The FDA recently issued draft guidelines that impact how pharma can communicate in social media, but leaves many in the industry underwhelmed.

The guidance addresses only off-label information. It doesn’t cover on-label promotions, which means the industry can continue to communicate using this channel.

These guidelines provide instructions for pharma on addressing unsolicited off-label questions presented within a public arena, like a forum or chat room.

What industry can do:
If a question about off-label use is stated in a public arena (i.e., within a social media forum), the company may publicly provide a response. This response should:

1. Convey that the question pertains to an unapproved use of the product, noting the approved indication and safety information, and
2. Include the contact information for medical affairs, and
3. Only link to the product’s package insert. Links to promotional websites or third-party websites are prohibited.

Lastly, the firm should record the person requesting information and any follow-up questions from the requestor.

Industry agrees that these guidelines shouldn’t prevent companies from getting involved in social media. As long as they act in the spirit of the law, communicating in social media shouldn’t be inhibited by the lack of more specific additional guidelines.

Welcome to Social Media. The party is all your potential customers (or patients, in our case). The people at the party know each other, like or dislike each other, and are, in some way, connected with one another. And, of course, this party never ends.

The problem is nobody knows much about you. And you don’t know them—not really.

So when the big moment comes, what are you going to say? Are you going to walk in the front door and start shouting your brand’s benefits? Who exactly are you going to shout them at? After spending 10 minutes at the party, are you going to head home, feeling like you’ve checked the box?

Many brands do just that. They don’t grasp that to use social media effectively absolutely requires a commitment of time and energy to understand the community you are engaging with. Who are the popular kids (the influencers)? What are they interested in, what do they care about? Is there a good reason for them to care about your brand?

Let’s go back to the party. Grab a brew. Now, the first thing most brands think to do is to ask the Homecoming Queen to the Prom. In other words, we’ve identified a key influencer who is extremely popular and active in the community, and look, she’s standing right over there, and the brand would really love for that influencer to advocate for the brand.

OK, but why would the Homecoming Queen allow you to take her to the Prom? Is that fantasy, or reality? She’s very popular; you’re not. She has her reputation to protect. What’s in it for her?

That’s what you have to understand before you approach any influencer: what are they interested in? How do they feel about your brand? Is there something that you can do for them? What is it? You have to carefully engage with each influencer and try to find common ground. (A social media landscape analysis is a good start.)

Hopefully, you’ll find it—but there’s a lot more you can do. There’s a misperception that the most obvious influencers are the only targets of a social media engagement. Quite the contrary, usually we find that the biggest influencers are only willing to play ball with the brand up to a certain point—they are often too independent, they have their own agenda driving them, and they don’t want to be seen as working for your brand. That could diminish their credibility.

So it pays to find other voices in the community who are willing to advocate for your brand—the more, the merrier. These are patients who are already positively predisposed toward the brand, either from what they’ve heard from others, or from what they’ve experienced themselves (by participating in your clinical trial). Note that we’re not looking for patients who are neutral and then trying to “convince them” to advocate for the brand; we are looking for the ones who have already drank the cool-aid. They’re out there. By finding the real brand advocates, listening to them, providing them support and value as part of an ongoing relationship, your brand advocates will reciprocate by communicating the brand’s POV within their community.

These are all extremely valuable connections for the brand to establish. In the rare disease space patients tend to band together and rely heavily on each other for information and advice. Brands that participate and contribute value (beyond just the drug) through social media channels can reach and influence a relatively high percentage of their potential patients.

But it requires an ongoing investment in managing key relationships on an almost daily basis. Think Facebook, Twitter, LinkedIn. Nothing ever stops, and you want to be part of the conversation. Every community has its own personality and influencers, and new issues pop up every day. This is real-time learning that can help you evaluate how your brand overlaps with the needs of the community, and how to talk about (position) your brand to best fit with those unmet needs.

