Wednesday, December 22, 2010

The FDA & Social Media: What To Expect In 2011

If you could have put all the people working in marketing at pharmaceutical companies together in a room today, you might have heard a collective sigh of disappointment. As many suspected for weeks or even months now, the FDA quietly confirmed that the long awaited guidelines for how to use social media for which they held a hearing in late 2009 won’t be coming this year and to expect them (perhaps) in Q1 of 2011. Earlier this month, however, the FDA did release a sweeping document that received much less fanfare from marketers - even though the implications of it may change the world of pharmaceutical marketing for the next half decade at least.

That document focused on the FDA’s “Strategic Priorities: 2011 - 2015″ and offers nearly 50 pages of insights into the future direction of the FDA and offers many hidden insights that everyone who is considering doing any marketing or communications for a drug, medical device, healthcare organization or biomedical research organization should pay attention to. Here are a few of the most noteworthy passages in that document along with thoughts from our Ogilvy Digital Healthcare team on their significance.

“FDA’s primary responsibility is to protect the American people from unsafe or mislabeled food, drugs, and other medical products and to make sure consumers have access to accurate, science-based information about the products they need and rely on every day.”

1. What It Means: Despite Lots Of Hope From The Industry, Social Media Guidance Isn’t A Priority For The FDA
There is only one point in the entire 48 page document of strategic priorities where social media is even mentioned, and much of the document focuses on the much bigger challenges and scope of the FDA. When you work in Pharma, you tend to underestimate the scope of the FDA’s mission. As this document spells out, issuing social media guidance is nowhere near a priority for the FDA - and despite what anyone working in this area may want to see happen, it is unlikely that this will change in the near future.

“One of the most pressing FDA-wide goals is promoting transparency in FDA’s operations, activities, processes, and decision making, as well as making information and data available in user-friendly formats while also protecting confidential and proprietary information.”

2. What It Means: The FDA Will Continue To Actively Use Social Media To Spread Its Own Messages
Perhaps even more frustrating than not having concrete guidance will likely be the knowledge and easy evidence that the FDA is poised to use social media much more actively themselves to reach patients, healthcare professionals and other governmental organizations. They have already launched several forward thinking social media initiatives including tweeting about FDA Recalls and creating a dedicated YouTube Channel. A few smart people have already noted the irony of this fact, but in the coming year it is likely to continue unchanged.

“FDA recognizes that communications must be adapted to meet the needs of many groups who differ with respect to literacy, language, culture, race/ethnicity, disability, and other factors. Social media tools can help meet some of FDA’s communication challenge. We are planning to use social networks to create a virtual community of organizations and individuals to disseminate FDA science-based information on women’s health. We will also be collaborating with other government partners, to integrate FDA information on women’s health into their programs.”

3. What It Means: The FDA Is Already Prioritizing Social Media As A Channel For Reaching Special Populations
This passage reveals a somewhat narrow view of social media’s potential to reach smaller niche populations based on gender, ethnicity or rare conditions - however it does demonstrate that there may be particular situations where social media may face fewer barriers to usage by the FDA, and also serve a highly important patient need for authoritative and accurate information, as well as access to a hard-to-find support network.

“Summary Of Long Term Objectives For Human Drugs: Oversee drug promotion and marketing to ensure that marketed drug labeling and advertising is truthful and not misleading.”

4. What It Means: Most FDA Oversight And Regulation Will Continue To Focus On “Misleading” Promotional Efforts
Though there is certainly room for interpretation in what the definition of “misleading” might be - history has shown that this one metric continues to be the most important one that the FDA uses when monitoring communications efforts from pharmaceutical companies. Added to this is the consistent feedback from epatients and their loved ones that in most cases they would welcome informational content and support tools from pharma companies, as long as they are not presented in an underhanded, dishonest, manipulative or overly promotional manner.

“For FDA to achieve its mission of promoting and protecting the public health, the agency must have a well-defined communications strategy to address the information needs and concerns of both internal and external audiences. An FDA strategic communication strategy will ensure the agency has clear and concise messages about its work and will ensure those messages reach the right audiences using the most effective channels.

5. What It Means: The FDA Will Be More Vocal In Disseminating Its Authoritative Views Through All Channels
As most anyone working in pharma marketing will attest to, part of the challenge that the industry faces is that its own efforts get lumped together with online miracle cure scams and generally unscrupulous advertisers and organizations who work outside of FDA guidelines and manage to get away with it. As the FDA takes a more vocal role through its strategic communications, this can translate into great benefits online for reputable pharma organizations who have their new products approved and are trying to spread that news to relevant populations as widely as possible.

THE BOTTOM LINE:
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What this combination of the strategic priorities document and the recent admission that the social media guidelines will be delayed clearly points to is that we as pharma marketers need to stop praying for a magical guidance that will deliver the answer to all of our problems. Guidance may come in small pieces throughout 2011, but putting an entire effort on hold for the promise of clear rules is a bit like waiting to take the exit onto a highway until there are no cars on the road. You’ll be waiting a long time.

Instead, pharma marketing that promises to leverage social channels should voluntarily be transparent, useful, not overly promotional and serve a real need. Doing things right in this area doesn’t always mean looking for permission or waiting for someone else to do it first. Efforts launched in an ethical and non-manipulative way can and do work - and should be a part of your planning efforts for 2011, whether the social media guidelines from the FDA come in early 2011 or not.

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