,,ii  ,cal5d> ,no4 #cfg #aae? ,,congress
  #b;d ,session  ,h4 ,r4 #ebdg  ,,9 ,,! 
,,s5ate ,,( ,,! ,,unit$ ,,/ates  ,m>*   
#bb1 #bjah,receiv$  ,m>* #bc            
7legislative day1 ,m>* #bb71 #bjah,read 
! fir/ "t  ,april #i1 #bjah,read !      
second "t & plac$ on ! cal5d>  ,,an     
,,act  ,to au?orize ! use ( eligible    
inve/igational drugs by eligible pati5ts
 :o h be5 diagnos$ ) a /age ( a disease 
or condition 9 :i* !re is reasonable    
likelihood t dea? w occur )9 a matt] (  
mon?s1 or ) ano!r eligible illness1 & = 
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 ( #bjah4
  #b4 ,use ( unapprov$ inve/igational   
drugs by pati5ts diagnos$ ) a t]m9al    
illness  7a7 ,9 g5]al ,sub*apt] ,e (    
*apt] ,v ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb  
et seq47 is am5d$ 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 section3  
7#a7 ,! t]m eligible pati5t means a     
pati5t--  7,a7 :o has be5 diagnos$ ) an 
eligible illness2  7,b7 :o has exhau/$  
approv$ treatm5t options & is n eligible
 to p>ticipate 9 7= a reason su* z !    
pati5t n meet+ inclusion crit]ia7 a     
cl9ical trial design$ to evaluate an    
inve/igational drug = ! treatm5t ( su*  
eligible illness ) :i* ! pati5t has be5 
diagnos$1 includ+ "o involv+ ! eligible 
inve/igational drug1 or = :om           
p>ticipation 9 su* a cl9ical trial is n 
feasible 7= a reason su* z a lack (     
geographic proximity to ! cl9ical       
trial71 z c]tifi$ by a physician1 :o--  
7i7 is 9 good /&+ ) ! physician's lic5s+
 organization or bo>d2 &  7ii7 w n be   
comp5sat$ = s c]tify+2 &  7,c7 :o has   
provid$ to ! treat+ physician writt5    
in=m$ cons5t1 z describ$ 9 "p #ej (     
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulations71 reg>d+ !
 eligible inve/igational drug1 or1 z    

applicable1 on ^: behalf a legally      
au?oriz$ repres5tative ( ! pati5t has   
provid$ su* cons5t4  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     
,act1 z applicable1 t is active2 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*-- 7i7 is ongo+2     
7ii7 has n be5 discont9u$ by !          
manufactur]2 &  7iii7 is n ! subject ( a
 cl9ical hold "u ! regulations implem5t+
 section #eje7;i7 or section            
#cea7;a77#c7 ( ! ,public ,heal? ,s]vice 
,act1 z applicable4  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$]al ,regulations 7or any successor   
regulations74  7#d7 ,! t]m eligible     
illness means-- 7,a7 a /age ( a disease 
or condition 9 :i* !re is reasonable    
likelihood t dea? w occur )9 a matt] (  
mon?s2 or  7,b7 a disease or condition t
 w\ld result 9 significant irrev]sible  
morbidity t is likely to lead to sev]ely
 premature dea?4  7b7 ,alt]native pa?way
 = eligible pati5ts ) a t]m9al illness  
7#a7 ,9 g5]al ,eligible inve/igational  
drugs provid$ to eligible pati5ts 9     
compliance ) ?is section are exempt f   
sections #ejb7;f71 #ejc7;b77#d71 &      
subsections 7a7 & 7i7 ( section #eje (  

