,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #biag  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #bb1 #bjai,ms4   
,gabb>d 7= h]self & ,mr4 ,khanna7       
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce1 & 9 
addition to ! ,committee on ,education &
 ,labor1 = 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 hold ph>maceutical         
companies acc\ntable = dubi\s m>ket+ &  
di/ribution ( opioid products & = _!    
role 9 creat+ & exac]bat+ ! opioid      
epidemic 9 ! ,unit$ ,/ates4  #a4 ,%ort  
title ,?is ,act may be cit$ z ! ,opioid 
,crisis ,acc\ntability ,act ( #bjai4    
#b4 ,prohibition ( dubi\s m>ket+ &      
m$ically unreasonable di/ribution       
practices ) respect to opioids  7a7     
,dubi\s m>ket+ or di/ribution practice )
 respect to an opioid  7#a7 ,9 g5]al ,9 
?is section1 ! t]m dubi\s m>ket+ or     
di/ribution practice ) respect to an    

opioid1 subject to p>agraph 7#b71       
means--  7,a7 includ+ 9 any adv]tisem5t1
 promotion1 direct-to-consum] m>ket+    
mat]ials1 or o!r m>ket+ mat]ial a       
repres5tation t an opioid has no        
addiction-=m+ or addiction-su/a9+       
liability or has less ( an addiction-=m+
 or addiction-su/a9+ liability ?an #a or
 m o!r opioids1 kn[+ ! repres5tation to 
be false1 z det]m9$ by ! ,secret>y (    
,heal? & ,human ,s]vices 7ref]r$ to 9   
?is section z ! ,secret>y71 9           
consultation ) ! ,commission] ( ,food & 
,drugs 7ref]r$ to 9 ?is section z !     
,commission]71 bas$ on rese>*1          
te/imonials1 & o!r evid5ce2  7,b7 kn[+ly
 supply+ ,/ates or communities ) a      
quantity ( opioids t ! p]son kn[s is n  
m$ically reasonable2 or  7,c7 fail+ to  
report to ! ,secret>y any ord] or patt]n
 ( ord]s = ! di/ribution ( opioids 9 a  
,/ate or community t ! p]son kn[s are n 
be+ disp5s$ 9 a m$ically reasonable     
mann]4  7#b7 ,limitation ,an act does n 
con/itute a dubi\s m>ket+ or di/ribution

 practice ) respect to an opioid1 )     
respect to a natural p]son-- 7,a7 )9 !  
mean+ ( p>agraph 7#a77;,b71 if su*      
natural p]son 0 n involv$ 9 ! decision  
mak+ reg>d+ ! quantity ( opioids to     
supply2 or  7,b7 )9 ! mean+ ( p>agraph  
7#a77;,c7 if su* natural p]son kn[s t ! 
,secret>y %\ld reasonably be aw>e ( !   
relevant ord] or patt]n ( ord]s = !     
di/ribution ( opioids4  7b7 ,prohibition
 ,x %all be unlawful = any p]son involv$
 9 ! manufacture or di/ribution ( an    
opioid to engage 9 an dubi\s m>ket+ or  
di/ribution practice ) respect to an    
opioid4  7c7 ,p5alties  7#a7 ,9 g5]al   
,any p]son :o violates subsection 7b7-- 
7,a7 if a natural p]son employ$ by an   
opioid manufactur] or di/ributor1 %all  
be--  7i7 subject to a civil p5alty 9 an
 am\nt equal to ! sum (-- 7,i7 su*      
p]son's full am\nt ( sal>y = ea* ye>    
dur+ :i* su* p]son engag$ 9 dubi\s      
m>ket+ or di/ribution practices )       
respect to an opioid product2 &  7,,ii7 
! am\nt by :i* ! /ock or o!r c]tificates

