,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #bjij  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #bb1 #bjac ,mr4  
,griffi? ( ,virg9ia 7= himself1 ,mr4    
,mc,caul1 & ,mr4 ,pet]s ( ,cali=nia7    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d *apt] ,v ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act to p]mit 
provisional approval ( fa/ track        
products4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,pati5t ,*oice ,act (      
#bjac4  #b4 ,provisional approval = fa/ 
track products  7a7 ,9 g5]al ,section   
#ejf ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is  
am5d$ by add+ at ! end ! foll[+3  7f7   
,provisional approval  7#a7 ,provisional
 approval = adequately safe fa/ track   
products  7,a7 ,9 g5]al ,subject to !   
requirem5ts ( ?is subsection1 if !      
,secret>y det]m9es t a drug t is        
designat$ z a fa/ track product "u ?is  
section is adequately safe 7z su* t]m is
 def9$ 9 p>agraph 7#b771 ! ,secret>y    

%all grant provisional approval & ! drug
 may be introduc$ into int]/ate comm]ce 
on or aft] ! date su* provisional       
approval is grant$4  7,b7 ,treatm5t (   
provisional approval /atus ,!           
provisional approval ( a drug "u        
subp>agraph 7,a7 %all be treat$ 9 ! same
 mann] z approval ( a drug "u section   
#eje ( ?is ,act or section #cea ( !     
,public ,heal? ,s]vice ,act1 except t   
su* provisional approval %all be subject
 to ! requirem5ts ( ?is section1 includ+
 ! foll[+3  7i7 ,! requirem5ts "u       
p>agraph 7#c71 includ+ requirem5ts      
relat$ to--  7,i7 in=m$ cons5t2 &       
7,,ii7 cont9u$ pursuit ( safety &       
efficacy data = purposes ( ga9+ approval
 = su* drug "u section #eje ( ?is ,act  
or section #cea ( ! ,public ,heal?      
,s]vice ,act4  7ii7 ,! rules "u         
p>agraphs 7#d7 & 7#e7 relat+ to ! l5g? (
 ! t]m9ation ( ! provisional approval & 
)drawal ( a drug subject to provisional 
approval4  7,c7 ,reque/ = provisional   
approval  7i7 ,9 g5]al ,! sponsor ( a   

drug t is designat$ z a fa/ track       
product "u ?is section may reque/ t !   
,secret>y grant provisional approval =  
su* drug "u subp>agraph 7,a74  7ii7     
,response to reque/ ,n lat] ?an #ij days
 aft] receiv+ su* a reque/1 ! ,secret>y 
%all ei!r--  7,i7 grant provisional     
approval = ! drug "u subp>agraph 7,a72  
or  7,,ii7 provide notice to ! sponsor (
 ! drug t su* reque/ is d5i$4  7#b7     
,adequately safe def9$  7,a7 ,9 g5]al ,=
 purposes ( ?is subsection1 ) respect to
 a drug1 ! t]m adequately safe means t--
  7i7 = at lea/ "o population1 ! risk ( 
dea? or morbidity caus$ directly by an  
adv]se effect ( ! drug1 z det]m9$ 9 "o  
or m safety /udies or ?r\gh o!r data t !
 ,secret>y det]m9es are suffici5t1 is   
unlikely to be great] ?an ! comb9$      
direct & second>y risks ( dea? or       
morbidity1 z e/abli%$ 9 ! lit]ature or  
hi/orical data1 (--  7,i7 ! disease t   
su* drug is int5d$ to treat2 &  7,,ii7  
exi/+ !rapies 7includ+ infection7 = su* 
disease2 or  7ii7 ! drug has _h a valid 

m>ket+ au?orization1 = a p]iod ( at lea/
 #d ye>s1 by an au?ority 9 a c\ntry     
describ$ 9 section #hjb7;b77#a77;,a71 or
 designat$ by ! ,secret>y "u section    
#hjb7;b77#a77;,b71 & data adequate = !  
approval ( su* m>ket+ au?orization = su*
 drug 9 su* c\ntry h be5 submitt$ to !  
,secret>y4  7,b7 ,limitation ,!         
,secret>y may n impose any requirem5ts =
 purposes ( ! safety /udies or data "u  
subp>agraph 7,a77i7 t are 9 addition to1
 or diff]5t ?an1 ! requirem5ts = /udies 
to e/abli% safety = purposes ( ,phase #a
 or ,phase #b1 z su* t]ms are describ$ 9
 subsections 7a7 & 7b71 respectively1 ( 
section #cab4ba ( title #ba1 ,code (    
,f$]al ,regulations4  7#c7 ,requirem5ts 
,provisional approval ( a fa/ track     
product "u ?is subsection %all be       
subject to ! foll[+ requirem5ts3  7,a7  
,in=m$ cons5t  7i7 ,9 g5]al ,z a        
condition ( provisional approval "u     
p>agraph 7#a71 ! sponsor ( a drug %all  
ensure t1 be=e su* drug is disp5s$ to an
 individual--  7,i7 ! individual %all be

