As March progresses, increasing numbers of social media observers, communications professionals and marketers of medical products are left wondering whether or not the FDA will produce the Draft Guidance on the Internet and Social Media by its (second) deadline of the end of the first quarter of 2011 (after the original deadline by end of 2010 was missed). Then one wonders whether or not it matters.
For many years now, the FDA has examined the issue of, first the Internet, and more recently social media, without providing effective guidance other than through the issuance of notice of violation letters for violations that no one knew were violations because there was no guidance. At this point, we do not know when precisely the draft guidance will appear or what it will contain – FDA’s Transparency Initiative is not universal.
The guidance development process, which worked fine in the 1950s, does not work so well when we are talking about a new era of communications – where the hallmark is speed. That is speed not only of the development of new platforms, but their rapid uptake as well. Few foresaw that Twitter, which only began a few years ago, would become such a ubiquitous part of communications and media. And as to what is around the corner and additions to the social media milieu and Internet – who knows?
That is the challenge faced by FDA in developing guidance – what is here today, may not be here tomorrow and what is not here yet, may be fully changing the way we communicate in two years. That is a steep challenge. That said, applying an antiquated process for guidance development does not help the matter. To meet this challenge, the agency will have to aim for enunciating principles over discussing specific platforms, to keep guidance from quickly becoming outdated.
To that end, there is a constant to the Internet and social media that must be addressed by enunciating some specific principles regarding social media and if the draft guidance fails in this respect, then it perhaps fails altogether. That constant is this: the Internet has progressively been a platform that allows for a certain amount of sharing of information. Social media has added a participatory catalyst to the equation that has shifted the balance of power from the communicator to the audience. As people are able to pick up messages, modify them and share them – whether in chat rooms, message boards, via twitter, on a wiki or any other medium. The participatory aspect of communications is a constant. The social media guidance must address that.
A few weeks ago, the brilliant Dr. Berci Mesko posed the question on his ScienceRoll blog – “Can Pharma Companies Edit Wikipedia?” Certainly they are not prohibited by Wikipedia from editing, but there are definitely regulatory considerations. If a Wikipedia entry is giving misinformation about a treatment or device, does it not serve the public health if the entry is corrected? But if a company did so, and someone thereafter edits their correction, are they responsible. Certainly the notion gives many regulatory gatekeepers in pharma companies serious pause.
DDMAC keeps saying that if the companies it regulates stick to the rules already laid out by the agency for print and broadcast, then they won’t get into trouble. That, however, is obviously incomplete advice given that the Internet and social media necessarily raise questions unique to their media that are not present for print and broadcast. That, at a minimum, is what must be addressed by the FDA’s draft social media guidance. Without it, it is hard to see how the guidance will matter.
And, as mentioned in an earlier post, the agency has to meet one other challenge. Guidance development for this type of policy enunciation does not work. A new methodology needs to be applied – the 1950s are over.