FDA finds puppies and moths not guilty of DTC interference

Puppies and beach houses may not be as distracting as the FDA feared. The agency had been studying presentations of risk information in direct-to-consumer advertising to determine how graphics, video and audio might affect viewers' take-away. In other words, would a peripatetic bee or flitting moth or gamboling litter of puppies distract consumers from side-effects disclosures?

The answer? No. As Medical Marketing & Media reports, the agency's study determined the "emotional/affective tone of visual images" didn't sway consumers' understanding of a drug's risks. Nor did a mismatch between the information presented--a litany of potentially serious side effects, for instance--and the background video.

The agency also looked at whether consumers understood the side-effects recitation better when the text was also placed onscreen. In that case, the answer was yes. Presenting the risks in text and audio at the same time improved comprehension, the agency found.

The study grew out of a proposal that would have banned "distracting representations" from DTC ads. First floated back in 2010, the rule was designed to address concerns that DTC commercials were crafted to focus attention on a drug's benefits and deflect it from risks. As MM&M reports, FDA had expected its research to confirm that incongruously positive images did blur patients' understanding. Because it didn't, the agency is reopening public comment on the proposed rule; the new comment period ends Feb. 27.

- read the MM&M story