,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #ehed  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,decemb] #aa1 #bjad   
,mr4 ,grayson introduc$ ! foll[+ bill2  
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to all[ !        
importation1 di/ribution1 & sale (      
inve/igational drugs & devices int5d$ = 
use by t]m9ally ill pati5ts :o execute  
an in=m$ cons5t docum5t4  #a4 ,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 ! 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 ,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 ,act    
7#db ,u4,s4,c4 #bfb71 & _c o!rwise be   
lawfully m>ket$ 9 ! ,unit$ ,/ates2 &    

7#b7 is or has be5 ! subject ( "o or m  
cl9ical trials4  4