,i  #aaeth ,,congress  #b;d ,session    
,h4 ,r4 #ehjc  ,,in ,,the ,,house ,,of  
,,representatives  ,may #ae1 #bjah,mr4  
,gene ,green of ,texas introduced the   
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend the ,federal ,food1
 ,drug1 and ,cosmetic ,act to authorize 
the ,secretary of ,health and ,human    
,services to consider the potential for 
misuse and abuse when determining       
whether to approve certain drugs1 and   
for other purposes4  #a4 ,short title   
,this ,act may be cited as the ,saving  
,american ,families through ,efficacy   
and ,trusted ,ways ,act of #bjah or the 
,,safety ,act of #bjah4  #b4            
,consideration of potential for misuse  
and abuse required for drug approval    
7a7 ,in general ,section #eje7;d7 of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;d77 is        
amended--  7#a7 in the first sentence-- 
7,a7 by striking or 7#g7 and inserting  
7#g72 and  7,b7 by inserting 2 or 7#h7  

if the drug is or contains a controlled 
substance for which a listing in any    
schedule is in effect under the         
,controlled ,substances ,act or that is 
permanently scheduled pursuant to       
section #bja of such ,act1 on the basis 
of information submitted to him as part 
of the application1 or upon the basis of
 any other information before him with  
respect to such drug1 the drug is unsafe
 for use due to the risks of abuse or   
misuse or there is insufficient         
information to show that the drug is    
safe for use considering such risks2    
before he shall issue an order refusing 
to approve the application2 and  7#b7 in
 the second sentence1 by striking 7#f7  
and inserting 7#h74  7b7 ,withdrawal    
authority ,section #eje7;e7 of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;e77 is amended
 in the first sentence--  7#a7 by       
striking or 7#e7 and inserting 7#e72 and
  7#b7 by inserting the following3 2 or 
7#f7 that1 in the case of a drug that is

 or contains a controlled substance for 
which a listing in any schedule is in   
effect under the ,controlled ,substances
 ,act or that is permanently scheduled  
pursuant to section #bja of such ,act1  
on the basis of new information before  
him with respect to such drug1 evaluated
 together with the information available
 to him when the application was        
approved1 that the drug is unsafe for   
use due to the risks of abuse or misuse 
after of a material fact4  7c7 ,rule of 
construction ,nothing in the amendments 
made by this section shall be construed 
to limit or narrow1 in any manner1 the  
meaning or application of the provisions
 of paragraphs 7#a71 7#b71 7#c71 7#d71  
7#e71 and 7#g7 of section #eje7;d7 of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7;d77 or       
paragraphs 7#a7 and 7#b7 of section     
#eje7;e7 of such ,act 7#ba ,u4,s4,c4    
#cee7;e774