Much of the pharmaceutical social media conversation has focused on the need for change from the market tactics of yesteryear.  The argument goes something like this: “agree or disagree, the pharmaceutical industry is one of the most distrusted and its public perception is overwhelmingly negative.  Why?  Fair or unfair, many point the finger at the barrage of DTC ads as a sore point.”  Using that logic, the strategy tends to be something to the effect of “change everything.”

It’s not all wrong.  I for one have been a proponent of pharmaceutical social media as a step in the evolution of the industry’s marketing.  No doubt, the pharmaceutical marketing has been evolving over the years to fit better with a business less focused on blockbuster drugs and mass markets and more concerned with areas of high unmet needs and building relationships.  So by all means, move forward with radical changes to the way you form marketing strategy, but don’t disregard your past entirely—you might miss a crucial lesson.

Today, Wendy Blackburn from InTouch Solutions reposted an article that she authored (originally ran in Med Ad News) focused on how pharmaceutical companies can take a more customer-centric approach to marketing (similar to my Return on Health concept).  Within that post, Wendy briefly mentions an interesting point: “patient support call centers have been around a long time. What’s so difficult about duplicating that experience online? Why not empower a corporate spokesperson to speak online on behalf of your company and your brand?”

This is an example I’ve used on occasion before: if pharmaceutical companies can trust call center employees to handle patient support functions, why can’t they replicate that process for an online team?  There are really only two (honest) answers to this question.  The first is that online platforms expose the companies to added risk and exposure to the FDA.  The issues are the same as what might be handled in a call center but when dealt with in a public manner, the feeling is that companies are being watched.  Call centers don’t face that challenge.  Second is a problem of scale.  Call centers provide a finite and defined environment.  The company can control (to some extent) the calls it takes in a day, the hours it receives calls and the process for responding.  The real-time nature of the Web makes this level of control impossible.  That’s really about it: too much scrutiny and not enough resources.

Yet, people tend to ignore examples of the past even if they have worked.  Call centers have worked in the pharmaceutical industry for the most part.  So here is what it comes down to: do you trust your call center employees more than your communications manager?

Of course, this level of content creation takes a commitment to social media that many companies might not yet be willing to make.  Who can blame them?  In addition to appointing some individual to monitor and respond to social media conversations, you now need to create engaging content within the boundaries of FDA regulations.  A significant time sink indeed, but one well worth the investment if done properly.

But in thinking about the topic, it occurred to me that this outlook on the involvement of pharma companies in social media is far too narrow.  Sure, it is easy for a pharmaceutical company to serve as an information broker.  But what about their role as a creator or energizer of patient support groups?  Is it even appropriate for healthcare companies to step into this area?

I realize this is not an entirely new concept.  Some companies have already done a solid job of connecting patients around  disease states.  But by and large, this is an area that pharmaceutical companies tend to steer clear of for a variety of reasons.  For starters, there is often an active and engaging online support group established.  Why disrupt the status quo?  In addition, pharmaceutical marketers have long had trouble defining their customer.  Ultimately, the patient is overlooked in favor of efforts directed at doctors, insurance providers, etc…

That needs to change.  For pharmaceutical companies to have any measure of success in social media it needs to focus on Return on Health and the patient.  This patient-centric view leads me to believe that a large part of pharmaceutical social media efforts in the past will be about creating and energizing patient support groups online.

Right now, healthcare companies are best suited to dispense information. In the future, they would have a better grasp on their patients and be best suited to provide a platform for support.

Forget about extending your brand, getting more prescriptions and enhancing your reputation (all of which will come by the way).  This is about providing a much-needed outlet to an often underserviced community.

Will FDA guidance cause pharma to jump into social media head first?

The time for presentations and comments to the FDA on the use of social media by pharmaceutical companies has come and gone.  The FDA now has the not-so-enviable task of sifting through those comments and putting out some form of coherent social media guidance.

