Imagine for a moment being told that you can't tweet or use Facebook without getting guidelines for how to do so from the federal government, and that the government won't tell you what those guidelines are. That is basically the situation that the FDA is continuing to impose on the life-sciences industry by — again — guidelines on how companies can use social media to promote medical products.
FDA had a public meeting on the subject of Internet promotion of products in 1996, and another meeting after the development of social media in November of 2009, but has yet to issue guidelines indicating when the world can expect guidance. FDA initially promised guidance by the end of 2010, then by the first quarter of 2011, and after missing those deadlines, they have stopped giving out dates. Just this week, it opened a new comment period indicating that the agency is engaging in further study of this issue. As former FDA official Peter Pitts put it, the latest announcement indicates that the guidelines are "still a long way off."
The FDA itself, however, needs no further study to understand social media or its advantages. As this indicates, the FDA "is making almost daily use of Twitter, Facebook and other social media." This includes information regarding approvals and efficacy, even though FDA can't fit all of a drug's risks into Twitter's 140 character limit. As PhRMA notes, "Clearly, social media can be used to discuss new medical advances in appropriate ways that benefit patients and healthcare professionals, and improve the public health."
In the meantime, FDA has sent out official letters to companies, including Novartis, complaining of promotional activities in this sphere. Without guidance from FDA, though, there is no way to figure out in advance what FDA will and won't approve in terms of social media outreach.
FDA is understandably concerned that companies could make unproven assertions about their products or highlight benefits without acknowledging risks. If that is the case, though, they should let companies — and everyone else — know so that social-media campaigns can be tailored to official guidelines. As it stands now, companies are playing a guessing game about what FDA will let slide and what could prompt FDA's enforcement arm to spring into action. Issuing the guidance will involve challenges of its own in terms of figuring out appropriate parameters, but the agency needs to bring this guessing game to an end.