For many months since the FDA's Part 15 Public Meeting on the promotion of FDA-regulated products using the Internet and social media tools, many in the affected community, myself included, have lamented the seeming lack of participation both in the meeting, and as reflected by the submissions of public comment to the docket. No more. Yesterday, the mailbox grew quite full.
Important submissions entered the docket from many sources, including AstraZeneca, the National Organization for Rare Disorders (NORD), Lilly and PhRMA (both of which also participated in the meeting by sending a representative to provide commentary), Medtronic, Pfizer, Abbott, Novartis, Genentech, Sepracor, Merck, and BIO.
One of the more interesting aspects of this development is that the submissions are not only from companies that have been highly active in the social media space, but from those who have very little, if any, footprint of note. That will provide a healthy perspective for the FDA as the agency works to craft a response.
And the inclusion of commentary from the actual companies that are to be regulated by a presumed guidance from FDA gives much more meat to the discussion than the commentary from secondary stakeholders such as bloggers, consultants and communications firms. Without this cloudburst, the end-product would have been reflective of the lack of medical product manufacturer input, and that wouldn't have been good for them, the FDA, or the patients and consumers who are seeking valid information in order to make medical decisions.
Now the FDA finally has something to digest which will hopefully result in a draft guidance that will hopefully, by time it comes out, be relevant. Developments in social media are occurring at such a fast rate, with very fast uptake, that such a task will be quite a challenge. In some ways, the FDA is trying to map the universe by looking at a picture of the stars, even though that image is one of the stars in place as they were eons ago and since the picture, they have moved on and changed the picture. That will be the second order of challenge for the FDA – providing guidance that is broad enough to cover change – and not just be reflective of the social media world as it is – but as it will become, while at the same time, being specific enough to be effective and useful. That will be no small task.
To keep up with developments, frequently visit the site set up to track FDA Social Media developments – www.fdasm.com.