,,ii  #aae? ,,congress  #b;d ,session   
,s4 #bffe  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #ab1 #bjah,mr4  
,"y 7= himself & ,mr4 ,donnelly7        
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to require guidance on h[ ! 
,food & ,drug ,adm9i/ration w consid]   
claims ( opioid sp>+ & on ! conditions  
"u :i* ! ,food & ,drug ,adm9i/ration w  
consid] misuse & abuse ( drugs 9 mak+   
c]ta9 det]m9ations ( safety4  #a4       
,opioid sp>+ claims & indications  7a7  
,opioid sp>+  7#a7 ,draft guidance ,n   
lat] ?an #a ye> aft] ! date ( enactm5t (
 ?is ,act1 ! ,secret>y1 act+ ?r\gh !    
,commission] ( ,food & ,drugs1 %all     
issue draft guidance to cl>ify h[ !     
,food & ,drug ,adm9i/ration w assess    
evid5ce to support claims ( opioid sp>+ 
= non-opioid or o!r non-addictive m$ical
 products int5d$ to treat pa94 ,su*     
guidance %all include--  7,a7 data      
collection me?odologies1 includ+ ! use (

 innovative cl9ical trial designs       
7consi/5t ) section #cjba ( ! #ba/      
,c5tury ,cures ,act 7,public ,law       
#aad-bee771 & real _w evid5ce 7z def9$ 9
 section #eje;,f7b7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;g7b7771 z appropriate1 to support  
product label+2  7,b7 e?ical            
implications ( exposure to controll$    
sub/ances 9 cl9ical trials to support   
opioid sp>+ claims & consid]ations on   
me?ods to r$uce h>m2  7,c7 endpo9ts1    
includ+ prim>y1 second>y1 & surrogate   
endpo9ts1 to evaluate ! r$uction 9      
opioid use2  7,d7 be/ practices =       
communication betwe5 sponsors & ! ag5cy 
on ! developm5t ( su* data collection   
me?ods1 includ+ ! initiation ( data     
collection2 &  7,e7 ! appropriate =mat  
to submit su* data results to !         
,secret>y4  7#b7 ,f9al guidance ,n lat] 
?an #f mon?s aft] ! close ( ! p]iod =   
public comm5t on ! draft guidance "u    
p>agraph 7#a71 ! ,secret>y %all f9alize 
su* guidance4  7b7 ,risk ( abuse &      

misuse  7#a7 ,draft guidance ,n lat] ?an
 #a ye> aft] ! date ( enactm5t ( ?is    
,act1 ! ,secret>y1 act+ ?r\gh !         
,commission] ( ,food & ,drugs1 %all     
issue draft guidance to cl>ify !        
circum/ances "u :i* ! ,food & ,drug     
,adm9i/ration consid]s misuse & abuse ( 
drugs 9 mak+ det]m9ations ( safety "u   
p>agraphs 7#b7 & 7#d7 ( subsection 7d7 (
 section #eje ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 & 9
 f9d+ t a drug is unsafe "u p>agraph    
7#a7 or 7#b7 ( subsection 7e7 ( su*     
section4  7#b7 ,f9al guidance ,n lat]   
?an #f mon?s aft] ! close ( ! p]iod =   
public comm5t on ! draft guidance "u    
p>agraph 7#a71 ! ,secret>y %all f9alize 
su* guidance4  7c7 ,def9itions ,9 ?is   
section-- 7#a7 ! t]m m$ical product     
means a drug 7z t t]m is def9$ by       
section #bja7;g77#a7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cba7;g77#a7771 biological product 7z t 
t]m is def9$ by section #cea7;i7 ( ?is  
,act 7#db ,u4,s4,c4 #bfb7;i7771 or      

device 7z t t]m is def9$ by section     
#bja7;h7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cba7;h7772 &  7#b7 ! t]m opioid sp>+   
means r$uc+ ! use ( opioids or o!r      
controll$ sub/ances4