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In June 2014, the Food and Drug Administration (FDA) issued a draft guidance document, “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation about Prescription Drugs and Medical Devices.” While the draft guidance is not legally binding, it offers insight into the FDA's expectations and issues for industry to consider as it continues to develop social media campaigns. The draft guidance indicates that the FDA will not hold responsible companies that choose to correct (or not correct) third-party misinformation. However, companies should consider the implications of whether or not to correct misinformation.
This article briefly summarizes the draft guidance and offers issues to consider. The article is not intended to make recommendations in a vacuum, as each case is fact-specific. However, it is hoped that describing the issues will allow companies to make educated decisions.
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