 in=m$ t ! drug is subject to           
provisional approval bas$ on limit$     
safety data & t ! efficacy ( ! drug has 
n be5 prov52  7,,ii7 ! individual %all  
be in=m$ ( ! kn[n risks ( ! drug & any  
unkn[n b reasonably pr$ictable risks ( !
 drug1 includ+1 z appropriate1 pot5tial 
risks ( dea?1 complications1 or injury  
result+ f use ( ! drug1 & risks relat$  
to ! pot5tial ineffectiv5ess ( ! drug1  
includ+ progression ( ! disease t may   
result 9 dea? or morbidity1 or !        
pot5tial = ! drug to accel]ate or       
exac]bate ! disease process2 &  7,,iii7 
! individual provides writt5 in=m$      
cons5t ackn[l$g+ t individual has be5   
provid$ ) & und]/&s ! in=mation "u      
subclauses 7,i7 or 7,,ii74  7ii7        
,regulations ,! ,secret>y %all issue    
regulations on ! requirem5ts = in=m$    
cons5t "u clause 7i74 ,su* regulations  
%all be simil> to ! requirem5ts = in=m$ 
cons5t = human subjects "u subp>t ,b (  
"p #ej ( title #ba1 ,code ( ,f$]al      
,regulations1 adju/$ z appropriate =    

purposes ( ?is subsection4  7,b7        
,pursuit ( full approval requir$ ,a     
sponsor ( a drug t receives a           
provisional approval "u p>agraph 7#a7   
%all cont9ue to dilig5tly conduct       
appropriate /udies1 aft] su* provisional
 approval is grant$1 to--  7i7 e/abli% t
 ! drug has an effect on a cl9ical      
endpo9t or on a surrogate endpo9t t is  
reasonably likely to pr$ict cl9ical     
b5efit2 &  7ii7 collect ! data necess>y 
to demon/rate t ! drug is safe &        
effective 7or1 9 ! case ( a biologic1   
safe & pot5t7 = purpose ( obta9+        
approval = su* drug "u section #eje7;c7 
( ?is ,act or section #cea ( ! ,public  
,heal? ,s]vice ,act4  7,c7 ,promotional 
mat]ials ,dur+ ! p]iod t provisional    
approval "u p>agraph 7#a7 applies to a  
drug1 ! sponsor ( ! drug %all submit    
copies ( all promotional mat]ials relat$
 to ! drug at lea/ #cj days prior to    
dissem9ation ( ! mat]ials4  7,d7 ,risk  
evaluation & mitigation /rategy  7i7 ,9 
g5]al ,section #eje-a %all apply to a   

drug subject to provisional approval "u 
?is subsection 9 ! same mann] t su*     
section applies to a drug approv$ "u    
section #eje ( ?is ,act or section #cea 
( ! ,public ,heal? ,s]vice ,act4  7ii7  
,rule ( con/ruction ,no?+ 9 ?is         
subp>agraph %all be con/ru$ to limit !  
,secret>y's au?ority "u section #eje-a  
to det]m9e if a risk evaluation &       
mitigation /rategy is necess>y4  7,e7   
,indication ( use ,! provisional        
approval "u p>agraph 7#a7 %all only     
apply to ! indication ( use = ! drug--  
7i7 :i* is relat$ to ! treatm5t ( !     
condition ) respect to :i* su* drug 0   
designat$ z a fa/ track product2 &  7ii7
 = :i* ! drug is demon/rat$ to be       
adequately safe4  7#d7 ,t]m9ation (     
provisional approval  7,a7 ,9 g5]al ,9 !
 case ( a drug t is n designat$ "u      
section #ebf1 ! provisional approval ( !
 drug "u p>agraph 7#a7 %all t]m9ate on !
 e>li] ( ! foll[+3  7i7 ,! date t ! drug
 is approv$ "u section #eje7;c7 ( ?is   
,act or section #cea ( ! ,public ,heal? 

,s]vice ,act4  7ii7 ,at ! end ( ! #e-ye>
 p]iod beg9n+ on ! date on :i*          
provisional approval 0 grant$ = su*     
drug1 except--  7,i7 if ! ,secret>y     
det]m9es t ! sponsor ( ! drug is        
dilig5tly engag+ 9 actions 7includ+     
conduct+ cl9ical trials7 = ! purpose (  
seek+ approval "u section #eje7;c7 ( ?is
 ,act or section #cea ( ! ,public ,heal?
 ,s]vice ,act 7exclud+ provisional      
approval "u p>agraph 7#a77 & ! ,secret>y
 det]m9es t ! sponsor requires          
additional "t to complete su* actions & 
atta9 su* approval1 ! ,secret>y may     
ext5d su* p]iod = an appropriate l5g? ( 
"t to all[ ! sponsor to complete su*    
actions & atta9 su* approval2 or  7,,ii7
 if ! ,secret>y det]m9es t ! t]m9ation (
 ! provisional approval is adv]se to    
protect+ or promot+ ! public heal?1 !   
,secret>y may ext5d su* p]iod = an      
appropriate l5g? ( "t to protect or     
promote ! public heal?4  7,b7 ,special  
rule = orphan drugs ,9 ! case ( a drug  
designat$ "u section #ebf1 ! provisional

