,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #dajf  ,,in ,,the ,,house ,,of  
,,representatives  ,july #cj1 #bjai,ms4 
,de,lauro 7for herself1 ,mr4 ,khanna1   
and ,mr4 ,grijalva7 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 restrict  
direct-to-consumer drug advertising4    
#a4 ,short title ,this ,act may be cited
 as the ,responsibility in ,drug        
,advertising ,act of #bjai4  #b4        
,direct-to-consumer drug advertising    
,the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4 #cja et   
seq47 is amended--  7#a7 in section #cja
 7#ba ,u4,s4,c4 #cca71 by adding at the 
end the following3  7fff7 ,the conduct  
of direct-to-consumer advertising of a  
drug in violation of section #ejf;,j4  2
 and  7#b7 in chapter ,v1 by inserting  
after section #ejf;,i 7#ba ,u4,s4,c4    
#cef;f7 the following3  #ejf;,j4        
,direct-to-consumer drug advertising    

7a7 ,prohibitions  7#a7 ,first three    
years  7,a7 ,in general ,subject to     
subparagraph 7,b71 no person shall      
conduct direct-to-consumer advertising  
of a drug for which an application is   
submitted under section #eje7;b7 before 
the end of the #c-year period beginning 
on the date of the approval of such     
application4  7,b7 ,waiver ,the         
,secretary may waive the application of 
subparagraph 7,a7 to a drug during the  
third year of the #c-year period        
described in such subparagraph if--  7i7
 the sponsor of the drug submits an     
application to the ,secretary pursuant  
to subparagraph 7,c72 and  7ii7 the     
,secretary1 after considering the       
application and any accompanying        
materials1 determines that              
direct-to-consumer advertising of the   
drug would have an affirmative value to 
public health4  7,c7 ,application for   
waiver ,to seek a waiver under          
subparagraph 7,b71 the sponsor of a drug
 shall submit an application to the     

,secretary at such time1 in such manner1
 and containing such information as the 
,secretary may require4  7#b7           
,subsequent years ,the ,secretary may   
prohibit direct-to-consumer advertising 
of a drug during the period beginning at
 the end of the #c-year period described
 in paragraph 7#a77;,a7 if the          
,secretary determines that the drug has 
significant adverse health effects based
 on post-approval studies1 risk-benefit 
analyses1 adverse event reports1 the    
scientific literature1 any clinical or  
observational studies1 or any other     
appropriate resource4  7b7 ,regulations 
,not later than #a year after the date  
of the enactment of this section1 the   
,secretary shall revise the regulations 
promulgated under this ,act governing   
drug advertisements to the extent       
necessary to implement this section4    
7c7 ,rule of construction ,this section 
shall not be construed to diminish the  
authority of the ,secretary to prohibit 
or regulate direct-to-consumer          

advertising of drugs under other        
provisions of law4  7d7 ,effective date 
,this section applies only with respect 
to a drug for which an application      
submitted under section #eje7;b7 is     
approved on or after the date that is #a
 year before the date of the enactment  
of this section4  4