,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #cafb  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,janu>y #h1 #bjbj,ms4  
,w>r5 introduc$ ! foll[+ bill2 :i* 0    
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,public ,heal?    
,s]vice ,act to e/abli% an ,(fice (     
,drug ,manufactur+4  #a4 ,%ort title    
,?is ,act may be cit$ z ! ,af=dable     
,drug ,manufactur+ ,act ( #bjbj4  #b4   
,public manufactur+ ( ph>maceuticals ,"p
 ,a ( title ,,iii ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4 #bda et     
seq47 is am5d$ by add+ at ! end !       
foll[+3  #caj;,b4 ,manufactur+ ( drugs  
7a7 ,e/abli%m5t ( ,(fice ( ,drug        
,manufactur+  7#a7 ,9 g5]al ,!re is     
e/abli%$ )9 ! ,dep>tm5t ( ,heal? &      
,human ,s]vices an (fice to be kn[n z ! 
,(fice ( ,drug ,manufactur+ 7ref]r$ to 9
 ?is section z ! ,(fice74  7#b7 ,purpose
 ,! purpose ( ! ,(fice is-- 7,a7 to     
increase competition1 l[] prices1 &     
address %ortages 9 ! m>ket =            

prescription drugs1 includ+ insul91     
naloxone1 & antibiotics2  7,b7 to r$uce 
! co/ ( prescription drugs to ,f$]al &  
,/ate heal? programs1 taxpay]s1 &       
consum]s2 &  7,c7 to increase pati5t    
access to af=dable drugs4  7#c7         
,p]sonnel  7,a7 ,director  7i7 ,9 g5]al 
,! ,(fice %all be head$ by a ,director1 
:o %all be appo9t$ by ! ,presid5t1 by & 
) ! advice & cons5t ( ! ,s5ate4  7ii7   
,comp5sation ,! ,director %all be       
comp5sat$ at ! rate prescrib$ = level   
,,iii ( ! ,executive ,s*$ule4  7,b7     
,employees ,! ,director ( ! ,(fice1 9   
consultation ) ! ,secret>y1 may fix !   
numb] (1 & appo9t & direct1 all         
employees ( ! ,(fice4  7,c7 ,bann$      
individuals  7i7 ,drug company lobbyi/s 
,no =m] regi/]$ drug manufactur]        
lobbyi/-- 7,i7 may be appo9t$ to !      
position ( ,director ( ! ,(fice2 or     
7,,ii7 may be employ$ by ! ,(fice dur+ !
 #f-ye> p]iod beg9n+ on ! date on :i* ! 
regi/]$ lobbyi/ t]m9ates its regi/ration
 9 accordance ) section #d7;d7 ( !      

,lobby+ ,disclosure ,act ( #aiie 7#b    
,u4,s4,c4 #afjc7;d77 or ! ag5t t]m9ates 
its /atus1 z applicable4  7ii7 ,s5ior   
executives ( law-break+ companies ,no   
=m] s5ior executive ( a cov]$ entity 7z 
def9$ 9 clause 7iii77-- 7,i7 may be     
appo9t$ to ! position ( ,director ( !   
,(fice2 or  7,,ii7 may be employ$ by !  
,(fice dur+ ! #f-ye> p]iod beg9n+ on !  
lat] (--  7aa7 ! date ( ! settlem5t2 &  
7bb7 ! date on :i* ! en=cem5t action has
 conclud$4  7iii7 ,cov]$ entity ,! t]m  
cov]$ entity means any entity t is--    
7,i7 a drug manufactur]2 &  7,,ii7 7aa7 
op]at+ "u ,f$]al settlem5t1 includ+ a   
,f$]al cons5t decree2 or  7bb7 ! subject
 ( an en=cem5t action 9 a c\rt ( !      
,unit$ ,/ates or by an ag5cy4  7#d7     
,duties  7,a7 ,9 g5]al ,! ,(fice %all-- 
7i7 prep>e & submit applications =      
approval to ! ,food & ,drug             
,adm9i/ration1 or ent] into contracts = 
su* submission1 = ! manufacture (       
applicable drugs :5 au?oriz$ "u ?is     
section2  7ii7 acquire rights to        

