#aaeth ,,congress  #ast ,session  ,s4   
#bjd  ,,an ,,act  ,to authorize the use 
of unapproved medical products by       
patients diagnosed with a terminal      
illness in accordance with ,state law1  
and for other purposes4  #a4 ,short     
title ,this ,act may be cited as the    
,trickett ,wendler1 ,frank ,mongiello1  
,jordan ,mc,linn1 and ,matthew ,bellina 
,right to ,try ,act of #bjag4  #b4 ,use 
of unapproved investigational drugs by  
patients diagnosed with a terminal      
illness  7a7 ,in general ,chapter ,v of 
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act is amended by inserting after     
section #efa;,a 7#ba ,u4,s4,c4          
#cfj;bbb-#j7 the following3  #efa;,b4   
,investigational drugs for use by       
eligible patients  7a7 ,definitions ,for
 purposes of this section-- 7#a7 the    
term eligible patient means a patient-- 
7,a7 who has been diagnosed with a      
life-threatening disease or condition   
7as defined in section #cab4ha of title 
#ba1 ,code of ,federal ,regulations 7or 

any successor regulations772  7,b7 who  
has exhausted approved treatment options
 and is unable to participate in a      
clinical trial involving the eligible   
investigational drug1 as certified by a 
physician1 who-- 7i7 is in good standing
 with the physician's licensing         
organization or board2 and  7ii7 will   
not be compensated directly by the      
manufacturer for so certifying2 and     
7,c7 who has provided to the treating   
physician written informed consent      
regarding the eligible investigational  
drug1 or1 as applicable1 on whose behalf
 a legally authorized representative of 
the patient has provided such consent2  
7#b7 the term eligible investigational  
drug means an investigational drug 7as  
such term is used in section #efa7--    
7,a7 for which a ,phase #a clinical     
trial has been completed2  7,b7 that has
 not been approved or licensed for any  
use under section #eje of this ,act or  
section #cea of the ,public ,health     
,service ,act2  7,c7 7i7 for which an   

application has been filed under section
 #eje7;b7 of this ,act or section       
#cea7;a7 of the ,public ,health ,service
 ,act2 or  7ii7 that is under           
investigation in a clinical trial that--
 7,i7 is intended to form the primary   
basis of a claim of effectiveness in    
support of approval or licensure under  
section #eje of this ,act or section    
#cea of the ,public ,health ,service    
,act2 and  7,,ii7 is the subject of an  
active investigational new drug         
application under section #eje7;i7 of   
this ,act or section #cea7;a77#c7 of the
 ,public ,health ,service ,act1 as      
applicable2 and  7,d7 the active        
development or production of which is   
ongoing and has not been discontinued by
 the manufacturer or placed on clinical 
hold under section #eje7;i72 and  7#c7  
the term phase #a trial means a phase #a
 clinical investigation of a drug as    
described in section #cab4ba of title   
#ba1 ,code of ,federal ,regulations 7or 
any successor regulations74  7b7        

,exemptions ,eligible investigational   
drugs provided to eligible patients in  
compliance with this section are exempt 
from sections #ejb7;f71 #ejc7;b77#d71   
#eje7;a71 and #eje7;i7 of this ,act1    
section #cea7;a7 of the ,public ,health 
,service ,act1 and parts #ej1 #ef1 and  
#cab of title #ba1 ,code of ,federal    
,regulations 7or any successor          
regulations71 provided that the sponsor 
of such eligible investigational drug or
 any person who manufactures1           
distributes1 prescribes1 dispenses1     
introduces or delivers for introduction 
into interstate commerce1 or provides to
 an eligible patient an eligible        
investigational drug pursuant to this   
section is in compliance with the       
applicable requirements set forth in    
sections #cab4f1 #cab4g1 and            
#cab4h7;d77#a7 of title #ba1 ,code of   
,federal ,regulations 7or any successor 
regulations7 that apply to              
investigational drugs4  7c7 ,use of     
clinical outcomes  7#a7 ,in general     