 ( own]%ip int]e/ ( ! p]son t is own$ by
 ! individual has increas$ 9 value dur+ 
! p]iod dur+ :i* su* p]son engag$ 9     
dubi\s m>ket+ or di/ribution practices (
 an opioid product1 )\t reg>d to :e!r ! 
individual has sold any ( ! /ock or     
c]tificates f su* opioid manufactur] or 
di/ributor2 &  7ii7 subject to a t]m (  
imprisonm5t-- 7,i7 ) respect to a       
violation involv+ a drug 9 s*$ule ,,ii (
 section #bjb ( ! ,controll$ ,sub/ances 
,act 7#ba ,u4,s4,c4 #hab71 ( n m ?an #aj
 ye>s2 or  7,,ii7 ) respect to a        
violation involv+ a drug 9 s*$ule ,,iii 
( section #bjb ( ! ,controll$ ,sub/ances
 ,act 7#ba ,u4,s4,c4 #hab71 ( n m ?an #e
 ye>s2 or  7,b7 if a corporate entity1  
%all be subject to a civil p5alty 9 !   
am\nt equal to #ge p]c5t ( ! total pr(it
 su* corporate entity made on lawful    
sales ( opioids 9 ! ,unit$ ,/ates dur+ !
 p]iod 9 :i* ! corporate entity engag$ 9
 dubi\s m>ket+ or di/ribution practices4
  7#b7 ,o!r p5alties applicable 9 ! case
 ( a violation by a corporate entity ,if

 a p]son t is a corporate entity        
violates subsection 7b71 ! c\rt1 )\t    
reg>d to ! p>ticipation ( su*           
individuals 91 or k ( su* individuals (1
 ! violation1 %all--  7,a7 impose on !  
*ief executive (fic] 7or equival5t7 ( ! 
corporate entity a civil p5alty 9 an    
am\nt equal to ! sum (--  7i7 ! sal>y ( 
! individual dur+ ! p]iod 9 :i* !       
corporate entity engag$ 9 dubi\s m>ket+ 
or di/ribution practices & su*          
individual s]v$ z *ief executive (fice2 
&  7ii7 ! am\nt by :i* ! /ock or o!r    
c]tificates ( own]%ip int]e/ ( !        
corporate entity t is own$ by !         
individual has increas$ 9 value dur+ !  
p]iod t ! corporate entity engag$ 9     
dubi\s m>ket+ or di/ribution practices &
 su* individual s]v$ z *ief executive   
(fic]1 )\t reg>d to :e!r ! individual   
has sold any ( ! /ock or c]tificates2   
7,b7 impose on any executive o!r ?an !  
*ief executive (fic] 7or equival5t7 :o  
l$ ! f9ance1 rese>*1 m>ket+1 or sales   
dep>tm5t ( ! corporate entity a civil   

p5alty 9 ! am\nt equal to ! sum (--  7i7
 #be p]c5t ( ! sal>y ( ! individual dur+
 ! p]iod t ! corporate entity engag$ 9  
dubi\s m>ket+ or di/ribution practices &
 su* individual s]v$ z su* an executive2
 &  7ii7 #be p]c5t ( ! am\nt by :i* !   
/ock or o!r c]tificates ( own]%ip int]e/
 ( ! corporate entity t is own$ by !    
individual has increas$ 9 value dur+ !  
p]iod t ! corporate entity engag$ 9     
dubi\s m>ket+ or di/ribution practices &
 su* individual s]v$ z su* an executive1
 )\t reg>d to :e!r ! individual has sold
 any ( ! /ock or c]tificates2 &  7,c7   
impose on any executive1 includ+ ! *ief 
executive (fic] 7or equival5t7 :o l$ !  
f9ance1 rese>*1 m>ket+1 or sales        
dep>tm5t ( ! corporate entity dur+ !    
cal5d> ye> 9 :i* a c\rt ent]s a judgm5t 
t ! corporate entity violat$ subsection 
7b7 & :o is n subject to a civil p5alty 
"u subp>agraph 7,a7 or 7,b71 a civil    
p5alty 9 ! am\nt equal to ! sum (--  7i7
 #be p]c5t ( ! sal>y ( ! individual f ! 
corporate entity dur+ ! cal5d> ye> 9 :i*

