,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #ddge  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,april #aj1 #bjad ,mr4
 ,griffi? ( ,virg9ia 7= himself & ,mr4  
,hanna7 introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to all[ !         
manufacture1 importation1 di/ribution1 &
 sale ( inve/igational drugs & devices  
int5d$ = use by t]m9ally ill pati5ts :o 
execute an in=m$ cons5t docum5t1 & = o!r
 purposes4  #a4 ,%ort title ,?is ,act   
may be cit$ z ! ,compassionate ,fre$om (
 ,*oice ,act ( #bjad4  #b4 ,drugs &     
devices = use by t]m9ally ill pati5ts ,!
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
is am5d$ by ins]t+ aft] section #efa    
7#ba ,u4,s4,c4 #cfj;bbb7 ! foll[+3      
#efa;,a4 ,drugs & devices = use by      
t]m9ally ill pati5ts  7a7 ,9 g5]al ,no?+
 9 ?is ,act or section #cea ( ! ,public 
,heal? ,s]vice ,act prev5ts or re/ricts1
 & ! ,food & ,drug ,adm9i/ration %all n 
implem5t or en=ce any provision ( law   
prev5t+ or re/rict+1 ! manufacture1     

importation1 di/ribution1 or sale ( an  
inve/igational drug or device int5d$ =  
use by a t]m9ally ill pati5t 9          
accordance ) subsection 7b74  7b7       
,pati5t requirem5ts ,9 ord] = an        
inve/igational drug or device to be     
int5d$ = use 9 accordance ) ?is         
subsection1 su* drug or device mu/ be   
int5d$ = use by a pati5t :o has--  7#a7 
be5 diagnos$ ) a t]m9al illness by a    
lic5s$ physician2  7#b7 be5 in=m$ by a  
lic5s$ physician t no drug or device t  
is lawfully m>ket$ 9 ! ,unit$ ,/ates is 
likely to cure ! illness2 &  7#c7       
execut$ a writt5 in=m$ cons5t docum5t t 
/ates--  7,a7 ! kn[n & pot5tial risks & 
b5efits ( su* drug or device2 &  7,b7   
any indications ( ! illness = :i* a drug
 or device is lawfully m>ket$1 or = :i* 
treatm5t is o!rwise available1 9 !      
,unit$ ,/ates4  7c7 ,prohibition on     
requir+ ! disclosure1 collection1 &     
report+ ( c]ta9 in=mation by ,food &    
,drug ,adm9i/ration  7#a7 ,9 g5]al ,!   
,commission] ( ,food & ,drugs may n     

require ! disclosure1 collection1 or    
report+ (--  7,a7 any in=mation relat$  
to ! deliv]y1 adm9i/ration1 or use ( an 
inve/igational drug or device pursuant  
to ?is section2 or  7,b7 any in=mation  
relat$ to ! cl9ical outcomes exp]i5c$ by
 a t]m9ally ill pati5t suppli$ an       
inve/igational drug or device pursuant  
to ?is section4  7#b7 ,exception ,no?+ 9
 ?is subsection prev5ts ! sponsor ( a   
cl9ical trial f volunt>ily disclos+1    
collect+1 or report+ in=mation to !     
,food & ,drug ,adm9i/ration4  7d7       
,def9ition ( inve/igational drug or     
device ,9 ?is section1 ! t]m            
inve/igational drug or device means a   
drug or device t--  7#a7 has n yet be5  
approv$1 lic5s$1 or cle>$ = comm]cial   
di/ribution "u section #eje1 #eaj7k71 or
 #eae ( ?is ,act or section #cea ( !    
,public ,heal? ,s]vice ,act1 & _c       
o!rwise be lawfully m>ket$ 9 ! ,unit$   
,/ates2 &  7#b7 is or has be5 ! subject 
( "o or m cl9ical trials4  4  #c4       
,liability protection ,! ,f$]al ,food1  

,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cja et seq47 is am5d$ by ins]t+ aft]   
section #efa;,a1 z ins]t$ by section #b 
( ?is ,act1 ! foll[+3  #efa;,b4         
,liability protection ,except 9 ! case (
 gross neglig5ce or willful misconduct1 
any p]son :o manufactures1 imports1     
di/ributes1 prescribes1 disp5ses1 or    
adm9i/]s an inve/igational drug or      
device 9 accordance ) section #efa;,a   
%all n be liable 9 any action "u ,f$]al 
or ,/ate law = any loss1 damage1 or     
injury aris+ out (1 relat+ to1 or       
result+ f--  7#a7 ! design1 developm5t1 
cl9ical te/+ & inve/igation1            
manufactur+1 label+1 di/ribution1 sale1 
pur*ase1 donation1 disp5s+1             
prescription1 adm9i/ration1 or use ( !  
drug or device2 or  7#b7 ! safety or    
effectiv5ess ( ! drug or device4  4