,,ii  #aadth ,,congress  #ast ,session  
,s4 #ied  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,april #ae1 #bjae   
,mr4 ,manchin 7for himself1 ,mr4        
,vitter1 ,mrs4 ,capito1 and ,mr4 ,kaine7
 introduced the following bill2 which   
was read twice and referred to the      
,committee on ,health1 ,education1      
,labor1 and ,pensions  ,a ,,bill  ,to   
establish procedures regarding the      
approval of opioid drugs by the ,food   
and ,drug ,administration4  #a4 ,short  
title  ,this ,act may be cited as the   
,,fda ,accountability for ,public       
,safety ,act4  #b4 ,approval of opioid  
drugs  7a7 ,in ,general ,notwithstanding
 any other provision of law1 the        
,commissioner of ,food and ,drugs       
7referred to in this ,act as the        
,commissioner7 shall ensure that1 with  
respect to each application for an      
opioid drug submitted under section #eje
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7--   
7#a7 an advisory committee of the       

,center for ,drug ,evaluation and       
,research of the ,food and ,drug        
,administration evaluates the           
application and issues a recommendation 
regarding approval of such drug prior to
 a final decision to approve such drug2 
and  7#b7 if a final decision to approve
 such drug is inconsistent with the     
recommendation under paragraph 7#a71    
such final decision shall be made by the
 ,commissioner and shall not be         
delegated4  7b7 ,reports to ,congress   
,if the advisory committee recommends   
under subsection 7a77#a7 that the       
,commissioner not approve an opioid drug
 under section #eje of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee71 and the ,commissioner  
approves that drug under subsection     
7a77#b71 the ,commissioner shall--  7#a7
 submit a report to the ,committee on   
,health1 ,education1 ,labor1 and        
,pensions of the ,senate and the        
,committee on ,energy and ,commerce of  
the ,house of ,representatives1 and to  

any member of ,congress that requests   
the report1 that includes--  7,a7       
medical and scientific evidence         
regarding patient safety that clearly   
supports the ,commissioner's decision to
 approve the opioid drug against the    
recommendation of the advisory          
committee2 and  7,b7 a disclosure of any
 potential conflicts of interest that   
may exist regarding any official of the 
,food and ,drug ,administration who was 
involved in the decision to approve the 
drug prior to the ,commissioner's final 
decision under subsection 7a77#b72 and  
7#b7 at the request of the ,committee on
 ,health1 ,education1 ,labor1 and       
,pensions of the ,senate or the         
,committee on ,energy and ,commerce of  
the ,house of ,representatives1 testify 
before that committee regarding the     
,commissioner's decision to approve the 
opioid drug against the recommendation  
of the advisory committee4  7c7         
,prohibition on marketing ,a drug       
described in subsection 7b7 shall not be

 introduced or delivered for            
introduction into interstate commerce   
until the report described in subsection
 7b77#a7 has been submitted to          
,congress4