 a c\rt ent]s su* judgm5t2 &  7ii7 #be  
p]c5t ( ! am\nt by :i* ! /ock or o!r    
c]tificates ( own]%ip int]e/ ( !        
corporate entity t is own$ by !         
individual has increas$ 9 value dur+ !  
cal5d> ye> 9 :i* a c\rt ent]s su*       
judgm5t4  7d7 ,rules = application  7#a7
 ,quantity ( opioids cov]$  7,a7 ,=mula 
,= purposes ( subp>agraphs 7,b7 & 7,c7 (
 subsection 7a77#a71 ! ,secret>y1 9     
consultation ) ! ,attorney ,g5]al &1 z  
appropriate1 provid] gr\ps & pati5t     
advocacy gr\ps1 us+1 if applicable1 data
 f ! ,automat$ ,reports & ,consolidat$  
,ord]+ ,sy/em ( ! ,dep>tm5t ( ,ju/ice1  
%all e/abli% a =mula = det]m9+ !        
quantity ( opioids t is n m$ically      
reasonable ) respect to a community or  
,/ate4  7,b7 ,rebuttable presumption    
,!re %all be a rebuttable presumption t 
a p]son :o supplies a ,/ate or community
 ) a quantity ( opioids t is n m$ically 
reasonable1 z det]m9$ us+ ! =mula       
e/abli%$ "u p>agraph 7#a71 kn[+ly       
suppli$ su* quantity 9 violation (      

subsection 7a77#a77;,b74  7#b7 ,m$ically
 reasonable quantities 9 an ord]  7,a7  
,guidance ,= purposes ( subsection      
7a77#a77;,c71 ! ,secret>y %all issue    
guidance sett+ =? a proc$ure t opioid   
manufactur]s & di/ributors %all foll[ to
 recognize ord]s or patt]ns ( ord]s = ! 
di/ribution ( opioids t are n m$ically  
reasonable4  7,b7 ,rebuttable           
presumption ,!re %all be a rebuttable   
presumption t a p]son :o-- 7i7 receives 
an ord] t ! ,secret>y det]m9es to be n  
m$ically reasonable & does n report su* 
ord]2 &  7ii7 did n foll[ ! proc$ure set
 =? 9 ! guidance describ$ 9 subp>agraph 
7,a7 ) respect to su* ord]1  kn[+ly     
fail$ to report z describ$ 9 subsection 
7a77#a77;,c74  7e7 ,fees applicable to  
all opioid manufactur]s & di/ributors   
7#a7 ,9 g5]al ,! ,secret>y %all assess a
 fee aga9/ ea* corporate entity t1 dur+ 
! p]iod beg9n+ on ,janu>y #a1 #aiic1 &  
end+ on ! day be=e ! date ( enactm5t (  
?is ,act1 manufactur$ or di/ribut$ any  
opioid drug t 0 cov]$ by a ,f$]al heal? 

program at lea/ once dur+ su* p]iod1 9  
am\nts1 = ea* su* manufactur] or        
di/ributor1 det]m9$ by ! ,secret>y ?r\gh
 rulemak+4  7#b7 ,total am\nt ,!        
,secret>y %all ensure t ! total am\nt   
assess$ "u p>agraph 7#a7 equals         
#bj1jjj1jjj1jjj4  7#c7 ,due dates ,)    
respect to a fee assess$ "u ?is         
subsection-- 7,a7 n less ?an #ej p]c5t (
 ! am\nt ( ! fee %all be paid )9 #a ye> 
( ! date ( enactm5t ( ?is ,act2 &  7,b7 
#ajj p]c5t ( su* am\nt %all be paid n   
lat] ?an #b ye>s aft] ! date ( enactm5t 
( ?is ,act4  7#d7 ,)drawal ( approval 9 
! case ( nonpaym5t by manufactur] ,if a 
manufactur] assess$ a fee "u ?is        
subsection fails to pay ! full fee z    
requir$ "u p>agraph 7#c71 ! ,secret>y   
%all )draw approval ( ! application "u  
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 = ! 
drug until ! fee is paid 9 full4  7#e7  
,inve/igation ,imm$iately aft] ! date ( 
enactm5t ( ?is ,act1 ! ,secret>y1 act+  
?r\gh ! ,commission] & 9 consultation ) 

