AstraZeneca Urges FDA to Regulate the Whole and Nothing But the Whole SM Conversation

AstraZeneca (AZ) submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

Again and again throughout its comments to the FDA, AstraZeneca defends the concept that social media conversations by drug companies are just like real world conversations and should be similarly regulated; ie, FDA should consider the whole conversation, not just one part of it.

"It is our view that the FDA, in developing its guidance, should view such participation in a manner analogous to its existing regulation of in person and telephonic promotional activities," said AZ. "In that case, the FDA examines not just one part of the conversation but the entire conversation as a whole."

"It is similarly appropriate for the agency to view a social media conversation as a whole and not regulate each and every 'post' as if it were, in itself, a promotional piece," said AZ in its comments where it cites FDA's draft guidance on risk communication. AZ quoted this precedent from the FDA guidance: "FDA looks not just at specific risk-related statements, but at the net impression – i.e., the message communicated by all elements of the piece as a whole. The purpose of the evaluation is to determine whether the piece as a whole conveys an accurate and nonmisleading impression of the benefits and risks of the promoted product." [FDA's words]

AZ takes this concept to new heights, however, when it attempts to include all sorts of things in the "conversation": "We recommend a framework that understands that a conversation may include text, video, sounds, and other elements that are appropriate to consider together." These elements, says AZ, can appear together or as near as together as the site or format allows.

AZ cites Twitter as an example: "... on Twitter or another micro-blogging site, a sponsor might use multiple, simultaneous 'posts' to convey information on risks and benefits including using links or other reference marks or symbols."

I once posted several tweets one after the other in an attempt to mimic a particular kind of conversation in the real world, ie, Burma-Shave roadside advertisements. You may be too young to remember this outdoor marketing trick. Typically, six consecutive small signs would be posted along the edge of a highway, spaced for sequential reading by passing motorists. The last sign was the name of the product (ie, "Burma-Shave"; see this wikipedia entry.) Here's an example (imagine each of the following phrases on a separate roadside sign separated by 100 feet or so):

That big blue tube


is like Louise


it gives a thrill


with every squeeze


Burma-Shave!

Each sign is part of the "conversation," but looked at in isolation it makes no sense.

BTW, my Twitter experiment was a disaster. No one strung the tweets together to get the entire message. I looked like a complete idiot who did not know how to use Twitter to communicate!