A few weeks ago, and nearly five years after its open hearing on the topic, the Food and Drug Administration (FDA) finally released its proposed guidelines for how drug and device makers should navigate social media. Much has been written on the new guidelines including a few informative posts by Ed Silverman at the Wall Street Journal. As Silverman notes, among the 50 largest drug makers, half are still not using social media to engage consumers or patients, according to a survey by the IMS Institute for Health Informatics. He also suggests that the FDA will likely use the guidances as trial-and-error blueprints themselves as they run across questions that were not answered or situations that may not have been anticipated.
The draft guidances offer instructions on how companies should attempt to correct product information on websites hosted by outside sources, such as chat rooms, and address how products – including risk and benefit information – can be discussed on social platforms like Twitter, as well as in paid search on Google and Yahoo.
Not surprisingly, all information shared should be factually correct and non-promotional. Companies should avoid touting drugs, as the goal is to share information that is consistent with FDA-approved labeling and information.
At BBK, we've been instrumental in helping our clients manage the challenges and rewards of utilizing social media as a patient recruitment tactic. There's an inherent risk for any industry, but perhaps an even greater risk for the pharmaceutical industry. Social campaigns thrive when community relationships are cultivated and honest dialogues flourish – both not easy when the conversation is about one's condition, related therapy, or healthcare experiences. Additionally, challenges such as regulatory complexities and restraints, establishing a timely online presence, and engagement through content and carefully crafted messaging must be evaluated in order to build a social media campaign that successfully fits a study’s patient recruitment needs.
Perhaps with the proposed FDA guidelines for navigating social media, we may see an increase in sponsor buy-in and increased interest surrounding social media as a tactic for patient recruitment. At least we hope.
What are your thoughts? Too little too late or a helpful move in the right direction?