A lot has been said among the community of people who work in medical product communications about the news released here evening before yesterday that the FDA would not be meeting its target for releasing a draft guidance on social media. Here is one more voice to raise a few ideas and thoughts.
First, was it a surprise to anyone to know that there would be delay? The commentary on Twitter made it clear that for many, this news was not a surprise, and indeed, as the days of 2010 ticked down, it seemed to be pretty clear that the target was not going to be met – and whenever anyone from DDMAC talked in public venues about the possible release, it was always accompanied with the caveat that it was a target, but that it was not entirely within the control of those at DDMAC to say for sure that the target would be met. So first – yes, it was not a surprise.
Another line of thought – does it matter? Is regulatory guidance too late to be relevant? It is an interesting notion and speaks to the challenges that are faced by the fast paced nature of the change that has occurred -both with respect to the breadth and the depth to which social media has become enmeshed in the fabric of our communications. Society has not waited for regulatory guidance, and in order to communicate effectively, medical product manufacturers, while more cautious and reticent than other industries – and certainly cautious about things it can and cannot do – has by necessity increasingly embraced social media. This is particularly true on Twitter and Facebook – though the approach has varied widely and many companies still sit on the sidelines or execute ineffective tactics (like not allowing commentary on, or embedding of, videos on a YouTube channel). But there is no getting away from the fact that the FDA’s original approach of “it’s not the medium, it’s the message” does not work because the Internet and social media raise nuanced and distinct situations and questions that cannot be satisfied by the agency’s regulatory approach to print and broadcast media. Those questions still need an answer. So, yes, we do need the guidance.
My third point – but is the guidance process the way to provide that regulatory guidance? The cumbersome nature of guidance development (it took years, for example, for the agency to release a guidance on procedures for the Open Public Comment period of advisory committee meetings) makes it an inappropriate means for proving regulation over media that are changing at the speed of light the fundamental way we communicate. Imagine if a drug had to go through a guidance process to get approved. It would take forever. It used to take drugs 18 months to get approved prior to PDUFA, so the system was changed to accommodate demand for a faster process. There needs to be a faster process for rule making in this regard as well – and perhaps necessitates the FDA putting into place a Communications Advisory Committee to hold AdComms and address regulatory issues around communications the same way it does around products. That, at least, would be faster and more definitive, while still being participatory.
And lastly, a concern about the delay centers on the fact that the agency may now move to provide regulatory parameters by the issuance of NOV and Warning Letters rather than by guidance. In other words, you don’t know you violated a rule because you didn’t know the rule existed (remember the paid search NOV letters). That would be unfortunate as it would have a chilling effect on vital communications, and would likely result in further confusion than enlightenment – again like the 14 letters (See NY Times, April 16, 2009 – FDA Rules on Drug Ads Sow Confusion As Applied to the Web).
Unfortunately, since then little has changed, but it appears we still need the guidance, but we need a better process for getting it.