Unlocking That Social-Media Policy

DRAFT, November 19, 2009

By Kevin H. Nalty, Kevin@naltsconsulting.com

www.NaltsConsulting.com

This article is written to inform pharmaceutical manufacturers about some of the key elements of a social-media policy, and help guide employees through the development

of a company-specific policy. It is written based on the author’s experience with various pharmaceutical companies and how they’ve approached the medium, but does not constitute legal or FDA advice. Individual manufacturers will ultimately need input from various disciplines, and make choices base on their legal and regulatory policies

and risk threshold.

Leaders at nearly every pharmaceutical company are in a flurry of meetings about social media, but few have developed private or public policies on such emerging “conversational” mediums as Facebook, YouTube, Google’s SideWiki, Wikipedia or Twitter. Like students cramming for an exam, the industry became somewhat obsessed with social media in preparation for November’s FDA public hearing and a spring deadline for docket submissions.

The uneventful hearing in November made two things abundantly clear. First, there is no shortage of interest, insight and information being disseminated passionately by pharmaceutical companies, other healthcare providers, and consultants and agencies. Second, waiting for the FDA to provide guidance would be as useful as holding one’s breath while driving through the Lærdal-Aurland tunnel. Perhaps an FDA guidance on social media will remain, like electronic medical records or mobile advertising, an elusive promise that is perpetually just “one year away.”

Another good reason not to wait for a DDMAC handbook to social media – besides from obvious customer, legal and business needs – is that FDA laws are just one ingredient in a pharmaceutical company’s social-media policy. A manufacturer’s guidelines shaped strictly by FDA laws would be as complete as a holiday fruitcake containing only flower. And there is no shortage of social-media policies we can

leverage today, just like there are plenty enough fruitcakes in “re-gift circulation.” So manufacturers would be wise not to bake their own from scratch.

A manufacturer engaging in social media based on FDA requirements is like trying to get into Heaven by driving the speed limit. There are social-media unwritten rules that, when broken, can be more damaging to a manufacturer’s reputation as an FDA letter or scandalous Wall Street Journal article.

Like a child bound eternally to parental approval, we have become unhealthily dependent on a government agency that understands less than we do about the true dynamics of emerging media. At a recent pharmaceutical conference I proposed manufacturers use our collective knowledge and consciences to develop our own policies, as manufacturers and those in their service. I saw several audience members tilt their head like a hopeless dog, convinced by steady conditioning that an invisible electronic fence would provide the boundaries.

The FDA uses Twitter, but has not provided guidance on how pharmaceutical firms can use emerging social-media channel. “There are no guidelines for corporations like Pfizer and what we can and cannot do in social media. And that’s a problem” said Ray Kerins, Pfizer’s VP Worldwide Communications. “We may never have Twitter pages for products without proper guidance,” Kerins told attendees of last July’s Social Communications & Healthcare conference in New York. Pfizer uses Twitter to disseminate company news at Pfizer_News. The results from a Pharma Marketing News “social media readiness” survey suggest that Pfizer’s frustration is not unique.

As a result, manufacturers have proceeded with caution in social media, or with reckless abandon have avoided the uncomfortable topic completely. I have seen well-intentioned pilots backfire and important tactics postponed continuously. More importantly, I have seen corporations too frightened to monitor the Internet, and I believe that will result in more consequential risks than the ones they hope to avoid. What defendant in court will be granted absolution because they were not aware of a product problem – when it was well documented on the Internet?

That said, without FDA guidelines we have legitimate concerns about legal ramifications, and we are uncertain where our legal or moral obligation to monitor and engage social media begins or ends. So, like our industry did when we saw the frightening arrival of the Internet, many companies have chosen what appears to be the safest approach: rather than collect insights that could be used by litigators, we wait.

But do we have that luxury? Put aside the growing damage to our industry’s reputation as we cede public opinion to those with anti-pharma biases and are unbound by regulations. Instead consider that as you read this, well-intentioned marketers are editing competitors’ Wikipedia entries, covertly hiring “brand ambassadors” to seed unbalanced claims, and desperately trying to host social media on pharmaceutical websites (a horrific waste of time for manufacturers).

The understandably frustrated marketer – driven to frustration – is trying to do their job despite regulatory “fog,” and sometimes unaware of damaging implications unrelated to FDA policies. And what marketer is not guilty of diverting budget toward advertising channels that have lost their relevance and impact, but spare them avoid uncomfortable internal meetings or scrutiny?

