A new FDA draft guideline addresses one limited usage of social media by pharmaceutical companies.
Social media has changed the way business is run. In virtually every industry, the influence of Facebook, Twitter, and community has altered many aspects of the business. Every industry, but one - the highly-regulated pharmaceutical business remains largely on the outside looking in. This is, in no small part, due to a lack of guidance in the U.S. from the Food and Drug Administration. However, a breakthrough may have finally arrived in the form of language provided in the FDA's December 2011 guidance for the industry.
The document specifically speaks to "Emerging Electronic Media," a.k.a. social media, and provides guidance on responding to unsolicited requests for off-label information about prescription drugs and medical devices. In doing so, pharmaceutical marketing experts believe the FDA is finally willing to let brands get a toe in the water with social media. This is important because the FDA will be pressed to recognize the remainder of the issues surrounding the use of social media and the pharma industry. This is one limited usage of social as detailed by the FDA, but it is a start. However, it is not one step onto a flat plain; rather it is the boulder rolling down the hill. More will have to follow.
What the FDA has done is give marketers an opportunity to engage with consumers who may not have specifically asked questions of the brand, but rather of the social community, regarding off-label use of a drug. The FDA has acknowledged that brands are capable of responding responsibly regarding their product in an honest, non-misleading, and accurate manner, and that a brand's response would be the best respondent regarding those queries versus other respondents that don’t have the background knowledge of a particular drug and recent clinical trials. This acknowledgement provides clarity on the role a brand can play in this line of questioning and opens up the opportunity for a brand to enter the conversations already going on in a meaningful, but regulated way.
With the FDA's evolution on the subject, the next step is for brands to map out a strategy for managing this opportunity. Given this is a less-than-complete commentary from the FDA, some brands may choose to remain side-lined. For those that are ready to move ahead with the gift of guidance, there is a three-step process to undertake:
The reward outweighs the cost and risk, and for many brands, a response would require, initially, no more staffing than is already used to answer consumer queries regarding on-label usage. The advantage to the company is that the consumer query, assuming the forum moderator does not delete the conversation, would remain on the site allowing others who have interest in the off-label usage to see the contact information and access the company source.
While this guidance may be minor in overall impact, given the broad spectrum of the social media opportunity, it is a critical signal that the FDA is now ready to start making commentary in an area where brands are desperate for guidance. What is to come will have far greater impact, as the FDA must provide guidance on how to deal with adverse event (AE) questions that may arise in social media. The model now exists, per this guidance, on how to transform a social query into a proper FDA-approved response and direction for further guidance. Now, brands need to understand the depths they may be expected to go to take appropriate action regarding AE comments/questions in the space and the infrastructure required to satisfy those guidelines. These guidelines provided by the FDA give brands an immediate action, but now that they exist, pharma companies will be hungry and needing of the remaining guidance required to safely and compliantly engage in social media.
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Joseph Cowan serves as partner, group director, and senior search strategist at MEC, specializing in the pharmaceutical and medical/health industries.
Hong Kong, May 5-6, 2015
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