,,ii  #aagth ,,congress  #ast ,session  
,s4 #afcd  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #ac1      
#bjba,mr4 ,manchin 7for himself and ,mr4
 ,braun7 introduced the following bill2 
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
require the ,food and ,drug             
,administration to determine whether to 
permit the use of enriched enrollment   
randomized withdrawal methodology with  
respect to clinical trials4  #a4 ,short 
title ,this ,act may be cited as the    
,,fda ,review of ,efficacy of ,,eerw    
,double-,blinds of ,opioids ,act or the 
,,freed of ,opioids ,act4  #b4          
,consideration of enriched enrollment   
randomized withdrawal methodology  7a7  
,in general ,not later than #b years    
after the date of enactment of this     
,act1 the ,secretary of ,health and     
,human ,services 7referred to in this   
section as the ,secretary71 acting      
through the ,commissioner of ,food and  

,drugs1 shall convene a meeting of the  
,anesthetic and ,analgesic ,drug        
,products ,advisory ,committee and the  
,drug ,safety and ,risk ,management     
,advisory ,committee of the ,food and   
,drug ,administration to vote on whether
 to permit the use of the enriched      
enrollment randomized withdrawal        
methodology in clinical trials of drugs1
 including opioid drugs4 ,in conducting 
such review1 the ,secretary shall       
consider the report issued by the       
,national ,academy of ,sciences under   
subsection 7c74  7b7 ,presentations ,if 
the ,secretary allows for formal        
presentations in support of the use of  
the enriched enrollment randomized      
withdrawal methodology at the meeting   
described in subsection 7a71 the        
,secretary shall also allow for equal   
time at such meeting for presentations  
that are critical of such methodology4  
7c7 ,,nas study and report ,the         
,secretary shall seek to enter into a   
contract with the ,national ,academy of 

,sciences under which the ,national     
,academy-- 7#a7 conducts a study on the 
effectiveness of enriched enrollment    
randomized withdrawal methodology in    
demonstrating the efficacy of opioid    
drugs in treating chronic pain2 and     
7#b7 not later than #a year after the   
date of enactment of this ,act1 submits 
a report on such study to the           
,secretary4