,,ii  #aaeth ,,congress  #b;d ,session  
,s4 #bffi  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #af1    
#bjah ,mr4 ,hatch 7for himself1 ,mr4    
,bennet1 ,mr4 ,donnelly1 and ,mr4       
,young7 introduced the following bill2  
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
provide for accelerated approval of pain
 and addiction therapies4  #a4 ,short   
title  ,this ,act may be cited as the   
,advancing ,innovation in ,alternative  
,pain and ,addiction ,therapies ,act4   
#b4 ,accelerated approval of pain and   
addiction therapies  7a7 ,purpose ,it is
 the purpose of this section to clarify 
the appropriate processes for           
encouraging and expediting the review of
 non-opioid or non-addictive medical    
products to treat chronic or acute pain 
or substance use disorders4  7b7 ,draft 
guidance  7#a7 ,in general ,not later   
than #a year 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 issue draft guidance1     
clarifying the methods and processes by 
which the ,food and ,drug               
,administration may provide accelerated 
approval for non-opioid or non-addictive
 drugs developed to treat chronic or    
acute pain or substance use disorders4  
7#b7 ,contents ,the guidance under      
paragraph 7#a7 shall address-- 7,a7     
eligibility requirements for such drugs 
to receive accelerated approval2  7,b7  
opportunities for engagement with the   
,food and ,drug ,administration with    
respect to the accelerated approval     
pathway2  7,c7 considerations for       
different types of pain and product     
mechanism of action2 and  7,d7 potential
 criteria for novel surrogate or        
intermediate clinical endpoints or      
biomarkers to assess pain4  7c7 ,final  
guidance ,not later than #f months after
 the close of the period for public     

comment on the draft guidance under     
subsection 7b71 the ,secretary shall    
finalize such guidance4  7d7 ,data in   
performance reports  7#a7 ,in general   
,as a component of the annual           
performance report under section        
#gcf;,b7a7 of the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4      
#cgi;h-#b7;a771 the ,secretary shall    
include information1 as appropriate1 on 
policies and processes of the ,division 
of ,anesthesia1 ,analgesia1 and         
,addiction ,products of the ,food and   
,drug ,administration 7referred to in   
this section as the ,,daaap7 for the    
accelerated approval pathway with       
respect to drugs developed to treat pain
 or substance use disorders1 during the 
previous fiscal year4  7#b7 ,contents   
,information submitted as a part of the 
performance reports under section       
#gcf;,b7a7 of the ,federal ,food1 ,drug1
 and ,cosmetic ,act may address--  7,a7 
the number of requests for accelerated  
approval submitted to the ,,daaap for   

non-opioid or non-addictive medical     
products2  7,b7 the number of           
applications for accelerated approval   
that the ,,daaap granted1 and a         
description of the common reasons for   
granting applications for accelerated   
approval2  7,c7 the number of           
applications for accelerated approval   
that the ,,daaap denied1 and a          
description of the common reasons for   
denying applications for accelerated    
approval2  7,d7 the percentage of       
products in such review division which  
met the review goals identified in the  
letters described in section #aja7;b7 of
 the ,prescription ,drug ,user ,fee     
,amendments of #bjag 7,public ,law      
#aae-eb72  7,e7 agency efforts to ensure
 consistency across review divisions in 
the metrics and processes by which new  
drug applications for non-addictive or  
non-opioid products intended to treat   
pain are reviewed2  7,f7 a discussion   
and summary of the common reasons for   
applications which did not meet the     

review goals identified in the letters  
described in section #aja7;b7 of the    
,prescription ,drug ,user ,fee          
,amendments of #bjag 7,public ,law      
#aae-eb71 as applicable and appropriate2
 and  7,g7 recommendations to better    
enable utilization of the accelerated   
approval pathway4  #c4 ,breakthrough    
therapy status for pain and addiction   
therapies  7a7 ,draft guidance  7#a7 ,in
 general ,not later than #a year 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
 issue draft guidance1 clarifying the   
methods and processes by which the ,food
 and ,drug ,administration may provide a
 breakthrough therapy designation for   
non-opioid or non-addictive drugs or    
devices developed to treat chronic or   
acute pain or substance use disorders4  
7#b7 ,contents ,the guidance under      
paragraph 7#a7 shall address-- 7,a7     

eligibility requirements for such drugs 
and devices to receive breakthrough     
therapy designation2  7,b7 opportunities
 for engagement with the ,food and ,drug
 ,administration with respect to the    
breakthrough therapy pathway2  7,c7     
specific actions to ensure that the     
design of the clinical trials is as     
efficient as practicable1 when          
applicable and scientifically           
appropriate1 for such drugs and devices2
 and  7,d7 the application of           
organizational commitment of the ,food  
and ,drug ,administration to            
facilitating breakthrough designation   
for qualified drugs and devices1        
including involvement of senior managers
 of the ,food and ,drug ,administration 
for such drugs and devices4  7b7 ,final 
guidance ,not later than #f months after
 the close of the period for public     
comment on the draft guidance under     
subsection 7a71 the ,secretary shall    
finalize such guidance4  7c7 ,data in   
performance reports  7#a7 ,in general   

,as a component of the performance      
reports under sections #gcf;,b7a7 and   
#gch;,a7a7 of the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4      
#cgi;h-#b1 #cgi;j-#a71 the ,secretary   
shall include information1 as           
appropriate1 on policies and processes  
of the ,division of ,anesthesia1        
,analgesia1 and ,addiction ,products of 
the ,food and ,drug ,administration     
7referred to in this section as the     
,,daaap7 for the breakthrough therapy   
pathway1 with respect to drugs and      
devices developed to treat chronic or   
acute pain or substance use disorders1  
during the previous fiscal year4  7#b7  
,contents ,information provided as a    
component of the performance reports    
under sections #gcf;,b7a7 and #gch;,a7a7
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act may address--  7,a7 the  
number of requests for breakthrough     
therapy designation submitted to the    
,,daaap2  7,b7 the number of            
applications for breakthrough therapy   

designation that the ,,daaap granted1   
and a description of the common reasons 
for granting applications for           
breakthrough therapy designation2  7,c7 
the number of applications for          
breakthrough therapy designation that   
the ,,daaap denied1 and a description of
 the common reasons for denying         
applications for breakthrough therapy   
designation2 and  7,d7 recommendations  
to better enable utilization of the     
breakthrough therapy designation pathway
 for non-addictive or non-opioid        
products intended to treat pain4