,,ii  #aahth ,,congress  #ast ,session  
,s4 #fjg  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,march #a1 #bjbc,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   
allow the ,secretary of ,health and     
,human ,services to deny approval of a  
new drug application for an opioid      
analgesic drug on the basis of such drug
 not being clinically superior to other 
commercially available drugs4  #a4      
,short title ,this ,act may be cited as 
the ,ensuring the ,,fda ,fully ,examines
 ,clinical ,trial ,impact and ,vitalness
 before ,endorsement ,act or the        
,,effective ,act4  #b4 ,requirement for 
approval of new opioid analgesics       
,section #eje7;c7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cee7;c77 is amended by adding
 at the end the following3  7#f7        
,notwithstanding any other provision of 

this section1 the ,secretary may deny   
approval of an application submitted    
under subsection 7b7 for an opioid      
analgesic drug if the ,secretary        
determines that such drug does not      
provide a significant advantage1 in     
terms of greater safety or              
effectiveness1 compared to an           
appropriate comparator drug1 as         
determined by the ,secretary4  4