Leigh Householder, VP/Managing Director of Innovation Strategy 
Do you remember the episode of the West Wing called “Take out the trash day”? Any stories they had to give the press that they weren’t wild about, they’d give all in a lump on Friday.
Donna: Why do you do it on Friday?
Josh: Because no one reads the paper on Saturday.
The FDA may have made a similar move last week. After years of hubbub about social media guidance, they actually released some during that very quiet, very disconnected last week of December.
Back at our computers today, commentators and brand managers are digging into the draft guidance and talking and typing away about what it means.
The good news: What it means is pretty straight forward
The particular topic they’re tackling is unsolicited requests for off-label information – both those that come directly (think: email) and those that are posted in a public forum (think: message board). The guidance itself is only 12 pages long and full of good examples – definitely worth reading – but, in short, comes down to these 4 things:
- Be specific: Only respond to questions/issues that are clearly about an off-label use for your brand and only include messaging that answers/addresses that issue. (Make sure to identify yourself, too.)
- Be scientific: No marketing or sales messages. And when it gets down to the details, the responder should be a medical or science officer, not the marketing suite.
- Balance public and private: Any public response should just convey that the question pertains to an unapproved or uncleared use of the product and then point the reader to a specific medical or science officer for more info. Everything else: Answer one on one.
- Keep great records: The internet is always changing – you want the definitive record on hand with your brand
NOTE: This guidance only applies to brands that choose to respond. The FDA is not requiring monitoring or response.
The better news: The context around the content is very social savvy.
Reading the guidance, my first take away is: The hearings were worth it. The FDA’s perspective on what brands can and should do online is really progressive – and, it sounds a lot like some of the conversations that happened on the floor of those hearings. The challenge they’re facing, of course, is how to adequately act on it.
A few of the great signposts found in the guidance:
- The FDA believes that brands can be trusted to take on a bigger educational role: “FDA recognizes that firms are capable of responding to requests about their own named products in a truthful, non-misleading, and accurate manner.”
- They know more, direct information is what will most benefit people: “Moreover, because firms usually have robust and current information about their products, it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off label uses of the firm’s products that are made in public forums, especially since other responders may not provide or have access to the most accurate and up-to-date medical product information…”
- They get the unique challenges of the web – especially the social space: “…because product information posted on websites and other public electronic forums is likely to be available to a broad audience and for an indefinite period of time, FDA is concerned that firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information about FDA-regulated medical products to individuals who have not requested such information?
The challenge: The human connection.
We’re going to be talking more here over the next week or so about the guidance – figuring out what, if any, areas there are to ask for further consideration or improvement. The one watchout we see so far is the named speakers. There’s a heavy, heavy emphasis on making sure all responses are scientific in nature – the guidance goes so far as to recommend specific types of authors: “Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments.”
That could create a real challenge for true communication. Will the content be easily understood by average consumers? Can medical and science personnel – who are used to working with healthcare professionals – reliably translate complex concepts into consumable health information? If not, we see new challenges afoot…
