December 15, 2008
FDA to test out 1-800-AERS
The FDA is weighing requiring DTC TV ads to carry a toll-free number for adverse events reports and is surveying 1,600 consumers to find out what they think, the Associated Press reported. The requirement would dovetail with one already in place for print ads, but some at the agency are concerned that a toll-free number would distract viewers from risk information.
The survey will test ads for a fictitious blood pressure drug, Associated Press reported, with an eye to how the placement, wording and timing of the statement impacts comprehension and recall of the ads. The FDA did not indicate when it would launch the study.