FDA -- On Formalizing Review of Pharma's "Social Media" Marketing -- And Already, AstraZeneca May Be "Jumping the Couch", Here. . . .

Whew! A busy Monday for the blog. . . .

I am still digesting the Center for Digital Democracy's call for a formal study, and ultimately, regulatory pronouncements on the now-exploding topic -- but here it is (H/T Christine Truelove @ PharmaLive) as a 26 page PDF file. Here is the November 2009 FDA agenda, from its hearing -- and an archive of the FDA's webcast. Here is some of the CDD's piece:

. . . .As part of its effort to market Gardasil^®, a cervical cancer vaccine, Merck engaged the Rapp agency to set up a branded Facebook page, Take a Step Against Cervical Cancer, "triggering news feeds and advocating our message. A destination where anyone can find out the facts about cervical cancer and how to prevent it, the page also allows visitors to feel inspired, educated, and empowered to act for themselves and to help others.

A key feature is a virtual wall that visitors can ‘tag’ with a logo and message. It allows each visitor to express their own uniqueness and intent. . . ."

And here are AstraZeneca's quick-draw "principles" on the topic. [AZ's full PDF document.] More in the coming weeks, but this sets up an important new opportunity to sort out how pharma's burgeoning use of nascent social media -- as it matures -- should be filtered through the FDA's existing regulatory overlays on communicating with patients and doctors for promotion, advertising and labeling purposes. Of course, front and center is the question of timely communication of appropriate and meaningful risk disclosures. Earlier background here, here and here.

Stay tuned.