Earlier this month, FDA set forth specific requirements for the use of social media by pharmaceutical and medical device manufacturers, packers, and distributors. In two draft guidance documents, the agency highlighted its expectations for firms engaging in product promotion through internet and social media platforms.
One draft guidance describes FDA's approach to advertising and promotional labeling on social media platforms with character space limitations. Such communications must present both benefit and risk information about the promoted pharmaceutical or medical device. For example, a 140-character tweet on Twitter intended to describe a particular drug's benefits should also include adequate information about the product's safety risks.
FDA issued another draft guidance with standards for correcting third-party misinformation on social media. This guidance recognizes a public health benefit associated with having firms correct misrepresentations and other false implications about their products. If a drug or device company chooses to use social media to respond to misinformation submitted by an independent third party, the company must do so in a "truthful and non-misleading manner," using relevant information that is limited and tailored to the misinformation.
These guidance documents reflect FDA's efforts to expand its enforcement policies for promoting FDA-regulated products using evolving platforms attendant to the digital age. Interested parties may submit public comments on the draft documents through September 16.
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