#aaeth ,,congress  #b;d ,session  ,h4   
,r4 #ehaa  ,,an ,,act  ,to amend the    
,federal ,food1 ,drug1 and ,cosmetic    
,act with respect to postapproval study 
requirements for certain controlled     
substances1 and for other purposes4  #a4
 ,postapproval study requirements  7a7  
,purposes of study ,section             
#eje7o77#c77;,b7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7o77#c77;,b77 is amended by adding 
at the end the following3  7iv7 ,to     
assess a potential reduction in         
effectiveness of the drug for the       
conditions of use prescribed1           
recommended1 or suggested in the        
labeling thereof if--  7,i7 the drug    
involved-- 7aa7 is or contains a        
substance for which a listing in any    
schedule is in effect 7on a temporary or
 permanent basis7 under section #bja of 
the ,controlled ,substances ,act2 or    
7bb7 is a drug that has not been        
approved under this section or licensed 
under section #cea of the ,public       

,health ,service ,act1 for which an     
application for such approval or        
licensure is pending or anticipated1 and
 for which the ,secretary provides      
notice to the sponsor that the          
,secretary intends to issue a scientific
 and medical evaluation and recommend   
controls under the ,controlled          
,substances ,act2 and  7,,ii7 the       
potential reduction in effectiveness    
could result in the benefits of the drug
 no longer outweighing the risks4  4    
7b7 ,establishment of requirement       
,section #eje7o77#c77;,c7 of the        
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7o77#c77;,c77 is
 amended by striking such requirement   
and all that follows through safety     
information4 and inserting the          
following3 such requirement--  7i7 in   
the case of a purpose described in      
clause 7i71 7ii71 or 7iii7 of           
subparagraph 7,b71 only if the          
,secretary becomes aware of new safety  
information2 and  7ii7 in the case of a 

purpose described in clause 7iv7 of such
 subparagraph1 if the ,secretary        
determines that new effectiveness       
information exists4  4  7c7             
,applicability ,section #eje7o77#c7 of  
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7o77#c77 is    
amended by adding at the end the        
following new subparagraph3  7,g7       
,applicability ,the conduct of a study  
or clinical trial required pursuant to  
this paragraph for the purpose specified
 in subparagraph 7,b77iv7 shall not be  
considered a new clinical investigation 
for the purpose of a period of          
exclusivity under clause 7iii7 or 7iv7  
of subsection 7c77#c77;,e7 or clause    
7iii7 or 7iv7 of subsection             
7j77#e77;,f74  4  7d7 ,new effectiveness
 information defined ,section           
#eje7o77#b7 of the ,federal ,food1      
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7o77#b77 is amended by adding at   
the end the following new subparagraph3 
7,d7 ,new effectiveness information ,the

 term new effectiveness information1    
with respect to a drug that is or       
contains a controlled substance for     
which a listing in any schedule is in   
effect 7on a temporary or permanent     
basis7 under section #bja of the        
,controlled ,substances ,act1 means new 
information about the effectiveness of  
the drug1 including a new analysis of   
existing information1 derived from--    
7i7 a clinical trial2 an adverse event  
report2 a postapproval study or clinical
 trial 7including a study or clinical   
trial under paragraph 7#c772  7ii7      
peer-reviewed biomedical literature2    
7iii7 data derived from the postmarket  
risk identification and analysis system 
under subsection 7k72 or  7iv7 other    
scientific data determined to be        
appropriate by the ,secretary4  4  7e7  
,conforming amendments with respect to  
labeling changes ,section #eje7o77#d7 of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7o77#d77 is amended-- 7#a7 in       

subparagraph 7,a7--  7,a7 in the        
heading1 by inserting or new            
effectiveness after safety2  7,b7 by    
striking safety information and         
inserting new safety information or new 
effectiveness information such2 and     
7,c7 by striking believes should be and 
inserting believes changes should be    
made to2  7#b7 in subparagraph 7,b77i7--
  7,a7 by striking new safety           
information and by inserting new safety 
information or new effectiveness        
information2 and  7,b7 by inserting     
indications1 after boxed warnings12     
7#c7 in subparagraph 7,c71 by inserting 
or new effectiveness information after  
safety information2 and  7#d7 in        
subparagraph 7,e71 by inserting or new  
effectiveness information after safety  
information4  7f7 ,rule of construction 
,nothing in the amendments made by this 
section shall be construed to alter1 in 
any manner1 the meaning or application  
of the provisions of paragraph 7#c7 of  
section #eje7o7 of the ,federal ,food1  

,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7o77 with respect to the authority 
of the ,secretary of ,health and ,human 
,services to require a postapproval     
study or clinical trial for a purpose   
specified in clauses 7i7 through 7iii7  
of subparagraph 7,b7 of such paragraph  
7#c7 or paragraph 7#d7 of such section  
#eje7o7 with respect to the ,secretary's
 authority to require safety labeling   
changes4  ,passed the ,house of         
,representatives ,june #ai1             
#bjah4;,clerk4