,,ii  #aafth ,,congress  #ast ,session  
,s4 #feh  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,march #e1 #bjai    
,mr4 ,braun introduced the following    
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to provide for an accelerated  
approval pathway for certain drugs that 
are authorized to be lawfully marketed  
in other countries4  #a4 ,short title   
,this ,act may be cited as the          
,accelerated ,drug ,approval for        
,prescription ,therapies ,act or the    
,,adapt ,act4  #b4 ,accelerated approval
 of certain drugs that are authorized to
 be lawfully marketed in other countries
 ,chapter ,v of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cea et seq47 is amended by inserting  
after section #ejf the following3       
#ejf-a4 ,accelerated approval of certain
 drugs that are authorized to be        
lawfully marketed in other countries    
7a7 ,in general ,the ,secretary may     

approve an application for approval for 
a drug under subsection 7c7 or 7j7 of   
section #eje that is currently          
authorized to be marketed in one or more
 of the countries included in the list  
under section #hjb7;b77#a71 upon a      
determination by the ,secretary that the
 sponsor has submitted evidence         
sufficient to demonstrate all of the    
criteria under subsection 7b77#a74  7b7 
,criteria  7#a7 ,in general ,the        
,secretary may approve a drug under     
subsection 7a7 only if the ,secretary   
determines that there is evidence that--
  7,a7 at the time of application1 the  
drug is authorized to be marketed in a  
country included in the list under      
section #hjb7;b77#a72  7,b7 the drug is 
safe and clinically effective and has a 
satisfactory history of clinical trials 
and data2  7,c7 the manufacturer is     
capable of manufacturing the drug safely
 and consistently1 and can assure the   
safety of the supply chain outside the  
,united ,states2  7,d7 all relevant     

,united ,states patents or legal        
exclusivities are expired2  7,e7 absent 
reciprocal marketing approval1 the drug 
is not approved for marketing in the    
,united ,states2  7,f7 the ,secretary   
has not1 because of any concern relating
 to safety or effectiveness1 rescinded  
or withdrawn any such approval2 and     
7,g7 there is a public health or unmet  
medical need for the drug in the ,united
 ,states4  7#b7 ,limitation ,approval of
 a drug under this section may1 as the  
,secretary determines appropriate1 be   
subject to #a or both of the following  
requirements3  7,a7 ,the sponsor conduct
 appropriate postapproval studies to    
verify and describe the predicted effect
 on irreversible morbidity or mortality 
or other clinical benefit of the drug4  
7,b7 ,the sponsor submit copies of all  
promotional materials related to the    
product during the preapproval review   
period and1 following approval and for  
such period thereafter as the ,secretary
 determines to be appropriate1 at least 

#cj days prior to dissemination of the  
materials4  7c7 ,timeline ,the          
,secretary shall make a determination on
 an application described in subsection 
7a7 not later than #ahj days after the  
date of submission of such application4 
4