,,ii  #aahth ,,congress  #ast ,session  
,s4 #ceeg  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,december #ai1 
#bjbc,mr4 ,murphy 7for himself and ,mr4 
,braun7 introduced the following bill2  
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
require the ,secretary of ,health and   
,human ,services to prepare a report    
that outlines a plan for completing a   
review of approved opioid analgesic     
drugs that considers the public health  
effects of such opioid drugs4  #a4      
,review of opioid drugs and actions ,not
 later than one year after the date of  
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services         
7referred to in this section as the     
,secretary7 shall publish on the website
 of the ,food and ,drug ,administration 
7referred to in this section as the     
,,fda7 a report that outlines a plan for
 completing a review of opioid analgesic
 drugs that are approved under section  

#eje of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 that
 considers the public health effects of 
such opioid drugs as part of the        
benefit-risk assessment1 and that       
addresses the activities of the ,,fda   
that relate to increasing the           
development of non-addictive medical    
products intended to treat pain or      
addiction4 ,such report shall include-- 
7#a7 an opportunity for public input    
concerning the regulation by the ,,fda  
of opioid analgesic drugs1 including    
scientific evidence that relates to     
conditions of use1 safety1 or           
benefit-risk assessment 7including      
consideration of the public health      
effects7 of such opioid drugs2  7#b7 an 
update on the actions taken by the ,,fda
 to review the effectiveness1 safety1   
benefit-risk profile 7which may include 
public health effects71 and use of      
approved opioid analgesic drugs2  7#c7 a
 timeline for an assessment of the      
potential need1 as appropriate1 for     

labeling changes1 revised or additional 
postmarketing requirements1 enforcement 
actions1 or withdrawals for opioid      
analgesic drugs2  7#d7 an overview of   
the steps that the ,,fda has taken to   
support the development and approval of 
non-addictive medical products intended 
to treat pain or addiction1 and actions 
planned to further support the          
development and approval of such        
products2 and  7#e7 an overview of the  
consideration by the ,,fda of clinical  
trial methodologies for analgesic drugs1
 including the enriched enrollment      
randomized withdrawal methodology1 and  
the benefits and drawbacks associated   
with different trial methodologies for  
such drugs1 incorporating any public    
input received under paragraph 7#a74