,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #biag  ,,in ,,the ,,house ,,of  
,,representatives  ,may #bb1 #bjai,ms4  
,gabbard 7for herself and ,mr4 ,khanna7 
introduced the following bill2 which was
 referred to the ,committee on ,energy  
and ,commerce1 and in addition to the   
,committee on ,education and ,labor1 for
 a period to be subsequently determined 
by the ,speaker1 in each case for       
consideration of such provisions as fall
 within the jurisdiction of the         
committee concerned  ,a ,,bill  ,to hold
 pharmaceutical companies accountable   
for dubious 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 #bjai4  #b4 ,prohibition of dubious 
marketing and medically unreasonable    
distribution practices with respect to  
opioids  7a7 ,dubious marketing or      
distribution practice with respect to an

 opioid  7#a7 ,in general ,in this      
section1 the term dubious marketing or  
distribution practice with respect to an
 opioid1 subject to paragraph 7#b71     
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 #a  
or more other opioids1 knowing the      
representation to be false1 as          
determined by the ,secretary of ,health 
and ,human ,services 7referred to in    
this section as the ,secretary71 in     
consultation with the ,commissioner of  
,food and ,drugs 7referred to in this   
section as the ,commissioner71 based on 
research1 testimonials1 and other       
evidence2  7,b7 knowingly supplying     
,states or communities with a quantity  
of opioids that the person knows is not 

medically reasonable2 or  7,c7 failing  
to report to the ,secretary any order or
 pattern of orders for the distribution 
of opioids in a ,state or community that
 the person knows are not being         
dispensed in a medically reasonable     
manner4  7#b7 ,limitation ,an act does  
not constitute a dubious marketing or   
distribution practice with respect to an
 opioid1 with respect to a natural      
person-- 7,a7 within the meaning of     
paragraph 7#a77;,b71 if such natural    
person was not involved in the decision 
making regarding the quantity of opioids
 to supply2 or  7,b7 within the meaning 
of paragraph 7#a77;,c7 if such natural  
person knows that the ,secretary should 
reasonably be aware of the relevant     
order or pattern of orders for the      
distribution of opioids4  7b7           
,prohibition ,it shall be unlawful for  
any person involved in the manufacture  
or distribution of an opioid to engage  
in an dubious marketing or distribution 
practice with respect to an opioid4  7c7

 ,penalties  7#a7 ,in general ,any      
person who violates subsection 7b7--    
7,a7 if a natural person employed by an 
opioid manufacturer or distributor1     
shall be--  7i7 subject to a civil      
penalty in an amount equal to the sum   
of-- 7,i7 such person's full amount of  
salary for each year during which such  
person engaged in dubious marketing or  
distribution practices with respect to  
an opioid product2 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 during which such person    
engaged in dubious 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  7ii7  
subject to a term of imprisonment-- 7,i7
 with respect to a violation involving a
 drug in schedule ,,ii of section #bjb  

of the ,controlled ,substances ,act 7#ba
 ,u4,s4,c4 #hab71 of not more than #aj  
years2 or  7,,ii7 with respect to a     
violation involving a drug in schedule  
,,iii of section #bjb of the ,controlled
 ,substances ,act 7#ba ,u4,s4,c4 #hab71 
of not more than #e years2 or  7,b7 if a
 corporate entity1 shall be subject to a
 civil penalty in the amount equal to   
#ge percent of the total profit such    
corporate entity made on lawful sales of
 opioids in the ,united ,states during  
the period in which the corporate entity
 engaged in dubious marketing or        
distribution practices4  7#b7 ,other    
penalties applicable in the case of a   
violation by a corporate entity ,if a   
person that is a corporate entity       
violates subsection 7b71 the court1     
without regard to the participation of  
such individuals in1 or knowledge of    
such individuals of1 the violation1     
shall--  7,a7 impose on the chief       
executive officer 7or equivalent7 of the
 corporate entity a civil penalty in an 

amount equal to the sum of--  7i7 the   
salary of the individual during the     
period in which the corporate entity    
engaged in dubious marketing or         
distribution practices and such         
individual served as chief executive    
office2 and  7ii7 the amount by which   
the stock or other certificates of      
ownership interest of the corporate     
entity that is owned by the individual  
has increased in value during the period
 that the corporate entity engaged in   
dubious 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  7,b7     
impose on any executive other than the  
chief executive officer 7or equivalent7 
who led the finance1 research1          
marketing1 or sales department of the   
corporate entity a civil penalty in the 
amount equal to the sum of--  7i7 #be   
percent of the salary of the individual 
during the period that the corporate    

entity engaged in dubious marketing or  
distribution practices and such         
individual served as such an executive2 
and  7ii7 #be percent of the amount by  
which the stock or other certificates of
 ownership interest of the corporate    
entity that is owned by the individual  
has increased in value during the period
 that the corporate entity engaged in   
dubious 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  7,c7    
impose on any executive1 including the  
chief executive officer 7or equivalent7 
who led the finance1 research1          
marketing1 or sales department of the   
corporate entity during the calendar    
year in which a court enters a judgment 
that the corporate entity violated      
subsection 7b7 and who is not subject to
 a civil penalty under subparagraph 7,a7
 or 7,b71 a civil penalty in the amount 
equal to the sum of--  7i7 #be percent  

