FDA to release 'guidances' for medical ads that target consumers

ROCKVILLE, MD: The Food and Drug Administration is expected to unveil draft "guidances" this week designed to help make direct-to-consumer (DTC) advertising for medical products more potent public health tools.

ROCKVILLE, MD: The Food and Drug Administration is expected to unveil draft "guidances" this week designed to help make direct-to-consumer (DTC) advertising for medical products more potent public health tools.

The guidances are not binding regulations, but are being presented as best-practice suggestions for DTC marketing. DTC advertising involves companies promoting prescription drugs to consumers and has become a staple of pharmaceutical marketing in recent years.

According to industry sources, the guidances cover three areas: the presentation of the summary that describes the risks and benefits of prescription drugs in print ads; disease awareness ads that do not promote specific products; and the presentation of risk information for restricted medical devices.

According to Peter Pitts, the FDA's director of external relations, complying with the recommendation for more consumer-friendly DTC ads presents a PR opportunity for companies.

Said Pitts, "Right now, a lot of DTC falls into the ambient noise category. The question is, what company is going to step up to the plate and say, 'If we more accurately present risk information, we will be seen as a more honest and up-front company.'"

Tom Jones, executive director of communications for drug firm Novartis, said, "If DTC trends move more to unbranded condition awareness strategies, then PR can be even more valuable, not only for elevating credibility of ad messages, but for maximizing brand awareness too."

Steve Lampert, AstraZeneca's senior director of public affairs, agreed that the new guidances could "have brand managers looking for more creative ways to get our their messages."

Pitts emphasized that the guidances, which were initially expected to come out last week, will be issued in draft form, and said FDA encourages manufacturers and the public to comment on them.

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