajj ( title #ce1  
,unit$ ,/ates ,code2 &  7#g7 ! t]m      
section #bjb7;c77#f7 means section      
#bjb7;c77#f7 ( title #ce1 ,unit$ ,/ates 
,code4  7b7 ,actions = failure ,to      
disclose gov]nm5t support  7#a7 ,private
 "r ( action  7,a7 ,9 g5]al ,a p]son    
7includ+ a gov]nm5t entity7 may br+ a   
civil action 9 an appropriate di/rict   
c\rt ( ! ,unit$ ,/ates aga9/ a cov]$    
pat5tee--  7i7 on ! gr\nd t !           
application = ! pat5t ) respect to :i* !
 cov]$ pat5tee holds title fail$ to     
comply ) ! requirem5t "u section        
#bjb7;c77#f72 &  7ii7 if ! p]son is     
injur$ by ! failure to comply describ$ 9
 clause 7i74  7,b7 ,scope ,9 an action  
br\ght "u subp>agraph 7,a71 if ! c\rt   
f9ds by a prepond]ance ( ! evid5ce t !  
application describ$ 9 t subp>agraph    
fail$ to comply ) ! requirem5t "u       
section #bjb7;c77#f71 ! c\rt %all cancel
 z unpat5table any claim ( ! pat5t issu+

 f t application4  7#b7 ,int] p>tes     
review ,section #caa ( title #ce1 ,unit$
 ,/ates ,code1 is am5d$ by /rik+        
subsection 7b7 & ins]t+ ! foll[+3  7b7  
,scope ,a petition] 9 an int] p>tes     
review may reque/ to cancel z           
unpat5table #a or m claims ( a pat5t--  
7#a7 7,a7 on a gr\nd t c\ld be rais$ "u 
section #ajb or #ajc2 &  7,b7 on ! basis
 ( prior art consi/+ ( pat5ts or pr9t$  
publications2 or  7#b7 on ! gr\nd t !   
application ) respect to ! pat5t 0      
subject to ! requirem5t 9 section       
#bjb7;c77#f7 & fail$ to comply ) t      
requirem5t4  4  7c7 ,disclosure ( grants
 ,section #aaa7;a77#b7 ( title #ce1     
,unit$ ,/ates ,code1 is am5d$-- 7#a7 9  
subp>agraph 7,b71 by /rik+ & at ! end2  
7#b7 9 subp>agraph 7,c71 by /rik+ !     
p]iod & ins]t+ 2 &2 &  7#c7 by add+ at !
 end ! foll[+3  7,d7 ) respect to a drug
 7z def9$ 9 section #bja ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act7 cov]$ by
 a qualify+ pat5t on ! drug1 on a me?od 
( us+ su* drug1 or on a me?od or ma*9e  

us$ to manufacture or adm9i/] su* drug1 
a disclosure ( any ,f$]al grant receiv$ 
9 ! #aj-ye> p]iod prior to submitt+ !   
application1 9 :i* ! applicant is li/$ z
 ! pr9cipal inve/igator or              
co-inve/igator ) respect to ! grant4  4 
7d7 ,,gao report ,n lat] ?an #e ye>s    
aft] ! date ( enactm5t ( ?is ,act1 &    
once e #e ye>s !reaft]1 ! ,comptroll]   
,g5]al ( ! ,unit$ ,/ates %all--  7#a7   
conduct a /udy t reviews-- 7,a7 !       
compliance by cov]$ contractors ) !     
requirem5t "u section #bjb7;c77#f72 &   
7,b7 ! effectiv5ess ( ! ,national       
,in/itutes ( ,heal? 9 conduct+ ov]sight 
( ! ext5t to :i* cov]$ contractors are  
comply+ ) ! requirem5t "u section       
#bjb7;c77#f72 &  7#b7 submit to         
,congress ! results ( ea* /udy conduct$ 
"u p>agraph 7#a71 :i* %all include1 9   
ea* case1 recomm5dations = additional   
practices & policies to improve !       
effectiv5ess ( ! requirem5t "u section  
#bjb7;c77#f71 includ+ any me*anism to   
bett] en=ce t requirem5t4