Still No Answers for Digital Pharma Marketers, Says FDA

Food and pharma regulator won't issue draft guidance on online marketing related topics until Q1 at the earliest.

Over a year ago, online pharma marketers came together to air their concerns about the lack of clear guidance from the Food and Drug Administration on how to market online. They’ll have to wait until next year for any hints from the FDA.

The FDA announced recently that it would issue draft guidance on at least one of several online marketing related topics sometime during Q1 of 2011. The agency said in a statement that its Division of Drug Marketing, Advertising, and Communications – the body which reviews ads for prescription drugs – is currently researching digital and social media marketing topics.

“Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed,” said the FDA in a statement sent to ClickZ News. “The public will be notified officially when any guidance is issued via Federal Register announcements.”

Among the issues the FDA said it is evaluating: responding to unsolicited requests in digital channels, abiding by regulations calling for risk information in restricted environments such as Twitter, fulfilling post-marketing submission requirements, use of Web links, and correction of misinformation.

The lack of clear guidance on how to navigate social media and online advertising while abiding by the FDA’s strict requirements has frozen many pharma marketers. Indeed, when Google introduced a search ad format intended to satisfy what it hoped the FDA was looking for, pharma brands were so leery of violating the FDA’s cloudy rules that Google had to test the product claim ad format itself.

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