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The Limits of Manufacturer Accountability in Social Media

In its call for public comments on the promotion of regulated medical products using the internet and social media, the FDA sparked renewed interest in the role the agency's guidelines might play in pharma's embrace or avoidance of social media.  While many manufacturers have moved forward with innovative programs (See the Pharma and Healthcare Social Media Wiki) there are still organizations unsure or simply unwilling to engage online in an uncertain regulatory environment.

It's easy for some to accept that fear and hesitancy are warranted when billion dollar blockbuster drug franchises and patient safety are at stake.  Yet, those of us who believe the power of the social web can improve both the bottom line and the public good will continue to push pharma to engage more openly and effectively online.  As an example, Digital Pharma Europe is being hosted by Bayer Schering Pharma in Berlin this week.  While I cannot attend in person, I will follow along via twitter (use #digpharm) and am encouraged by the fact that Bayer, among others, is taking social media seriously in Europe.   Joining with Bayer in their respective comments to the FDA, manufacturers demonstrated they can come together to provide a near unanimous opinion on issues relating to the use of social media (See our summary of PhRMA comments here).

When it comes to defining what they should be held accountable for online, PhRMA, Abbot Labs, AstraZeneca, Bayer, Eli Lilly, Genentech, Johnson & Johnson, Novartis, Pfizer, Sanofi-Aventis, and Sepracor seek to limit accountability to content that is company owned and controlled.  Novartis proposes that companies “should only be held accountable for those online communications which they directly own or control", while Pfizer distinguishes between company-controlled web properties and company-controlled content, saying that “statements by unregulated persons on manufacturer-hosted (or -supported) online forums are not statements by the manufacturers themselves.”

If the FDA adopted these recommendations today, would manufacturers more fully embrace social media?  One would hope so, but in the absence of formal guidance, manufacturers still hesitate to engage openly with patients and providers alike.  Behind closed walls on manufacturer sponsored or controlled private sites for patients and providers, some allow real conversations to take place.  However, on the public sites they control, such as branded and unbranded Facebook pages, most manufacturers restrict commenting and often disable posting all together.  If patients and providers can't engage the brand or company in an open conversation online because the manufacturer fears being held accountable for their statements, how much value does a presence on Facebook really provide?  Clearly, we need to encourage more open, engaging and credible conversations in these settings.  Without such an approach, we will continue to see manufacturers stumble in their social media efforts, as recent events illustrate.

As many of us have discussed over the past week, Sanofi-Aventis came under fire recently for not reacting quickly to a social media communications backlash.  It started when they failed to display a guideline for posting on their VOICES Facebook page and garnered interest when they overreacted by shutting down comments as word spread of the situation.   Following a swift reaction from the social media community, Sanofi subsequently posted a disclaimer on the Voices page that states, "This page is not intended as a forum for discussing sanofi-aventis’ or other companies products including the reporting of side effects associated with the use of prescription drugs. As such, postings that contain product discussions may be removed by sanofi-aventis."

The confusion around accountability and responsiveness expressed by Sanofi's actions is widely shared throughout the industry.   In addition to reporting on Sanofi's social media backlash last week, John Mack critiqued the official Pfizer Facebook page for its own confusing approach towards comment and video sharing policies.   

AstraZeneca doesn't seem to be taking any chances in its public-facing efforts either.  Although AstraZeneca sponsors private discussions among HCPs on GI Circle, there are no comments or open discussions on their officially-branded Facebook page even though the page clearly states that comments are allowed.  AstraZeneca does provide for moderated discussion on their branded Nexium page.  While AstraZeneca won't let visitors post to the Nexium page wall  or comment on its posts, they do take a step forward by allowing moderated discussions in a specified area.  However, in the Nexium discussion area, all posts are reviewed before they are displayed on the page.  Unfortunately, this results in a disjointed and limited conversation that first requires the user to allow a third party application access to their profile before they can even see or comment on the post.  In the era of the real-time social web, we need to encourage more seamless and open conversations if we want true engagement (I'll share more on the subject of "real-time" conversations in my next post).

As these examples clearly illustrate, while manufacturers are beginning to participate in various forms of social media their fears or confusion around accountability hinder their effectiveness in more open and public domains.  To erase the confusion around accountability, we believe companies should be held responsible for content according to the "3 C's Rule" for pharma marketing offered by Rohit Bhargava of Oglivy.  Rohit's model is clear and concise: if a piece of content was created, collaborated on, or compensated for by a marketer, then they are accountable for it.  Companies should not be accountable, as Pfizer recommends, for the statements of individuals who post on manufacturer-controlled sites (with two exceptions: companies should take care to monitor their sites for off label comments and remove them, and also report any adverse event cases submitted by an identifiable reporter).

In the absence of FDA guidance, manufacturers should come together once again and agree to a common framework for accountability.  They should announce their adherence to such an approach so all interested parties, including the FDA, take notice.  In addition to following the 3C's Rule, manufacturers should overcome their hesitancy and embrace real-time conversations whenever appropriate.  This means that manufacturers should allow posting and commenting on public sites with the proper structure in place to support it.  This structure would include clear public guidelines and sufficient resources to monitor and respond in a timely fashion.  On any site a manufacturer is accountable for, their posting policy should state:

1. That inappropriate content will be removed from the site and provide easy to understand examples of what is not appropriate (i.e, define what an off label discussion is).
2. If comments must be moderated due to explicit regulatory concerns, then state how long the review and approval process will take.  Then stick to your stated timing.
3. How to submit negative side effects (via direct link) or to speak online with a customer service representative.
4. Any party working for or affiliated with the manufacturer will disclose their identity and affiliation when posting on the site.

A clear framework on accountability and well-disclosed commenting policies are essential for pharmaceutical manufacturers to engage their intended audience more effectively and with less cause for confusion.   Manufacturers can continue to hide behind their fear, or they can come together and work with organizations such as Ozmosis to define the right approach to engaging patients and providers online.

Joel Selzer
Co-founder & CEO, Ozmosis

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