,,ii  #aafth ,,congress  #b;d ,session  
,s4 #cche  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,march #d1     
#bjbj,mr4 ,wicker 7for himself and ,ms4 
,klobuchar7 introduced the following    
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,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 #bjbj or   
the ,,benefit ,act of #bjbj4  #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