But good news. The pharmaceutical sector is not the first or last regulated industry to struggle with the nuances of social media. The automotive industry was not eager to read about passenger-side airbags failing to deploy, but eventually developed an approach to monitoring and engaging in social media that placated nervous attorneys and senior executives.

I am not the only pharmaceutical executive to dabble in social media, although I am the only career marketer who also has one of the most-viewed YouTube channels. By keeping one foot in marketing and another emerged in social media, I have gained a unique perspective on what constitutes both safe and productive approaches. I am passionate about how pharmaceutical companies can improve their reputation and commercial relevance via new tools. But sadly the proliferation of articles – about social-media and its criticality to pharmaceutical manufacturers – provide few tips to help a manufacturers develop a social-media policy. While at Merck and Johnson & Johnson, I had the opportunity to inform social-media policies, and I know it can months and years to agree upon one, then communicate it.

So how can company cross-functional teams accelerate the development of initial policies and processes? Each pharmaceutical firm will set specific policies according to their own risk threshold and interpretation of FDA guidelines, but this article can serve as a foundation. I also hope it helps readers appreciate that what may be okay with the FDA may not be appropriate social-media behavior.

A good pharmaceutical social-media policy is brief, clear about roles, and is built on the foundation of existing policies and processes. For instance:

If public affairs is responsible for ongoing media monitoring and outreach, then it is likely already engaging with prominent bloggers (who are often former media writers).

If market research is responsible for data collection, it might oversee ongoing social-media monitoring and analysis. Or this may fit nicely into the ongoing “clipping services” provided by public-relations firms (although many remain naïve about emerging media).

If a medical affairs group is answering product inquiries, it might be accountable to ensure the company’s medications are accurately represented on Wikipedia (which is often the first Google result for a search on a pharmaceutical brand).

Pharmaceutical manufacturers typically address social-media in several stages:

1. First, we have to care about social media, but it is beyond the scope of this article to demonstrate the criticality of social media. Unless a company sees

the opportunity for enhancing reputation and engaging with customers, the residual stages are difficult or impossible to complete.

2. Second, we charge cross-functional teams to debate policies and roles. Disciplines include public relations, legal, medical, regulatory, market research, advertising, marketing and technology groups. Many pharmaceutical firms have formed cross-functional teams that meet weekly or monthly to set and revise guidelines, develop policies and form processes to address monitoring and engaging (distinctly separate activities).

3. For a period, manufacturers will likely centralize social media like they did with eBusiness and eMarketer at the turn of the millennium. A person or team will be accountable for educating, issuing policies, and communicating guidelines to various divisions. This will provide role clarity, can ensure accountability for identifying opportunities and risks, and establish a mutually agreed upon “plan of action.”

4. I would advocate that much of social-media activity eventually will be managed by public relations professionals, because social-media is – in some respects – another form of media. However since public relations departments often lack knowledge on emerging media (as well as consumer and physician insights), the budget-holding brand teams should expect oversight and active participation by marketing.

5. Inside the next decade, we’ll see social-media activity (or whatever it is then called) being as vital to a marketing mix as advertising and sales. Manufacturers will increase resources (people and budgets) to fund social media programs in excess of most Internet budgets today. Social-media will increasingly impact a consumer through every stage of a brand’s buying process – from awareness to persistence. Advertising, of course, will continue to drive brand awareness and preference, but with diminished impact than it has in past decades. Patients trust each other, as evidenced by CureTogether.com, a site that invites participants to “crowd source” diagnosis and treatment options. Physicians, although trusted more than pharmaceutical firms, are often less helpful than the collective knowledge of patients who have personally faced a disease. And well-funded television campaigns will not offset a product with a poor risk/benefit profile, weak formulary status, unrealized benefits or a lackluster reputation.

Since most companies are stuck between stages two and three, let’s focus on policies that can help unlock social-media today without causing undo legal and regulatory conflicts. A solid policy will address at least three key areas: employee rights and obligations, monitoring guidelines, and engagement processes/roles.