?is ,act1 & section #cea7;a7 ( ! ,public
 ,heal? ,s]vice ,act s long z !         
conditions specifi$ 9 p>agraphs 7#b71   
7#c71 & 7#d7 are met ) respect to !     
provision ( su* inve/igational drugs4   
7#b7 ,compliance ) c]ta9 regulations ,! 
conditions specifi$ 9 ?is p>agraph1 )   
respect to an eligible inve/igational   
drug ref]r$ to 9 p>agraph 7#a71 are t-- 
7,a7 ! eligible inve/igational drug is  
label$ 9 accordance ) section #cab4f (  
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulations72 &  7,b7 
! provision ( su* eligible              
inve/igational drug occurs 9 compliance 
) ! applicable requirem5ts set =? 9     
sections #cab4g & #cab4h7;d77#a7 ( title
 #ba1 ,code ( ,f$]al ,regulations 7or   
any successor regulations7 t apply to   
inve/igational drugs1 subject to        
p>agraph 7#e74  7#c7 ,notification ,!   
condition specifi$ 9 ?is p>agraph1 )    
respect to an eligible inve/igational   
drug ref]r$ to 9 p>agraph 7#a71 is t !  
sponsor ( su* eligible inve/igational   

drug notifies ! ,secret>y ( ! provision 
( su* eligible inve/igational drug = use
 by an eligible pati5t pursuant to ?is  
section4 ,su* notification %all be      
submitt$ )9 #g bus9ess days ( !         
provision ( su* eligible inve/igational 
drug z correspond5ce to ! inve/igational
 new drug application describ$ 9        
subsection 7a77#b74  7#d7 ,adv]se ev5t  
report+ ,! condition specifi$ 9 ?is     
p>agraph1 ) respect to an eligible      
inve/igational drug ref]r$ to 9 p>agraph
 7#a71 is t ! sponsor or manufactur] (  
su* eligible inve/igational drug has    
requir$1 z a condition ( provid+ ! drug 
to a physician = use by an eligible     
pati5t pursuant to ?is section1 t su*   
physician w imm$iately report to su*    
sponsor or manufactur] any s]i\s adv]se 
ev5ts1 z su* t]m is def9$ 9 section     
#cab4cb ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations71 associat$ ) ! use ( !     
eligible inve/igational drug by !       
eligible pati5t4  7#e7 ,application ,=  

purposes ( ?is section1 ! requirem5ts   
set =? 9 sections #cab4g &              
#cab4h7;d77#a7 ( title #ba ( ! ,code (  
,f$]al ,regulations 7or any successor   
regulations7 are deem$ to apply to 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 section4  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+ ,!   
manufactur] or sponsor ( an eligible    
inve/igational drug t provides an       
eligible inve/igational drug pursuant to
 ?is section %all po/ on ! same publicly
 available int]net website us$ by !     
manufactur] = purposes ( section        
#efa;,a7b7 an annual summ>y ( any       
provision by ! manufactur] or sponsor ( 
an eligible inve/igational drug "u ?is  
section4 ,! summ>y %all include ! numb] 
( reque/s receiv$1 ! numb] ( reque/s    
grant$1 ! numb] ( pati5ts treat$1 !     

!rapeutic area ( ! drug made available1 
& any kn[n or suspect$ s]i\s adv]se     
ev5ts1 z su* t]m is def9$ 9 section     
#cab4cb ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations71 associat$ ) ! use ( !     
eligible inve/igational drug4  7e7 ,rule
 ( con/ruction ,no?+ 9 ?is section %all 
be con/ru$ z limit+ ! au?ority ( !      
,secret>y to require manufactur]s or    
sponsors ( inve/igational drugs to      
review & report in=mation relevant to ! 
safety ( su* inve/igational drug obta9$ 
or o!rwise receiv$ by ! sponsor pursuant
 to "p #cab ( title #ba1 ,code ( ,f$]al 
,regulations 7or successor regulations74
  4  7b7 ,no liability ,section #efa;,b 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act1 z add$ by subsection 7a71 is am5d$
 by add+ at ! end ! foll[+3  7f7        
,liability  7#a7 ,alleg$ acts or        
omissions  7,a7 ,manufactur] or sponsor 
,no manufactur] or sponsor 7or _! ag5t  
or repres5tative7 ( an inve/igational   
drug %all be liable = any alleg$ act or 

