,,ii  #aae? ,,congress  #b;d ,session   
,s4 #bfia  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #ag1 #bjah ,mr4 
,s&]s 7= himself & ,ms4 ,h>ris7         
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,f9ance  ,a ,,bill  ,to hold            
ph>maceutical companies acc\ntable =    
illegal 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 ( #bjah4  #b4       
,prohibition ( illegal m>ket+ &         
di/ribution practices ) respect to      
opioids  7a7 ,9 g5]al ,section #cjc ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #ccc7 is am5d$ by add+ at
 ! end ! foll[+3  7h7 7#a7 ,9 ?is       
subsection1 ! t]m illegal m>ket+ or     
di/ribution practice ) respect to an    
opioid 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 "o or m o!r opioids1 kn[+ 
! repres5tation to be false1 z det]m9$  
by ! ,secret>y1 9 consultation ) !      
,commission]1 bas$ on rese>*1           
te/imonials1 & o!r evid5ce2  7,b7       
supply+ ,/ates or communities ) a       
quantity ( opioids t is n m$ically      
reasonable1 z det]m9$ by ! ,secret>y1 9 
consultation ) ! ,attorney ,g5]al us+1  
if applicable1 data f ! ,automat$       
,reports & ,consolidat$ ,ord]+ ,sy/em ( 
! ,dep>tm5t ( ,ju/ice2 or  7,c7 fail+ to
 report to ! ,secret>y any ord] or      
patt]n ( ord]s = ! di/ribution ( opioids
 t w\ld cause a reasonable p]son to     
believe ! opioids 7 n be+ disp5s$ 9 a   
m$ically reasonable mann]4  7#b7 ,x %all
 be unlawful = any p]son :o manufactures
 or di/ributes an opioid to engage 9 an 
illegal m>ket+ or di/ribution practice )
 respect to an opioid4  7#c7 7,a7 ,any  

p]son :o violates p>agraph 7#b7-- 7i7 if
 a natural p]son employ$ by an opioid   
manufactur] or di/ributor1 %all be--    
7,i7 subject to a civil p5alty 9 an     
am\nt equal to ! sum (-- 7aa7 su*       
p]son's full am\nt ( sal>y = ea* ye>    
dur+ :i* su* p]son engag$ 9 illegal     
m>ket+ or di/ribution practices )       
respect to an opioid product2 &  7bb7 ! 
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       
illegal 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 &  7,,ii7 ) respect to a    
violation t occurs on or aft] ! date (  
enactm5t ( ! ,opioid ,crisis            
,acc\ntability ,act ( #bjah1 subject to 
! p]iod ( imprisonm5t specifi$ "u       
section #dja ( ! ,controll$ ,sub/ances  
,act t w\ld be applicable = a violation 
( subsection 7a7 ( su* section t involv$

 ! quantity ( opioids t 7 involv$ 9 !   
illegal m>ket+ or di/ribution practices 
) respect to an opioid2  7ii7 if n a    
natural p]son1 %all be subject to a     
civil p5alty 9 ! am\nt equal to ! sum   
(-- 7,i7 #g1hjj1jjj1jjj2 plus  7,,ii7   
#be p]c5t ( ! total pr(it su* p]son made
 on lawful sales ( opioids 9 ! ,unit$   
,/ates dur+ ! p]iod 9 :i* ! p]son engag$
 9 illegal m>ket+ or di/ribution        
practices4  7,b7 ,if a p]son t is n a   
natural p]son violates p>agraph 7#b71 ! 
c\rt1 )\t reg>d to ! p>ticipation ( su* 
individuals 91 or k ( su* individuals (1
 ! violation1 %all--  7i7 impose on !   
*ief executive (fic] 7or equival5t7 ( ! 
p]son a civil p5alty 9 an am\nt equal to
 ! sum (--  7,i7 ! sal>y ( ! individual 
dur+ ! p]iod 9 :i* ! p]son engag$ 9     
illegal m>ket+ or di/ribution practices 
& su* individual s]v$ z *ief executive  
(fice2 &  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 t ! p]son 