It’s a long road and nobody can accurately predict when that guidance will come.  Yet, hordes of people wait anxiously for the FDA to “rule” on the matter.  The pent up anticipation seems to indicate that with one wave of the wand the FDA will magically deem social media the pharmaceutical industry’s play pen.  The indication is that the FDA’s silence on the matter to this point is the only remaining hurdle to social media adoption by healthcare companies.  It is not.  Plenty of hurdles and landmines remain.

By issuing guidance, the FDA will not suddenly unleash a stampede of pharmaceutical companies that were waiting for the flood gates to open.  The participation of pharmaceutical companies will still be a slow trickle.  Why?

Number one: nobody is quite certain what the FDA will say on the matter.  It is quite possible that any guidance issued will be so limiting it will make social media engagement even more challenging that it already is today.  That possibility is slim though, as the FDA’s silence to date has acted as a repellant to any would-be social media efforts.

Number two: regulatory and legal hurdles will still exist.  You can bet that whatever guidance is issued by the FDA it will not encourage a free-for-all—nor should it.  This means that pharmaceutical companies will still have to operate within a controlled and sanctioned environment.  The practical implication of this is that the regulatory department inside pharmaceutical companies remains the biggest roadblocks to an engagement getting off the ground.  They will still harbor concerns and express a reluctance to move forward.  It is the job of the social media advocate/evangelist/expert/wingnut to understand those concerns.  The regulatory people should be folded into the process early and often.  Embrace them; don’t keep them at arm’s length.

Number three: I am still not convinced that the lack of FDA guidance is the biggest roadblock on the path to social media bliss for pharmaceutical companies.  Similar trajectories have unfolded in other industries (albeit, not regulated ones).  For example, B2B technology companies have been slow to adopt social media.  The reason is a mix of a corporate culture that has yet to embrace it and a lack of clear understanding of where the B2B audience is online.  This same dynamic holds true for pharmaceutical companies.  In order to move forward with social media engagement strategies, a significant shift in thinking is required.

This list could probably extend on for another 1,000 words and still not encompass the litany of challenges that exist.  The point of this is not to dash the optimism many feel about the FDA’s pending guidance.  I too am optimistic that this will help nudge some apprehensive companies off the sidelines.  Call me cynical (I prefer realistic or pragmatic): I simply don’t think the FDA’s guidance on social media will create explosive growth.  Instead, I think it will help to sustain the steady growth path already in progress.

(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.

Don't let your social media strategy go up in flames.

Nobody ever said social media was easy.  sanofi-aventis is learning that lesson the hard way as its Facebook page has been the target of an onslaught of negative commentary from a patient named Shirley. 

Before I go any further with this post, let me first point out that I am passing no judgment on Shirley and what she has gone through nor am I condemning sanofi-aventis.  I fully realize that there is a heaping pile of information that very few people have access to in this case.  So again, this is not about criticizing Shirley’s actions; it is about evaluating what we can learn from this situation as outside observers.

First a quick synopsis: basically, Shirley is contending she was deceived about the side effects of cancer drug Taxotere—which she claims is responsible for permanent hair loss.  She goes on to indicate that after numerous efforts to get in touch with sanofi-aventis through traditional channels, she has taken her quest to social media channels.  If that is in fact the case, then sanofi-aventis has a bigger problem on its hands—a fatally flawed customer relationship management process.  Keep in mind, people don’t geenrally turn to social media as a first-line venting platform but your efforts on social media can bear the brunt of failures in other parts of your company.    

In this case, the target of her attacks has been the sanofi-aventis VOICES Facebook page (after posting it to a fake sanofi-aventis page that tipped its hand by botching the proper company branding—another post for another day).  She has also seemingly recruited her friends and family to join in the cause.

To sum it up: Shirley has hijacked a Facebook page to air her discontent with the adverse effects of a cancer treatment.  Pharma social media folks: we have a problem.

