#aae? ,,congress  #a/ ,session  ,s4 #bjd
  ,,an ,,act  ,to au?orize ! use (      
unapprov$ m$ical products by pati5ts    
diagnos$ ) a t]m9al illness 9 accordance
 ) ,/ate law1 & = o!r purposes4  #a4    
,%ort title ,?is ,act may be cit$ z !   
,trickett ,w5dl]1 ,frank ,mongiello1    
,jordan ,mc,linn1 & ,mat!w ,bell9a ,"r  
to ,try ,act ( #bjag4  #b4 ,use (       
unapprov$ inve/igational drugs by       
pati5ts diagnos$ ) a t]m9al illness  7a7
 ,9 g5]al ,*apt] ,v ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act is am5d$ by     
ins]t+ aft] section #efa;,a 7#ba        
,u4,s4,c4 #cfj;bbb-#j7 ! foll[+3        
#efa;,b4 ,inve/igational drugs = use by 
eligible pati5ts  7a7 ,def9itions ,=    
purposes ( ?is section-- 7#a7 ! t]m     
eligible pati5t means a pati5t-- 7,a7 :o
 has be5 diagnos$ ) a life-?reat5+      
disease or condition 7z def9$ 9 section 
#cab4ha ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations772  7,b7 :o has exhau/$     
approv$ treatm5t options & is unable to 

p>ticipate 9 a cl9ical trial involv+ !  
eligible inve/igational drug1 z c]tifi$ 
by a physician1 :o-- 7i7 is 9 good /&+ )
 ! physician's lic5s+ organization or   
bo>d2 &  7ii7 w n be comp5sat$ directly 
by ! manufactur] = s c]tify+2 &  7,c7 :o
 has provid$ to ! treat+ physician      
writt5 in=m$ cons5t reg>d+ ! eligible   
inve/igational drug1 or1 z applicable1  
on ^: behalf a legally au?oriz$         
repres5tative ( ! pati5t has provid$ su*
 cons5t2  7#b7 ! t]m eligible           
inve/igational drug means an            
inve/igational drug 7z su* t]m is us$ 9 
section #efa7-- 7,a7 = :i* a ,phase #a  
cl9ical trial has be5 complet$2  7,b7 t 
has n be5 approv$ or lic5s$ = any use "u
 section #eje ( ?is ,act or section #cea
 ( ! ,public ,heal? ,s]vice ,act2  7,c7 
7i7 = :i* an application has be5 fil$ "u
 section #eje7;b7 ( ?is ,act or section 
#cea7;a7 ( ! ,public ,heal? ,s]vice     
,act2 or  7ii7 t is "u inve/igation 9 a 
cl9ical trial t-- 7,i7 is int5d$ to =m !
 prim>y basis ( a claim ( effectiv5ess 9

 support ( approval or lic5sure "u      
section #eje ( ?is ,act or section #cea 
( ! ,public ,heal? ,s]vice ,act2 &      
7,,ii7 is ! subject ( an active         
inve/igational new drug application "u  
section #eje7;i7 ( ?is ,act or section  
#cea7;a77#c7 ( ! ,public ,heal? ,s]vice 
,act1 z applicable2 &  7,d7 ! active    
developm5t or production ( :i* is ongo+ 
& has n be5 discont9u$ by ! manufactur] 
or plac$ on cl9ical hold "u section     
#eje7;i72 &  7#c7 ! t]m phase #a trial  
means a phase #a cl9ical inve/igation ( 
a drug z describ$ 9 section #cab4ba (   
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulations74  7b7    
,exemptions ,eligible inve/igational    
drugs provid$ to eligible pati5ts 9     
compliance ) ?is section are exempt f   
sections #ejb7;f71 #ejc7;b77#d71        
#eje7;a71 & #eje7;i7 ( ?is ,act1 section
 #cea7;a7 ( ! ,public ,heal? ,s]vice    
,act1 & p>ts #ej1 #ef1 & #cab ( title   
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulations71 provid$ t !    

sponsor ( su* eligible inve/igational   
drug or any p]son :o manufactures1      
di/ributes1 prescribes1 disp5ses1       
introduces or deliv]s = introduction    
into int]/ate comm]ce1 or provides to an
 eligible pati5t an eligible            
inve/igational drug pursuant to ?is     
section is 9 compliance ) ! applicable  
requirem5ts set =? 9 sections #cab4f1   
#cab4g1 & #cab4h7;d77#a7 ( title #ba1   
,code ( ,f$]al ,regulations 7or any     
successor regulations7 t apply to       
inve/igational drugs4  7c7 ,use (       
cl9ical outcomes  7#a7 ,9 g5]al ,not)/&+
 any o!r provision ( ?is ,act1 ! ,public
 ,heal? ,s]vice ,act1 or any o!r        
provision ( ,f$]al law1 ! ,secret>y may 
n use a cl9ical outcome associat$ ) !   
use ( an eligible inve/igational drug   
pursuant to ?is section to delay or     
adv]sely affect ! review or approval (  
su* drug "u section #eje ( ?is ,act or  
section #cea ( ! ,public ,heal? ,s]vice 
,act unless-- 7,a7 ! ,secret>y makes a  
det]m9ation1 9 accordance ) p>agraph    