None of this can be done solely by “monitoring” and “observing” the community from afar. Personal relationships are an absolute necessity in order to gain trust, and yes, even friendship. Meeting patients in person (often at advocacy group meetings), listening to what people are dealing with as they attempt to manage their disease (only a small part of which is your brand), and being able to demonstrate that you understand the patient experience are all critically important if you hope to dance with the Homecoming Queen—or anyone else, for that matter.

A posting on the website of an online rare diseases group, which I’m a member, described the frustrations and despair of Antonieta, a Brazilian mother whose 33-year-old son has a rare disease known as Cerebrotendinous Xanthomatosis, or CTX. Since 1993, he had been treated with a medication that had changed manufacturers numerous times. The medication was now being offered for a price 10 times higher than what Antonieta was used to paying, and she could no longer afford the treatment that her son needed for survival. Antonieta, who had already pursued legal measures within her country to get help paying for the medicine (to no avail), had run out of options. She ended her post: “I don’t know what to do…”

The disease sounded familiar, so we at Compass researched it and tracked down the pharmaceutical company that is now in the process of filing an NDA for the drug. At that point, we sent an email to both Antonieta and the president of the company to put them in touch with one another.

That simple online introduction was all it took.

Antonieta thanked us very much for reaching out to her, and in 24 hours we got word from the pharmaceutical company that Antonieta will now be receiving the drug her son so desperately needs through the organization’s compassionate use program.

It was a great feeling knowing that one simple action could have such a profound impact on the lives of others. As a full-service patient marketing agency we understand the intricacies of marketing to patients—from message development and disease education to patient advocacy and support services. But it’s always rewarding to hear from patients directly to know that our contributions make such a difference.

Compass Healthcare Marketers will be holding our 5^th Annual Innovation Lab: Translating the Patient Experience into Commercial Success, to answer these essential questions. Join us for one day at San Francisco’s Cavallo Point lodge where rare disease industry professionals will come together to talk about the important role of the patient in their commercial planning, as well as address key topics in the orphan drug space.

This “closed-door” session—no media or regulatory agents—with leaders from several orphan drug companies and expert consultants will provide a safe and intimate environment in which we can have a very honest and productive dialogue about:

• The unique commercialization challenges in the rare disease and orphan drug space
• Pricing, reimbursement, and market access strategies for orphan drugs
• Social media’s unique and significant influence on the patient experience
• How to find, acquire, and inspire patients with rare diseases
• Case studies of orphan brands leveraging the patient experience for commercial success

Vew the complete agenda or register now to attend this exclusive, industry-only, “closed-door” event to learn more about understanding and leveraging the patient experience in the rare disease and orphan drug space.

After the workshop, we will also be hosting a wine tasting event featuring Cavallo Point’s extensive collection of Old World and New World wines.

We look forward to seeing you on the 20^th in San Francisco!

A few companies have remained on Facebook and are committed to moderating comments. Pfizer has done a respectable job establishing parameters for comments; they don’t allow the mentioning of products, side effects, or being vulgar or “off topic.” (Pharma Facebook page owners still have the right to remove comments on a case-by-case basis.) They have also responded timely to posts, proving that pharma can interact with patients in a safe way.

Other examples of companies that have maintained their Facebook pages include:

• Sanofi-aventis U.S. Diabetes
• AstraZeneca U.S. Community Connections
• Changing Possibilities in Hemophilia (Novo Nordisk)

These are in addition to a disease page that has always allowed comments—Janssen’s (an ex-U.S. page) [link to Psoriasis 360. Crohn’s & Me, a UCB page that previously allowed comments, was removed recently, perhaps in a review of Facebook pages.

Other disease education/awareness pages sponsored by pharma have gone by the wayside, proving that for some, Facebook is not worth the commitment to moderate comments. Here are a few examples:

• Drive for COPD (Boehringer Ingelheim)
• ADHD Moms (J&J)
• Epilepsy Advocate (UCB)

The comment disabling policy does not impact branded pages or disease pages where there is only one FDA-approved treatment. An example can be found at the sparsely populated Lunesta Facebook page.

