,i  #aae? ,,congress  #b;d ,session  ,h4
 ,r4 #ehjc  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #ae1 #bjah,mr4   
,g5e ,gre5 ( ,texas introduc$ ! foll[+  
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
to au?orize ! ,secret>y ( ,heal? &      
,human ,s]vices to consid] ! pot5tial = 
misuse & abuse :5 det]m9+ :e!r to       
approve c]ta9 drugs1 & = o!r purposes4  
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,sav+ ,am]ican ,families ?r\gh        
,efficacy & ,tru/$ ,ways ,act ( #bjah or
 ! ,,safety ,act ( #bjah4  #b4          
,consid]ation ( pot5tial = misuse &     
abuse requir$ = drug approval  7a7 ,9   
g5]al ,section #eje7;d7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;d77 is am5d$--  7#a7 9 !
 fir/ s5t5ce-- 7,a7 by /rik+ or 7#g7 &  
ins]t+ 7#g72 &  7,b7 by ins]t+ 2 or 7#h7
 if ! drug is or conta9s a controll$    
sub/ance = :i* a li/+ 9 any s*$ule is 9 
effect "u ! ,controll$ ,sub/ances ,act  

or t is p]man5tly s*$ul$ pursuant to    
section #bja ( su* ,act1 on ! basis (   
in=mation submitt$ to him z "p ( !      
application1 or ^u ! basis ( any o!r    
in=mation be=e him ) respect to su*     
drug1 ! drug is unsafe = use due to !   
risks ( abuse or misuse or !re is       
insuffici5t in=mation to %[ t ! drug is 
safe = use consid]+ su* risks2 be=e he  
%all issue an ord] refus+ to approve !  
application2 &  7#b7 9 ! second s5t5ce1 
by /rik+ 7#f7 & ins]t+ 7#h74  7b7       
,)drawal au?ority ,section #eje7;e7 ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;e77 is am5d$ 9 !   
fir/ s5t5ce--  7#a7 by /rik+ or 7#e7 &  
ins]t+ 7#e72 &  7#b7 by ins]t+ ! foll[+3
 2 or 7#f7 t1 9 ! case ( a drug t is or 
conta9s a controll$ sub/ance = :i* a    
li/+ 9 any s*$ule is 9 effect "u !      
,controll$ ,sub/ances ,act or t is      
p]man5tly s*$ul$ pursuant to section    
#bja ( su* ,act1 on ! basis ( new       
in=mation be=e him ) respect to su*     
drug1 evaluat$ toge!r ) ! in=mation     

available to him :5 ! application 0     
approv$1 t ! drug is unsafe = use due to
 ! risks ( abuse or misuse aft] ( a     
mat]ial fact4  7c7 ,rule ( con/ruction  
,no?+ 9 ! am5dm5ts made by ?is section  
%all be con/ru$ to limit or n>r[1 9 any 
mann]1 ! mean+ or application ( !       
provisions ( p>agraphs 7#a71 7#b71 7#c71
 7#d71 7#e71 & 7#g7 ( section #eje7;d7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cee7;d77 or p>agraphs  
7#a7 & 7#b7 ( section #eje7;e7 ( su*    
,act 7#ba ,u4,s4,c4 #cee7;e774