7#b71 t use ( su* cl9ical outcome is    
critical to det]m9+ ! safety ( !        
eligible inve/igational drug2 or  7,b7 !
 sponsor reque/s use ( su* outcomes4    
7#b7 ,limitation ,if ! ,secret>y makes a
 det]m9ation "u p>agraph 7#a77;,a71 !   
,secret>y %all provide writt5 notice (  
su* det]m9ation to ! sponsor1 includ+ a 
public heal? ju/ification = su*         
det]m9ation1 & su* notice %all be made  
"p ( ! adm9i/rative record4 ,su*        
det]m9ation %all n be delegat$ bel[ !   
director ( ! ag5cy c5t] t is *>g$ ) !   
prem>ket review ( ! eligible            
inve/igational drug4  7d7 ,report+  7#a7
 ,9 g5]al ,! manufactur] or sponsor ( an
 eligible inve/igational drug %all      
submit to ! ,secret>y an annual summ>y (
 any use ( su* drug "u ?is section4 ,!  
summ>y %all include ! numb] ( doses     
suppli$1 ! numb] ( pati5ts treat$1 !    
uses = :i* ! drug 0 made available1 &   
any kn[n s]i\s adv]se ev5ts4 ,!         
,secret>y %all specify by regulation !  
deadl9e ( submission ( su* annual summ>y

 & may am5d section #cab4cc ( title #ba1
 ,code ( ,f$]al ,regulations 7or any    
successor regulations7 to require !     
submission ( su* annual summ>y 9        
conjunction ) ! annual report = an      
applicable inve/igational new drug      
application = su* drug4  7#b7 ,po/+ (   
in=mation ,! ,secret>y %all po/ an      
annual summ>y report ( ! use ( ?is      
section on ! int]net website ( ! ,food &
 ,drug ,adm9i/ration1 includ+ ! numb] ( 
drugs = :i* cl9ical outcomes associat$ )
 ! use ( an eligible inve/igational drug
 pursuant to ?is section 0-- 7,a7 us$ 9 
accordance ) subsection 7c77#a77;,a72   
7,b7 us$ 9 accordance ) subsection      
7c77#a77;,b72 &  7,c7 n us$ 9 ! review (
 an application "u section #eje ( ?is   
,act or section #cea ( ! ,public ,heal? 
,s]vice ,act4  4  7b7 ,no ,liability    
7#a7 ,alleg$ acts or omissions ,)       
respect to any alleg$ act or omission ) 
respect to an eligible inve/igational   
drug provid$ to an eligible pati5t      
pursuant to section #efa;,b ( ! ,f$]al  

,food1 ,drug1 & ,cosmetic ,act & 9      
compliance ) su* section1 no liability 9
 a cause ( action %all lie aga9/-- 7,a7 
a sponsor or manufactur]2 or  7,b7 a    
prescrib]1 disp5s]1 or o!r individual   
entity 7o!r ?an a sponsor or            
manufactur]71 unless ! relevant conduct 
con/itutes reckless or willful          
misconduct1 gross neglig5ce1 or an      
int5tional tort "u any applicable ,/ate 
law4  7#b7 ,det]m9ation n to provide    
drug ,no liability %all lie aga9/ a     
sponsor manufactur]1 prescrib]1 disp5s] 
or o!r individual entity = its          
det]m9ation n to provide access to an   
eligible inve/igational drug "u section 
#efa;,b ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act4  7#c7 ,limitation       
,except z set =? 9 p>agraphs 7#a7 &     
7#b71 no?+ 9 ?is section %all be con/ru$
 to modify or o!rwise affect ! "r ( any 
p]son to br+ a private action "u any    
,/ate or ,f$]al product liability1 tort1
 consum] protection1 or w>ranty law4    
#c4 ,s5se ( ! ,s5ate ,x is ! s5se ( !   

,s5ate t section #efa;,b ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act1 z add$  
by section #b-- 7#a7 does n e/abli% a   
new entitlem5t or modify an exi/+       
entitlem5t1 or o!rwise e/abli% a        
positive "r to any p>ty or individual2  
7#b7 does n e/abli% any new m&ates1     
directives1 or additional regulations2  
7#c7 only exp&s ! scope ( individual    
lib]ty & ag5cy among pati5ts1 9 limit$  
circum/ances2  7#d7 is consi/5t )1 & w  
act z an alt]native pa?way alongside1   
exi/+ exp&$ access policies ( ! ,food & 
,drug ,adm9i/ration2  7#e7 w n1 & _c1   
create a cure or effective !rapy :]e    
none exi/s2  7#f7 recognizes t !        
eligible t]m9ally ill pati5t population 
(t5 consi/s ( ^? pati5ts ) ! highe/ risk
 ( mortality1 & use ( exp]im5tal        
treatm5ts "u ! crit]ia & proc$ure       
describ$ 9 su* section #efa;,a involves 
an in=m$ assumption ( risk2 &  7#g7     
e/abli%es national /&>ds & rules by :i* 
inve/igational drugs may be provid$ to  
t]m9ally ill pati5ts4  ,pass$ ! ,s5ate  

,augu/ #c1 #bjag4,secret>y