Could the use of social media be considered “off-label” promotion?
Thanks to the explosion of social media networks like Twitter and Facebook, drug and medical device companies now have a direct link to users of their products. Although the U.S. Food and Drug Administration (FDA) addresses legal and regulatory issues associated with off-label promotion medical devices and drugs, it has only recently directed enforcement towards companies that who are utilizing these new mediums to promote their products.
Many Product Liability policy forms contain an exclusion for loss arising out of the dissemination of information in violation of any law, regulation or order of any governmental authority. It will be interesting to see how insurers will address social media and if they will consider using these new mediums a form of off-label promotion. Ropes & Gray LLP will host a webinar tomorrow on the regulatory challenges posed by social networking and online media tools, to explore FDA’s approach to enforcement in this area and provide practical advice for companies to consider when developing their compliance strategies. Check it out “Using Social Media Outlets for Drug Promotion“.