When it comes to communications, the environment has been fast, the FDA – slow.
A few months ago I talked about a few of the potentially game changing implications of some relatively new platforms – Meerkat and Periscope, which allow for a person to live stream video and to reach large audiences doing so.
The emergence of live-streaming characterizes the times in which we live, from a communications perspective. New platforms come onto the scene – many disappear, though that doesn’t mean that they don’t present some serious strategic challenges, particularly from a regulatory/legal point of view (remember Sidewiki?).
FDA took into account the rapid velocity of change when it considered its approach to providing regulatory guidance (albeit limited) given the emergence of digital media in that the agency did not seek to address platform-specific circumstances.
Rather, FDA sought to enunciate principles for operating within the digital environment that could be applied across media. So the guidance regarding use of platforms with character space limitations is called exactly that – and not the “Guidance on Twitter”. That guidance, in particular, addresses what not only what is obviously Twitter but also talks about creating ads where there is limited space.
However in reading it, one would be hard pressed to entirely understand FDA’s thinking with regard to optimizing a web site for mobile. (See “Regulatory Considerations in Optimizing a Site for Mobile” – June 3, 2015) Not having such guidance is more than an inconvenience, mobile access is the primary means for accessing the internet for many people who are seeking health information.
While the agency considered changing platforms when devising the actual guidance itself, FDA did not take into account the rapid shifts when it considered its process for providing guidance.
What little guidance has been provided has never addressed the full scope of questions raised in the public meeting of November 2009 and in the end has probably not changed the status quo much. Manufacturers were concerned about a branded approach to Twitter before the guidance documents were issued and continue to be afterwards. There was a risk associated with correcting misinformation before the guidance on that topic and there is risk associated with it after.
As stated here many times, when it comes to digital media, the world has had to move on without FDA in many respects. The agency has developed its own assets, but has been mum about how it will proceed with regulation in this area and when – a silence that does not serve any visible good purpose.
It is way past time for FDA to take a more engaged approach and develop a Communications Advisory Committee to support its thinking in this space. Such a committee could meet four times a year to consider changes to the social media scene, such as Meerkat and Periscope, as well as unfinished business – such as providing guidance on how companies should go about optimizing their websites for mobile. A communications advisory committee would also add something that has been lacking up until now to the process – transparency. And it would allow for the agency to consider changes in platforms, strategic questions and get input from both industry and patients on an on-going basis. In short, it would be a vast improvement over the existing system of the sporadic issuance of incomplete guidance documents, an opaque process, and the lack of regulatory enforcement to help define the environment.