,,ii  #aad? ,,congress  #a/ ,session    
,s4 #ied  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,april #ae1 #bjae ,mr4 
,man*9 7= himself1 ,mr4 ,vitt]1 ,mrs4   
,capito1 & ,mr4 ,ka9e7 introduc$ !      
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to      
e/abli% proc$ures reg>d+ ! approval (   
opioid drugs by ! ,food & ,drug         
,adm9i/ration4  #a4 ,%ort title  ,?is   
,act may be cit$ z ! ,,fda              
,acc\ntability = ,public ,safety ,act4  
#b4 ,approval ( opioid drugs  7a7 ,9    
,g5]al ,not)/&+ any o!r provision ( law1
 ! ,commission] ( ,food & ,drugs 7ref]r$
 to 9 ?is ,act z ! ,commission]7 %all   
ensure t1 ) respect to ea* application =
 an opioid drug submitt$ "u section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7--  7#a7 an    
advisory committee ( ! ,c5t] = ,drug    
,evaluation & ,rese>* ( ! ,food & ,drug 
,adm9i/ration evaluates ! application & 
issues a recomm5dation reg>d+ approval (

 su* drug prior to a f9al decision to   
approve su* drug2 &  7#b7 if a f9al     
decision to approve su* drug is         
inconsi/5t ) ! recomm5dation "u p>agraph
 7#a71 su* f9al decision %all be made by
 ! ,commission] & %all n be delegat$4   
7b7 ,reports to ,congress ,if ! advisory
 committee recomm5ds "u subsection      
7a77#a7 t ! ,commission] n approve an   
opioid drug "u section #eje ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee71 & ! ,commission]       
approves t drug "u subsection 7a77#b71 !
 ,commission] %all--  7#a7 submit a     
report to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives1 & 
to any memb] ( ,congress t reque/s !    
report1 t includes--  7,a7 m$ical &     
sci5tific evid5ce reg>d+ pati5t safety t
 cle>ly supports ! ,commission]'s       
decision to approve ! opioid drug aga9/ 
! recomm5dation ( ! advisory committee2 
&  7,b7 a disclosure ( any pot5tial     

conflicts ( int]e/ t may exi/ reg>d+ any
 (ficial ( ! ,food & ,drug ,adm9i/ration
 :o 0 involv$ 9 ! decision to approve ! 
drug prior to ! ,commission]'s f9al     
decision "u subsection 7a77#b72 &  7#b7 
at ! reque/ ( ! ,committee on ,heal?1   
,education1 ,labor1 & ,p5sions ( !      
,s5ate or ! ,committee on ,en]gy &      
,comm]ce ( ! ,h\se ( ,repres5tatives1   
te/ify be=e t committee reg>d+ !        
,commission]'s decision to approve !    
opioid drug aga9/ ! recomm5dation ( !   
advisory committee4  7c7 ,prohibition on
 m>ket+ ,a drug describ$ 9 subsection   
7b7 %all n be introduc$ or deliv]$ =    
introduction into int]/ate comm]ce until
 ! report describ$ 9 subsection 7b77#a7 
has be5 submitt$ to ,congress4