As the year is rapidly coming to a close, many are wondering – where is the FDA on the Internet and Social Media Draft Guidance that was promised? It has been a long time since the FDA first enunciated anything about the regulation of social media (“it’s not the medium, it’s the message) and since the November 2009 public meeting on the topic. Much has changed and people continue to gravitate to social media. Mobile applications have proliferated. The world has changed, the regulation has not.
To be fair, in public statements about the Guidance, DDMAC has always been clear that the end of 2010 was a target and one not necessarily in their control. Still, those in the community of people who care about this thing are reasonably focused on the end of 2010 for the report. And let’s face it, it is an issue that has been up in the air for many years now. So what’s been going on?
One Twitter feed today said that there is a rumor that the date for release is later this week.
While many are highly interested in the content of what is in the draft guidance, there are some important things to remember to keep some perspective on the impact of this document.
- First, it is probably only going to be a partial guidance, addressing a part of the spectrum of questions regarding the Internet and Social Media.
- Second, it is a process, and not an event and this part of the process will involve additional commentary that needs to be digested.
- Third, whatever the document says, it isn’t actually likely to change a heck of a whole lot. Engagement in social media and the Internet by health care stakeholders like medical product manufacturers is increasing because that is where people are and how they are communicating. The draft guidance isn’t going to change that. In some respects, the FDA has waited so long to provide guidance on the Internet, any offering made at this point is reactive to the burgeoning environment, not so much an act to help define it.
As the days tick by and hopes dim for a 2010 release, perhaps the best thing to do is to make sure that you have your holiday shopping list complete, the cards addressed and stamped, the annual letters written and the menu planned. In the end, all of that may be more important….