For those of you waiting for FDA to reveal the magical regulations that will unleash the power of healthcare social media – don’t hold your breath.
According to DDMAC Director Thomas Abrams, some social media guidance might be released by the end the year and will address issues related to Internet drug promotion --not how to use specific social media tools like Facebook, YouTube and Twitter
“What we’re going to do is address questions like how to respond to unsolicited requests for information, what’s the corporate responsibility for correcting and monitoring third party sites for misinformation, what’s the corporate accountability for having people post promotional videos and things like that,” Abrams said during a Food and Drug Law Institute conference on enforcement.
And things like that.
In other words, and as predicted, the low hanging fruit.
Since last November’s Part 15 hearing, DDMAC has communicated that efficacy claims must be accompanied by risk information and cast doubt on the concept of a “One-Click Rule.” So much for regulations setting pharma free.
“In an instant all will vanish and we'll be alone once more, in the midst of nothingness!"
-- Waiting for Godot
For more on why industry shouldn’t wait for regulatory holy writ, see here.
