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.