,,ib  ,union ,calendar ,no4 #dca  #aadth
 ,,congress  #b;d ,session  ,h4 ,r4     
#digf  ,report ,no4 #aad-eeg  ,,in ,,the
 ,,house ,,of ,,representatives  ,april 
#ah1 #bjaf ,mr4 ,sean ,patrick ,maloney 
of ,new ,york 7for himself and ,mr4     
,lance7 introduced the following bill2  
which was referred to the ,committee on 
,energy and ,commerce  ,may #aj1 #bjaf  
,committed to the ,committee of the     
,whole ,house on the ,state of the      
,union and ordered to be printed  ,a    
,,bill  ,to require the ,commissioner of
 ,food and ,drugs to seek               
recommendations from an advisory        
committee of the ,food and ,drug        
,administration before approval of      
certain new drugs that are opioids      
without abuse-deterrent properties1 and 
for other purposes4  #a4 ,short title   
,this ,act may be cited as the ,opioid  
,review ,modernization ,act of #bjaf4   
#b4 ,,fda opioid action plan ,chapter ,v
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act is amended by inserting  

after section #efi of such ,act 7#ba    
,u4,s4,c4 #cej;bbb-#h7 the following3   
#efi-a4 ,opioid action plan  7a7 ,new   
drug application  7#a7 ,in general      
,subject to paragraph 7#b71 prior to the
 approval pursuant to an application    
under section #eje7;b7 of a new drug    
that is an opioid and does not have     
abuse-deterrent properties1 the         
,secretary shall refer the application  
to an advisory committee of the ,food   
and ,drug ,administration to seek       
recommendations from such advisory      
committee4  7#b7 ,public health         
exemption ,a referral to an advisory    
committee under paragraph 7#a7 is not   
required with respect to a new drug if  
the ,secretary--  7,a7 finds that such a
 referral is not in the interest of     
protecting and promoting public health2 
7,b7 finds that such a referral is not  
necessary based on a review of the      
relevant scientific information2 and    
7,c7 submits a notice containing the    
rationale for such findings to the      

,committee on ,health1 ,education1      
,labor1 and ,pensions of the ,senate and
 the ,committee on ,energy and ,commerce
 of the ,house of ,representatives4  7b7
 ,pediatric opioid labeling ,the        
,secretary shall convene the ,pediatric 
,advisory ,committee of the ,food and   
,drug ,administration to seek           
recommendations from such ,committee    
regarding a framework for the inclusion 
of information in the labeling of drugs 
that are opioids relating to the use of 
such drugs in pediatric populations     
before the ,secretary approves any      
labeling or change to labeling for any  
drug that is an opioid intended for use 
in a pediatric population4  7c7 ,sunset 
,the requirements of subsections 7a7 and
 7b7 shall cease to be effective on     
,october #a1 #bjbb4  4  #c4 ,prescriber 
education ,not later than #a year after 
the date of the enactment of this ,act1 
the ,secretary of ,health and ,human    
,services1 acting through the           
,commissioner of ,food and ,drugs1 as   

part of the ,food and ,drug             
,administration's evaluation of the     
,extended-,release_/,long-,acting       
,opioid ,analgesics ,risk ,evaluation   
and ,mitigation ,strategy1 and in       
consultation with relevant stakeholders1
 shall develop recommendations regarding
 education programs for prescribers of  
opioids pursuant to section #eje-a of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee-a71 including 
recommendations on--  7#a7 which        
prescribers should participate in such  
programs2 and  7#b7 how often           
participation in such programs is       
necessary4  #d4 ,guidance on evaluating 
the abuse deterrence of generic solid   
oral opioid drug products ,not later    
than #b years after the end of the      
period for public comment on the draft  
guidance entitled ,general ,principals  
for ,evaluating the ,abuse ,deterrence  
of ,generic ,solid ,oral ,opioid ,drug  
,products issued by the ,center for     
,drug ,evaluation and ,research of the  

,food and ,drug ,administration in      
,march #bjaf1 the ,commissioner of ,food
 and ,drugs shall publish in the        
,federal ,register a final version of   
such guidance4  ,may #aj1 #bjaf         
,committed to the ,committee of the     
,whole ,house on the ,state of the      
,union and ordered to be printed