,i  #aagth ,,congress  #ast ,session    
,h4 ,r4 #ddgb  ,,in ,,the ,,house ,,of  
,,representatives  ,july #af1 #bjba ,ms4
 ,matsui 7for herself and ,mr4          
,wenstrup7 introduced the following     
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,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 #bjba or   
the ,,benefit ,act of #bjba4  #b4       
,strengthening the use of               
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#a71 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