,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #cgg  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #g1 #bjai,mr4 
,br[n 7= himself1 ,ms4 ,baldw91 & ,ms4  
,klobu*>7 introduc$ ! foll[+ bill2 :i* 0
 read twice & ref]r$ to ! ,committee on 
,f9ance  ,a ,,bill  ,to am5d title      
,,xviii ( ! ,social ,security ,act to   
require ! ,secret>y ( ,heal? & ,human   
,s]vices to negotiate prices (          
prescription drugs furni%$ "u "p ,d ( ! 
,m$ic>e program4  #a4 ,%ort title ,?is  
,act may be cit$ z ! ,m$ic>e            
,negotiation & ,competitive ,lic5s+ ,act
 ( #bjai4  #b4 ,requir+ ! ,secret>y (   
,heal? & ,human ,s]vices to negotiate   
prices ( prescription drugs furni%$ "u  
"p ,d ( ! ,m$ic>e program ,section      
#ahfj;,d-#aa ( ! ,social ,security ,act 
7#db ,u4,s4,c4 #aciew-#aaa7 is am5d$ by 
/rik+ subsection 7i7 & ins]t+ ! foll[+  
new subsection3  7i7 ,negotiation ( l[] 
drug prices  7#a7 ,9 g5]al ,not)/&+ any 
o!r provision ( law1 ! ,secret>y %all1 =
 plan ye>s beg9n+ on or aft] ! date ( ! 

enactm5t ( ?is subsection1 negotiate )  
ph>maceutical manufactur]s ! prices     
7includ+ disc\nts1 rebates1 & o!r price 
concessions7 t may be *>g$ to ,,pdp     
sponsors & ,,ma organizations dur+ a    
negotiat$ price p]iod 7z specifi$ by !  
,secret>y7 = cov]$ "p ,d drugs = "p ,d  
eligible individuals :o are enroll$ "u a
 prescription drug plan or "u an        
,,ma-,,pd plan4 ,9 negotiat+ su* prices 
"u ?is section1 ! ,secret>y %all take   
into acc\nt ! foll[+ factors3  7,a7 ,!  
comp>ative cl9ical effectiv5ess & co/   
effectiv5ess1 :5 available f an imp>tial
 s\rce1 ( su* drug4  7,b7 ,! budget>y   
impact ( provid+ cov]age ( su* drug4    
7,c7 ,! numb] ( simil>ly effective drugs
 or alt]native treatm5t regim5s = ea*   
approv$ use ( su* drug4  7,d7 ,!        
associat$ f9ancial burd5 on pati5ts t   
utilize su* drug4  7,e7 ,! associat$    
unmet pati5t ne$ = su* drug4  7,f7 ,!   
total rev5ues f global sales obta9$ by !
 manufactur] = su* drug & ! associat$   
inve/m5t 9 rese>* & developm5t ( su*    

drug by ! manufactur]4  7#b7            
,f9alization ( negotiat$ price ,!       
negotiat$ price ( ea* cov]$ "p ,d drug =
 a negotiat$ price p]iod %all be f9aliz$
 n lat] ?an #cj days be=e a ,,pdp       
sponsor is requir$ to submit in=mation  
describ$ 9 subsection 7b77#b7 = ! fir/  
plan ye> 9 su* negotiat$ price p]iod4   
7#c7 ,competitive lic5s+ au?ority  7,a7 
,9 g5]al ,not)/&+ any exclusivity "u    
clause 7iii7 or 7iv7 ( section          
#eje7;j77#e77;,f7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act1 clause 7iii7 or
 7iv7 ( section #eje7;c77#c77;,e7 ( su* 
,act1 section #cea7k77#g77;,a7 ( !      
,public ,heal? ,s]vice ,act1 or section 
#ebg7;a7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act1 or by an ext5sion ( su* 
exclusivity "u section #eje;,a ( su*    
,act or section #eje;,e ( su* ,act1 &   
any o!r provision ( law t provides =    
m>ket exclusivity 7or ext5sion ( m>ket  
exclusivity7 ) respect to a drug1 9 !   
case t ! ,secret>y is unable to         
successfully negotiate an appropriate   

price = a cov]$ "p ,d drug = a negotiat$
 price p]iod1 ! ,secret>y %all au?orize 
! use ( any pat5t1 cl9ical trial data1  
or o!r exclusivity grant$ by ! ,f$]al   
,gov]nm5t ) respect to su* drug z !     
,secret>y det]m9es appropriate =        
purposes ( manufactur+ su* drug = sale  
"u a prescription drug plan or ,,ma-,,pd
 plan4 ,any entity mak+ use ( a         
competitive lic5se to use pat5t1 cl9ical
 trial data1 or o!r exclusivity "u ?is  
section %all provide to ! manufactur]   
hold+ su* exclusivity reasonable        
comp5sation1 z det]m9$ by ! ,secret>y   
bas$ on ! foll[+ factors3  7i7 ,!       
risk-adju/$ value ( any ,f$]al ,gov]nm5t
 subsidies & inve/m5ts 9 rese>* &       
developm5t us$ to support ! developm5t (
 su* drug4  7ii7 ,! risk-adju/$ value ( 
any inve/m5t made by su* manufactur] 9 !
 rese>* & developm5t ( su* drug4  7iii7 
,! impact ( ! price1 includ+ lic5se     
comp5sation paym5ts1 on meet+ ! m$ical  
ne$ ( all pati5ts4  7iv7 ,! relation%ip 
betwe5 ! price ( su* drug1 includ+      

