,,ii  #aaeth ,,congress  #b;d ,session  
,s4 #bfia  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #ag1    
#bjah ,mr4 ,sanders 7for himself and    
,ms4 ,harris7 introduced the following  
bill2 which was read twice and referred 
to the ,committee on ,finance  ,a ,,bill
  ,to hold pharmaceutical companies     
accountable for illegal marketing and   
distribution of opioid products and for 
their role in creating and exacerbating 
the opioid epidemic in the ,united      
,states4  #a4 ,short title  ,this ,act  
may be cited as the ,opioid ,crisis     
,accountability ,act of #bjah4  #b4     
,prohibition of illegal marketing and   
distribution practices with respect to  
opioids  7a7 ,in general ,section #cjc  
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is  
amended by adding at the end the        
following3  7h7 7#a7 ,in this           
subsection1 the term illegal marketing  
or distribution practice with respect to
 an opioid means-- 7,a7 including in any

 advertisement1 promotion1              
direct-to-consumer marketing materials1 
or other marketing material a           
representation that an opioid has no    
addiction-forming or                    
addiction-sustaining liability or has   
less of an addiction-forming or         
addiction-sustaining liability than one 
or more other opioids1 knowing the      
representation to be false1 as          
determined by the ,secretary1 in        
consultation with the ,commissioner1    
based on research1 testimonials1 and    
other evidence2  7,b7 supplying ,states 
or communities with a quantity of       
opioids that is not medically           
reasonable1 as determined by the        
,secretary1 in consultation with the    
,attorney ,general using1 if applicable1
 data from the ,automated ,reports and  
,consolidated ,ordering ,system of the  
,department of ,justice2 or  7,c7       
failing to report to the ,secretary any 
order or pattern of orders for the      
distribution of opioids that would cause

 a reasonable person to believe the     
opioids were not being dispensed in a   
medically reasonable manner4  7#b7 ,it  
shall be unlawful for any person who    
manufactures or distributes an opioid to
 engage in an illegal marketing or      
distribution practice with respect to an
 opioid4  7#c7 7,a7 ,any person who     
violates paragraph 7#b7-- 7i7 if a      
natural person employed by an opioid    
manufacturer or distributor1 shall be-- 
7,i7 subject to a civil penalty in an   
amount equal to the sum of-- 7aa7 such  
person's full amount of salary for each 
year during which such person engaged in
 illegal marketing or distribution      
practices with respect to an opioid     
product2 and  7bb7 the amount by which  
the stock or other certificates of      
ownership interest of the person that is
 owned by the individual has increased  
in value during the period during which 
such person engaged in illegal marketing
 or distribution practices of an opioid 
product1 without regard to whether the  

individual has sold any of the stock or 
certificates from such opioid           
manufacturer or distributor2 and  7,,ii7
 with respect to a violation that occurs
 on or after the date of enactment of   
the ,opioid ,crisis ,accountability ,act
 of #bjah1 subject to the period of     
imprisonment specified under section    
#dja of the ,controlled ,substances ,act
 that would be applicable for a         
violation of subsection 7a7 of such     
section that involved the quantity of   
opioids that were involved in the       
illegal marketing or distribution       
practices with respect to an opioid2    
7ii7 if not a natural person1 shall be  
subject to a civil penalty in the amount
 equal to the sum of-- 7,i7             
#g1hjj1jjj1jjj2 plus  7,,ii7 #be percent
 of the total profit such person made on
 lawful sales of opioids in the ,united 
,states during the period in which the  
person engaged in illegal marketing or  
distribution practices4  7,b7 ,if a     
person that is not a natural person     

violates paragraph 7#b71 the court1     
without regard to the participation of  
such individuals in1 or knowledge of    
such individuals of1 the violation1     
shall--  7i7 impose on the chief        
executive officer 7or equivalent7 of the
 person a civil penalty in an amount    
equal to the sum of--  7,i7 the salary  
of the individual during the period in  
which the person engaged in illegal     
marketing or distribution practices and 
such individual served as chief         
executive office2 and  7,,ii7 the amount
 by which the stock or other            
certificates of ownership interest of   
the person that is owned by the         
individual has increased in value during
 the period that the person engaged in  
illegal marketing or distribution       
practices and such individual served as 
chief executive officer1 without regard 
to whether the individual has sold any  
of the stock or certificates2  7ii7     
impose on any executive other than the  
chief executive officer 7or equivalent7 

who led the finance1 research1          
marketing1 or sales department of the   
person a civil penalty in the amount    
equal to the sum of--  7,i7 #be percent 
of the salary of the individual during  
the period that the person engaged in   
illegal marketing or distribution       
practices and such individual served as 
such an executive2 and  7,,ii7 #be      
percent of the amount by which the stock
 or other certificates of ownership     
interest of the person that is owned by 
the individual has increased in value   
during the period that the person       
engaged in illegal marketing or         
distribution practices and such         
individual served as such an executive1 
without regard to whether the individual
 has sold any of the stock or           
certificates2 and  7iii7 impose on any  
executive1 including the chief executive
 officer 7or equivalent7 who led the    
finance1 research1 marketing1 or sales  
department of the person during the     
calendar year in which a court enters a 

