Novartis is one of a slew of pharmaceutical companies that have submitted comments to the FDA on the appropriate use of social media.  As I have said before, I applaud the effort of any organization willing to step above the noise and offer pragmatic solutions.  Far too many organizations criticize from the sideline without proposing a plan to move forward.  That’s a futile exercise.

(Note: If you’d like to read Novartis’ full comments, John Mack of the Pharma Marketing Blog, has the document posted along with his thoughts)

The Novartis document covers a wide-range of issues, but I would like to cover the two most relevant to the business of moving social media forward.

1.) The Use of Shortened Links and Hashtags

Novartis tackles the space constraints of social media—particularly Twitter—head on by suggesting the use of a “bit.ly for the FDA that points to drug information on an FDA controlled Website.”  The idea is that any time a pharmaceutical company engages on a topic that requires fair-balance and risk information, it could provide an FDA-approved link providing all appropriate risk information.  This would pertain to both branded product communications and disease-state conversations.  Novartis has made an interesting suggestion here.  But the problem of space will remain. What happens when a pharma company would like to direct a patient to an educational site?  This URL, along with the FDA-approved URL, would make space limitations a huge hurdle.  There would be virtually no room remaining for additional text.  Perhaps this idea would be better suited as a solution pertaining only to product communications.  This would ease another major concern I have—that a solution like this would tempt far too many companies into abusing social media and constantly pushing product.  To its credit: Novartis seems to recognize this can’t be the case. On more than one occasion, the company points out that a clear line has to be drawn between social media efforts with the intent to education and those with the intent to promote.  The latter has virtually no place in social media.

In addition, Novartis suggests the use of standard hashtags that would be approved by the FDA.  These hashtags would follow any sanctioned communications coming from the pharmaceutical company.  For example, if a company had a product intended to treat diabetes, each communication would be followed by a tag such as #diabetes.  This is more of a suggestion for the FDA than it is for the pharmaceutical companies.  One of the major questions surrounding the use of social media by healthcare companies is who will assume the burden of monitoring these conversations?  The FDA is clearly concerned that the newfound volume will cripple the organization.  It’s a legitimate concern, and the goal of Novartis’ suggestion seems to be geared toward offering a solution to that end.  Even still, while this suggestion might lessen the burden, it does not eliminate it entirely.  There are far too many treatment options and health conditions to manage under one roof (or hashtag as the case may be).  The suggestion by Novartis acknowledges that without working with the FDA to manage the process, it likely will fail before it starts.

2.) Redefining Adverse Events

If you surveyed ten execs inside of pharmaceutical companies, nine of them would tell you the biggest hurdle they face in getting social media efforts started is how to deal with adverse events.  Right or wrong: this remains a major issue.

In its comments to the FDA, Novartis correctly points out that the AE reporting system was not intended to function in the fluid environment of social media.  The identifiable reporter section of adverse event reporting is particularly sticky when it comes to social media.  How is a pharmaceutical company supposed to decipher identifiable reporters in the anonymous world of social media?  It can be near impossible.  With that in mind, Novartis has proposed a reworking of the AE reporting structure to account for this difficulty.  Essentially, Novartis has suggested an extra layer that would deem a reporter as identifiable only if they can be privately contacted.

Whether or not this type of suggestion is taken seriously by the FDA, Novartis has pinpointed a key problem: you can’t apply outdated systems to new-era communication technologies.  It would be like retro-fitting a 2010 Corvette with the engine of a Chevy Nova—you won’t get very far.

As we continue to sift through the comments made by pharmaceutical companies, the FDA will be tasked with the job of boiling it all down to a succinct recommendation.  I don’t envy their task.  Everyone has an opinion on how this should go.  Inevitably, some people will feel the FDA did its job while others will feel slighted.  But that’s not important.  Currently, we have been working within a self-imposed set of regulations.  The regulatory environment has been so uncertain that marketers have proceeded with extreme caution.  Whatever the guidance will be, at least it will provide some parameters for pharmaceutical companies to evaluate and move forward.

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