comp5sation paym5ts1 & ! heal? b5efits (
 su* drug4  7v7 ,o!r relevant factors   
det]m9$ appropriate by ! ,secret>y to   
provide reasonable comp5sation4  7,b7   
,reasonable comp5sation ,! manufactur]  
describ$ 9 subp>agraph 7,a7 may seek    
recov]y aga9/ ! ,unit$ ,/ates 9 ! ,unit$
 ,/ates ,c\rt ( ,f$]al ,claims4  7,c7   
,int]im p]iod  7i7 ,9 g5]al ,until #a   
ye> aft] a drug describ$ 9 subp>agraph  
7,a7 is approv$ "u section #eje7;j7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act or
 section #cea7k7 ( ! ,public ,heal?     
,s]vice ,act & is provid$ "u lic5se     
issu$ by ! ,secret>y "u su* subp>agraph1
 ,,pdp plans & ,,ma-,,pd plans %all n   
pay m = su* drug ?an ! av]age ( ! prices
 available1 dur+ ! mo/ rec5t #ab-mon?   
p]iod = :i* data is available prior to !
 beg9n+ ( su* negotiat$ price p]iod1 f !
 manufactur] to any :olesal]1 retail]1  
provid]1 heal? ma9t5ance organization1  
nonpr(it entity1 or gov]nm5tal entity 9 
! t5 ,,oecd 7,organization = ,economic  
,coop]ation & ,developm5t7 c\ntries t h 

! l>ge/ gross dome/ic product ) a p]    
capita income t is n less ?an half ! p] 
capita income ( ! ,unit$ ,/ates1 z      
report$ by ! manufactur] to ! ,secret>y4
  7ii7 ,f$]al program lic5s+ ,if su*    
drug is n made available at ! price     
det]m9$1 ! ,secret>y %all au?orize su*  
entities to use any pat5t1 cl9ical trial
 data1 or o!r exclusivity grant$ by !   
,f$]al ,gov]nm5t ) respect to su* drug z
 ! ,secret>y det]m9es appropriate =     
purposes ( manufactur+ su* drug = sale  
"u any ,f$]al program1 includ+ ^?       
provid$ by ,m$ic>e1 ,m$icaid1 ,vet]ans  
,affairs1 ! ,dep>tm5t ( ,def5se1 & !    
,coa/ ,gu>d4  7,d7 ,au?orization =      
secret>y to procure drugs directly  7i7 
,9 g5]al ,! ,secret>y may procure a drug
 manufactur$ pursuant to a competitive  
lic5se "u subp>agraph 7,a7 = purposes ( 
?is "p or pursuant to a ,f$]al program  
lic5se "u subp>agraph 7,c77ii7 =        
purposes ( a ,f$]al program directly f !
 entity manufactur+ ! drug pursuant to  
su* a lic5se4  7ii7 ,cl>ification reg>d+

 application ( ,buy ,am]ican ,act ,9 !  
case :]e ! ,secret>y procures a drug "u 
?is subp>agraph1 ! provisions ( *apt]   
#hc ( title #da1 ,unit$ ,/ates ,code    
7commonly ref]r$ to z ! ,buy ,am]ican   
,act7 %all apply4  7,e7 ,priority =     
,u4,s4 manufactur]s 9 au?oriz+          
competitive lic5ses ,9 au?oriz+ a       
competitive lic5se "u ?is p>agraph1 !   
,secret>y-- 7i7 %all give pref]5ce to   
entities t ! ,secret>y det]m9es h !     
highe/ safety & security /&>ds2 &  7ii7 
may give priority to entities t w       
manufacture su* drug 9 ! ,unit$ ,/ates4 
7#d7 ,,fda review ( lic5s$ drug         
applications ,! ,secret>y %all          
prioritize review ( applications "u     
section #eje7;j7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act = drugs lic5s$  
"u p>agraph 7#c77;,a74  7#e7            
,prohibition ( anticompetitive behavior 
,no drug manufactur] may engage 9       
anticompetitive behavior ) ano!r        
manufactur] t may int]f]e ) ! issuance &
 implem5tation ( a competitive lic5se or

 run contr>y to public policy4  7#f7    
,requir$ report+ ,! ,secret>y may       
require drug manufactur]s to disclose to
 ! ,secret>y su* in=mation t ! ,secret>y
 det]m9es necess>y = purposes ( c>ry+   
out ?is subsection4  7#g7 ,cl>ification 
,no?+ 9 ?is subsection %all be con/ru$ z
 prev5t+ ! sponsor ( a prescription drug
 plan or an organization (f]+ an        
,,ma-,,pd plan f obta9+ a disc\nt or    
r$uction ( ! price = a cov]$ "p ,d drug 
bel[ ! price negotiat$ by ! ,secret>y4  
4