The Food and Drug Administration’s much anticipated draft guidance related to the use of social media by pharmaceutical companies fell far short of what the industry expected. More than two years after the FDA held initial hearings on the topic, it quietly released social-media guidelines that addressed only one particular issue: communications relative to off-label uses of their products. But, there is more guidance to come. The FDA indicated upon release of this limited guidance that it expects to release multiple draft guidances relative to social media and other issues, including fulfilling regulatory requirements when there are space limitations (i.e., the 140- character limit of Twitter) and correcting misinformation.
While the guidance itself is important and marks the first time that social media channels such as Twitter and YouTube have been mentioned by name in FDA guidance, its narrow focus provides little in the way of direction to an industry yearning for clarity relative to online marketing issues generally. Despite its narrow focus, there is a silver lining. The pharmaceutical industry can take comfort in the fact that the guidance does not appear to suggest that the industry stop using social media for marketing purposes.
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