1) Employee Rights and Obligations

Employees are entitled to free speech. So as long as the employee isn’t identified as such, it shouldn’t matter whether they have their own photo website, cooking blog, Facebook profile or YouTube videos. Using a familiar example, an employee

should feel comfortable writing a “letter to the editor” about local issues without fear of retaliation. However if they identify themselves using their employer’s name, they should first gain approval from their management or public affairs… just as if they were speaking at a conference or event.

The Internet is not a refuge from our confidentially and “code of conduct” obligation to our employers. If we disparage our employers or reveal trade secrets via social media, the same consequences apply if we did so at such public events like trade shows or conferences.

Unlike most daily activity, our social-media behaviors can more easily be traced to our employers. A moment of road rage will not likely harm our employer, but 140 characters on Twitter can kill a career. So policies should encourage “common sense” and training and education should help employees see the implications of what might otherwise appear as trivial.

2) Monitoring Guidelines

Encourage Monitoring Despite Perceived Risks: Social-media monitoring should be encouraged, and policies should address the method of monitoring, and what is done with the results. In putting patients first, we need to overcome fear of these reports being “discoverable” by plaintiffs. In the future, a manufacturer is likely to learn first of additional potential drug indications (and real-world risks that did not surface in trials) via the Internet. This is inevitable, and I believe a positive thing for patients and manufacturers.

Rinse and Repeat. In the pharmaceutical industry, many marketers equate social-media monitoring with conducting a one-time market research project. The results are analyzed, used to guide decisions and messaging, then the study is placed in a binder next to the one from last year’s sales meeting. However social-media is fluid, and challenges and opportunities are perpetual. Few manufacturers have a tool to monitor the bulk of social media (as they do with print and broadcast), but few will be without one in the coming years. Today’s “tweet” can be tomorrow’s CNN story, and social-media is an opportunity for a proactive firm to address problems before they start.

Legal & Medical Oversight: Monitoring research should be done with oversight to ensure the methodology is appropriate, reporting obligations are held, and with legal and regulatory guidance on how to proceed with discoveries that might have labeling implications.

Fear of Adverse-Events is a Red Herring: Studies have shown that it’s extremely rare that a serious adverse event can be reported with information garnered from social-media monitoring. However in the rare instances where manufacturers identify and document instances of recurring adverse events or off-label use, it should make some good-faith efforts to correct the information or encourage the individual to report the AE via existing reporting channels (typically a call center). If a blog, video or chat comment does not contain sufficient information for reporting, it should be routed urgently to the team responsible for reporting AEs. This solution is common sense, but “fear of AEs” is

one of the largest hurdles facing manufacturers that wish to engage more deeply with customers.

“Not Looking at Internet” is Not a Sound Legal Defense. Currently lawyers are legitimately concerned that evidence of monitoring could create an FDA expectation that the manufacturer is obliged to read and respond to all of social media. That is obviously impossible and an the FDA will not soon demand manufacturers to read the entire Internet. However if a product issue is identified, trending, and ignored, a poor defense would be “we didn’t know it was happening because we didn’t use the Internet.” It is not unreasonable to expect the FDA to take action on a company that did not update labeling based on newly evident side effects that are well documented online. It is also reasonable to assume that manufacturers would be expected to take reasonable efforts to clarify labeling in prominent forums where patients or doctors are promoting off-label use.

Don’t “Freeze” Corporate Efforts or Look the Other Way: For this reason, it’s important that social-media monitoring be shared beyond public relations and marketing, so medical affairs or legal can determine if the insights warrant FDA communication. So in effect, by “freezing” or “avoiding” social-media monitoring, manufacturers may be taking a greater risk than reasonable efforts to monitor and respond.

3) Engagement Policies

Monitor First: A best-practice related to social media is to monitor mediums for a period (3 to 6 months) before engaging. This gives an organization time to understand the context, and the appropriate approach for engaging.

Fish Where Fish Are: Pharmaceutical firms are not in the business of publishing or hosting social media, and can’t do so given regulatory constraints and with objectivity. As a result, marketers should look not to host social media but to reach customers via prevailing social-media sites and tools… using paid and earned media (ads and PR influence). When I hear a product director aspire to become the trusted resource for content and social-media surrounding his or her brand, I am often reminded of my 7-year-old’s ambition to fly. Perhaps it’s not entirely impossible, but naively charming nonetheless.