engag$ 9 illegal 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  7ii7 impose on any        
executive o!r ?an ! *ief executive (fic]
 7or equival5t7 :o l$ ! f9ance1 rese>*1 
m>ket+1 or sales dep>tm5t ( ! p]son a   
civil p5alty 9 ! am\nt equal to ! sum   
(--  7,i7 #be p]c5t ( ! sal>y ( !       
individual dur+ ! p]iod t ! p]son engag$
 9 illegal m>ket+ or di/ribution        
practices & su* individual s]v$ z su* an
 executive2 &  7,,ii7 #be p]c5t ( !     
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 t ! p]son engag$ 9 illegal 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 &  7iii7 impose
 on any executive1 includ+ ! *ief       
executive (fic] 7or equival5t7 :o l$ !  
f9ance1 rese>*1 m>ket+1 or sales        

dep>tm5t ( ! p]son dur+ ! cal5d> ye> 9  
:i* a c\rt ent]s a judgm5t t ! p]son    
violat$ p>agraph 7#b7 & :o is n subject 
to a civil p5alty "u clause 7i7 or 7ii71
 a civil p5alty 9 ! am\nt equal to ! sum
 (--  7,i7 #be p]c5t ( ! sal>y ( !      
individual dur+ ! cal5d> ye> 9 :i* a    
c\rt ent]s su* judgm5t2 &  7,,ii7 #be   
p]c5t ( ! 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+ ! cal5d> ye> 9 :i* a c\rt    
ent]s su* judgm5t4  7,c7 ,any p]son     
describ$ 9 clause 7i7 or 7ii7 (         
subp>agraph 7,a7 %all be requir$ to     
issue a public /atem5t apologiz+ = _!   
role 9 creat+1 su/a9+1 & exac]bat+ !    
opioid epidemic 9 ! ,unit$ ,/ates4  4   
7b7 ,inve/igation2 retroactive effect   
7#a7 ,inve/igation ,imm$iately aft] !   
date ( enactm5t ( ?is ,act1 ! ,secret>y 
( ,heal? & ,human ,s]vices1 act+ ?r\gh !
 ,commission] ( ,food & ,drugs & 9      
consultation ) ! ,attorney ,g5]al1 act+ 
?r\gh ! ,adm9i/rator ( ! ,drug ,en=cem5t

 ,adm9i/ration1 %all beg9 inve/igat+ all
 opioid manufactur]s & all executives   
employ$ by su* manufactur]s to det]m9e  
:e!r any su* manufactur]s or executives1
 at any "t be=e or aft] su* date (      
enactm5t1 violat$ subsection 7h77#b7 (  
section #cjc ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 7z  
add$ by subsection 7a774  7#b7          
,retroactive effect ,subsection 7h77#b7 
( section #cjc ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 7z
 add$ by subsection 7a77 %all take      
effect on ,janu>y #a1 #aihe1 & %all h   
retroactive effect4  7c7 ,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>y ( ,heal? &      
,human ,s]vices 7ref]r$ to 9 ?is        
subsection z ! ,secret>y71 9            
consultation ) ! ,commission] ( ,food & 
,drugs4  7#b7 ,transf]s to ! ,fund ,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 ! 
am\nt ( ! civil p5alties collect$ "u    
subsection 7h77#c7 ( section #cjc ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #ccc7 7z add$ by         
subsection 7a771 :i* %all rema9         
available until exp5d$4  7#c7 ,use (    
funds  7,a7 ,9 g5]al ,! ,secret>y1 9    
consultation ) ! ,commission] ( ,food & 
,drugs1 may1 )\t fur!r appropriation1   
use am\nts 9 ! ,fund to combat ! abuse (
 opioids 9 ! ,unit$ ,/ates1 :i* may     
include transf]r+ am\nts f ! ,fund to   
o!r ag5cies to c>ry out programs1       
projects1 & activities ( ! ag5cies to   
combat ! 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 & !