Given the situation that sanofi-aventis has found itself in, what can it do to course correct?  More importantly, how could it have better planned for such a social media calamity?

It is easy to point the finger at sanofi-aventis without understanding the dynamics of Facebook. Facebook itself has no advanced moderation functionality (again, a post for another day) if it is set up as an open group.  This means companies setting up a presence on Facebook as an open group are provided two options: allow open commentary or disable the feature entirely.  For some industries, that’s an easy decision, but for pharmaceutical companies the question is enormously difficult.  sanofi-aventis is not the only pharmaceutical company to allow open and un-moderated comments on its wall.  Johnson and Johnson has done the same and has weathered the storm during recent negative publicity events such as the Tylenol recall and a round of layoffs.  But this is different.  This involves the worst fears of every opponent of pharmaceutical social media—adverse events. 

So was this preventable?  Could sanofi-aventis have designed a social media strategy that would have prevented the firestorm that occurred?  Here again I feel it is worth mentioning I am not suggesting sanofi-aventis should have covered up Shirley’s claims.  Rather, I am suggesting that with better planning, those claims could have been directed to the right department and aired in the right forum.  I have been sitting on this since the news first broke, racking my brain to pinpoint where it went wrong and figure out how to prevent future missteps.  While I do think there were missteps, I’m not sure it was entirely preventable.  sanofi-aventis made the decision to allow un-moderated content.  Short of completely disabling conversation—this situation was not preventable.  However, sanofi-aventis could have taken some precautionary measures to mitigate its risk.  The other options with these types of groups would be to make them entirely closed off and not viewable by the outside world.  This allows only members to comment and see the content.  The group is not even searchable on this setting.  There is an in between that allows the administrator to approve all members, but the content is still viewable by all.   

Instead of preventing this from happening, what could sanofi-aventis have done differently to keep it under control?  First, there is some benefit to limiting the hours during which comments are permitted on Facebook.  For example, you can lock down the wall during the hours when there is no employee available to monitor commentary.  At least this allows a company to prevent inappropriate comments during off hours.  If they occur during office hours, they can be handled accordingly and directed to the right channels.  Of course, this does not prevent the situation, but would help to mitigate the risk.  In evaluating what happened here, most of the comments came during office hours.  It begs the question: what took so long to shut the wall down?  You can forgive one, but after the second comment, the wall should have been shut down entirely until further notice.  Now you have to be careful here.  It could certainly appear as though you are attempting to cover up information.  People that work in the pharmaceutical industry know that there are far too many risks associated with having a discussion like this in a public forum.  Upon shutting down the wall, sanofi-aventis could consider posting a message to the wall that indicates why the wall was shut down, that the compliant was being handled through appropriate channels and that once resolved it would be opened back up for discussion.  In doing so, you would effectively acknowledge the situation and not hide from it, but allow it to be handled in an appropriate manner.  

Another apparent misstep in this process was that there are no terms and conditions posted on the Facebook page of sanofi-aventis.  While this would not automatically prevent a user from posting negative comments, it would at least lay the ground work for the actions that would follow and would set a standard for all users to abide by.  It should also point patients to the easiest way to report adverse events.   

Finally, sanofi-aventis seems to be caught off guard by this situation.  It shouldn’t be.  Any company opening itself up to the risks associated with social media should have a crisis communications policy in place.  This policy should have pre-approved language that any approved administrator can use to handle an adverse event report, off-label usage discussion, etc…While you can never be prepared for every circumstance that develops, you can certainly put the pieces in place to act quickly and decisively.  

What this recent social media challenge has demonstrated is what most social media advocates have known all along—it’s difficult and there are risks.  That’s why as agencies we need to stop overpromising, neglecting strategy and following the shiny object.  There are risks associated with social media and no program will go flawlessly—but your response to challenges will say as much as your initial foray.  How will you respond?