For brands and markets with an active social community (Read: nearly all), a thorough social media analysis can provide vast information from all audiences from the casual observer to the defending brand advocate.  Patients and caregivers are communicating in blogs, commenting on articles, tweeting and participating in forums.  We can learn real-time feedback.  More importantly, it can provide real insights to business objectives.  So, why aren’t all pharma marketers listening?

• Cost (time and budget)
• Fear of social media
• They don’t know what they should or can

Looking for the “Why” and the “What’s Next”

Social media is by no means a replacement for traditional market research.  It should never replace a quantitative survey, or supplant a focus group.  It can, however, provide marketers with a solid foundation of knowledge of consumer needs, sentiment and opinion towards the disease and/or brand.  It should empower marketers to establish the information they’ve learned by using traditional market research to quickly validate hypotheses.  Thus, using more traditional market research to spend more time drilling down  (the “why”) and uncover new findings (the “what’s next”).   

Take, for example, a recent project supporting a global brand.  A thorough and detailed social media analysis informed us of the brand’s limitations (limited brand awareness against a well-entrenched competitor) and marketplace expectations (desire for greater efficacy).  Using this research, we developed a patient message platform to test in traditional market research and discovered results that most aligned with our initial assumptions, based on our social media research.  More importantly, we were able to spend more time covering the “why” – why patients and caregivers acted in particular what and what motivations were driving their behavior.

Social media observation should be a part of every brand’s activities.  For brand managers planning market research, social media is an essential tool to lay a solid foundation:

• Establish what questions need to be asked
• Determine information to validate
• Discover baseline patient and caregiver needs

Additionally, social media provides brand managers with information that may or may not be truthfully conveyed in a patient panel.  It is because participants are not being led by moderators or thinking about the expectations for responses that can make social media more revealing.  One of the products we support has a challenge in helping patients adhere to their treatment, where side effects can temporarily overcome symptom relief.  In this scenario, we have identified where patients drop-off in treatment.  We can provide specific indicators that predict if patients will stop taking their medication.  This information drives adherence programs and other relationship marketing initiatives.

Have you conducted a social media analysis of your brand?  Do you currently use social media chatter as the most informal method of market research?  If so, what have you found to be the pros and cons?

On July 29, 2010 the FDA issued a warning letter to Novartis for the Facebook share button and sharebar on the Tasigna product website – both consumer and HCP sides. The issue was that when a user clicked the share button, it displayed a post on the user’s Facebook wall. The post was a statement (that varied by page) that typically included the brand name and the indication. It was a brief statement with a link to the website, so of course it did not include fair balance. Further, language within the statement used on some of the pages used superiority language that FDA had previously told them not to use.

So, what does this mean?

First, just as in the instance of the Gleevec unbranded letters this spring, it actually changes nothing. Novartis, for the second time this year, simply violated known and understood DDMAC policies. It’s shocking, actually, that after the unbranded letters, that they did not do a better job following well established rules in the rest of their communications (particularly interactive communications).

This letter is certainly NOT a new FDA policy prohibiting the use of share tools or social media in branded pharma. It does reinforce the FDA policies regarding claims and balance and that channel and format does not change the rules. As with all things, the devil is in the execution.

What concerns us, is that, as with the unbranded Gleevec letters, the industry will overreact and start pulling back on their investments or efforts within social media. This should not be our response; we should take this as confirmation that DDMAC sees the internet and social media the same as every other channel and applies the same rules. We as an industry just need to accept that fact and follow the rules!

In an age that prides itself on learning more through interaction and less through reading, YouTube provides users with a plethora of health information that may or may not be the most accurate, but where your video falls in line depends on you and how much effort and creativity you put into it.

According to a BBC News release , YouTube videos account for 60% of all videos watched online, so while placing a video on your website may give you an edge among the targeted few, posting it on YouTube makes it available to the interested many surfing YouTube channels.

