I crammed a lot into that title. But here is the skinny. A few weeks ago, FDA issued some new guidances around social media. This week, (yesterday) an untitled letter was posted about a sponsored link – the subject matter of one of the guidances. More on that later.
Next week I am providing a free Webinar on social media and FDA which includes, among other things, my take on the most recent guidance documents. But overall, we will look at the fact that it has been a five year wait to get an answer to five questions. Has it been worth the wait?
A few years back, FDA issued a guidance that merely mentioned social media that ended up creating headiness that the agency had issued social media guidelines, when in fact, that was not the case. Subsequently, there have been other guidances. There have also been a few warning letters. And recently there were two more substantive guidances issued by the agency.
- What, in its totality, does it all mean?
- Which of the five questions now has answers and what are we still waiting for?
- What do we know now that we didn’t know before?
- Will it change anything?
- What difference does it make for those in the pharma industry responsible for communications?
I provided some insight in a prior blog post about the two most recent guidances and I also gave some thoughts in an interview for Pharmalot. On July 17 at 12 noon EST, I am going to provide a comprehensive Webinar on the regulation of social media by FDA – where we’ve been and where we are. I hope you will join me! You can register by clicking here.