Social media has been around for 10 years, yet it is still an onerous initiative for many life science organizations.
Medical device and pharmaceutical companies are waiting for the FDA to publish official social media guidelines. Until then, the idea of communicating without a clear set of rules is daunting for companies with high levels of regulatory oversight. Without official FDA guidance, there is a fear that internal regulatory affairs people won’t let them participate, or social media will force them into public conversations about off-label use of their products, or their company will be flooded with reports of adverse events.
These fears are compounded by the fact that social media is still untested territory for most life sciences brands and they are uncertain how to proceed.
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Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
Despite the uncertainty, the fact is the buyer is now including you in their conversation and social media is one of the most effective ways of engaging with your customers.
Still waiting for those FDA standards?
Congress passed the Food and Drug Administration Safety and Innovation Act in 2012. If all goes according to plan, the FDA must issue final social media and mobile guidance by July 2014. Formal guidance may be released this summer but life sciences companies don’t need to wait before creating a social media strategy.
Despite the lack of official rules, the FDA has been active in its regulation of all digital channels. Through its history of regulatory behavior, they have established a set of de facto rules for social media and are demonstrating that the same rules apply, regardless of the media used. Just like creating a print ad or product information web page:
- off-label use cannot be promoted
- risks cannot be omitted or minimized and
- claims of superiority or efficacy are not allowed.
In general, FDA regulatory action has been consistent across media outlets and has focused on the content, rather than the channel. Exceptions include the FDA treating the “liking” of a comment regarding an off label use on a brand’s Facebook page as constituting official endorsement.
Life sciences organizations have well-established processes for reviewing marketing content. They also have procedures for handling inquiries about off-label use, usually by responding with an appropriate disclaimer and routing the inquiry to an internal clinical resource. Similarly, companies have protocols for incidents of adverse events that meet the requirements for reporting to the FDA. While there have been few comprehensive studies, from the information available, it appears that there has been no significant increase in reportable adverse events emerging through social channels.
Time to Get Started
Once you decide the regulatory landscape is not as intimidating as it first appeared, it’s time to develop a clear social strategy. The first step is to identify the business goals for your social media channels. For example, you could:
- build brand awareness
- demonstrate thought leadership
- create trust through greater transparency
- generate leads through content marketing, or
- improve customer service by gaining insights.
Your brand’s social channels should not be just another vehicle to broadcast marketing collateral and press releases.
Next step, do your research. Learn about your target audience. Discover their needs and interests. Then, develop a social strategy that aligns with your audience members’ interests and behaviors as part of an ongoing engagement process. Understand how your audience uses each social channel and deliver content that is appropriate. Leveraging social channels is not an isolated campaign, it requires an ongoing commitment to regular participation.
Get Your Team Ready
Minimize your exposure by developing a set of approved social media policies for your official channels and for employees to participate on their own. Identify the person within your organization who will own your social presence.
They will coordinate with key stakeholders, including legal and regulatory, to ensure that social activities align with and support the efforts of the overall brand. If these activities are new to the organization, start small and create a pilot program.
Most importantly, test and learn, by measuring your successes and identifying areas for improvement. Once you’ve achieved a level of proficiency, widen the opportunities for engagement. If you still need to wait for the official FDA guidelines, you can develop a plan and hit the ground running.
