,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #dah  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #g1 #bjai,mr4 
,man*9 7= himself1 ,mrs4 ,capito1 & ,mr4
 ,k+7 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 aga9/ ! recomm5dation ( ! 
,,fda advisory committee on opioid drugs
  7a7 ,9 ,g5]al ,any approval ( an      
application or supplem5t to an          
application "u section #eje7;b7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;b77 = a drug t is  
an opioid aga9/ ! recomm5dation ( !     
advisory committee pursuant to section  
#ajf ( ! ,compreh5sive ,drug & ,recov]y 
,act ( #bjaf 7,public ,law #aad-aih7    
%all be made by ! ,commission] ( ,food &
 ,drugs 7ref]r$ to 9 ?is section z !    

,commission]7 & %all n be delegat$4  7b7
 ,reports to ,congress ,if !            
,commission] approves a drug z describ$ 
9 subsection 7a71 ! ,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 7a72 &  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 approv$ z describ$ 9    
subsection 7a7 %all n be introduc$ or   
deliv]$ = introduction into int]/ate    
comm]ce until ! report describ$ 9       
subsection 7b77#a7 has be5 submitt$ to  
,congress4  7d7 ,scope ( advisory       
committee review ,section               
#ajf7;a77#a77;,a7 ( ! ,compreh5sive     
,addiction & ,recov]y ,act ( #bjaf      
7,public ,law #aad-aih7 is am5d$--  7#a7
 by ins]t+ 1 or supplem5t to an         
application1 aft] application ea* place 
su* t]m appe>s2 &  7#b7 by /rik+ ( a new
 & ins]t+ =4