 ,dep>tm5t ( ,ju/ice2  7ii7 programs1   
projects1 & activities t provide s]vices
 to individuals directly affect$ by !   
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-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 abuse 
by /ud5ts & address ! m5tal heal? ne$s (
 /ud5ts affect$ by opioid 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 seq471 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$4  #c4 ,r$uc$     
exclusivity  7a7 ,9 g5]al ,if a drug    
manufactur] violates subsection 7h77#b7 
( section #cjc ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 7z
 add$ by section #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 ( subsection 7h77#b7 ( section
 #cjc ( ! ,f$]al ,food1 ,drug1 &        
,cosmetic ,act 7#ba ,u4,s4,c4 #ccc71 has
 g5]at$ 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* ,act1 or section #cea7k77#g7 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bfb7k77#g771 & 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  #d4 ,p5alty ) respect to     
opioids develop$ us+ ,f$]al fund+ ,if a 
drug manufactur] or di/ributor violates 
subsection 7h77#b7 ( section #cjc ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #ccc7 7z add$ by section 
#b7 ) respect to an opioid t 0 develop$ 
) ! support ( ,f$]al fund+1 9 addition  
to ! applicable p5alties "u su*         
subsection 7h71 su* manufactur] or      
di/ributor %all be subject to a civil   
p5alty 9 an am\nt equal to ! sum (--    
7#a7 su* ,f$]al fund+1 reg>dless ( :e!r 
! ,f$]al fund+ 0 receiv$ by !           
manufactur] or di/ributor or ano!r      
entity2 plus  7#b7 #be p]c5t ( ! total  
pr(it su* manufactur] or di/ributor     
receiv$ 9 connection ) manufactur+ or   
di/ribut+ su* opioid4  #e4 ,treatm5t (  
c]ta9 tax cr$its = violators ( illegal  
m>ket+ & di/ribution practices ) respect
 to opioids  7a7 ,9 g5]al ,section #da (
 ! ,int]nal ,rev5ue ,code ( #aihf is    
am5d$ by add+ at ! end ! foll[+ new     
subsection3  7i7 ,treatm5t ( c]ta9      

taxpay]s violat+ illegal m>ket+ &       
di/ribution practices ) respect to      
opioids  7#a7 ,9 g5]al ,9 ! case ( any  
taxpay] :o has engag$ 9 an illegal      
m>ket+ or di/ribution practice ) respect
 to an opioid 7)9 ! mean+ ( section     
#cjc7;h7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #ccc77--  
7,a7 no cr$it %all be all[$ "u          
subsection 7a71 section #de;,c7a71 or   
section #caaa7;f7 = any taxable ye> 9 ! 
applicable p]iod1 &  7,b7 ! taxpay]'s   
tax "u ?is *apt] = ! taxable ye>        
describ$ 9 p>agraph 7#b77;,a7 %all be   
increas$ by an am\nt equal to ! am\nt ( 
cr$its all[$ to su* taxpay] by reason ( 
subsection 7a71 section #de;,c7a71 &    
section #caaa7;f7 = ! p]iod describ$ 9  
p>agraph 7#b77;,b74  7#b7 ,applicable   
p]iod ,= purposes ( ?is subsection1 !   
t]m applicable p]iod means ! p]iod (    
taxable ye>s :i*-- 7,a7 beg9s ) !       
taxable ye> 9 :i* a civil p5alty has be5
 impos$ = an illegal m>ket+ or          
di/ribution practice ) respect to an    

opioid "u section #cjc7;h77#c7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act1 &
  7,b7 has a duration equal to ! numb] (
 taxable ye>s 9 ! p]iod t beg9s ) ! fir/
 day on :i* ! illegal m>ket+ or         
di/ribution practice ) respect to !     
opioid occurr$ & ends on ! e>li] ( date 
on :i*--  7i7 ! illegal m>ket+ or       
di/ribution practice ) respect to !     
opioid p]man5tly ceas$1 or  7ii7 ! date 
on :i* ! civil p5alty describ$ 9        
subp>agraph 7,a7 is impos$4  ,= purposes
 ( subp>agraph 7,b71 any portion ( a    
taxable ye> t is less ?an a :ole taxable
 ye> %all be treat$ z a :ole taxable    
ye>4  4  7b7 ,effective date ,! am5dm5ts
 made by ?is section %all apply to      
taxable ye>s end+ aft] ! date ( !       
enactm5t ( ?is ,act4