manufacture applicable drugs z au?oriz$ 
"u ?is section2  7iii7 manufacture1 or  
ent] into contracts ) entities to       
manufacture1 applicable drugs z au?oriz$
 "u ?is section2  7iv7 det]m9e a fair   
price = ea* applicable drugs1 9         
accordance ) subp>agraph 7,b72  7v7 sell
 manufactur$ applicable drugs at a fair 
price z au?oriz$ "u ?is section2 &  7vi7
 manufacture1 or ent] into contracts )  
entities to manufacture1 active         
ph>maceutical +r$i5ts = use by ! ,(fice 
or = sale to o!r entities4  7,b7 ,fair  
price ,9 det]m9+ a fair price = an      
applicable drug "u subp>agraph 7,a77iv7 
! ,(fice %all consid]--  7i7 ! impact ( 
price on pati5t access to ! applicable  
drug2  7ii7 ! co/ ( ! applicable drug to
 ,f$]al or ,/ate heal? c>e programs2    
7iii7 ! co/ to ! ,f$]al ,gov]nm5t (     
manufactur+ ! applicable drug2  7iv7 !  
adm9i/rative co/s ( op]at+ ! ,(fice2    
7v7 ! co/ to acquire or manufacture     
applicable drugs "u ?is section2 &  7vi7
 ! impact ( price on m>ket competition =

 ! applicable drug4  7,c7 ,acquir+ "r to
 manufacture & m>ket ,! ,(fice may      
acquire ! rights to manufacture & m>ket 
applicable drugs z au?oriz$ "u ?is      
section4  7,d7 ,active ph>maceutical    
+r$i5ts  7i7 ,9 g5]al ,! ,(fice %all    
manufacture1 or ent] into contracts )   
entities to manufacture1 an active      
ph>maceutical +r$i5t if--  7,i7 ! ,(fice
 det]m9es t su* +r$i5t is n readily     
available f exi/+ suppli]s2  7,,ii7 !   
manufacture ( su* +r$i5t w\ld improve ! 
ability ( o!r entities to ent] ! m>ket =
 ! manufacture ( g5]ic drugs or o!rwise 
exp& ! manufacture ( g5]ic drugs2 or    
7,,iii7 ! manufacture ( su* +r$i5t is   
necess>y = ! ,(fice to c>ry out its     
duties "u ?is section4  7ii7 ,price     
det]m9ations ,9 det]m9+ :at price at :i*
 to sell an active ph>maceutical +r$i5t 
"u clause 7i71 ! ,(fice %all consid] !  
co/ to manufacture ! +r$i5t1 !          
adm9i/rative co/s ( ! ,(fice ) respect  
to ! +r$i5t1 & ! impact ( su* price on  
m>ket competition = ! +r$i5t4  7#e7     

,reports to congress ,! ,director %all  
prep>e & submit to ! ,presid5t1 !       
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions ( ! ,s5ate1 & !      
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives1 an annual      
report t includes--  7,a7 an assessm5t (
 ! major problems fac$ by pati5ts 9     
access+ af=dable g5]ic m$ications2  7,b7
 a description ( ! /atus ( all          
m$ications = :i* manufactur+ has be5    
au?oriz$ "u ?is section1 includ+        
m$ications be+ manufactur$1 m$ications =
 :i* ! ,(fice has submitt$ an           
application to ! ,food & ,drug          
,adm9i/ration b has n yet receiv$       
approval1 & m$ications = :i* ! ,(fice   
has receiv$ approval f ! ,food & ,drug  
,adm9i/ration b are n be+ manufactur$2  
7,c7 9 ! case ( antibiotics manufactur$ 
"u ?is section1 an assessm5t f ! ,c5t]s 
= ,disease ,control & ,prev5tion & !    
,food & ,drug ,adm9i/ration on ! impact 
( ! manufactur+ ( antibiotics on        
antimicrobial resi/ance2 &  7,d7 an     

