It's no secret the pharmaceutical industry lags way behind other sectors when it comes to leveraging social media to meet business objectives. A big reason for this has long been a lack of clear guidelines from FDA.
This month FDA released its draft guidance on the use of "Interactive Promotional Media,"1 ending several years of speculation and finally providing the industry with substantial guidance on its use of digital media. Though this draft guidance document is currently being distributed for comment only, for the first time it sets out a clear position on tools and technologies that allow for real-time communications and interactions, which includes social media.
In the new guidelines, FDA explains that pharma firms should identify the parts of websites that are interactive and allow for real-time communications, in addition to describing its communications within these third-party sites. On a monthly basis, marketers will also need to submit a Form FDA 2253 or Form FDA 2301 for websites that include interactive or real-time communications. To facilitate the submission process, FDA will allow multiple sites and the corresponding documents within a single form — a stark departure from its policies governing static promotional pieces.
FDA will be accepting comments and suggestions on these draft guidelines for the next 90 days. As of July 9, FDA is mandated to release final guidance "regarding Internet promotion, including social media, of medical products regulated by FDA" as per the Food and Drug Administration Safety and Innovation Act (FDASIA) that was signed into law in 2012. This means that, as of this summer, pharma will finally have a clear and official set of guidelines from FDA regarding the medium.
According to a recent Pew Internet study, as of September of last year, 73% of online adults use social networking sites. As of 2012, close to three-quarters of Fortune 500 companies were active on Twitter, with more than 80% of executives at these firms believing social media engagement actually led to increased sales. Across industries, an astounding 93% of marketers report they use social media for business.
Despite years of exposure and ample case studies of success from other sectors, however, most pharma companies don't currently have much of a social media strategy and the vast majority enjoys a rudimentary presence at best. To drive home this fact, in a recent survey more than 90% of 88 executives representing big Pharma firms said "no" when asked: Does your company engage potential or current customers via social media?
By and large, pharma companies have been extremely conservative in their approach to social media. In addition to a lack of clear FDA guidelines, many firms have kept the medium at arm's length due to compliance concerns related to Adverse Event reporting and potential off-label discussion between reps and patients taking place in a public forum.
|Learn more about topics like this one at
The most compelling and comprehensive
marketing meeting for life sciences professionals.
MAY 8-9, NEW YORK, NY
On the face of it, pharma is not alone in being heavily regulated. Indeed, any industry that faces regulation of its communications must ensure that its use of social media is compliant.
In pharma there has long been an underlying and troubling belief that the absence of social media activity voids potential responsibility for user-generated content relating to adverse events. This has resulted in the industry taking a "see no evil, hear no evil" approach to social media monitoring in which it essentially ducks its head in the sand. Recent trends suggest, however, that this attitude may soon be nearing its sell-by date.
Relative to the US, in the EU pharma companies, in collaboration with regulators, are making greater efforts to leverage social media to monitor adverse events. More specifically, the Innovative Medicines Initiative (IMI) has been created in the aim to build electronic reporting platforms and mobile apps to enable patient reporting of adverse events to regulatory authorities themselves.
When reviewed in its entirety, it's not difficult to conclude that compliance issues alone fail to explain fully pharma's disdain for the medium. If nothing else, a significant reason for the industry's hands-off approach most likely stems from pervasive skepticism of the channel's overall benefit for an industry that generally does not usually have direct relationships with its end-customers.
Pharma must accept the fact the relationship it enjoys with its customers doesn't take place in a vacuum. Its customers bring a high level of service expectations based on these other non-pharma interactions. And let's face it, consumers are talking about pharma companies whether they are using social media or not. And believe it or not, pharma's customers actually want pharma to play a bigger role in social media-sphere. As proof, Manhattan Research recently reported that 42% of online consumers think pharma companies should be involved in online health communities.
Now that social media guidelines are falling into place, in coming months we can probably expect to see a growing shift in mentality across the industry as firms recalibrate their marketing strategy to include a social component. Due to heavy regulations and ever-present compliance concerns, of course, jumping on the social media bandwagon will still require a measured and deliberate approach. But it will require an approach nevertheless.
Because promotional messaging is highly regulated by FDA, social media engagement will require a scripted and automated response from pharma to ensure communication is compliant, supported by human interaction to deal with events that fall outside of the system's parameters. For pharma marketers, the good news is recent advances in social media monitoring make it possible to listen to or engage with patients on social media websites and set up automated systems that can route potential adverse event to proper channels with a high degree of accuracy.
In other industries, a high proportion of all social media engagements are already automated. Some companies have even reported automating up to 80% of their social media interactions — and there is no reason why this cannot be replicated in pharma, making it possible for the industry to communicate with patients in a manner that is 100% compliant. Now, of course, 80% as a benchmark may seem arbitrarily high, but in a heavily regulated and compliance-driven industry like pharma, it may be exactly what the doctor ordered.
Regarding the creation and approval of content, as a general trend both FDA and pharma companies are slowly becoming accustomed to the approval and use of digital media, with a movement toward modularization of content align and business rules. Social media will require a similar approach.
Pharma companies now need to rethink how content is produced, submitted, disseminated, stored and archived. This will require building new processes for brand marketers, creative agencies, technology vendors and others stakeholders that make up the content ecosystem. At the same time, given the present dearth of social media experience in the industry, some fresh talent from outside will undoubtedly need to be added to the mix to help the industry get up to speed quickly.
1. FDA, Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, January 2014.
Rio Longacre is a Managing Consultant; he can be reached at firstname.lastname@example.org
; David Mun is a Consultant; and Timothy Moore is a Vice President, all at Capgemini Consulting Life Sciences.