2004D-0042 - Draft Guidances for Industry on Making Direct-to-Consumer Advertising More User Friendly; Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC7
  



  

  

  



  

  
Submitter : 
  

  
Dr. Steven Woloshin
  

  
Date & Time: 
  

  
06/10/2004 05:06:11
  



  

  
Organization : 
  

  
VA Outcomes Group (White River Jct., VT)
  



  

  
Academia
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 We submit the attached examples of prescription drug benefit boxes to supplement our filed 'public comment' on the FDA's recent

guidance for industry on improving direct to consumer pharmaceutical

advertisements.



The drug benefit boxes are standardized tables with published data on the chance of various outcomes with and without the drug.  



Steven Woloshin, MD, MS

Lisa Schwartz, MD, MS

H. Gilbert Welch, MD, MPH

VA Outcomes Group, White River Jct., VT and

  Dartmouth Medical School, Hanover, NH