What if the rapid-fire list of side effects at the end of a TV commercial or YouTube video could be cut to a few discrete items? If that sounds like an idea made in advertising heaven, you're wrong. It's an idea coming out of the FDA.
The agency says it's planning to study paring down that disclosure of safety risks to the few most serious ones. Lumping the less-serious side effects together with the truly serious ones just confuses people, the FDA theorizes. It plans to recruit 500 people for a pilot study and 1,500 for the main event.
The main study would involve patients with one of three medical conditions. Participants will view one of four different versions of an ad, for products to treat their conditions. One version will mimic the existing ad format. Another will include the usual disclosure statement, plus a statement advising of other potential risks. A third version will use a shorter risk disclosure without the "additional risks apply" addendum, and the fourth would include the shorter disclosure, plus the "additional risks apply."
"Our hypothesis is ... providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks," the FDA says in a statement in the Federal Register.
After watching the ad, participants will answer a questionnaire designed to determine how well they understood the risks they heard, among other things--including how well they trust the company making the drug advertised. Because one other bit of the FDA's theory is that the long list of side effects might deter people from using drugs at all, even drugs they really need.
The FDA has been known to study people's perceptions of DTC advertising before. A few years ago, the agency looked at the images in advertising, to see whether flitting moths, buzzing bees or gamboling puppies dampened consumers' concerns about side effects. The answer? The images weren't as distracting as the FDA feared. That was in early 2012. Now, as of November, the FDA plans to revisit the issue with a new viewer-distraction study, this time using eye-tracking technology.
- read the Federal Register statement (PDF)
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