,,ii  #aahth ,,congress  #ast ,session  
,s4 #fhi  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,march #g1 #bjbc,mr4
 ,booker 7for himself and ,mr4 ,paul7   
introduced the following bill2 which was
 read twice and referred to the         
,committee on the ,judiciary  ,a ,,bill 
,to amend the ,controlled ,substances   
,act to define currently accepted       
medical use with severe restrictions1   
and for other purposes4  #a4 ,currently 
accepted medical use with severe        
restrictions  7a7 ,definitions ,section 
#ajb of the ,controlled ,substances ,act
 7#ba ,u4,s4,c4 #hjb7 is amended by     
inserting after paragraph 7#g7 the      
following3  7#g7 7,a7 ,subject to       
subparagraph 7,b71 the term currently   
accepted medical use with severe        
restrictions1 with respect to a drug or 
other substance1 includes a drug or     
other substance that is an active       
metabolite1 moiety1 or ingredient       
7whether in natural or synthetic form7  
of an investigational new drug for which

 a waiver is in effect under section    
#eje7;i7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cee7;i77 or section #cea7;a77#c7 of the
 ,public ,health ,service ,act 7#db     
,u4,s4,c4 #bfb7;a77#c77 and that the    
,secretary-- 7i7 designates as a        
breakthrough therapy under section      
#ejf7;a7 of the ,food ,drug and         
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a772
 or  7ii7 authorizes for expanded access
 under subsection 7b7 or 7c7 of section 
#efa of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb71
 either alone or as part of a           
therapeutic protocol1 to treat patients 
with serious or life-threatening        
diseases for which no comparable or     
satisfactory therapies are available4   
7,b7 ,a drug or other substance shall   
not meet the criteria under subparagraph
 7,a7 for having a currently accepted   
medical use with severe restrictions    
if-- 7i7 in the case of a drug or other 
substance described in subparagraph     

7,a77ii7-- 7,i7 the ,secretary places   
the expanded access or protocol for such
 drug on clinical hold as described in  
section #cab4db of title #ba1 ,code of  
,federal ,regulations 7or any successor 
regulations72  7,,ii7 there is no other 
investigational new drug containing the 
drug or other substance for which       
expanded access has been authorized     
under section #efa7;a7 of the ,federal  
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cfj;bbb7a772 and  7,,iii7 the
 drug or other substance does not meet  
the requirements of subparagraph        
7,a77i72 or  7ii7 the drug or other     
substance is approved under section #eje
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
section #cea of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bfb74  4  
7b7 ,authority and criteria for         
classification of substances ,section   
#bja7;j7 of the ,controlled ,substances 
,act 7#ba ,u4,s4,c4 #haa7;j77 is        
amended-- 7#a7 in paragraph 7#a71 by    

inserting a drug designated as a        
breakthrough therapy under section      
#ejf7;a7 of the ,food ,drug and         
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a771
 or a drug authorized for expanded      
access under subsection 7b7 or 7c7 of   
section #efa of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;bbb7 after subsection 7f712  7#b7 
in paragraph 7#b7-- 7,a7 in subparagraph
 7,a71 by striking 2 or and inserting a 
semicolon2  7,b7 in subparagraph 7,b71  
by striking the period at the end and   
inserting a semicolon2 and  7,c7 by     
adding at the end the following3  7,c7  
the date on which the ,attorney ,general
 receives notification from the         
,secretary of ,health and ,human        
,services that the ,secretary has       
designated a drug as a breakthrough     
therapy under section #ejf7;a7 of the   
,food ,drug and ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef7;a77 or authorized a drug
 for expanded access under subsection   
7b7 or 7c7 of section #efa of the       

,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;bbb72 or  7,d7 
the date on which the ,attorney ,general
 receives any written notification      
demonstrating that the ,secretary1      
before the date of enactment of this    
subparagraph1 designated a drug as a    
breakthrough therapy under section      
#ejf7;a7 of the ,food ,drug and         
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a77 
or authorized a drug for expanded access
 under subsection 7b7 or 7c7 of section 
#efa of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb74
  2  7#c7 in paragraph 7#c71 by         
inserting or paragraph 7#d7 after       
paragraph 7#a72 and  7#d7 by adding at  
the end the following3  7#d7 ,with      
respect to a drug moved from schedule ,i
 to schedule ,,ii pursuant to paragraph 
7#a7 and the expedited procedures       
described under this subsection1 if the 
drug no longer has a currently accepted 
medical use with severe restrictions and
 the ,secretary of ,health and ,human   

,services recommends that the ,attorney 
,general control the drug in schedule ,i
 pursuant to subsections 7a7 and 7b71   
the ,attorney ,general shall1 not later 
than #ij days after receiving written   
notification from the ,secretary1 issue 
an interim final rule controlling the   
drug in accordance with such subsections
 and section #bjb7;b7 using the         
procedures described in paragraph 7#c7  
of this subsection4  4