,,ii  #aaeth ,,congress  #b;d ,session  
,s4 #bffe  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #ab1    
#bjah,mr4 ,young 7for himself and ,mr4  
,donnelly7 introduced the following     
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to require guidance on how the 
,food and ,drug ,administration will    
consider claims of opioid sparing and on
 the conditions under which the ,food   
and ,drug ,administration will consider 
misuse and abuse of drugs in making     
certain determinations of safety4  #a4  
,opioid sparing claims and indications  
7a7 ,opioid sparing  7#a7 ,draft        
guidance ,not later than #a year after  
the date of enactment of this ,act1 the 
,secretary1 acting through the          
,commissioner of ,food and ,drugs1 shall
 issue draft guidance to clarify how the
 ,food and ,drug ,administration will   
assess evidence to support claims of    
opioid sparing for non-opioid or other  

non-addictive medical products intended 
to treat pain4 ,such guidance shall     
include--  7,a7 data collection         
methodologies1 including the use of     
innovative clinical trial designs       
7consistent with section #cjba of the   
#bast ,century ,cures ,act 7,public ,law
 #aad-bee771 and real world evidence 7as
 defined in section #eje;,f7b7 of the   
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee;g7b7771 as     
appropriate1 to support product         
labeling2  7,b7 ethical implications of 
exposure to controlled substances in    
clinical trials to support opioid       
sparing claims and considerations on    
methods to reduce harm2  7,c7 endpoints1
 including primary1 secondary1 and      
surrogate endpoints1 to evaluate the    
reduction in opioid use2  7,d7 best     
practices for communication between     
sponsors and the agency on the          
development of such data collection     
methods1 including the initiation of    
data collection2 and  7,e7 the          

appropriate format to submit such data  
results to the ,secretary4  7#b7 ,final 
guidance ,not later than #f months after
 the close of the period for public     
comment on the draft guidance under     
paragraph 7#a71 the ,secretary shall    
finalize such guidance4  7b7 ,risk of   
abuse and misuse  7#a7 ,draft guidance  
,not later than #a year after the date  
of enactment of this ,act1 the          
,secretary1 acting through the          
,commissioner of ,food and ,drugs1 shall
 issue draft guidance to clarify the    
circumstances under which the ,food and 
,drug ,administration considers misuse  
and abuse of drugs in making            
determinations of safety under          
paragraphs 7#b7 and 7#d7 of subsection  
7d7 of section #eje of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7 and in finding that a   
drug is unsafe under paragraph 7#a7 or  
7#b7 of subsection 7e7 of such section4 
7#b7 ,final guidance ,not later than #f 
months after the close of the period for

 public comment on the draft guidance   
under paragraph 7#a71 the ,secretary    
shall finalize such guidance4  7c7      
,definitions ,in this section-- 7#a7 the
 term medical product means a drug 7as  
that term is defined by section         
#bja7;g77#a7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cba7;g77#a7771 biological product 7as 
that term is defined by section #cea7;i7
 of this ,act 7#db ,u4,s4,c4 #bfb7;i7771
 or device 7as that term is defined by  
section #bja7;h7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cba7;h7772 and  7#b7 the term opioid  
sparing means reducing the use of       
opioids or other controlled substances4