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

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC8
  



  

  

  



  

  
Submitter : 
  

  
Dr. Steven Woloshin
  

  
Date & Time: 
  

  
06/10/2004 05:06:39
  



  

  
Organization : 
  

  
VA Outcomes Group (White River Jct., VT)
  



  

  
Academia
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 We submit the attached manuscript as our "public comment" on the FDA's recent

guidance for industry on improving direct to consumer pharmaceutical

advertisements.



In prior work (Lancet 2001; 358:1141-6) we have shown that DTC ads rarely

provide any data on how well a drug works, information needed if consumers are

to appreciate their treatment options.  The enclosed manuscript details our

proposal for providing such information.  We designed and tested a prescription

drug "benefit box" - a standardized table with published data of the chance of

various outcomes with and without the drug.  In our study, people found the

table easy to understand, they were able to correctly extract data from it and

most thought the box should be required in DTC ads.  



The manuscript, which was recently published as a web exclusive in the journal

Health Affairs (April 28, 2004

--http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w4.234), builds

on work we presented at the FDA's September 2003 public meeting on DTC ads.



While we applaud the FDA for updating its thinking on DTC advertising, we were

very disappointed that the new guidance for industry makes no mention at all

about providing drug benefit data.  If DTC ads are to have meaningful

educational value for the public, they need to help consumers appreciate the

magnitude of the drug's benefit, in addition to disclosing its potential harms. 

We believe that the FDA should mandate the provision of such data in DTC ads.



Steven Woloshin, MD, MS

Lisa M. Schwartz, MD, MS

H. Gilbert Welch, MD, MPH

VA Outcomes Group, White River Jct., VT and

  Dartmouth Medical School, Hanover, NH