,,ic  #aaeth ,,congress  #ast ,session  
,s4 #ajeb  ,,in ,,the ,,house ,,of      
,,representatives  ,august #d1 #bjag    
,referred to the ,committee on ,energy  
and ,commerce  ,,an ,,act  ,to          
strengthen the use of patient-experience
 data within the benefit-risk framework 
for approval of new drugs4  #a4 ,short  
title ,this ,act may be cited as the    
,better ,empowerment ,now to ,enhance   
,framework and ,improve ,treatments ,act
 of #bjag or the ,,benefit ,act of      
#bjag4  #b4 ,strengthening the use      
patient-experience data within          
benefit-risk framework ,section #efi;,c 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb-#h;c7 is amended--  7#a7 in    
subsection 7a77#a7-- 7,a7 in            
subparagraph 7,a71 by striking 2 and and
 inserting a semicolon2  7,b7 in        
subparagraph 7,b71 by striking the      
period and inserting 2 and2 and  7,c7 by
 adding at the end the following3  7,c7 
as part of the risk-benefit assessment  

framework in the new drug approval      
process described in section #eje7;d71  
considering relevant patient-focused    
drug development data1 such as data from
 patient preference studies             
7benefit-risk71 patient reported outcome
 data1 or patient experience data1      
developed by the sponsor of an          
application or another party4  2 and    
7#b7 in subsection 7b77#a74 by inserting
 1 including a description of how such  
data and information were considered in 
the risk benefit assessment described in
 section #eje7;d7 before the period4    
,passed the ,senate ,august #c1         
#bjag4;,julie ,e4 ,adams1,secretary