,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #acia  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #i1 #bjai,ms4     
,baldw9 7= h]self1 ,mr4 ,braun1 ,ms4    
,murk[ski1 & ,ms4 ,smi?7 introduc$ !    
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to      
require report+ reg>d+ c]ta9 drug price 
increases1 & = o!r purposes4  #a4 ,%ort 
title ,?is ,act may be cit$ z ! ,fair   
,acc\ntability & ,innovative ,rese>*    
,drug ,pric+ ,act ( #bjai4  #b4 ,report+
 on ju/ification = drug price increases 
,title ,,iii ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bda et seq47 is    
am5d$ by add+ at ! end ! foll[+3  ,w    
,drug ,price ,report+2 ,drug ,value     
,fund  #cii,,oo4 ,report+ on            
ju/ification = drug price increases  7a7
 ,def9itions ,9 ?is section3 7#a7       
,manufactur] ,! t]m manufactur] means ! 
p]son-- 7,a7 t holds ! application = a  
drug approv$ "u section #eje ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act or !     

lic5se issu$ "u section #cea ( ?is ,act2
 or  7,b7 :o is responsible = sett+ !   
price = ! drug4  7#b7 ,qualify+ drug ,! 
t]m qualify+ drug means any drug t is   
approv$ "u subsection 7c7 or 7j7 (      
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act or lic5s$ "u subsection  
7a7 or 7k7 ( section #cea ( ?is ,act--  
7,a7 t has a :olesale acquisition co/ ( 
#ajj or m p] mon? supply1 or p] a c\rse 
( treatm5t t la/s less ?an a mon?1 &    
is-- 7i7 7,i7 subject to section        
#ejc7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act2 or  7,,ii7 commonly     
adm9i/]$ by hospitals 7z det]m9$ by !   
,secret>y72 &  7ii7 n designat$ by !    
,secret>y z a vacc9e2 &  7,b7 = :i*1    
dur+ ! previ\s cal5d> ye>1 at lea/ #a   
doll> ( ! total am\nt ( sales 7 =       
individuals enroll$ "u ! ,m$ic>e program
 "u title ,,xviii ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acie et seq47 or "u
 a ,/ate ,m$icaid plan "u title ,,xix ( 
su* ,act 7#db ,u4,s4,c4 #acif et seq47  
or "u a waiv] ( su* plan4  7#c7         

,: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  7b7 ,report  
7#a7 ,report requir$ ,! manufactur] ( a 
qualify+ drug %all submit a report to ! 
,secret>y = ea* price increase ( a      
qualify+ drug t w result 9 an increase 9
 ! :olesale acquisition co/ ( t drug t  
is equal to-- 7,a7 #aj p]c5t or m ov] a 
#ab-mon? p]iod2 or  7,b7 #be p]c5t or m 
ov] a #cf-mon? p]iod4  7#b7 ,report     
deadl9e ,ea* report describ$ 9 p>agraph 
7#a7 %all be submitt$ to ! ,secret>y n  
lat] ?an #cj days prior to ! plann$     
effective date ( su* price increase4    
7c7 ,cont5ts ,a report "u subsection 7b7
 %all1 at a m9imum1 include-- 7#a7 )    
respect to ! qualify+ drug-- 7,a7 !     
p]c5tage by :i* ! manufactur] w raise ! 
:olesale acquisition co/ ( ! drug on !  
plann$ effective date ( su* price       
increase2  7,b7 a ju/ification =1 &     

description (1 ea* manufactur]'s price  
increase t w occur dur+ ! #ab-mon? p]iod
 describ$ 9 subsection 7b77#a77;,a7 or !
 #cf-mon? p]iod describ$ 9 subsection   
7b77#a77;,b71 z applicable2  7,c7 !     
id5tity ( ! initial develop] ( ! drug2  
7,d7 a description ( ! hi/ory ( !       
manufactur]'s price increases = ! drug  
s9ce ! approval ( ! application = ! drug
 "u section #eje ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act or ! issuance ( 
! lic5se = ! drug "u section #cea1 or   
s9ce ! manufactur] acquir$ su* approv$  
application or lic5se2  7,e7 ! curr5t   
li/ price ( ! drug2  7,f7 ! total       
exp5ditures ( ! manufactur] on-- 7i7    
mat]ials & manufactur+ = su* drug2 &    
7ii7 acquir+ pat5ts & lic5s+ = su* drug2
  7,g7 ! p]c5tage ( total exp5ditures ( 
! manufactur] on rese>* & developm5t =  
su* drug t 0 d]iv$ f ,f$]al funds2  7,h7
 ! total exp5ditures ( ! manufactur] on 
rese>* & developm5t = su* drug t is us$ 
=-- 7i7 basic & precl9ical rese>*2  7ii7
 cl9ical rese>*2  7iii7 new drug        

