,,ii  #aacth ,,congress  #b;d ,session  
,s4 #bacd  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,march #ac1    
#bjad ,mr4 ,manchin introduced the      
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to withdraw approval for the   
drug ,zohydro ,,er and prohibit the     
,food and ,drug ,administration from    
approving such drug unless it is        
reformulated to prevent abuse4  #a4     
,short title  ,this ,act may be cited as
 the ,act to ,ban ,zohydro4  #b4        
,findings  ,congress finds as follows3  
7#a7 ,the drug ,zohydro ,,er is a       
high-dose hydrocone-only opioid narcotic
 painkiller listed in schedule ,,ii of  
section #bjb7;c7 of the ,controlled     
,substances ,act 7#ba ,u4,s4,c4         
#hab7;c774  7#b7 ,the ,food and ,drug   
,administration ,anesthetic and         
,analgesic ,drug ,products ,advisory    
,committee report cited available       
dosages of ,zohydro ,,er that1 according

 to health care and substance abuse     
professionals1 have up to #aj times more
 hydrocodone than any hydrocodone       
painkiller currently on the market4     
7#c7 ,zohydro ,,er is manufactured      
without an abuse deterrent formulation4 
7#d7 ,zohydro's time-released effect1 an
 important element of its pharmaceutical
 use1 is easily negated by abusers to   
achieve a heroin-like effect4  7#e7 ,the
 ,anesthetic and ,analgesic ,drug       
,products ,advisory ,committee concluded
 that1 if approved and marketed1        
,zohydro ,,er will be abused1 possibly  
at a rate greater than that of currently
 available hydrocodone combination      
products4  7#f7 ,the ,anesthetic and    
,analgesic ,drug ,products ,advisory    
,committee voted #aa to #b against      
approval of ,zohydro ,,er1 citing the   
high possibility for addiction4  7#g7   
,the ,food and ,drug ,administration    
approved ,zohydro ,,er without an abuse 
deterrent formulation despite the fact  
that the ,anesthetic and ,analgesic     

,drug ,products ,advisory ,committee    
voted #aa to #b against doing so4  7#h7 
,the ,food and ,drug ,administration has
 acknowledged that the widespread abuse 
of opioid drugs across the country has  
reached epidemic proportions in some    
parts of the country4  7#i7 ,according  
to the ,centers for ,disease ,control   
and ,prevention1 deaths connected to    
prescription opioids have more than     
quadrupled in the ,united ,states1 from 
#d1jcj deaths involving the painkillers 
in #aiii to #af1fea deaths in #bjaj4    
7#aj7 ,the ,centers for ,disease        
,control and ,prevention has identified 
reducing deaths attributable to         
prescription painkiller abuse and       
overdose as a top health priority for   
#bjad4  7#aa7 ,attorneys ,general from  
#bh ,states have asked the ,food and    
,drug ,administration to reconsider its 
approval of ,zohydro ,,er4  7#ab7       
,health care professionals1 addiction   
treatment providers1 and community-based
 drug and alcohol prevention programs   

are groups opposed to the approval of   
,zohydro ,,er4  7#ac7 ,the burdens of   
,zohydro ,,er to the public health      
outweigh its potential therapeutic      
benefits4 ,given that alternative pain  
medicines and methods are widely        
available1 approval of ,zohydro ,,er    
should be withdrawn until such time that
 there is available a ,food and ,drug   
,administration-approved abuse deterrent
 formulation4  #c4  ,withdrawal of      
approval of drug ,zohydro ,,er  7a7     
,withdrawal of approval  ,effective     
beginning on the day that is #de days   
after the date of enactment of this     
,act1 approval of the application with  
respect to pure hydrocodone bitartrate  
extended-release capsules 7marketed as  
the drug ,zohydro ,,er7 under section   
#eje7;c7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cee7;c77 is deemed to have been        
withdrawn under section #eje7;e7 of such
 ,act 7#ba ,u4,s4,c4 #cee7;e774  7b7    
,no approval of any formulation that is 

not abuse deterrent  ,the ,commissioner 
of ,food and ,drugs shall not approve   
any application under section #eje of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7 for pure     
hydrocodone bitartrate extended-release 
capsules unless such drug is formulated 
to prevent abuse4