February 7th, 2012
FDA: Replace Babies In Ads With More Risk Info
By Ed Silverman
Fifteen years after the FDA greatly expanded direct-to-consumer advertising, the agency is proposing new rules that would require drugmakers to limit the happy-go-lucky images that - sometimes, incongruously - are used to promote meds for extremely serious and sobering illnesses. And, not surprisingly, the agency may revise current rules so side effect info is easier to digest.
The FDA proposed the change two years ago and then conducted a ‘Distraction Study,’ in which 75-second ads for a fictitious blood-pressure drug called Zintria were shown to 2,134 adults over the age of 40, half of whom were diagnosed with the affliction. The agency examined the presence or absence of superimposed text, the emotional (or affective) tone of visual images and the consistency of the visual images with the risk information.