Today, the PhRMA turned up the pressure on the FDA by putting a bit of marketing muscle behind its FDA comments. Knowing full well that few people would take the time to read the entire 16-page document that makes up the PhRMA’s comments to the FDA, the organization issued a statement containing only the highlights.

As expected, the statement built the case on why social media is an important tool for pharmaceutical companies.  The PhRMA highlighted that more patients than ever before are going online to access health information and healthcare companies have a responsibility to ensure that information is timely and accurate.

From there, the PhRMA took an interesting approach to forcing the FDA’s hand.  They went with what I will call the “if you can do it why can’t we” approach.

Behold: “What’s more, the Agency should avoid chilling manufacturers’ responsible communication about their medical products and should permit them to take full advantage of the same technologies that the FDA and the White House use – including blogs, video, search and such social networking sites as Twitter™ – to communicate important health information directly to patients and their doctors.”

That’s fairly strong language for an organization that tends to tilt toward the conservative when it comes to messaging.  There are a number of sections in the PhRMA’s public comments to the FDA that read very similar.  Bravo!  They are dead on when it comes to this topic.  The FDA has demonstrated through its actions that it sees the value provided by social media in communicating information to doctors, patients and other relevant healthcare audiences.  The PhRMA is just conveniently pointing that out.

Pharmaceutical companies engaging in social media should do so only if they have more value to add to the community than they extract.  They should not be there solely to push product and should focus on the Return on Health of the patient.  This means a commitment to creating better health outcomes for patients by providing more access to information.  The PhRMA is not-so-subtly driving this message home and attempting to place added pressure on the FDA. I for one hope it works!

And while I did gather data for this post, my survey of healthcare Twitter accounts will be less focused on the analytical side and more focused on pulling out some general observations and putting them in the context of helping to move the industry forward.  Plus, I can’t put together graphs that are nearly as sharp as the ones Silja put together.

For my research, I relied mostly on Jonathan Richman’s unbelievably helpful Pharma and Healthcare Social Media Wiki to identify as many healthcare Twitter accounts as possible.  For the purposes of this post, I evaluated 39 Twitter accounts.  After pouring through the data, Tweets and usage, I was able to boil it down to a five key lessons:

1.)    People Care: The average number of followers for a Twitter account in my sample size was 1,290.  That’s a pretty healthy number when you consider that pharma accounts only followed 421 people back on average and had an average total Tweets number of 57.  The follow-back rate of 31 percent and infrequent Tweets does not warrant the hefty followers number that pharma has garnered.  So why the high number?  People care.  It’s certainly debatable what types of people are currently following the Twitter accounts of life sciences companies (marketers, social media advocates, journalists, etc…).  But it’s hard to question that there is a genuine interest in the foray of pharmaceutical companies into social media.  Take the Bristol-Myers Squibb Twitter account for example.  BMS has established a presence on Twitter with a corporate handle, but has yet to send out a single Tweet or follow a single user.  Despite that, 642 people have followed BMS based on the mere fact that it has set up shop in Twitter land.  People care—pharma just need to demonstrate it does as well.

2.)    Lots of Back Patting: It’s no secret that pharmaceutical companies are entering uncharted waters when engaging on Twitter.  This lack of familiarity is only compounded by the fact that regulatory challenges make the water excessively choppy.  The response from pharmaceutical companies has been to skew so far in the other direction that the value of their content is diminished.  Paralyzed by a fear of interacting with patients, encountering adverse events or mentioning a brand, healthcare companies have tended to stick to promoting “safe” content such as company press releases.  There is nothing wrong with directing people to your company news page on occasion, but the problem is that for many companies, this represents the majority of their Twitter account.  You should offer something of value on Twitter that is unique to that user group—not something that can be found by scouring the wires.

