,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #ajdf  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,febru>y #g1 #bjai,mr4
 ,doggett 7= himself1 ,mr4 ,wel*1 ,mr4  
,cumm+s1 ,ms4 ,adams1 ,ms4 ,bass1 ,mrs4 
,beatty1 ,mr4 ,blum5au]1 ,ms4 ,bonamici1
 ,mr4 ,c>twright1 ,mr4 ,case1 ,mr4 ,ca/5
 ( ,ill9ois1 ,ms4 ,ca/or ( ,florida1    
,mr4 ,ca/ro ( ,texas1 ,ms4 ,judy ,*u (  
,cali=nia1 ,mr4 ,cicill9e1 ,mr4         
,cisn]os1 ,mr4 ,clay1 ,mr4 ,cleav]1 ,mr4
 ,coh51 ,mr4 ,c\rtney1 ,mr4 ,cri/1 ,mr4 
,cr[1 ,mr4 ,danny ,k4 ,davis ( ,ill9ois1
 ,mr4 ,de,fazio1 ,ms4 ,de,lauro1 ,mr4   
,de,saulnier1 ,mrs4 ,d+ell1 ,mr4 ,mi*ael
 ,f4 ,doyle ( ,p5nsylvania1 ,ms4        
,escob>1 ,mr4 ,espaillat1 ,mr4 ,evans1  
,ms4 ,frankel1 ,mr4 ,gallego1 ,mr4      
,g>am5di1 ,mr4 ,gold51 ,mr4 ,gonzalez ( 
,texas1 ,mr4 ,gre5 ( ,texas1 ,mr4       
,grijalva1 ,ms4 ,haal&1 ,mr4 ,h>d] (    
,cali=nia1 ,mr4 ,ha/+s1 ,mr4 ,higg9s (  
,new ,york1 ,ms4 ,hill ( ,cali=nia1 ,ms4
 ,jackson ,lee1 ,ms4 ,jayapal1 ,ms4     
,johnson ( ,texas1 ,ms4 ,kaptur1 ,mr4   

,khanna1 ,mr4 ,kim1 ,mrs4 ,kirkpatrick1 
,mr4 ,kri%namoor?i1 ,mr4 ,langev91 ,mr4 
,l>son ( ,connecticut1 ,mr4 ,lawson (   
,florida1 ,ms4 ,lee ( ,cali=nia1 ,mrs4  
,lee ( ,nevada1 ,mr4 ,lev9 ( ,mi*igan1  
,mr4 ,lewis1 ,mr4 ,lip9ski1 ,mr4        
,loebsack1 ,ms4 ,l(gr51 ,mr4 ,l[5?al1   
,mr4 ,lyn*1 ,mrs4 ,c>olyn ,b4 ,maloney (
 ,new ,york1 ,mr4 ,sean ,patrick        
,maloney ( ,new ,york1 ,ms4 ,mc,collum1 
,mr4 ,mc,nerney1 ,ms4 ,moore1 ,mr4      
,nadl]1 ,mrs4 ,napolitano1 ,mr4 ,neguse1
 ,ms4 ,norton1 ,ms4 ,ocasio-,cortez1    
,ms4 ,om>1 ,mr4 ,p]lmutt]1 ,mr4         
,pet]son1 ,mr4 ,phillips1 ,ms4 ,p+ree1  
,mr4 ,pocan1 ,ms4 ,port]1 ,ms4          
,pressley1 ,mr4 ,rask91 ,mr4 ,ri*mond1  
,mr4 ,rose ( ,new ,york1 ,ms4           
,roybal-,all>d1 ,mr4 ,rupp]sb]g]1 ,mr4  
,ru%1 ,mr4 ,ryan1 ,mr4 ,s>banes1 ,ms4   
,s*ak[sky1 ,mr4 ,s*iff1 ,mr4 ,scott (   
,virg9ia1 ,mr4 ,s]rano1 ,mr4 ,%]man1    
,ms4 ,slotk91 ,ms4 ,spanb]g]1 ,mr4      
,suozzi1 ,mr4 ,takano1 ,mr4 ,?ompson (  
,mississippi1 ,ms4 ,titus1 ,ms4 ,tlaib1 

,mrs4 ,torres ( ,cali=nia1 ,ms4         
,velzquez1 ,mr4 ,visclosky1 ,ms4        
,wass]man ,s*ultz1 ,ms4 ,wat]s1 ,ms4    
,wild1 ,mr4 ,y>mu?1 & ,mr4 ,mal9[ski7   
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$ic>e ,negotiation & ,competitive   
,lic5s+ ,act ( #bjai4  #b4 ,requir+ !   
,secret>y ( ,heal? & ,human ,s]vices to 
negotiate prices ( prescription drugs   
furni%$ "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$ ,/ates4  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 = u4s4           
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 ph>maceutical 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