Know Who Matters: Social-media engagement requires individuals who are accountable not just to journalists but also to everyday individuals who have an influential voice online. This doesn’t mean an employee needs to read and reply to every Twitter or YouTube video tagged with the company or its products name. But if an individual with a large social-media following has a legitimate inquiry or problem, it often merits the speed and attention otherwise reserved to investment or media inquiries.

Set Guidelines to Avoid Mistakes or Apathy: Marketing should have clear policies on advertising around social media, and this is similar to advertising in

print or television. If the ads are placed adjacent to condition-specific information, they should be unbranded and not “reminder” ads. Otherwise, the media agency should inform the brand of taste/tone of the site where it runs the ad. Initially manufacturers viewed social media and consumer-generated media with the same bewilderment and contempt of the Internet. Now most brands have websites, advertise on search engines, and run digital advertising campaigns. Similarly, I do believe pharmaceutical manufacturers will gain comfort with running ads wherever their target customers are, and not fear ad placement surrounding uncontrollable social media. The ad may be the only appropriate way to reach some patients, and most consumers know that the difference between ads and other content.

Revise Review Processes & Develop 911 Plan: For good reasons, manufacturers maintain thorough and somewhat lengthy review processes. However public relations professionals are often granted “fast track” reviews for time-sensitive matters like product issues or launches. Similarly, the process by which ads are approved cannot facilitate handling of a timely event in social media. Some matters need rapid attention and resolution. I believe the next product recall will involve a manufacturer directly communicating with customers, rather than shaped by the media. I spoke recently with an individual who manages a major airline’s Twitter presence, and he knows exactly what he would “tweet” if one of his company’s planes should crash. Similarly, that dated company “crisis-management guide” needs to be revised, given new mediums for mass communication that are not dependent on print and television reporters.

Sidebar: Wikipedia as Starting Point

Naturally, there’s a right and a wrong way to respond to consumers, answer questions, and reply to criticism. However a social-media policy can’t possibly provide a protocol for every interaction. Wikipedia is a good place to start because it’s important and simpler than many other forms of social media.

In 2007 employees of Abbott and AstraZeneca were caught (via their IP address) editing their product’s Wikipedia page without disclosing their roles. Today, vendors lure manufacturers with offerings that allow their physicians to quietly serve that role. The reality is that – FDA guidance or not – this violates one of social media’s most vital principals: transparency.

So what does a Wikipedia process look like?

1. Check monthly (or more often) the Wikipedia listings for your products. They’re a vital source of neutrality, and Wikipedia has been shown to be more accurate than the encyclopedia Britannica.

2. If your product’s Wikipedia page is inaccurate, have a physician employee briefly provide additional sources or suggested edits on the “discussion” tab. I do not recommend editing the actual entry itself… instead use the vivid community that manages these entries as an objective “learned intermediary.”

3. Ensure the employee is a “badged” physician, meaning they’re self-identified as a representative of the manufacturer. Don’t hire an agency that contracts with physicians that hide their motives.

4. Document the suggested edits in the event there’s a dispute about your source or the context of your edits (although Wikipedia also captures this).

5. Fix errors or omissions whether they’re in the favor of the product or not. For instance, if a side effect is overstated… provide the accurate statement with a link to the PI. If an off-label indication is discussed (or a benefit overstated) then note that as well. This is not a place to “market” or “sell” the brand, but a place to ensure it’s accurately represented. The community will quickly observe and hold you accountable if your edits are one sided.

6. Eventually, the community will fix the entry if the facts substantiate it. If the manufacturer’s corrections are misinterpreted, then simply indicate that later in the discussion tab. Wikipedia is “self healing,” so eventually “crowdsourcing” will provide accuracy.

7. Finally, wait for the FDA letter. It won’t come if you do this honestly, objectively and transparently. Be mindful of the words of Dr. Jean Ah Kang, special assistant to Tom Abrams at the FDA's Division for Drug Marketing, Advertising and Communications, in charge of Web 2.0 policy development. In an podcast, Kang told Mark Senak, a Fleishman Hillard executive who runs the EyeonFDA blog: “the agency takes into account third-party involvement in social media. A key consideration would be whether the marketer, or any companies working with it, had any role in prompting user-made changes.”

8. But keep sales and marketing informed of this policy, so a frustrated employee isn’t tempted to perform rogue edits at home or work. Side effects of that behavior may include social-media humiliation, bad press, termination and the dreaded warning letter.