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)
Category :
Issue Areas/Comments
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

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