,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #ajaej  ,,9 ,,! ,,h\se ,,(         
,,repres5tatives  ,augu/ #bg1 #bjbf,ms4 
,boeb]t 7= h]self & ,mr4 ,van ,ord57    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to provide a p]iod (   
m>ket exclusivity = botanical drugs1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,advanc+ ,botanical
 ,drug ,developm5t ,act ( #bjbf4  #b4   
,f9d+s ,congress f9ds ! foll[+3  7#a7   
,*ronic & age-relat$ diseases are among 
! lead+ causes ( disability1 impair$    
quality ( life1 & heal? c>e sp5d+ 9 !   
,unit$ ,/ates4  7#b7 ,_m *ronic &       
age-relat$ diseases involve multiple    
biological pa?ways & complex            
pa?ophysiology1 yet mo/ curr5tly approv$
 !rapies are design$ to t>get a s+le    
molecul> pa?way4  7#c7 ,botanical drugs 
regulat$ by ! ,food & ,drug             
,adm9i/ration 79 ?is section ref]r$ to z
 ! ,,fda7 "u section #eje ( ! ,f$]al    

,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 may conta9 multiple     
naturally occurr+ active con/itu5ts     
capable ( act+ on multiple biological   
pa?ways simultane\sly & safely4  7#d7   
,s9ce ! ,,fda e/abli%$ a regulatory     
pa?way = botanical drugs 9 #bjjd1 only a
 limit$ numb] ( botanical drugs h       
receiv$ approval1 despite significant   
sci5tific & !rapeutic pot5tial & ! gr[+ 
int]e/ ( pati5ts 9 evid5ce-bas$1        
,,fda-approv$ treatm5t options d]iv$ f  
natural products4  7#e7 ,9 addition to !
 co/s associat$ ) ! cl9ical developm5t (
 conv5tional syn!tic drugs1 botanical   
drugs pres5t unique sci5tific &         
manufactur+ *all5ges aris+ f ! natural  
v>iability ( plant-d]iv$ raw mat]ials1  
includ+ ! ne$ = ext5sive s\rc+ controls1
 bat* consi/5cy te/+1 con/itu5t         
*>act]ization1 & /&>dization processes  
to ensure safety1 quality1 &            
effectiv5ess4 ,^! additional developm5t 
burd5s may increase co/s & comm]cial    
unc]ta9ty = sponsors seek+ to br+       

innovative botanical !rapies to m>ket4  
7#f7 ,z a result ( ^! unique sci5tific1 
manufactur+1 & regulatory *all5ges1     
exi/+ intellectual prop]ty & regulatory 
exclusivity frameworks may n provide    
suffici5t inc5tives to support private  
inve/m5t 9 ! rese>* & developm5t (      
innovative botanical drugs4  7#g7       
,congress has previ\sly recogniz$ t     
c]ta9 categories ( complex m$ical       
products require tailor$ p]iods (       
regulatory exclusivity to enc\rage      
innovation & facilitate long-t]m        
inve/m5t 9 rese>* & developm5t4  7#h7   
,exp&+ inc5tives = ! developm5t ( safe &
 effective botanical drugs may increase 
multi-t>get treatm5t options = pati5ts  
suff]+ f multi-pa?way1 *ronic &         
age-relat$ diseases :ile promot+        
biom$ical innovation & economic gr[? 9 !
 ,unit$ ,/ates4  7#i7 ,advances 9       
computational biology1 artificial       
intellig5ce1 & sy/ems ph>macology h     
creat$ new opportunities to id5tify &   
develop innovative botanical drug       

comb9ations capable ( address+ complex  
diseases ?r\gh multi-pa?way me*anisms ( 
action4  7#aj7 ,x is 9 ! public int]e/  
to enc\rage ! developm5t & approval (   
multi-t>get1 evid5ce-bas$1              
,,fda-regulat$ botanical drugs subject  
to ! same /&>ds ( safety & effectiv5ess 
applicable to o!r drugs regulat$ by !   
,,fda4  #c4 ,p]iod ( m>ket exclusivity =
 botanical drugs ,section               
#eje7;c77#c77;,e7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;c77#c77;,e77 is am5d$ by add+ at !
 end ! foll[+3  7vi7 7,i7 ,a botanical  
drug approv$ "u subsection 7b77#a7      
pursuant to an application submitt$ aft]
 ! date ( enactm5t ( ?is clause %all be 
entitl$ to a #ab-ye> p]iod dur+ :i* no  
application submitt$ "u subsection      
7b77#b7 or 7j7 t ref]5ces or relies ^u  
su* drug may become effective4  7,,ii7  
,9 ?is clause1 ! t]m botanical drug     
means a botanical drug subject to       
subsection 7a71 z det]m9$ by ! ,secret>y
 by regulation4  4