developm5t2  7iv7 pursu+ new or exp&$   
indications = su* drug ?r\gh supplem5tal
 applications "u section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act or      
section #cea ( ?is ,act2 &  7v7 c>ry+   
out po/m>ket requirem5ts relat$ to su*  
drug1 includ+ ^? "u section #eje7o77#c7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act2  7,i7 ! total rev5ue & ! net pr(it
 g5]at$ f ! qualify+ drug = ea* cal5d>  
ye> s9ce ! approval ( ! application = ! 
drug "u section #eje ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act or ! issuance ( 
! lic5se = ! drug "u section #cea1 or   
s9ce ! manufactur] acquir$ su* approv$  
application or lic5se2 &  7,j7 ! total  
co/s associat$ ) m>ket+ & adv]tis+ = !  
qualify+ drug2  7#b7 ) respect to !     
manufactur]-- 7,a7 ! total rev5ue & !   
net pr(it ( ! manufactur]-- 7i7 = !     
#ab-mon? p]iod prec$+ ! date ( ! report1
 9 ! case ( a report bas$ on an increase
 describ$ 9 subsection 7b77#a77;,a72 or 
7ii7 = ! #cf-mon? p]iod prec$+ ! date ( 
! report1 9 ! case ( a report bas$ on an

 increase describ$ 9 subsection         
7b77#a77;,b72  7,b7 all /ock-bas$       
p]=mance metrics us$ by ! manufactur] to
 det]m9e executive comp5sation-- 7i7 = !
 #ab-mon? p]iod prec$+ ! date ( !       
report1 9 ! case ( a report bas$ on an  
increase describ$ 9 subsection          
7b77#a77;,a72 or  7ii7 = ! #cf-mon?     
p]iod prec$+ ! date ( ! report1 9 ! case
 ( a report bas$ on an increase describ$
 9 subsection 7b77#a77;,b72 &  7,c7 any 
additional in=mation ! manufactur]      
*ooses to provide relat$ to drug pric+  
decisions1 su* z total exp5ditures on-- 
7i7 drug rese>* & developm5t2 or  7ii7  
cl9ical trials on drugs t fail$ to      
receive approval by ! ,food & ,drug     
,adm9i/ration2 &  7#c7 su* o!r relat$   
in=mation z ! ,secret>y consid]s        
appropriate4  7d7 ,civil p5alty ,any    
manufactur] ( a qualify+ drug t fails to
 submit a report = ! drug z requir$ by  
?is section %all be subject to a civil  
p5alty ( #ajj1jjj = ea* day on :i* !    
violation cont9ues4  7e7 ,public po/+   

7#a7 ,9 g5]al ,subject to p>agraph 7#c71
 n lat] ?an #cj days aft] ! submission (
 a report "u subsection 7b71 ! ,secret>y
 %all po/ ! report on ! public website (
 ! ,dep>tm5t ( ,heal? & ,human ,s]vices4
  7#b7 ,=mat ,9 develop+ ! =mat ( su*   
report = public po/+1 ! ,secret>y %all  
consult /akehold]s1 includ+ b5efici>y   
gr\ps1 & %all seek fe$back on ! cont5t &
 =mat f consum] advocates & readability 
exp]ts to ensure su* public reports are 
us]-fri5dly to ! public & are writt5 9  
pla9 language t consum]s c readily      
und]/&4  7#c7 ,trade secrets &          
confid5tial in=mation ,9 c>ry+ out ?is  
section ! ,secret>y %all en=ce curr5t   
law conc]n+ ! protection ( confid5tial  
comm]cial in=mation & trade secrets4  4 
#cii,,oo-#a4 ,use ( civil p5alty am\nts 
,! ,secret>y %all1 )\t fur!r            
appropriation1 collect civil p5alties "u
 section #cii,,oo & use ! funds d]iv$ f 
su* civil p5alties1 9 addition to any   
o!r am\nts available to ! ,secret>y1 to 
c>ry out activities describ$ 9 ?is "p & 

to improve consum] & provid] in=mation  
ab\t drug value & drug price transp>5cy4
  #cii,,oo-#b4 ,annual report to        
,congress  7a7 ,9 ,g5]al ,subject to    
subsection 7b71 ! ,secret>y %all submit 
to ,congress1 & po/ on ! public website 
( ! ,dep>tm5t ( ,heal? & ,human ,s]vices
 9 a way t is easy to f9d1 use1 &       
und]/&1 an annual report-- 7#a7 summ>iz+
 ! in=mation report$ pursuant to section
 #cii,,oo2 &  7#b7 includ+ copies ( !   
reports & support+ detail$ economic     
analyses submitt$ pursuant to su*       
section4  7b7 ,trade secrets &          
confid5tial in=mation ,9 c>ry+ out ?is  
section ! ,secret>y %all en=ce curr5t   
law conc]n+ ! protection ( confid5tial  
comm]cial in=mation & trade secrets4  4