,,ii  #aagth ,,congress  #b;d ,session  
,s4 #cegf  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,february #c1  
#bjbb,mr4 ,braun 7for himself and ,mr4  
,paul7 introduced the following bill2   
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
allow sponsors of certain new drug      
applications to rely upon investigations
 conducted in certain foreign countries1
 and for other purposes4  #a4 ,short    
title ,this ,act may be cited as the    
,accelerated ,drug ,approval for        
,prescription ,therapies #b4j ,act or   
the ,,adapt #b4j ,act4  #b4 ,drugs      
approved in certain foreign countries   
7a7 ,in general ,section #eje of the    
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7 is amended--  
7#a7 in subsection 7b71 by adding at the
 end the following3  7#g7 ,an           
application described in paragraph 7#b7 
may rely upon investigations conducted  
in a country listed under section       

#hjb7;b77#a77;,a7 or designated under   
section #hjb7;b77#a77;,b71 including    
premarket clinical and nonclinical      
investigations and postmarket           
surveillance studies1 if the drug that  
is the subject of such application has  
been approved in such country4  2 and   
7#b7 in subsection 7c7-- 7,a7 in        
paragraph 7#a71 by striking ,within and 
inserting ,except as provided in        
paragraph 7#f71 within2 and  7,b7 by    
adding at the end the following3  7#f7  
7,a7 ,in the case of an application that
 relies on investigations conducted in a
 foreign country1 as described in       
subsection 7b77#g71 within #ij days     
after the filing of such application    
under subsection 7b71 the ,secretary    
shall approve the application if the    
,secretary determines evidence that--   
7i7 at the time of application1 the drug
 is authorized to be marketed in a      
country listed under section            
#hjb7;b77#a77;,a7 or designated under   
section #hjb7;b77#a77;,b72  7ii7 the    

drug is safe and clinically effective2  
7iii7 the manufacturer is capable of    
manufacturing the drug safely and       
consistently1 and can ensure the safety 
of the supply chain outside the ,united 
,states2  7iv7 all relevant ,united     
,states patents or legal periods of     
exclusivity are expired2  7v7 absent    
reciprocal marketing approval1 the drug 
is not approved for marketing in the    
,united ,states2  7vi7 the ,secretary   
has not1 because of any concern relating
 to safety or effectiveness1 rescinded  
or withdrawn any such approval2 and     
7vii7 the ,secretary finds that none of 
the grounds for denying approval        
specified in subsection 7d7 applies4    
7,b7 ,limitations ,approval of a drug   
under this section may1 as the          
,secretary determines appropriate1 be   
subject to #a or both of the following  
requirements3 7i7 ,the sponsor conduct  
appropriate postapproval studies to     
verify and describe the predicted effect
 of the drug on irreversible morbidity  

or mortality or another clinical benefit
 of the drug4  7ii7 ,the sponsor submit 
copies of all promotional materials     
related to the drug 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 
the dissemination of the materials4     
7,c7 ,timeline ,if the ,secretary does  
not approve the application or take such
 other action within such #ij-;day      
period1 the application shall be        
considered approved under this          
subsection4  7,d7 ,advisory committee   
7i7 ,establishment ,for the purpose of  
providing expert scientific advice and  
recommendations to the ,secretary       
regarding the approval of applications  
described in subsection 7b77#g71 the    
,secretary shall establish a standing   
,foreign ,drug ,review ,advisory        
,committee4  7ii7 ,membership ,the      
standing ,foreign ,drug ,review         
,advisory ,committee established under  

clause 7i7 shall consist of employees of
 the ,food and ,drug ,administration and
 individuals appointed by the           
,secretary1 reflecting a balanced       
composition of sufficient scientific    
expertise4 ,the ,secretary shall appoint
 members who have diverse interests1    
education1 training1 experience1 and    
expertise in biopharmacology1           
statistics1 chemistry1 legal issues1    
ethics1 and other appropriate expertise 
pertaining to the drugs under review1   
such as expertise in foreign regulatory 
and manufacturing practices and drug    
development1 and other individuals1 as  
the ,secretary determines appropriate4  
7iii7 ,review of applications ,upon the 
filing of an application described in   
subsection 7b77#g7-- 7,i7 the ,secretary
 shall immediately refer the application
 to the ,foreign ,drug ,review ,advisory
 ,committee for review2 and  7,,ii7     
within #fj days after the receipt by    
such advisory committee of such         
application1 the advisory committee     

shall provide the ,secretary with       
recommendations with respect to such    
application4  7,e7 ,publication of final
 decision ,the ,secretary shall make    
publically available1 on the website of 
the ,food and ,drug ,administration1    
each final decision on whether to       
approve an application described in     
subsection 7b77#g71 including the       
rationale for the decision and the      
recommendations and conclusions of the  
,foreign ,drug ,review ,advisory        
,committee under subparagraph 7,d77iii74
  4  7b7 ,technical amendment ,section  
#hjb7;b77#a77;,a77i7 of the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #chb7;b77#a77;,a77i77 is      
amended by striking or ,south ,africa   
and inserting ,south ,africa1 or the    
,united ,kingdom4