A key question is the extent to which the FDA may emulate the FTC rules. The FDA, as you know, has yet to issue its own social media guidance and the pharmaceutical industry and its marketing gurus are hoping the agency will do so sooner than later, rather than rely on piecemeal clues that occasionally arrive in the form of a warning letter (see this). The agency, however, is not required to issue guidance until July 2014 (see this).
One unanswered question concerns the so-called one-click rule. Would an advertiser be permitted to include, or embed, a hyperlink that allows a consumer to migrate from an ad to another web location that contains additional information? Drugmakers that want to use Twitter are confined by a 140-character Tweet, but what remains unclear is whether the FDA would allow a quick click on a link that takes consumers elsewhere to read safety information.
So what does the FTC say about this? If you read page 10 of the FTC guidance, the agency writes that “disclosures that are an integral part of a claim or inseparable from it should not be communicated through a hyperlink. Instead, they should be placed on the same page and immediately next to the claim, and be sufficiently prominent so that the claim and the disclosure are read at the same time... This is particularly true for cost information and certain health and safety disclosures."
The FTC then directs us to an example of an ad for a cooler and has this to say: "Hyperlinks should not be used to communicate disclosures that are an integral part of a claim or inseparable from it, including important health and safety information. In this example, the hyperlink 'Important Health Information' leads to a disclosure, 'Frost-a-tron may not keep perishable food items cold enough to prevent the growth of bacteria when the temperature is over 80ºF, such as in a hot car. Use in these conditions could lead to food-borne illness.'
"The fact that the cooler might not keep food cold enough to prevent the growth of dangerous bacteria should not be hidden behind a hyperlink, even one labeled 'Important Health Information.' This is especially true when the cooler is promoted for keeping perishable food fresh and cold on road trips. Moreover, any disclosure that is integral to the primary claim should be immediately adjacent to that claim."
To make certain there is no confusion, the FTC also says that, "Indeed, required disclosures about serious health and safety issues are unlikely to be effective when accessible only through a hyperlink." This language seems pretty clear and would suggest that FDA officials now have a model, of sorts, as they think through the rules they want to promulgate.
"The FDA can certainly hang its hat on this language to say that even the FTC rejects disclosures via hyperlink of important health and safety information, e.g. 'fair balance” information,'” says Arnie Friede, a former FDA associate chief counsel and former senior corporate counsel at Pfizer.
Hyperlinks, in other words, may remain challenging.