Two and a half years ago, the FDA stated that “it was not the medium, it was the message” to sum up its approach to regulating the use of social media in healthcare. While tidy, that approach did not take into account the many nuanced aspects and open questions wrought by social media that are not present when it comes to print and broadcast regulation.
Social media has fundamentally changed communications – so much so that when speaking of communications, we are talking about an entirely different animal than we were just five years ago. The Pew Internet & American Life Project has provided a framework of characteristics that are the hallmarks of this new communications era – today communications must be personal, it must be portable and it must be participatory. The days of being broadcast at and talked to have yielded to days when the masses prefer to get the news they want, in the form they want it, from sources they trust, when they want it and to be able to comment on it and pass it along. Anyone not communicating without taking that into account is operating from a time warp that was five years ago.
Also thanks to observers of the internet such as Pew, we also know that healthcare is one of the primary reasons people use the Web. Some internet sources are third party generated content that talk about medical treatments. Most of it is accurate, some of it is not. But a medical product manufacturer who might be aware of such mistaken content has not guidance as to whether or not they can or should correct such content.
In short, the lack of guidance from the FDA on social media doesn’t just affect the marketing and education by medical product manufacturers but rather, has the potential to cause harm when patients or caregivers rely on third party generated material such as a Wiki, that might be incorrect. It’s not about marketing, it’s about public health.
FDA has struggled for years in attempting to regulate aspects of the Internet, having held its first public meeting in 1996 on the topic, yet not producing any guidance. In late 2009 the agency again held such a meeting with public assurances that production of a guidance was a priority and that the agency was aiming to produce a draft by the end of 2010.
When that deadline was missed, it was slated to come out by the end of the first quarter. When that deadline was missed, the agency produced a bland statement that has become its stock response that only offers an open-ended commitment and restatement that the issue is a “priority”. Lacking is any insight as to the internal process by which such guidance is being developed nor understanding of what the roadblocks have been to timely completion.
Also in 2009, the FDA launched a new and heightened effort at transparency and there has been some success in broadening the concept, though in this case, it has been selectively applied. There is no good reason why we should not have greater transparency in the development of guidances, particularly in cases such as this where the product has been delayed for unknown reasons. And as called for here in the past, the agency should streamline its process and get the support of outside experts through an advisory process that would help it anticipate and understand how the changes in communication affect the consumption of healthcare information by patients and caregivers.