,,ii  #aadth ,,congress  #b;d ,session  
,s4 #cdff  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,september #bi1
 #bjaf ,mr4 ,paul 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 ,accelerating ,new  
,pharmaceutical ,competition ,act4  #b4 
,drugs approved in certain foreign      
countries ,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 subparagraph 7,a7  
or designated under subparagraph 7,b7 of
 section #hjb7;b77#a71 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#e71 within2 and  7,b7 by    
adding at the end the following3  7#e7  
,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 finds that none of the       
grounds for denying approval specified  
in subsection 7d7 applies or take action
 described in paragraph 7#a77;,b74 ,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  4  #c4         
,approval of generic drugs  7a7 ,stays  
in the case if patent infringement      
lawsuits ,section #eje7;j77#e77;,b77iii7
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;j77#e77;,b77iii77 is amended by   
striking the expiration of the          
thirty-month period beginning on the    
date of the receipt of the notice       
provided under paragraph 7#b77;,b77i7   
and inserting the date upon final       
judgment is entered in such action4  7b7
 ,expedited generic review ,section     
#eje7;j77#e7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;j77#e77 is amended-- 7#a7 in     
subparagraph 7,a71 by striking ,within  
and inserting ,except as provided in    
subparagraph 7,g71 within2 and  7#b7 by 
adding at the end the following3  7,g7  
7i7 ,the ,secretary shall prioritize the
 review1 and act not later than #aej    
calendar days after the date of the     
submission of an application1 or        

supplement to an application1 in the    
case of an application or supplement to 
an application described in clause 7ii74
  7ii7 ,clause 7i7 shall apply to an    
application or supplement to an         
application under this subsection with  
respect to which the applicable listed  
drug1 or another drug approved under    
this subsection with reference to such  
listed drug--  7,i7 has been introduced 
into interstate commerce by not more    
than one manufacturer or sponsor in the 
#c-month period immediately preceding   
the date of submission of such          
application or supplement and with      
respect to which tentative approval has 
been granted for not more than #b       
applications under this subsection2 or  
7,,ii7 has been included on the drug    
shortage list under section #ejf;,e4  4