The U.S. Food and Drug Administration says that a Facebook Share button that Novartis Pharmaceuticals used to promote a cancer-fighting drug violated its requirements to disclose side effects or risks about such medications. The agency sent a letter to the company telling it that its promotion of Tasigna was "incomplete and misleading" - probably the first time FDA has issued a warning about using Facebook, according to Jeffrey Chester , a privacy advocate and executive director of the Center for Digital Democracy. (via Business Week)
The company has taken down the widget referenced by the FDA, it said. "Novartis will continue to have active discussions with the FDA to understand fully all of the concerns. We also will assess all of our Web assets and materials based on these concerns."
Silence, and Then Action
The FDA has given pharma advertisers very little guidance on what it considers permissible web marketing. This latest salvo, according to health-care marketing agency Digitas Health "does NOT answer all of the questions raised during the social media hearings or about the use of social media in general" but does "clarify some issues." (via the Wall Street Journal). For instance, one could conclude that "the lessons of this enforcement action apply to all social media, not just Facebook," the alert says. Also, it appears that it was the Novartis-generated content that the FDA was targeting - and not the user-generated comments - ie "This saved my mom’s life with no side effects".
Companies have been cautiously testing the waters again after last year when FDA's Division of Drug Marketing, Advertising and Communications sent notices to 14 major pharmaceutical manufacturers informing them that their sponsored link ads were misleading because they did not adequately inform consumers about the drugs' associated risks. The result was a significant decrease in the use of sponsored ads by pharma companies.
In response Google created a "FDA-Friendly" online pharma ad format, which Bayer used to market the birth-control pill Yaz. These ads feature a headline linking to the product site, a line of text advising viewers to "Read important product info here," and a bottom line reading "Click to see full safety and prescribing information, including boxed warning." This is followed by a "fixed" link to physician labeling.
Also Tremor Media launched a video ad-banner format that may address government fair balance requirements for online pharma advertising - as well as hold users' attention online. The product, called Rx In-Stream, uses shorter-form, pre-roll video in place of the long-form video ads that typically convey safety information. An accompanying banner ad, instead, provides the data about the risks and side effects of the drug in question, while the shorter-form video ad focuses on product messaging and branding.