omission relat$ to ! provision ( su*    
drug to a s+le pati5t or small gr\p (   
pati5ts = treatm5t use 9 accordance )   
subsection 7b7 or 7c7 ( section #efa or 
! provision ( an eligible inve/igational
 drug to an eligible pati5t 9 accordance
 ) ?is section1 includ+1 ) respect to ! 
provision ( an inve/igational drug "u   
section #efa or an eligible             
inve/igational drug "u ?is section1 !   
report+ ( safety in=mation1 f cl9ical   
trials or any o!r s\rce1 z requir$ by   
section #cab4cb ( title #ba1 ,code (    
,f$]al ,regulations 7or any successor   
regulations74  7,b7 ,physician1 cl9ical 
inve/igator1 or hospital  7i7 ,no lic5s$
 physician1 cl9ical inve/igator1 or     
hospital %all be liable = any alleg$ act
 or omission relat$ to ! provision ( an 
inve/igational drug to a s+le pati5t or 
small gr\p ( pati5ts = treatm5t use 9   
accordance ) subsection 7b7 or 7c7 (    
section #efa1 z describ$ 9 clause 7ii71 
or ! provision ( an eligible            
inve/igational drug to an eligible      

pati5t 9 accordance ) ?is section1      
unless su* act or omission con/itutes on
 ! "p ( su* physician1 cl9ical          
inve/igator1 or hospital ) respect to   
su* inve/igational drug or eligible     
inve/igational drug--  7,i7 willful or  
crim9al misconduct2  7,,ii7 reckless    
misconduct2  7,,iii7 gross neglig5ce    
relative to ! applicable /&>d ( c>e &   
practice ) respect to ! adm9i/ration or 
disp5s+ ( su* inve/igational drug2 or   
7,,iv7 an int5tional tort "u applicable 
,/ate law4  7ii7 ,! requirem5ts describ$
 9 ?is clause are ! requirem5ts "u      
subsection 7b7 or 7c7 ( section #efa1   
includ+--  7,i7 ! report+ ( safety      
in=mation1 f cl9ical trials or any o!r  
s\rce1 z requir$ by section #cab4cb (   
title #ba1 ,code ( ,f$]al ,regulations  
7or any successor regulations72  7,,ii7 
ensur+ t ! in=m$ cons5t requirem5ts ( "p
 #ej ( title #ba1 ,code ( ! ,f$]al      
,regulations 7or any successor          
regulations7 are met2 &  7,,iii7 ensur+ 
t review by an in/itutional review bo>d 

is obta9$ 9 a mann] consi/5t ) !        
requirem5ts ( "p #ef ( title #ba1 ,code 
( ! ,f$]al ,regulations 7or any         
successor regulations74  7#b7           
,det]m9ation n to provide drug ,no      
manufactur]1 sponsor1 lic5s$ physician1 
cl9ical inve/igator1 or hospital %all be
 liable = det]m9+ n to provide access to
 an inve/igational drug "u ?is section  
or = discont9u+ any su* access t x      
initially det]m9$ to provide4  7#c7     
,limitation  7,a7 ,9 g5]al ,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 aga9/ a manufactur] or  
sponsor 7or _! ag5t or repres5tative71  
physician1 cl9ical inve/igator1         
hospital1 prescrib]1 disp5s]1 or o!r    
entity "u any ,/ate or ,f$]al product   
liability1 tort1 consum] protection1 or 
w>ranty law4  7,b7 ,f$]al ,gov]nm5t     
,no?+ 9 ?is section %all be con/ru$ to  
modify or o!rwise affect ! au?ority ( ! 
,f$]al ,gov]nm5t to br+ suit "u any     

,f$]al law4  4  ,pass$ ! ,h\se (        
,repres5tatives ,m>* #ba1 #bjah4,k>5 ,l4
 ,haas1,cl]k4  ,april #i1 #bjah,read !  
second "t & plac$ on ! cal5d>