YouTube, according to Alexa.com, is rated the third most visited website on the internet, falling right below Facebook and Google.  In 2008, YouTube surpassed Yahoo as the worlds #2 search engine.  Ensuring broad visibility of your video, YouTube provides Marketers with the capability to reach global audiences cost free.  With time and effort–because nothing worth looking at is created in mere minutes–YouTube can become not just a platform to another digital outlet, but can also serve broader purposes in your marketing campaign.  It becomes a powerful channel to those marketers striving to build awareness, allowing them to reach patients and HCP’s where they are online.

Pharma companies have just begun chomping at the bit when it comes to YouTube.  Those that have taken the initiative include Johnson & Johnson, Novartis, Sanofi-Aventis and Ortho-McNeil-Janssen Pharmaceuticals.  Johnson & Johnson, a dominant force in social media, has taken its content one step further by creating its own YouTube channel.  J&J’s channel presently has 2,706 subscribers and total upload views surpassing 2 million.  In comparison, the Novartis channel has 361 subscribers and over 57,000 views.  So why is there such an expansive difference between these two companies’ channels?  There could be a number of reasons but it may simply come down to the content, the flashiness of the site, and its entertainment value.  Many company channels and videos also post patient testimonials among their commercials and news updates giving audiences a handful of material to look at. 

YouTube has not yet reached its peak as the prevailing social media tool in the Pharma industry, but its simple setup and broad visibility represents itself as a prominent tool for growth and expansion.

So why not start today? Facing the unknown can always be a bit intimidating but with resources from helpful sites like http://www.doseofdigital.com/2009/09/8-tips-help-own-youtube-search-results and http://www.google.com/support/youtube/, the ability to create and upload will be easier than you think and the benefits will surly outweigh the hassles.

With viewers “tuning in” to watch video online, the consumption of broadcast content will continue to morph dramatically. Pepsi opted to skip advertising in the the most widely-viewed sports events to focus on social media efforts. Soon, Hulu could become more of a threat to traditional television than DVRs. Some companies continue to use long-form video, such as GlaxoSmithKline and the Alli-themed documentary, but brief, serial clips may yield an advantage for continued engagement.

In pharma, the opportunity is yet to be fully seized. Nearly half of online physicians in Western Europe reported watching Web videos for professional purposes. At the FDA social media hearing, we learned physicians watched instructional videos online the night before performing an orthopedic surgical procedure. And this doesn’t change translating from professionals to consumers. Video can be extremely effective in communicating with patients and caregivers beyond simple text. Video can communicate complex ideas, such as mechanism of action, more easily than the written word. Patients telling their own stories in their own words yields greater emotional engagement. And, very often it becomes viral.

This should encourage brand managers to recognize the unique benefits of video and leverage these assets online – whether on corporate, unbranded or products sites, or shared on social media channels.

The growth and usage of “new media tools” will always surpass and ultimately replace “traditional methods”. Smoke signals were replaced by guys with sandwich boards, who were replaced by newspapers, then radio then print and TV. There will always be a constant evolution. Marketing doesn’t change, the mediums that we use will always change, but at the end of the day, it is still marketing.

Having said that, how we approach marketing is changing, and quickly. In this past year we have heard a lot about Relationship Marketing or (RM). It was first discussed in the form of patient compliance programs, and most recently, given the changes in the sales force structure, size, and regulations, HCP RM. Both are the same, it’s about marketing to specific segments.

Segmented marketing the ability to identify and successfully reach and market to multiple different and distinct target audiences which has been pioneered and perfected by Interactive will continue to evolve as the marketing approach. In the past promotional campaigns consisted of leveraging one benefit into one message and then communicating that message through the reps, journal ads, and TV. The Intent has allowed us to think in segments. Going forward the agencies that will serve their brands best are the ones that internalize this approach across everything they do, from label design to brand messaging to all the promotional activities.  It is no longer what is the one message, it’s which segments do I want to reach, influence, empower; how do they want to consume my message (with or on the phone, online, in person, etc) and when do they need the information?