No More Babies in Drug Ads, More Risk Info, FDA Recommends

No More Babies in Drug Ads, More Risk Info, FDA Recommends

February 8th, 2012 // 1:06 pm @

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Source: Pharmalot

We’ve had greatly expanded DTC advertising for 15 years now, since FDA loosened the rules. Personally, I’ve always found all the happy images of little kids and families having fun in some of these ads for very serious medical problems to be a bit annoying. Now, however, FDA is in the beginning stages of proposing new regulations that would force pharma companies to limit the feel good images in ads that are 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 tone of visual images and the consistency of the visual images with the risk information.

How was this presented? Some participants heard a laundry list of side effects while watching images that were mildly positive, such as metal arches, colorful chairs and a stack of smooth rocks. But others got to see strongly positive images, such as a toddler frolicking with puppies, a baby’s hand and young girls at the beach. Some, but not all, side effects were displayed in superimposed.

Then, the participants were asked whether images that were obviously positive – or upbeat – in tone affected their ability to comprehend risks associated with the medication, and if the positive images influenced how they felt about the drug. The FDA also wanted to know if side effect info that appeared in text and was super-imposed over the images altered their perception.

What did the FDA ultimately find? The tone of the visuals influenced the affect that Zintria could have, but not the understanding of risk. And visual consistency influenced the comprehension of benefits, but again, not the ability to understand side effect risks. Put another way, everyone understood the risk info, but those who saw the positive images viewed the drug more favorably.

“The study demonstrated that reinforcing audio-delivered risk information with consistent text during the major statement of an advertisement improves consumers’ risk comprehension and does not impede their comprehension of benefit,” the FDA wrote in a summary of the study last June (here is the study slide show and this is the summary). Major statement, by the way, refers to most important risk info.

Now, the FDA is seeking public comment on plans to implement standards for “clear, conspicuous and neutral” ads. The agency wants info that is presented in readily understandable language; audio info that is presented with appropriate volume, articulation and pacing; text that appears against a contrasting background for a sufficient amount of time and in a size and font style that can be easily read; and ads that do not include distracting representations.

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Source: Pharmalot

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