 approval ( ! drug "u p>agraph 7#a7 %all
 t]m9ate on ! date t ! drug is approv$  
"u section #eje7;c7 ( ?is ,act or       
section #cea ( ! ,public ,heal? ,s]vice 
,act4  7,c7 ,rule ( con/ruction ,=      
purposes ( ?is p>agraph1 ! phrase       
approv$ "u section #eje7;c7 ( ?is ,act  
or section #cea ( ! ,public ,heal?      
,s]vice ,act %all n be con/ru$ to       
include a provisional approval "u       
p>agraph 7#a74  7#e7 ,)drawal  7,a7 ,9  
g5]al ,subsection 7b77#c7 %all apply to 
a drug subject to a provisional approval
 "u ?is subsection 9 ! same mann] z su* 
subsection applies to any fa/ track     
product4  7,b7 ,additional )drawal      
au?ority ,9 addition to subp>agraph     
7,a71 ! ,secret>y may )draw approval ( a
 fa/ track product us+ ! exp$it$        
proc$ures appli$ "u subsection 7b77#c7  
if ! requirem5ts ( p>agraph 7#c77;,a7 h 
n be5 met ) respect to ! drug4  7#f7    
,impact on m>ket+ exclusivity ,! rules  
relat$ to m>ket+ exclusivity "u sections
 #eje7;c77#c77;,e71 #eje7;j77#e77;,f71  

#eje;,a1 & #ebg %all apply to a drug    
subject to provisional approval "u ?is  
subsection 9 ! same mann] t su* rules   
apply to drugs approv$ "u section #eje (
 ?is ,act or section #cea ( ! ,public   
,heal? ,s]vice ,act1 except t ! p]iod ( 
provisional approval "u ?is subsection =
 a drug %all be an addition to !        
applicable p]iod ( m>ket+ exclusivity = 
su* drug4  4  7b7 ,misbr&+ = m>ket+ (   
t]m9at$ drug ,section #ejb ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act is am5d$ 
by add+ at ! end ! foll[+3  7bb7 ,if x  
is a drug t is introduc$ or deliv]$ =   
introduction into int]/ate comm]ce aft] 
! date ( ! t]m9ation ( ! provisional    
approval = su* drug "u section #ejf7;f71
 unless1 on or be=e ! date su* drug is s
 introduc$ or deliv]$1 su* drug is      
approv$ "u section #eje7;c7 ( ?is ,act  
or section #cea ( ! ,public ,heal?      
,s]vice ,act4  4  7c7 ,con=m+ am5dm5ts  
,! *apt] ,v ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is  
fur!r am5d$--  7#a7 9 section #ejb7;a71 

by ins]t+ 7or an indication subject to a
 provisional approval "u section        
#ejf7;f77 aft] an indication approv$ "u 
section #eje or "u section #cea7;a7 ( ! 
,public ,heal? ,s]vice ,act2  7#b7 9    
section #ejf;,a--  7,a7 9 subsection    
7a71 by ins]t+ 7or a provisional        
approval "u section #ejf7;f77 aft] a    
lic5se "u section #cea ( ! ,public      
,heal? ,s]vice ,act2 &  7,b7 by add+ at 
! end ! foll[+3  7e7 ,special rule =    
drugs subject to provisional approval ,9
 ! case ( a drug subject to a           
provisional approval "u section         
#ejf7;f71 any ref]5ce to safety &       
efficacy "u ?is section %all be treat$ z
 a ref]5ce to adequate safety1 z su* t]m
 is def9$ = purposes ( su* section      
#ejf7;f74  2  7#c7 9 section #ejf;,b7a71
 by add+ at ! end ! foll[+3  7#c7       
,special rule = provisional approval ,a 
sponsor ( a drug t is subject to a      
provisional approval "u section #ejf7;f7
 %all submit ! reports requir$ "u ?is   
section on ! /udies conduct$ on su* drug

 t are describ$ 9 section               
#ejf7;f77#c77;,b74 ,= purposes ( ?is    
section1 su* reports %all be treat$ z   
reports on po/m>ket+ /udies describ$ 9  
p>agraph 7#a74  2 &  7#d7 9 section     
#eea7;b77#a77;,a7 by ins]t+ 7or a       
provisional approval "u section         
#ejf7;f77 aft] ,public ,heal? ,s]vice   
,act4