At the end of 2012, 850 million users worldwide were on Facebook, more than one million websites have integrated with Facebook and 34 percent of U.S. marketers have generated leads using Twitter. You can see more social media statistics at the Huffington Post here. Guidance on legal compliance moves far more slowly than the innovation which spawns the need for that regulation. The Federal Trade Commission (FTC) has been at the forefront in shaping policy for online marketing and bringing enforcement actions against marketers for non-compliance; however, the Food and Drug Administration (FDA) has lagged behind, having offered little guidance concerning online marketing.
Over ten years ago, the FTC issued guidance to marketers on how consumer protection laws apply to online advertising and sales and explained how marketers could clearly and conspicuously present required disclosures and disclaimers in online advertising. On March 13, the FTC updated this advice in its .com Disclosures guidance to provide additional information on how marketers can truthfully and lawfully market their products to consumers online. In the meantime, we continue to wait for FDA to issue social media guidance, a process begun in 2009. Fed up with the delay, in the Food and Drug Administration Safety and Innovation Act, Congress ordered FDA to issue social media guidance by July 2014.
An ongoing concern for pharmaceutical marketers has been FDA enforcement actions requiring that all online promotion comply with the requirements applicable to traditional print promotions. Specifically prescription drug promotions that include the drug name and other information about the drug, such as its indication, must also include a fairly balanced presentation of risk information in proximity to the benefit information. Including this so-called “fair balance statement” in the body of many online promotions is impossible – a prescription drug’s fair balance statement cannot fit in a 140-character Tweet, a Facebook post, or a sponsored link. Regardless of the technological infeasibility, FDA issued a slew of enforcement letters in April 2009 to pharmaceutical manufacturers who had been run Google short text ads (the ads that run beside Google search results) that included the drug’s name and indication with hyperlinks and click-through to pages that provided the required disclosure of risk information. Examples of the FDA enforcement letters are here and here. A persistent hope has been that when FDA finally does issue its social media guidance, it would permit hyperlinks to fair balance statements rather than requiring the inclusion of the lengthy statement in the body of the online advertisement.
However, if FDA looks to the FTC .com Disclosures guidance for advice as it drafts its own social media guidance, the prospect of abandoning the old model and moving to a click-through model for provision of a prescription drug’s risk disclosures doesn’t look favorable. In the FTC’s .com Disclosures guidance, as expected for an agency with long experience in the area, the FTC proves to be savvy and conscious of the limitations posed by Twitter and other space-constraining media. The FTC allows for the use of hyperlinks “when a space-constrained ad requires a disclosure.”
If the FTC would have stopped here, pharmaceutical marketers might have been one step closer to a click-through model for prescription drugs. However, the FTC guidance also states that any disclosure that is an “integral” or “inseparable” from a claim “should not be communicated through a hyperlink.” See p. 10. The guidance goes on to state, that “this is particularly true for cost information and certain health and safety disclosures.”
If FDA continues to adhere to its current position, and adopts the FTC’s view, it will be effectively impossible for pharmaceutical manufacturers to include basic information about a prescription drug in limited space social media platforms. The irony is that unlawful, foreign website marketers, illegal off-shore pharmacies, and other similar sites will be able to continue to seemingly provide useful, basic information, such as what disease a drug treats, while pharmaceutical marketers, whose website promotions are regulated and closely scrutinized by FDA, will not be able to provide even this information in the social media sites consumers and patients are using.