of the salary of the individual from the
 corporate entity during the calendar   
year in which a court enters such       
judgment2 and  7ii7 #be percent of the  
amount by which the stock or other      
certificates of ownership interest of   
the corporate entity that is owned by   
the individual has increased in value   
during the calendar year in which a     
court enters such judgment4  7d7 ,rules 
for application  7#a7 ,quantity of      
opioids covered  7,a7 ,formula ,for     
purposes of subparagraphs 7,b7 and 7,c7 
of subsection 7a77#a71 the ,secretary1  
in consultation with the ,attorney      
,general and1 as appropriate1 provider  
groups and patient advocacy groups1     
using1 if applicable1 data from the     
,automated ,reports and ,consolidated   
,ordering ,system of the ,department of 
,justice1 shall establish a formula for 
determining the quantity of opioids that
 is not medically reasonable with       
respect to a community or ,state4  7,b7 
,rebuttable presumption ,there shall be 

a rebuttable presumption that a person  
who supplies a ,state or community with 
a quantity of opioids that is not       
medically reasonable1 as determined     
using the formula established under     
paragraph 7#a71 knowingly supplied such 
quantity in violation of subsection     
7a77#a77;,b74  7#b7 ,medically          
reasonable quantities in an order  7,a7 
,guidance ,for purposes of subsection   
7a77#a77;,c71 the ,secretary shall issue
 guidance setting forth a procedure that
 opioid manufacturers and distributors  
shall follow to recognize orders or     
patterns of orders for the distribution 
of opioids that are not medically       
reasonable4  7,b7 ,rebuttable           
presumption ,there shall be a rebuttable
 presumption that a person who-- 7i7    
receives an order that the ,secretary   
determines to be not medically          
reasonable and does not report such     
order2 and  7ii7 did not follow the     
procedure set forth in the guidance     
described in subparagraph 7,a7 with     

respect to such order1  knowingly failed
 to report as described in subsection   
7a77#a77;,c74  7e7 ,fees applicable to  
all opioid manufacturers and            
distributors  7#a7 ,in general ,the     
,secretary shall assess a fee against   
each corporate entity that1 during the  
period beginning on ,january #a1 #aiic1 
and ending on the day before the date of
 enactment of this ,act1 manufactured or
 distributed any opioid drug that was   
covered by a ,federal health program at 
least once during such period1 in       
amounts1 for each such manufacturer or  
distributor1 determined by the          
,secretary through rulemaking4  7#b7    
,total amount ,the ,secretary shall     
ensure that the total amount assessed   
under paragraph 7#a7 equals             
#bj1jjj1jjj1jjj4  7#c7 ,due dates ,with 
respect to a fee assessed under this    
subsection-- 7,a7 not less than #ej     
percent of the amount of the fee shall  
be paid within #a year of the date of   
enactment of this ,act2 and  7,b7 #ajj  

percent of such amount shall be paid not
 later than #b years after the date of  
enactment of this ,act4  7#d7           
,withdrawal of approval in the case of  
nonpayment by manufacturer ,if a        
manufacturer assessed a fee under this  
subsection fails to pay the full fee as 
required under paragraph 7#c71 the      
,secretary shall withdraw approval of   
the application under section #eje of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7 for the drug 
until the fee is paid in full4  7#e7    
,investigation ,immediately after the   
date of enactment of this ,act1 the     
,secretary1 acting through the          
,commissioner and in consultation with  
the ,attorney ,general1 acting through  
the ,administrator of the ,drug         
,enforcement ,administration1 shall     
begin an assessment to set fees under   
this subsection4  7f7 ,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 ,secretary1 in      
consultation with the ,commissioner4    
7#b7 ,appropriations2 transfers to the  
,fund  7,a7 ,appropriation ,there is    
appropriated1 out of any monies in the  
,treasury not otherwise appropriated1   
#bj1jjj1jjj1jjj to the ,fund4  7,b7     
,transfers ,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--  7i7 the amount of the
 civil penalties collected under        
subsection 7c72 plus  7ii7 the amount of
 fees collected under subsection 7e74   
7,c7 ,availability ,funds appropriated  
under paragraph 7#a7 and transferred    
under subparagraph 7,b7 shall remain    
available until expended4  7#c7 ,use of 
funds  7,a7 ,in general ,the ,secretary1
 in consultation with the ,commissioner1

 may1 without further appropriation1 use
 amounts in the ,fund to combat the     
misuse and 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 misuse and 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 the ,centers for 
,disease ,control and ,prevention1 and  
the ,health ,resources and ,services    
,administration2  7ii7 programs1        
projects1 and activities that provide   
services to individuals directly        
affected by the misuse and 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 misuse and 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 misuse and abuse by students and
 address the mental health needs of     
students affected by opioid misuse and  
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 seq47 and the   
,healthy ,start program of the ,health  
,resources and ,services ,administration
 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  7,d7 ,supplement not  
supplant ,amounts transferred to an     
agency under subparagraph 7,a7 to carry 
out programs1 projects1 and activities  
of the agency shall supplement1 and not 
supplant1 amounts otherwise available   
for such purpose4  #c4 ,reduced         
exclusivity  7a7 ,in general ,if a drug 
manufacturer violates section #b7;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 section #b7;b71 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 ,act 7#ba ,u4,s4,c4        
#cfj;cc71 or paragraph 7#f7 or 7#g7 of  
section #cea7k7 of the ,public ,health  
,service ,act 7#db ,u4,s4,c4 #bfb7k771  
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