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FDA mulls use of side effect voiceover in TV advertising

Agency considers updating how drug risks are communicated
FDA headquarters White Oak

The US Food and Drug Administration (FDA) is considering a change to the way drug side effects are disclosed in US TV adverts

At present, pharmaceutical companies advertising direct to consumers via TV ads are required to provide lengthy lists of side effects potentially caused by the product in question.

The FDA, however, has become concerned that the length of these lists – which are communicated through a voiceover – is such that consumers are failing to identify the more serious side effects. Another concern is that the list may make relatively innocuous drug appear dangerous.

“Our hypothesis is that, relative to inclusion of the full major statement, 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 announced this week.

As a result, the organisation will carry out a 1,500 participant-strong survey in order to gauge how well including a list of the major side-effects only would work. Each participant will be signed to one of four groups, each seeing a possible version of an advert, as follows:

•    The major statement without the disclosure regarding additional risks
•    The full major statement plus the disclosure about additional risks
•    An abbreviated statement of risks without the disclosure about additional risks
•    An abbreviated statement of risks as well as the disclosure about additional risks.

After viewing the ad, participants will respond to questions about information in the advert, said the FDA.

Preliminary measures will assess perception and understanding of: product risks and benefits; the disclosure about additional risks; product quality; intention to seek more information about the product; and perceptions of trust/scepticism regarding product claims and the sponsor.

Comments on the study are due in 60 days.

Article by
Tara Craig

20th February 2014

From: Marketing, Regulatory



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