Tunnah’s musings: FDA stays hands on with its social media guidance for pharma

As the FDA finally releases some long awaited 'social media guidance' for pharma, Paul Tunnah explores whether incorporating such new media into existing processes is sufficient, or whether it is the system that needs to change.

Quietly, a few days ago, the FDA released a draft guidance document entitled 'Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics'. It might not be the snappiest title around, but for some folks in digital pharma this is as significant as man first landing on the moon, as it represents the much overdue guidance on how pharmaceutical companies should use social media channels for marketing activities.

In reality, it's not quite so comprehensive. As John Mack points out in a recent piece, it is actually more guidance around how to submit information as part of the postmarketing reporting requirements for initiatives deemed as 'interactive promotional media'. The FDA goes onto define this term more specifically as:

'modern tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, and live podcasts) that firms use to promote their drugs'

(I wonder how much debate was involved in the wording of that sentence!)

The guidance does include some clarification on how pharma should be using social media, as a number of observers, including industry reporter Dominic Tyer, have noted, but I am not going to provide my own such summary as I think there is a much more fundamental issue that this raises.

The submission process itself remains the same and, quite frankly, could become quite burdensome for the industry, given the volume of interactive marketing it is now involved in. In fairness to the FDA, it does accept this and is trying to be pragmatic, stating:

'for some interactive promotional media, submission "at the time of initial dissemination" may pose a challenge for firms, particularly when these media communicate information that is displayed in real time. While "at the time of initial dissemination" does not refer to submissions on a weekly, monthly, or other routine schedule, FDA intends to exercise its enforcement discretion under certain circumstances due to the high volume of information that may be posted within short periods of time using interactive promotional media that allow for real-time communications.'

Even still, given that most online engagement is moving towards having some kind of interactive element, the burden this process creates for both the regulator and the industry is pretty significant. The pace of online engagement is frenetic at the best of times, which also means that campaigns may require multiple resubmissions as they adapt over time.

I cannot help but feel that the current regulatory process is rather analogous to a parent teaching their child to ride a bike, but one that refuses to take their hand off the seat for fear of them falling over. Here, I think the FDA could learn from some of the more social media savvy pharmaceutical companies. Those that are more active in this space do not require lengthy internal approval processes for every tweet, but have defined guidelines around what is acceptable engagement.

So my question to the FDA would be whether it is practical to require a lengthy submission for every interactive media activity as part postmarketing requirements, or better to define some clear rules around what is acceptable, with clear consequences for those who defy this? After all, even without formal upfront submission, it is pretty unlikely any pharma company would get away with breaking the rules.

It might sound a bit radical, but if the end result is less bureaucracy (and therefore cost) for both regulatory bodies and pharmaceutical companies, and more dynamic, constructive engagement between the industry and other healthcare stakeholders then is it not worth exploring? Surely, this would lead to downstream benefit for patients too.

Perhaps it is time for the FDA to take a look at its processes and ask whether they fit the online world we now live in? With the right set of rules laid down, keeping one hand on the bike may not be necessary, as pharma will have the stabilisers it needs to ride the social media roads more freely, which will help it find its own balance in time.

As always, let me know what you think in the comments box below and, until next month, stay well.

About the author:

Paul Tunnah is CEO & Founder of pharmaphorum media, which provides digital content marketing and communications solutions for the pharma sector and also manages the industry leading channel www.pharmaphorum.com, a digital podium for communicating thought leadership and innovation within pharma. For queries he can be reached through the site contact form or on Twitter @pharmaphorum.

Closing thought: Should the FDA step back from regulating social media?