3.)    Single-Use Accounts Gain Ground: Perhaps it’s a product of an excessively fragmented industry, but what I will refer to as “single-use” accounts seem to be gaining in popularity.  What I mean is accounts that are geared toward a specific type of content (SanofiTV), or were established as a result of a specific event (McNeil Recall) or serve a single function (AZHelps).  This is not to say that single-use accounts are ill advised.  Quite the contrary.  If used properly, single-use accounts can have a very positive impact.  However, there is a danger with relying on single-use accounts for your foray into social media.  There is a potential to treat social media more as a campaign than a sustained engagement.  Social media requires a sustained effort to add more value to the community than you extract.  That’s tough to achieve if people know you are only there for a single purpose or for a defined period of time.  However, uses like the McNeil Recall example and AZHelps are good examples of companies acknowledging the unique platform provided by social media in being able to directly engage with the patient.

4.)    Corporate Accounts without Human Identity or Interaction: The large majority of healthcare Twitter accounts lack any type of personal identity.  This misses an opportunity to bring a human element to the brand.  Is it a coincidence that two of the best examples of pharmaceutical companies on Twitter (Johnson and Johnson and Boehringer) have individuals behind the account?  I tend to doubt it.  Not to mention, the follow-back rates of 44% and 63% of J&J and Boehringer easily outpace the industry average.  The lesson?  Engagement in social media demands some form of interaction.  When dealing with health, that interaction is almost always of a personal nature.  Without a personal side to your corporate Twitter account, you are missing out on a key benefit of social media.

5.)    This is Just a Test: The infrequency of Tweets and the general tone of the content suggests that most pharmaceutical companies are just testing the social media waters with Twitter.  That’s okay.  While it points to a flawed social media strategy in the short-term, it also maximizes chances of future success.  Why?  Because as I have harped on before, we need social media realists, not purists.  A social media realist understands that in order to gain general acceptance at an organization or within an industry, you have to play by their rules.  That means, taking things slow and proving the model before you fully immerse yourself in the world of social media.

Social media focused on regulatory concerns only does not line up

Those of you that have read this blog more than once know that I have been beating the Return on Health (ROH) mantra lately when it comes to pharmaceutical social media.  The thought is that far too many social media programs start by considering how they will extract value and not how they can add value.

That’s a misaligned process.  Instead, marketers need to start by focusing on the patient with an eye toward how their interactions will enable access to more information and better health outcomes.  That’s the value you bring to the able as a pharma marketer.  That doesn’t mean you ignore your ultimate goal of building a brand that drives more revenue.  But instead of starting off with that at the forefront, you rely on a marketing principle that fosters long-term and authentic engagement.  It’s a significant shift in thinking but one that is critical if social media ever hopes to gain widespread adoption by pharmaceutical companies.

That shift in thinking is needed across the board and includes things like our fixation with adverse events and off-label usage.  I am as guilty as the next guy when it comes to spending an inordinate amount of time thinking about how to handle these very important issues in pharmaceutical marketing.  And we should continue to give careful consideration to where they fit into a social engagement strategy.  Dismissing AEs and off-label usage discussion as non issues demonstrates a clear lack of perspective.  These topics remain at the forefront of every pharmaceutical legal, compliance and regulatory department, and thus should remain a part of our conversation.

But we shouldn’t limit our discussion to solely focus on how to navigate the issues of adverse events and off-label usage in social media.  Why?  Because focusing the conversation in this area relegates the patient to the sidelines.  How many patients know what an adverse event is and even realize they are discussing off-label uses for a particular drug?  I would venture to guess is it a very small minority.  These types of issues, though important, are really geared at how a company can limit its liability with regulatory bodies.  It’s a necessary step and a conversation that needs to occur, but perhaps not at “stage one.”

The better approach would be to work from the patient out.  As pharmaceutical marketers, first ask yourself if there is a concrete reason for you to be engaged in social media.  If the answer is no—stop there.  Go no further.  Starting off the discussion focused on adverse events and off-label usage reverse engineers the process.  It starts with a company-centric point of view and eventually finds its way to the patient.

