FDA examines DTC close up

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DTC Report: Code Red for DTC?
FDA examines DTC close up

The FDA is kicking off a study to assess factors behind a viewer's ability to pay attention to risk information. The regulator announced in a Federal Register notice that this study will combine new elements with those already tested in the past—such as if drug risk recall is higher when screen text accompanies audio (it is) and if including the notice to dial the MedWatch 800 number interfered with risk recall (it did not).

This new test will use ads that incorporate the risk audio, risk text and the MedWatch information, along with assessing whether music and/or changing backgrounds have an effect on a viewer's ability to remember risk information. The FDA will use eye-tracking technology so researchers will be able to see if viewers look at warning information and for how long.

The study will use real TV content, and three ads—one will be for a non-existent prescription weight-loss medication. The prescription ad will be the only health-related advertisement, and the fake drug ad is the only one the FDA will look to for eye-tracking data.

The two-part study includes a pilot with 30 viewers and then a full-on study of 300. Both will watch TV and ads, but only the pilot group will also fill in a questionnaire after watching, and the quiz will test for risk perception, risk recall and if subjects remember the “call MedWatch” information.

Excluded from the study: anyone under 18 and anyone who wears glasses or hard contacts when they watch TV. The FDA says it's taking the no-glasses, no-hard contacts stance because they could interfere with the eye-tracking tools.

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