,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #hgcf  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,novemb] #ab1         
#bjbj,mr4 ,br5dan ,f4 ,boyle (          
,p5nsylvania introduc$ ! foll[+ bill2   
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act to all[ !
 sponsor ( a drug to use a non-animal   
te/ z an alt]native to an animal te/ =  
purposes ( demon/rat+ ! safety &        
effectiv5ess ( a drug if su* approa*    
satisfies ! requirem5ts ( ! applicable  
/atutes & regulations4  #a4 ,%ort title 
,?is ,act may be cit$ z ! ,alt]natives  
to ,animals = ,regulatory ,fairness ,act
 ( #bjbj or ! ,,a>f ,act ( #bjbj4  #b4  
,f9d+s ,! ,congress f9ds t-- 7#a7 !     
,food & ,drug ,adm9i/ration 79 ?is      
section ref]r$ to z ! ,,fda7 (t5        
requires ph>maceutical companies to     
conduct or commission te/+ on dogs & o!r
 animals to assess ! safety or          
effectiv5ess ( new drugs1 ev5 ?\gh su*  
te/+ is ineffici5t1 exp5sive1 &         

ineffective2  7#b7 ! ,national          
,in/itutes ( ,heal? /ates1              
,approximately #cj p]c5t ( promis+      
m$ications h fail$ 9 human cl9ical      
trials because !y are f\nd to be toxic  
despite promis+ precl9ical /udies 9     
animal models4 ,ab\t #fj p]c5t ( c&idate
 drugs fail due to lack ( efficacy2     
7#c7 curr5t ,,fda nonb9d+ ph>maceutical 
te/+ guidel9es support ! use (          
alt]natives to animal te/+ to improve ! 
effectiv5ess & effici5cy ( drug         
developm5t2  7#d7 curr5t ,,fda drug te/+
 guidance = ! ph>maceutical indu/ry     
/ates1 consid]ation %\ld be giv5 to use 
( new 9 vitro alt]native me?ods = safety
 evaluation2  7#e7 ! ,,fda's drug te/+  
guidance = indu/ry additionally /ates1  
alt]native approa*es ''' c also be us$  
''' 4 ,! use ( any ( ^! approa*es c     
r$uce ov]all animal use 9 drug          
developm5t2  7#f7 ! ,,fda writes t      
alt]natives to animal te/+1 may help br+
 ,,fda-regulat$ products to m>ket fa/]1 
) improv$ efficacy1 or prev5t products )

 increas$ toxicological risk f rea*+ !  
m>ket4 ,also critical is ! pot5tial = ^!
 advances to replace1 r$uce1 &_/or ref9e
 animal te/+2  7#g7 ph>maceutical       
companies are r$uc+ animal te/+ by      
inve/+ 9 ! developm5t & use ( alt]native
 me?ods1 :i* /udies %[ are (t5 m        
effective & effici5t ?an traditional    
animal use2  7#h7 ! ,,fda /ates1 ,,fda  
enc\rages sponsors to consult ) u if !y 
wi% to use a non-animal te/+ me?od !y   
believe is suitable1 adequate1 validat$1
 & feasible2 &  7#i7 9 "s cases1 drug   
manufactur]s & sponsors h n be5 all[$ by
 ! ,,fda to use alt]natives to animal   
te/+ to fulfill regulatory requirem5ts1 
despite ! ,,fda's support = ?is         
te*nology 9 its indu/ry guidance        
docum5t4  #c4 ,alt]natives to animal    
te/s ,section #eje ( ! ,f$]al ,food1    
,drug & ,cosmetic ,act 7#ba ,u4,s4,c4   
#cee7 is am5d$ by add+ at ! end ! foll[+
 new subsection3  7z7 ,alt]natives to   
animal te/s ,! ,secret>y %all all[ !    
sponsor ( a drug to use a non-animal te/

 z an alt]native to an animal te/ =     
purposes ( demon/rat+ ! safety &        
effectiv5ess ( a drug "u ?is section if 
su* approa* satisfies ! requirem5ts ( ! 
applicable /atutes & regulations4  4