,,ii  #aafth ,,congress  #ast ,session  
,s4 #dah  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,february #g1       
#bjai,mr4 ,manchin 7for himself1 ,mrs4  
,capito1 and ,mr4 ,king7 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    
against the recommendation of the ,,fda 
advisory committee on opioid drugs  7a7 
,in ,general ,any approval of an        
application or supplement to an         
application under section #eje7;b7 of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7;b77 for a    
drug that is an opioid against the      
recommendation of the advisory committee
 pursuant to section #ajf of the        
,comprehensive ,drug and ,recovery ,act 

of #bjaf 7,public ,law #aad-aih7 shall  
be made by the ,commissioner of ,food   
and ,drugs 7referred to in this section 
as the ,commissioner7 and shall not be  
delegated4  7b7 ,reports to ,congress   
,if the ,commissioner approves a drug as
 described in subsection 7a71 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 7a72 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 approved as described
 in subsection 7a7 shall not be         
introduced or delivered for introduction
 into interstate commerce until the     
report described in subsection 7b77#a7  
has been submitted to ,congress4  7d7   
,scope of advisory committee review     
,section #ajf7;a77#a77;,a7 of the       
,comprehensive ,addiction and ,recovery 
,act of #bjaf 7,public ,law #aad-aih7 is
 amended--  7#a7 by inserting 1 or      
supplement to an application1 after     
application each place such term        
appears2 and  7#b7 by striking of a new 

and inserting for4