,i  #aae? ,,congress  #b;d ,session  ,h4
 ,r4 #feje  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #be1 #bjah,mr4  
,doggett 7= himself1 ,mr4 ,wel*1 ,mr4   
,cumm+s1 ,mr4 ,khanna1 ,ms4 ,de,lauro1  
,ms4 ,s*ak[sky1 ,ms4 ,kaptur1 ,mr4      
,pocan1 ,mr4 ,grijalva1 ,ms4 ,adams1    
,ms4 ,b>ragn1 ,ms4 ,bass1 ,mrs4 ,beatty1
 ,mr4 ,blum5au]1 ,ms4 ,bonamici1 ,mr4   
,c>twright1 ,mr4 ,ca/ro ( ,texas1 ,ms4  
,judy ,*u ( ,cali=nia1 ,mr4 ,cicill9e1  
,ms4 ,cl>ke ( ,new ,york1 ,mr4 ,cleav]1 
,mr4 ,coh51 ,mr4 ,cri/1 ,mr4 ,de,fazio1 
,mr4 ,de,saulnier1 ,mr4 ,ellison1 ,mr4  
,evans1 ,mr4 ,g>am5di1 ,mr4 ,gonzalez ( 
,texas1 ,mr4 ,al ,gre5 ( ,texas1 ,mr4   
,gutirrez1 ,ms4 ,hanabusa1 ,mr4 ,ha/+s1 
,mr4 ,higg9s ( ,new ,york1 ,ms4 ,jackson
 ,lee1 ,ms4 ,jayapal1 ,ms4 ,eddie       
,b]nice ,johnson ( ,texas1 ,mr4 ,johnson
 ( ,georgia1 ,mr4 ,kri%namoor?i1 ,mr4   
,langev91 ,mr4 ,lawson ( ,florida1 ,ms4 
,lee1 ,mr4 ,lev91 ,mr4 ,lewis (         
,georgia1 ,mr4 ,l[5?al1 ,ms4 ,mi*elle   
,lujan ,gri%am ( ,new ,mexico1 ,mrs4    

,c>olyn ,b4 ,maloney ( ,new ,york1 ,ms4 
,mc,collum1 ,mr4 ,mc,nerney1 ,ms4       
,moore1 ,mr4 ,nadl]1 ,mrs4 ,napolitano1 
,mr4 ,nolan1 ,ms4 ,norton1 ,mr4         
,p]lmutt]1 ,ms4 ,p+ree1 ,mr4 ,rask91    
,mr4 ,rupp]sb]g]1 ,mr4 ,ryan ( ,ohio1   
,mr4 ,s>banes1 ,mr4 ,scott ( ,virg9ia1  
,ms4 ,%ea-,port]1 ,mr4 ,%]man1 ,mr4     
,takano1 ,mr4 ,?ompson ( ,mississippi1  
,ms4 ,titus1 ,mr4 ,v>gas1 ,mr4 ,veasey1 
,ms4 ,velzquez1 ,mr4 ,visclosky1 ,ms4   
,wass]man ,s*ultz1 ,ms4 ,max9e ,wat]s ( 
,cali=nia1 ,ms4 ,wilson ( ,florida1 ,mr4
 ,espaillat1 ,mr4 ,pet]son1 ,mr4 ,danny 
,k4 ,davis ( ,ill9ois1 ,mr4 ,l>son (    
,connecticut1 ,mr4 ,s]rano1 ,mr4        
,jeffries1 & ,ms4 ,frankel ( ,florida7  
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce1 & 9 
addition to ! ,committee on ,ways &     
,means1 = 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 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$ic>e ,negotiation & ,competitive   
,lic5s+ ,act ( #bjah4  #b4 ,requir+ !   
,secret>y ( ,heal? & ,human ,s]vices to 
negotiate prices ( prescription drugs   
furni%$ "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* drug4  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 ,,fda exp$it$ 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    
,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