Successful engagements will start with the patient in mind and incorporate regulatory planning only if the first criterion is met.

First off, let me start off by saying that I applaud the efforts of this group to make a concerted effort to offer solutions. Throughout this public discourse on the use of social media for pharmaceutical companies, there has been a noticeable lack of proposed solutions; replaced instead by unintelligible noise.  This group of five pharmaceutical companies has taken the opportunity to separate itself from the noise and help move the conversation forward.  Bravo!

Take one look at the document submitted by the Social Media Working Group and it is painstakingly clear how complicated of a problem this really is.  Clearly, the individuals that drafted this document went to great lengths to consider every FDA rebuttal before proposing an action plan.  I shudder at the effort it must have required to get this document through the appropriate channels at each company and out the door.  The fact that this document did make it to the final stages speaks volumes as to how seriously the pharma industry takes social media.  In addition, the very measured approach to this document illustrates that marketers view this as a strategic imperative—not a “shiny new object.”

When things like this emerge, it is important that we not only spend time criticizing—but also building off the base that was provided.  For starters, the SMWG makes it clear that its goal in social media is to ensure the accuracy and completeness of information as an authoritative source.  There’s no doubt that pharma’s primary role is as an information broker.  These companies are taking a patient-centric view that is imperative in any social media engagement.  This is a base that all pharma and bitotech companies must have before moving forward with social media.

The letter to the FDA also attempts to tackle possibly the two most difficult issues facing pharmaceutical marketers when it comes to social media: discussion around off-label usage and adverse events.  In my opinion, the trickier of the two issues is how to handle the discussion of off-label usage so we’ll start there.

Off-label usage is a very important part of medical care.  Doctors routinely prescribe medication for uses other than its approved list of indications.  In many cases, this type of prescribing can have a profound impact on a patient’s quality of life.  Naturally, patients are eager to share that type of information online and with communities of people they trust.  But as stipulated by the FDA, pharmaceutical companies are not permitted to promote off-label usage (and with good reason).  That leaves the question, what happens if a pharmaceutical company becomes aware of off-label usage discussion through social media channels?

The SMWG breaks this down into two buckets: sites maintained by the pharma company and those that are not.  The group suggests that on a company’s own site, it should clearly post rules of engaging in conversation (such as no discussion of off-label usage) but anticipate some community members will step out of bounds.  They are right on that part.  The group then suggests that if and when an off-label comment does appear, the pharmaceutical company should quickly notify the community the nature of that discussion is related to off-label discussion and direct the commenter to the right outlet inside the company.

I’m not sure that is viable.  At face value it makes sense.  Responding to the commenter in a public fashion ensures that transparent engagement remains intact and helps to ensure the community sees the pharma company is taking action.  But the speed at which social media spreads is going to make it nearly impossible to contain off-label discussion once it begins to occur.  That one comment is likely to spur another, and another, and another.  You get the picture.  Many of those comments are likely to take place off your own site.  Then what?  If they originated from your site, are you then responsible for every subsequent comment that spread throughout the vast social media landscape?

It’s an impossible task.  Instead, why not hold ALL comments for moderation and reserve the right to not publish those that refer to off-label usage.  You could even respond directly to that commenter offline with the appropriate channel within the company.  This way you still engage with the individual but spare the community of the discussion.  Sure, in a perfect world you wouldn’t have to moderate every comment, but this isn’t a perfect world.  And yes, this does introduce problems of scale, but doesn’t the alternative as well?  Ultimately, pharma companies cannot hope to moderate off-label discussion on a company site without approving comments.

As you can see, I have only begun to scratch the surface of the Social Media Working Group’s response in an attempt to expand on their recommendations.  In the coming days, I’ll dig a bit deeper into other aspects of the document and offer my two cents.

But what about you?  How would you have expanded or changed the document?  What would you add to complete this response to the FDA?