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)
Category :
Issue Areas/Comments
We submit the attached manuscript as our "public comment" on the FDA's recent
guidance for industry on improving direct to consumer pharmaceutical

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