Yes, it is true the FDA is now promising guidelines for social media by July 2014. But can anyone really afford to wait that long—and does anyone really expect anything on time or even worth the wait? In the meantime, and perhaps even after, take this advice from digital marketing experts.

The Digital Health Coalition (DHC) recently completed a comprehensive project with Klick Health reviewing the social media landscape for pharmaceutical and medical device companies. The good news: A handful of companies are putting forth an effort to engage in social media without direct guidance from the FDA. The bad news: The “best in class” sites are not that great compared to what we are used to seeing online today outside of pharma and device. And further bad news: If you have been watching the market evolve then you know the gap between pharma and device and the rest of the online world is growing—fast.

By highlighting the best practices of companies, brands and individuals moving forward in digital and social—and driving innovation—we hope to motivate a growing number of companies, brands and individuals to follow in their steps. If social media is to be an integral part of the media mix—and it is with most segments that consumers and physicians deal with today—pharma and device companies and brands must think about how to get from Point A (no engagement) to Point B (integrated digital and social media presence). If you are waiting for a “guidebook” from the FDA you could be stuck looking in the rear view mirror as your competition moves forward.

Three things we have learned along the way from the DHC membership:

1. Look Inside Before You Look Outside

One thing we continually observe from the market leaders today is that when it comes to digital and social, the biggest hurdle is often internal and usually involves organizational change. However, even if they had free reign in digital and social media, a majority of companies do not even know what they want—or should be doing. Once the hard questions have been asked internally and overarching policies and processes established, only then can you begin to debate the external environment.

2. Digital Constantly Evolves So Plan for Change

The Internet and online media will never stop evolving—get used to it. If you sit around waiting for sites, technology and platforms to stop evolving so you can catch up and write detailed guidelines, you will always be five, 10 or 20 steps behind the market. Building on a framework based on how you want to interact with your customers and how technology helps you execute on the overall brand strategy is key to success long term. Think overarching digital strategy as your North Star—not tactics for Twitter.

3. With Social Media, Think Broadly, Not Narrowly

It has been said hundreds of times, yet it still needs repeating—the FDA is not going to tell companies and brands how to operate on specific sites, networks and platforms. Companies and brands must think about digital and social media in a much broader sense. What is your strategy across the broader social media category? How do you define engagement? Measure engagement? How do you interact, communicate, or deliver service to your customers—irrespective of the site being used? These are the questions—and answers—that will follow you from site to site and year to year.

And now a few words from some of the thought leaders who are moving the industry forward.


Henry Anderson

Global Head, Social Media

Social media continues to rapidly evolve the communication dynamics between patients, caregivers, physicians and payors. Significant opportunities exist for major healthcare organizations through social media to personalize the patient journey, foster internal collaboration and support all facets of the business—both internally and externally. Novartis is embracing this new medium and is well underway planning for the future. One of the first exercises in defining “who we want to be” in the social/digital age was a conscious look at our internal culture and capability. Setting a vision consistent with our culture is driving the investments in people, processes and technologies that will enable the organization to sustain a successful presence.

The development of effective policies, governance and education of social media in many ways parallel those of the Internet adoption cycle a decade or more ago. Today, however, time scales are compressed and open innovation—together with the mobile revolution—are driving a massive influx of possibilities. This daunting mix of pressures is leading to successful engagement opportunities when teams are required to look at the potential together and break down traditional silos that are long overdue to evolve. Companies embracing change and following the tenets that underpin social media itself have a bright future.

Joan Mikardos

Senior Director
Sanofi US

Despite a lack of social media-specific guidelines from the FDA, there are ways for pharmaceutical companies to use social media. First, they need to think about social media as more than just a marketing channel for campaigns. Social media is really a place to gather insights and build connections with people. Companies that are not passively listening are missing an opportunity. Observing conversations about the therapeutic area you are interested in, as well as your brand, can glean important insights. These insights can help you better understand the needs of patients and their caregivers and supplement your traditional market research findings. The learnings can be applied to the development of patient education materials and marketing tactics, and help determine if your brand/company can engage with the online community to provide an appropriate and meaningful value exchange. If you do determine your value proposition and are ready to engage, follow existing FDA guidelines for advertising and promotion.

Tina Sampath & Dale Mehr

Tina Sampath
Director, Patient & eMarketing, IHD Marketing
Gilead Sciences

Dale Mehr
Associate Director, Business Conduct
Gilead Sciences

At Gilead, we have been approaching social media brand-by-brand through our Promotional Review Committees without formal external or internal guidelines. In the absence of official FDA guidance, we decided to develop internal social media guidelines to help ensure consistency and efficiency across brands. We formed a Social Media Working Group led by stakeholders from legal, regulatory and marketing focused on developing guidelines. For Phase 1, we prioritized developing guidelines for YouTube, Facebook and Twitter that will allow for establishing a branded or unbranded presence—including the potential of moderated commenting.

In 2012, the team met (mostly) weekly and was successful in developing a robust outline and gained alignment on the direction for the guidelines; however, it became clear that we needed outside help due to competing business priorities and bandwidth. We spent nearly six months identifying and onboarding an outside consulting firm and kicked off the project in late 2012.

As a first step, this firm conducted a landscape analysis of existing pharma/biotech YouTube channels, Facebook pages and Twitter profiles. This critical step allowed us to establish a baseline across the industry, and the case studies included in this analysis will help inform the final guidelines. Our goal is to have Phase 1 finalized in Q2 2013. We currently have a YouTube channel for an unbranded program—Speak From the Heart ( Our goal is to enable moderated comments and use this as a 
pilot for our new process in 2013.

Peter Pitts

Center for Medicine in the Public Interest

During an episode of Mad Men, the creative team was hard at work brainstorming on a “women’s product” campaign when someone asked, “What do women want?”

Strolling by, Roger Sterling quips, “Who cares!”

Well, when it comes to social media, what does pharma want—and who cares?

Alas, the use of social media by regulated industry is faltering because of fear, timidity and misunderstanding. What pharma wants (or should want) are specific areas of clarification from the FDA on this new and exciting zone of opportunity. Industry’s general response to its tenuous toe-dips into social media is, “Blame the FDA!” But that’s not fair.

How can the agency be blamed for industry’s reluctance to push the boundaries—even a little? Fear of warning letters?  Fear of unearthing adverse events? I say, where there’s a will, there’s a way. If you won’t blaze the path, then don’t expect anyone to know where you want to go. More regulation? Don’t wait for it.

Is social media about “collaborating” with consumers or “cooperating” with them? What’s the difference? Well, cooperation happens when both sides want to survive. Collaboration happens when they want to thrive. Collaboration means interacting honestly and transparently. And pharma’s opportunity (within the context of social media) is to be the first among equals.

Otherwise social media becomes the healthcare Hunger Games. And may the odds be ever in your favor.

  • Joe Farris

    Co-founder of the Digital Health Coalition, a nonprofit organization created to serve as the collective public voice and national public forum for the discussion of the current and future issues relevant to digital and electronic marketing of healthcare products and services.

  • Mark Bard

    Mark Bard is Co-founder of jumpRx. With more than 15 years industry experience, Mark is an internationally recognized expert on topics including the Internet and the healthcare system, new media, health information technology trends, mobile, social, and pharmaceutical sales and marketing.


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