Ever since RxP submitted citizen petitions to the FDA Wednesday, asking that 6 medical device ads without proper risk information be pulled from YouTube and that the FDA clarify its rules around internet marketing, the web has been abuzz with questions about whether the three devicemakers just missed this, or were trying to push the envelope around social media marketing rules and regs. As of this writing, all three companies – Abbott, Stryker and Medtronic -- have removed the YouTube videos referenced in the petition. On Wednesday, Abbott announced it will “embed safety and risk information in the videos moving forward."
It seems that experts from all corners think that drug and device companies ought to be held to the same rules in the brave new world of social media as they are in more established broadcast forms.
Peter Pitts at DrugWonks put it this way:
“After all, if the medium is the message – and the message is regulated – than the same rules apply. Specifically FDA rules, guidances – and draft guidances. This is not rocket science and pharmaceutical and medical device companies should know this without having to be told...
The Prescription Project (with whom we share almost no common ground) points out that these videos violate federal rules because they don't contain required warnings and disclosures. And they’re right...
Just follow the rules. Social media – indeed all media – must be used responsibly, in compliance, and for the benefit of the public health.”
It may not happen often, but we agree with Pitts.