analysis ( h[ ! public manufacture (    
drugs meet+ ! conditions describ$ 9     
p>agraph 7#f7 w\ld impact1 or has       
already impact$1 competition1 access to 
su* drugs1 ! co/s ( su* drugs1 ! co/s ( 
prescription drugs to ,f$]al & ,/ate    
heal? programs1 & public heal?4  7#f7   
,priority manufactur+ ,! ,(fice %all    
prioritize ! manufactur+ ( ^? applicable
 drugs t w\ld h ! greate/ impact on--   
7,a7 l[]+ drug co/s to pati5ts2  7,b7   
increas+ competition & address+ %ortages
 9 ! prescription drug m>ket2  7,c7     
improv+ public heal?2 or  7,d7 r$uc+ !  
co/ ( prescription drugs to ,f$]al &    
,/ate heal? programs4  7#g7 ,manufactur+
 levels ,n lat] ?an #a ye> aft] ! date (
 enactm5t ( ?is section1 ! ,(fice %all  
manufacture1 or ent] into contracts )   
entities = ! manufacture (1 n less ?an  
#ae applicable drugs4 ,n lat] ?an #c    
ye>s aft] su* date ( enactm5t1 ! ,(fice 
%all manufacture1 or ent] into contracts
 ) entities = ! manufacture (1 n less   
?an #be applicable drugs4  7b7          

,submission ( applications ,= ea*       
applicable drug t ! ,(fice det]m9es %\ld
 be manufactur$1 z provid$ = "u ?is     
section1 ! ,secret>y %all--  7#a7 submit
 an application "u section #eje7;j7 or  
#eae ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act or section #cea7k7 ( !   
,public ,heal? ,s]vice ,act or submit a 
notification "u section #eaj7k7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7or ent] into a contract ) ano!r entity 
to submit su* an application or         
notification72 or  7#b7 acquire f !     
hold] ( an application approv$ "u       
subsection 7c7 or 7j7 ( section #eje or 
section #eae ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act or section #cea ( !      
,public ,heal? ,s]vice ,act1 or cle>$ "u
 section #eaj7k7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act1 rights to      
manufacture su* applicable drug4  7c7   
,use  7#a7 ,9 g5]al ,! ,secret>y %all   
sell a drug produc$ "u ?is section at a 
fair price to o!r entities4 ,am\nts     
receiv$ f ! sale ( su* drugs %all be us$

 = ! activities ( ! ,(fice4  7#b7 ,sale 
( approv$ application  7,a7 ,9 g5]al ,= 
any applicable drug t ! ,(fice is       
manufactur+1 ! ,secret>y %all1 beg9n+ #c
 ye>s aft] ! date on :i* ! ,(fice fir/  
und]takes manufactur+ ( su* drug &      
annually !reaft]1 make available = sale1
 to any p]son :o commits to manufactur+ 
& m>ket+ ! applicable drug1 ! approv$   
application = ! drug4  7,b7 ,failure to 
use ,if a p]son pur*as+ an approv$      
application "u subp>agraph 7,a7-- 7i7   
fails to m>ket ! applicable drug )9 #f  
mon?s ( ! date ( su* pur*ase2 or  7ii7  
increases ! av]age manufactur] price = !
 applicable drug above ! fair price     
7increas$ by ! consum] price index = all
 urban consum]s 7z publi%$ by ! ,bureau 
( ,labor ,/ati/ics7 = t ye>71  !        
,secret>y %all revoke ! pur*as]'s       
approv$ application & resume production 
( ! applicable drug4  7d7 ,insul9 ,n    
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is section1 ! ,secret>y %all beg9 !   
public manufactur+ ( insul9 )9 a deliv]y

