FDA Eyes DTC

January 22nd, 2009 | Sources: MedPageToday

The FDA has announced plans to study whether TV ads for prescription drugs display side-effect information in a fair and balanced manner.

The plan is to concoct a series of sham TV advertisements for a fictitious blood pressure drug and play them for 2,000 adults. The ads will differ in the images displayed during the time the announcer recites side-effect information.

The ads will display scenes ranging from highly consistent with the information being presented to highly inconsistent—maybe something like a buff couple relaxing in bathtubs positioned for sunset-watching on a beach.

After being shown the sham ads, study participants will be quizzed about what was said regarding the risks and benefits of the drug.

The FDA requires that DTC ads strike a “fair balance” in presenting risks and benefits and worries that visual images can distract viewers to a point where they’re unable to retain information about risk.

“Do images of people frolicking on a beach counteract the risk information being presented?” Allan Coukell, policy director at the Prescription Project asked MedPageToday.

Rhetorically, we can only assume.

“The concern is that every ad ends with the litany of risks–you sort of discount it,” Coukell continued.

The FDA study also plans to assess whether the addition of text describing the risks, in addition to the announcer’s scripted remarks, might impact recall.


 

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