Novartis received a letter this week from the Food and Drug Administration, stating that a Facebook widget posted to a product website misled consumers, failed to communicate risk, and misbranded the drug.
An FDA warning letter addressing a social media tool could be all it takes for any company's legal team to shut down, or at least slow down, future marketing and communications plans that incorporate social media.
For healthcare communicators, many of whom recognize the patient need as well as the market need for a company to be involved online and managing its message in digital platforms, it's a sharp slap back to reality.
The FDA, long reticent to address social and online communications as anything different than a direct-to-consumer ad, has said it plans to release some form of guidelines in the near future.
Industry talk has focused on the need for guidelines, bubbling up when 14 drug companies received warning letters for online advertising in April 2009 and again at two days of hearings held by the federal agency in November.
If social media and online communications are critical to reaching new customers and correcting misperceptions about a drug or a company, the voice of the pharmaceutical industry should be louder.
Where is the patient who says a Facebook community helped her through an illness or a mobile application taught him to control diabetes? How are companies educating their own legal teams? Are agencies adding lawyers to healthcare practices? And, if companies and agencies are doing this, why aren't they talking about?
While issues ranging from drug safety and lawsuits to pipelines and layoffs understandably take up a bulk of the time and resources of communicators, advocating for a set of guidelines that can help prevent FDA action and add to a customer base should also be given time, resources, and a voice.