judgment that the person violated       
paragraph 7#b7 and who is not subject to
 a civil penalty under clause 7i7 or    
7ii71 a civil penalty in the amount     
equal to the sum of--  7,i7 #be percent 
of the salary of the individual during  
the calendar year in which a court      
enters such judgment2 and  7,,ii7 #be   
percent of the amount by which the stock
 or other certificates of ownership     
interest of the person that is owned by 
the individual has increased in value   
during the calendar year in which a     
court enters such judgment4  7,c7 ,any  
person described in clause 7i7 or 7ii7  
of subparagraph 7,a7 shall be required  
to issue a public statement apologizing 
for their role in creating1 sustaining1 
and exacerbating the opioid epidemic in 
the ,united ,states4  4  7b7            
,investigation2 retroactive effect  7#a7
 ,investigation ,immediately after the  
date of enactment of this ,act1 the     
,secretary of ,health and ,human        
,services1 acting through the           

,commissioner of ,food and ,drugs and in
 consultation with the ,attorney        
,general1 acting through the            
,administrator of the ,drug ,enforcement
 ,administration1 shall begin           
investigating all opioid manufacturers  
and all executives employed by such     
manufacturers to determine whether any  
such manufacturers or executives1 at any
 time before or after such date of      
enactment1 violated subsection 7h77#b7  
of section #cjc of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #ccc7 7as added by subsection 7a774    
7#b7 ,retroactive effect ,subsection    
7h77#b7 of section #cjc of the ,federal 
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #ccc7 7as added by subsection 
7a77 shall take effect on ,january #a1  
#aihe1 and shall have retroactive       
effect4  7c7 ,reimbursement of economic 
impact  7#a7 ,establishment of fund     
,there is established in the ,treasury  
of the ,united ,states a fund1 to be    
known as the ,opioids ,reimbursement    

,fund 7referred to in this subsection as
 the ,fund71 to be administered by the  
,secretary of ,health and ,human        
,services 7referred to in this          
subsection as the ,secretary71 in       
consultation with the ,commissioner of  
,food and ,drugs4  7#b7 ,transfers to   
the ,fund ,in a manner consistent with  
section #ccjb7;b7 of title #ca1 ,united 
,states ,code1 there shall be           
transferred to the ,fund from the       
,general ,fund of the ,treasury an      
amount equal to the amount of the civil 
penalties collected under subsection    
7h77#c7 of section #cjc of the ,federal 
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #ccc7 7as added by subsection 
7a771 which shall remain available until
 expended4  7#c7 ,use of funds  7,a7 ,in
 general ,the ,secretary1 in            
consultation with the ,commissioner of  
,food and ,drugs1 may1 without further  
appropriation1 use amounts in the ,fund 
to combat the abuse of opioids in the   
,united ,states1 which may include      

transferring amounts from the ,fund to  
other agencies to carry out programs1   
projects1 and activities of the agencies
 to combat the abuse of opioids in the  
,united ,states4  7,b7 ,priority ,in    
using amounts in the ,fund1 the         
,secretary shall give priority to       
providing funds for-- 7i7 programs1     
projects1 and activities of the         
,substance ,abuse and ,mental ,health   
,services ,administration1 the          
,department of ,labor1 and the          
,department of ,justice2  7ii7 programs1
 projects1 and activities that provide  
services to individuals directly        
affected by the abuse of opioids        
7including family members of such       
individuals72  7iii7 programs1 projects1
 and activities of the ,department of   
,education related to national          
activities for school safety1 including 
such activities authorized under section
 #dfca of the ,elementary and ,secondary
 ,education ,act of #aife 7#bj ,u4,s4,c4
 #gbha7 to help ,state and local        

educational agencies implement          
evidence-based opioid-abuse prevention  
strategies for schools in communities   
impacted by the opioid crisis1 and      
particularly for any applicant who      
describes how such applicant would use  
the funds to prevent opioid abuse by    
students and address the mental health  
needs of students affected by opioid    
abuse with their families or            
communities2 and  7iv7 ,head ,start     
programs1 including ,early ,head ,start 
programs1 under the ,head ,start ,act   
7#db ,u4,s4,c4 #ihca et seq471 to       
provide additional qualified child care 
providers trained in trauma-informed    
care in ,states with the largest number 
of children and families affected by the
 opioid crisis in their communities4    
7,c7 ,availability ,amounts transferred 
to an agency under subparagraph 7,a7    
shall remain available until expended4  
#c4 ,reduced exclusivity  7a7 ,in       
general ,if a drug manufacturer violates
 subsection 7h77#b7 of section #cjc of  

the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #ccc7 7as added by 
section #b7 with respect to a covered   
opioid1 effective on the date on which  
such manufacturer is found to have so   
violated such section--  7#a7 any       
remaining period of market exclusivity  
with respect to such covered opioid     
shall be revoked2  7#b7 the period of   
market exclusivity with respect to any  
other opioid for which such manufacturer
 is the holder of an approved           
application under section #eje of the   
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7 or a license  
under section #cea of the ,public       
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7 shall be reduced to one-half of   
the remaining period of market          
exclusivity2 and  7#c7 no new or        
additional exclusivity shall be awarded 
to any opioid for which an application  
is submitted by such manufacturer for   
approval under section #eje of the      
,federal ,food1 ,drug1 and ,cosmetic    

