,i  #aaith ,,congress  #ast ,session    
,h4 ,r4 #hdc  ,,in ,,the ,,house ,,of   
,,representatives  ,january #ca1        
#bjbe,ms4 ,barragn introduced the       
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend the ,federal ,food1
 ,drug1 and ,cosmetic ,act to provide   
for the prompt approval of drugs when   
safety information is added to labeling1
 and for other purposes4  #a4 ,short    
title ,this ,act may be cited as the    
,prompt ,approval of ,safe ,generic     
,drugs ,act4  #b4 ,prompt approval of   
drugs when safety information is added  
to labeling ,section #eje of the        
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7 is amended by 
adding at the end the following3  7aa7  
,prompt approval of drugs when safety   
information is added to labeling  7#a7  
,general rule ,a drug for which an      
application has been submitted or       
approved under subsection 7b77#b7 or 7j7
 shall not be considered ineligible for 

approval under this section or          
misbranded under section #ejb on the    
basis that the labeling of the drug     
omits safety information1 including     
contraindications1 warnings1            
precautions1 dosing1 administration1 or 
other information pertaining to safety1 
when the omitted safety information is  
protected-- 7,a7 by exclusivity under   
clause 7iii7 or 7iv7 of subsection      
7c77#c77;,e71 clause 7iii7 or 7iv7 of   
subsection 7j77#e77;,f71 or section     
#ebg7;a72  7,b7 by an extension of such 
exclusivity under section #eje;,a or    
#eje;,e2 or  7,c7 by patent4  7#b7      
,labeling ,notwithstanding clauses 7iii7
 and 7iv7 of subsection 7c77#c77;,e71   
clauses 7iii7 and 7iv7 of subsection    
7j77#e77;,f71 or section #ebg1 the      
,secretary shall require that the       
labeling of a drug approved pursuant to 
an application submitted under          
subsection 7b77#b7 or 7j7 that omits    
safety information described in         
paragraph 7#a7 include a statement of   

any appropriate safety information that 
the ,secretary considers necessary to   
assure safe use4  7#c7 ,availability and
 scope of exclusivity ,this subsection  
does not affect-- 7,a7 the availability 
or scope of exclusivity or an extension 
of exclusivity described in subparagraph
 7,a7 or 7,b7 of section #eje;,a7o77#c72
  7,b7 the question of the eligibility  
for approval under this section of any  
application described in subsection     
7b77#b7 or 7j7 that omits any other     
aspect of labeling protected by         
exclusivity under-- 7i7 clause 7iii7 or 
7iv7 of subsection 7c77#c77;,e72  7ii7  
clause 7iii7 or 7iv7 of subsection      
7j77#e77;,f72 or  7iii7 section         
#ebg7;a72 or  7,c7 except as expressly  
provided in paragraphs 7#a7 and 7#b71   
the operation of this section or section
 #ebg4  4