 device t does n violate active pat5ts1 
meet+ ! def9ition ( applicable drug & 9 
accordance ) ?is section4  7e7 ,naloxone
 ,n lat] ?an #a ye> aft] ! date (       
enactm5t ( ?is section1 ! ,secret>y %all
 beg9 ! public manufactur+ ( naloxone1  
includ+ naloxone indicat$ = community   
use1 meet+ ! def9ition ( applicable drug
 & 9 accordance ) ?is section4  7f7     
,antibiotics ,n lat] ?an #a ye> aft] !  
date ( enactm5t ( ?is section1 & 9      
consultation ) ! ,c5t]s = ,disease      
,control & ,prev5tion & ! ,food & ,drug 
,adm9i/ration to ensure ! appropriate   
use ( manufactur$ antibiotics1 !        
,secret>y %all beg9 ! public manufactur+
 ( no few] ?an ?ree discrete antibiotics
 meet+ ! def9ition ( applicable drug 9  
accordance ) ?is section4  7g7          
,applicable drug ,9 ?is section1 ! t]m  
applicable drug means a drug 7z def9$ 9 
section #bja ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act71 biological product 7z  
def9$ 9 section #cea ( ! ,public ,heal? 
,s]vice ,act71 or comb9ation product 7z 

describ$ 9 section #ejc7;g7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act7 = :i* an
 approv$ application "u section #eje or 
#eae ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act or section #cea ( !      
,public ,heal? ,s]vice ,act1 or cle>ance
 "u section #eaj7k7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act1 is 9 effect1   
&--  7#a7 7,a7 = :i*1 ) respect to a    
drug includ$ 9 ! li/ describ$ 9 section 
#eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act1 ea* pat5t includ$ )     
respect to su* drug 9 su* li/ has       
expir$1 or ea* pat5t t claims a         
biological product has expir$2  7,b7 any
 p]iod ( regulatory exclusivity grant$  
"u-- 7i7 clause 7ii71 7iii71 or 7iv7 (  
section #eje7;c77#c77;,e7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act1 section 
#eje7;j77#e77;,b77iv7 ( su* ,act1 clause
 7ii71 7iii71 or 7iv7 ( section         
#eje7;j77#e77;,f7 ( su* ,act1 section   
#ebg ( su* ,act1 & any ext5sion ( su* a 
p]iod grant$ "u section #eje;,a or      
#eje;,e ( su* ,act1 has expir$2 or  7ii7

 p>agraph 7#f7 or 7#g7 ( section #cea7k7
 ( ! ,public ,heal? ,s]vice ,act1 & any 
ext5sion ( su* a p]iod grant$ "u        
p>agraph 7#b7 or 7#c7 ( section #cea7m7 
( su* ,act1 has expir$2 &  7,c7 7i7 t is
 n be+ m>ket$ 9 ! ,unit$ ,/ates2 or     
7ii7 t is be+ m>ket$ 9 ! ,unit$ ,/ates  
by few] ?an #c manufactur]s1 & t--  7,i7
 9 ! previ\s #e-ye> p]iod1 has exp]i5c$ 
an increase 9 ! :olesale acquisition co/
 by at lea/ "o ( its manufactur]s t is  
great] ?an ! consum] price index = all  
urban consum]s 7z publi%$ by ! ,bureau (
 ,labor ,/ati/ics7 = "o ( ! ye>s 9 t    
same p]iod2  7,,ii7 is includ$ 9 ! drug 
%ortage li/ "u section #ejf;,e ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act2  
or  7,,iii7 7aa7 has an av]age :olesale 
acquisition co/ t ! ,secret>y det]m9es  
to be a b>ri] to pati5t access2 &  7bb7 
is li/$ by ! ,_w ,heal? ,organization z 
an ess5tial m$ic9e2 or  7#b7 = :i* !re  
is 9 effect a lic5se1 or pat5t use is   
au?oriz$1 "u--  7,a7 section #adih (    
title #bh1 ,unit$ ,/ates ,code2  7,b7   

section #bjb ( title #ce1 ,unit$ ,/ates 
,code2  7,c7 section #bjc ( title #ce1  
,unit$ ,/ates ,code 7m>*-9 rights72     
7,d7 section #bji ( title #ce1 ,unit$   
,/ates ,code2 or  7,e7 any o!r lic5s+   
au?ority ( ! ,f$]al ,gov]nm5t4  7h7     
,au?orization ( appropriations ,!re are 
au?oriz$ to be appropriat$ su* sums z   
may be necess>y to c>ry out ?is section4
  4