,i  #aafth ,,congress  #b;d ,session    
,h4 ,r4 #hgcf  ,,in ,,the ,,house ,,of  
,,representatives  ,november #ab1       
#bjbj,mr4 ,brendan ,f4 ,boyle of        
,pennsylvania 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 allow the  
sponsor of a drug to use a non-animal   
test as an alternative to an animal test
 for purposes of demonstrating the      
safety and effectiveness of a drug if   
such approach satisfies the requirements
 of the applicable statutes and         
regulations4  #a4 ,short title ,this    
,act may be cited as the ,alternatives  
to ,animals for ,regulatory ,fairness   
,act of #bjbj or the ,,aarf ,act of     
#bjbj4  #b4 ,findings ,the ,congress    
finds that-- 7#a7 the ,food and ,drug   
,administration 7in this section        
referred to as the ,,fda7 often requires
 pharmaceutical companies to conduct or 
commission testing on dogs and other    

animals to assess the safety or         
effectiveness of new drugs1 even though 
such testing is inefficient1 expensive1 
and ineffective2  7#b7 the ,national    
,institutes of ,health states1          
,approximately #cj percent of promising 
medications have failed in human        
clinical trials because they are found  
to be toxic despite promising           
preclinical studies in animal models4   
,about #fj percent of candidate drugs   
fail due to lack of efficacy2  7#c7     
current ,,fda nonbinding pharmaceutical 
testing guidelines support the use of   
alternatives to animal testing to       
improve the effectiveness and efficiency
 of drug development2  7#d7 current     
,,fda drug testing guidance for the     
pharmaceutical industry states1         
consideration should be given to use of 
new in vitro alternative methods for    
safety evaluation2  7#e7 the ,,fda's    
drug testing guidance for industry      
additionally states1 alternative        
approaches ''' can also be used ''' 4   

,the use of any of these approaches can 
reduce overall animal use in drug       
development2  7#f7 the ,,fda writes that
 alternatives to animal testing1 may    
help bring ,,fda-regulated products to  
market faster1 with improved efficacy1  
or prevent products with increased      
toxicological risk from reaching the    
market4 ,also critical is the potential 
for these advances to replace1 reduce1  
and_/or refine animal testing2  7#g7    
pharmaceutical companies are reducing   
animal testing by investing in the      
development and use of alternative      
methods1 which studies show are often   
more effective and efficient than       
traditional animal use2  7#h7 the ,,fda 
states1 ,,fda encourages sponsors to    
consult with us if they wish to use a   
non-animal testing method they believe  
is suitable1 adequate1 validated1 and   
feasible2 and  7#i7 in some cases1 drug 
manufacturers and sponsors have not been
 allowed by the ,,fda to use            
alternatives to animal testing to       

fulfill regulatory requirements1 despite
 the ,,fda's support for this technology
 in its industry guidance document4  #c4
 ,alternatives to animal tests ,section 
#eje of the ,federal ,food1 ,drug and   
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is  
amended by adding at the end the        
following new subsection3  7z7          
,alternatives to animal tests ,the      
,secretary shall allow the sponsor of a 
drug to use a non-animal test as an     
alternative to an animal test for       
purposes of demonstrating the safety and
 effectiveness of a drug under this     
section if such approach satisfies the  
requirements of the applicable statutes 
and regulations4  4