,act 7#ba ,u4,s4,c4 #cee7 or under      
section #cea of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bfb7 or   
marketed as a result of product hopping4
  7b7 ,definitions ,for purposes of this
 section3 7#a7 ,covered opioid ,a       
covered opioid is a prescription opioid 
drug1 the sales of which in the ,united 
,states1 beginning on the date on which 
the drug was first eligible to be       
marketed in the ,united ,states and     
ending on the date on which the         
manufacturer was found to be in         
violation of subsection 7h77#b7 of      
section #cjc of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #ccc71 has generated at least #a4  7#b7
 ,period of market exclusivity ,the term
 period of market exclusivity with      
respect to a drug means the total period
 of market exclusivity granted under    
clause 7ii71 7iii71 or 7iv7 of section  
#eje7;c77#c77;,e7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cee7;c77#c77;,e771 section   

#eje7;j77#e77;,b77iv7 of such ,act1     
clause 7ii71 7iii71 or 7iv7 of section  
#eje7;j77#e77;,f7 of such ,act1 section 
#ebg of such ,act1 or section           
#cea7k77#g7 of the ,public ,health      
,service ,act 7#db ,u4,s4,c4            
#bfb7k77#g771 and any extension of such 
a period granted under section #eje;,a  
or #eje;,e of the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4      
#cee;a1 #cee;f74  7#c7 ,product hopping 
,the term product hopping means a       
reformulation of an approved drug or    
biological product that allows a        
manufacturer to submit a new drug       
application under section #eje7;b7 of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7;b77 or new   
application for a license under section 
#cea7;a7 of the ,public ,health ,service
 ,act 7#db ,u4,s4,c4 #bfb7;a77 and      
that--  7,a7 is intended for the        
treatment of the same medical condition 
as the drug or biological product that  
was originally so approved2 and  7,b7 is

 undertaken in conjunction with the     
sponsor's actions to reduce or eliminate
 demand for the original formulation of 
the drug or biological product4  #d4    
,penalty with respect to opioids        
developed using ,federal funding ,if a  
drug manufacturer or distributor        
violates subsection 7h77#b7 of section  
#cjc of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 7as 
added by section #b7 with respect to an 
opioid that was developed with the      
support of ,federal funding1 in addition
 to the applicable penalties under such 
subsection 7h71 such manufacturer or    
distributor shall be subject to a civil 
penalty in an amount equal to the sum   
of--  7#a7 such ,federal funding1       
regardless of whether the ,federal      
funding was received by the manufacturer
 or distributor or another entity2 plus 
7#b7 #be percent of the total profit    
such manufacturer or distributor        
received in connection with             
manufacturing or distributing such      

opioid4  #e4 ,treatment of certain tax  
credits for violators of illegal        
marketing and distribution practices    
with respect to opioids  7a7 ,in general
 ,section #da of the ,internal ,revenue 
,code of #aihf is amended by adding at  
the end the following new subsection3   
7i7 ,treatment of certain taxpayers     
violating illegal marketing and         
distribution practices with respect to  
opioids  7#a7 ,in general ,in the case  
of any taxpayer who has engaged in an   
illegal marketing or distribution       
practice with respect to an opioid      
7within the meaning of section #cjc7;h7 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #ccc77--  
7,a7 no credit shall be allowed under   
subsection 7a71 section #de;,c7a71 or   
section #caaa7;f7 for any taxable year  
in the applicable period1 and  7,b7 the 
taxpayer's tax under this chapter for   
the taxable year described in paragraph 
7#b77;,a7 shall be increased by an      
amount equal to the amount of credits   

allowed to such taxpayer by reason of   
subsection 7a71 section #de;,c7a71 and  
section #caaa7;f7 for the period        
described in paragraph 7#b77;,b74  7#b7 
,applicable period ,for purposes of this
 subsection1 the term applicable period 
means the period of taxable years       
which-- 7,a7 begins with the taxable    
year in which a civil penalty has been  
imposed for an illegal marketing or     
distribution practice with respect to an
 opioid under section #cjc7;h77#c7 of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act1 and  7,b7 has a duration equal to
 the number of taxable years in the     
period that begins with the first day on
 which the illegal marketing or         
distribution practice with respect to   
the opioid occurred and ends on the     
earlier of date on which--  7i7 the     
illegal marketing or distribution       
practice with respect to the opioid     
permanently ceased1 or  7ii7 the date on
 which the civil penalty described in   
subparagraph 7,a7 is imposed4  ,for     

purposes of subparagraph 7,b71 any      
portion of a taxable year that is less  
than a whole taxable year shall be      
treated as a whole taxable year4  4  7b7
 ,effective date ,the amendments made by
 this section shall apply to taxable    
years ending after the date of the      
enactment of this ,act4