,notwithstanding any other provision of 
this ,act1 the ,public ,health ,service 
,act1 or any other provision of ,federal
 law1 the ,secretary may not use a      
clinical outcome associated with the use
 of an eligible investigational drug    
pursuant to this section to delay or    
adversely affect the review or approval 
of such drug under section #eje of this 
,act or section #cea of the ,public     
,health ,service ,act unless-- 7,a7 the 
,secretary makes a determination1 in    
accordance with paragraph 7#b71 that use
 of such clinical outcome is critical to
 determining the safety of the eligible 
investigational drug2 or  7,b7 the      
sponsor requests use of such outcomes4  
7#b7 ,limitation ,if the ,secretary     
makes a determination under paragraph   
7#a77;,a71 the ,secretary shall provide 
written notice of such determination to 
the sponsor1 including a public health  
justification for such determination1   
and such notice shall be made part of   
the administrative record4 ,such        

determination shall not be delegated    
below the director of the agency center 
that is charged with the premarket      
review of the eligible investigational  
drug4  7d7 ,reporting  7#a7 ,in general 
,the manufacturer or sponsor of an      
eligible investigational drug shall     
submit to the ,secretary an annual      
summary of any use of such drug under   
this section4 ,the summary shall include
 the number of doses supplied1 the      
number of patients treated1 the uses for
 which the drug was made available1 and 
any known serious adverse events4 ,the  
,secretary shall specify by regulation  
the deadline of submission of such      
annual summary and may amend section    
#cab4cc of title #ba1 ,code of ,federal 
,regulations 7or any successor          
regulations7 to require the submission  
of such annual summary in conjunction   
with the annual report for an applicable
 investigational new drug application   
for such drug4  7#b7 ,posting of        
information ,the ,secretary shall post  

an annual summary report of the use of  
this section on the internet website of 
the ,food and ,drug ,administration1    
including the number of drugs for which 
clinical outcomes associated with the   
use of an eligible investigational drug 
pursuant to this section was-- 7,a7 used
 in accordance with subsection          
7c77#a77;,a72  7,b7 used in accordance  
with subsection 7c77#a77;,b72 and  7,c7 
not used in the review of an application
 under section #eje of this ,act or     
section #cea of the ,public ,health     
,service ,act4  4  7b7 ,no ,liability   
7#a7 ,alleged acts or omissions ,with   
respect to any alleged act or omission  
with respect to an eligible             
investigational drug provided to an     
eligible patient pursuant to section    
#efa;,b of the ,federal ,food1 ,drug1   
and ,cosmetic ,act and in compliance    
with such section1 no liability in a    
cause of action shall lie against-- 7,a7
 a sponsor or manufacturer2 or  7,b7 a  
prescriber1 dispenser1 or other         

individual entity 7other than a sponsor 
or manufacturer71 unless the relevant   
conduct constitutes reckless or willful 
misconduct1 gross negligence1 or an     
intentional tort under any applicable   
,state law4  7#b7 ,determination not to 
provide drug ,no liability shall lie    
against a sponsor manufacturer1         
prescriber1 dispenser or other          
individual entity for its determination 
not to provide access to an eligible    
investigational drug under section      
#efa;,b of the ,federal ,food1 ,drug1   
and ,cosmetic ,act4  7#c7 ,limitation   
,except as set forth in paragraphs 7#a7 
and 7#b71 nothing in this section shall 
be construed to modify or otherwise     
affect the right of any person to bring 
a private action under any ,state or    
,federal product liability1 tort1       
consumer protection1 or warranty law4   
#c4 ,sense of the ,senate ,it is the    
sense of the ,senate that section       
#efa;,b of the ,federal ,food1 ,drug1   
and ,cosmetic ,act1 as added by section 

#b-- 7#a7 does not establish a new      
entitlement or modify an existing       
entitlement1 or otherwise establish a   
positive right to any party or          
individual2  7#b7 does not establish any
 new mandates1 directives1 or additional
 regulations2  7#c7 only expands the    
scope of individual liberty and agency  
among patients1 in limited              
circumstances2  7#d7 is consistent with1
 and will act as an alternative pathway 
alongside1 existing expanded access     
policies of the ,food and ,drug         
,administration2  7#e7 will not1 and    
cannot1 create a cure or effective      
therapy where none exists2  7#f7        
recognizes that the eligible terminally 
ill patient population often consists of
 those patients with the highest risk of
 mortality1 and use of experimental     
treatments under the criteria and       
procedure described in such section     
#efa;,a involves an informed assumption 
of risk2 and  7#g7 establishes national 
standards and rules by which            

investigational drugs may be provided to
 terminally ill patients4  ,passed the  
,senate ,august #c1 #bjag4,secretary