! ,attorney ,g5]al1 act+ ?r\gh !        
,adm9i/rator ( ! ,drug ,en=cem5t        
,adm9i/ration1 %all beg9 an assessm5t to
 set fees "u ?is subsection4  7f7       
,reimbursem5t ( economic impact  7#a7   
,e/abli%m5t ( fund ,!re is e/abli%$ 9 ! 
,treasury ( ! ,unit$ ,/ates a fund1 to  
be kn[n z ! ,opioids ,reimbursem5t ,fund
 7ref]r$ to 9 ?is subsection z ! ,fund71
 to be adm9i/]$ by ! ,secret>y1 9       
consultation ) ! ,commission]4  7#b7    
,appropriations2 transf]s to ! ,fund    
7,a7 ,appropriation ,!re is appropriat$1
 out ( any monies 9 ! ,treasury n       
o!rwise appropriat$1 #bj1jjj1jjj1jjj to 
! ,fund4  7,b7 ,transf]s ,9 a mann]     
consi/5t ) section #ccjb7;b7 ( title    
#ca1 ,unit$ ,/ates ,code1 !re %all be   
transf]r$ to ! ,fund f ! ,g5]al ,fund ( 
! ,treasury an am\nt equal to--  7i7 !  
am\nt ( ! civil p5alties collect$ "u    
subsection 7c72 plus  7ii7 ! am\nt (    
fees collect$ "u subsection 7e74  7,c7  
,availability ,funds appropriat$ "u     
p>agraph 7#a7 & transf]r$ "u subp>agraph

 7,b7 %all rema9 available until exp5d$4
  7#c7 ,use ( funds  7,a7 ,9 g5]al ,!   
,secret>y1 9 consultation ) !           
,commission]1 may1 )\t fur!r            
appropriation1 use am\nts 9 ! ,fund to  
combat ! misuse & abuse ( opioids 9 !   
,unit$ ,/ates1 :i* may include transf]r+
 am\nts f ! ,fund to o!r ag5cies to c>ry
 out programs1 projects1 & activities ( 
! ag5cies to combat ! misuse & abuse (  
opioids 9 ! ,unit$ ,/ates4  7,b7        
,priority ,9 us+ am\nts 9 ! ,fund1 !    
,secret>y %all give priority to provid+ 
funds =-- 7i7 programs1 projects1 &     
activities ( ! ,sub/ance ,abuse & ,m5tal
 ,heal? ,s]vices ,adm9i/ration1 !       
,dep>tm5t ( ,labor1 ! ,c5t]s = ,disease 
,control & ,prev5tion1 & ! ,heal?       
,res\rces & ,s]vices ,adm9i/ration2     
7ii7 programs1 projects1 & activities t 
provide s]vices to individuals directly 
affect$ by ! misuse & abuse ( opioids   
7includ+ family memb]s ( su*            
individuals72  7iii7 programs1 projects1
 & activities ( ! ,dep>tm5t ( ,education

 relat$ to national activities = s*ool  
safety1 includ+ su* activities au?oriz$ 
"u section #dfca ( ! ,elem5t>y &        
,second>y ,education ,act ( #aife 7#bj  
,u4,s4,c4 #gbha7 to help ,/ate & local  
educational ag5cies implem5t            
evid5ce-bas$ opioid misuse & abuse      
prev5tion /rategies = s*ools 9          
communities impact$ by ! opioid crisis1 
& p>ticul>ly = any applicant :o         
describes h[ su* applicant w\ld use !   
funds to prev5t opioid misuse & abuse by
 /ud5ts & address ! m5tal heal? ne$s (  
/ud5ts affect$ by opioid misuse & abuse 
) _! families or communities2 &  7iv7   
,head ,/>t programs1 includ+ ,e>ly ,head
 ,/>t programs1 "u ! ,head ,/>t ,act    
7#db ,u4,s4,c4 #ihca et seq47 & !       
,heal?y ,/>t program ( ! ,heal?         
,res\rces & ,s]vices ,adm9i/ration to   
provide additional qualifi$ *ild c>e    
provid]s tra9$ 9 trauma-in=m$ c>e 9     
,/ates ) ! l>ge/ numb] ( *ildr5 &       
families affect$ by ! opioid crisis 9 _!
 communities4  7,c7 ,availability       

,am\nts transf]r$ to an ag5cy "u        
subp>agraph 7,a7 %all rema9 available   
until exp5d$4  7,d7 ,supplem5t n        
supplant ,am\nts transf]r$ to an ag5cy  
"u subp>agraph 7,a7 to c>ry out         
programs1 projects1 & activities ( !    
ag5cy %all supplem5t1 & n supplant1     
am\nts o!rwise available = su* purpose4 
#c4 ,r$uc$ exclusivity  7a7 ,9 g5]al ,if
 a drug manufactur] violates section    
#b7;b7 ) respect to a cov]$ opioid1     
effective on ! date on :i* su*          
manufactur] is f\nd to h s violat$ su*  
section--  7#a7 any rema9+ p]iod ( m>ket
 exclusivity ) respect to su* cov]$     
opioid %all be revok$2  7#b7 ! p]iod (  
m>ket exclusivity ) respect to any o!r  
opioid = :i* su* manufactur] is ! hold] 
( an approv$ application "u section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7 or a lic5se "u
 section #cea ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bfb7 %all be r$uc$
 to "o half ( ! rema9+ p]iod ( m>ket    
exclusivity2 &  7#c7 no new or          

additional exclusivity %all be aw>d$ to 
any opioid = :i* an application is      
submitt$ by su* manufactur] = approval  
"u section #eje ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7  
or "u section #cea ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bfb7 or    
m>ket$ z a result ( product hopp+4  7b7 
,def9itions ,= purposes ( ?is section3  
7#a7 ,cov]$ opioid ,a cov]$ opioid is a 
prescription opioid drug1 ! sales ( :i* 
9 ! ,unit$ ,/ates1 beg9n+ on ! date on  
:i* ! drug 0 fir/ eligible to be m>ket$ 
9 ! ,unit$ ,/ates & end+ on ! date on   
:i* ! manufactur] 0 f\nd to be 9        
violation ( section #b7;b71 has g5]at$  
at lea/ #a4  7#b7 ,p]iod ( m>ket        
exclusivity ,! t]m p]iod ( m>ket        
exclusivity ) respect to a drug means ! 
total p]iod ( m>ket exclusivity grant$  
"u clause 7ii71 7iii71 or 7iv7 ( section
 #eje7;c77#c77;,e7 ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;c77#c77;,e771 section             
#eje7;j77#e77;,b77iv7 ( su* ,act1 clause

 7ii71 7iii71 or 7iv7 ( section         
#eje7;j77#e77;,f7 ( su* ,act1 section   
#ebg ( su* ,act 7#ba ,u4,s4,c4 #cfj;cc71
 or p>agraph 7#f7 or 7#g7 ( section     
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k771 & any ext5sion 
( su* a p]iod grant$ "u section #eje;,a 
or #eje;,e ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a1   
#cee;f74  7#c7 ,product hopp+ ,! t]m    
product hopp+ means a re=mulation ( an  
approv$ drug or biological product t    
all[s a manufactur] to submit a new drug
 application "u section #eje7;b7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;b77 or new         
application = a lic5se "u section       
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a77 & t--  7,a7 is
 int5d$ = ! treatm5t ( ! same m$ical    
condition z ! drug or biological product
 t 0 orig9ally s approv$2 &  7,b7 is    
und]tak5 9 conjunction ) ! sponsor's    
actions to r$uce or elim9ate dem& = !   
orig9al =mulation ( ! drug or biological

 product4