In a follow up to two social media and internet guidance documents issued last month, FDA hosted a webinar last week to present additional information and answer questions. The two new draft guidance documents outline FDA's thinking on the presentation of risk and benefit information on social media and correction of third-party misinformation on the internet. Jones Day recently reported on these guidance documents in a Jones Day Alert. Although the live webinar experienced technical difficulties, a significant portion of the training focused on the importance of conveying risk information, particularly on technology platforms that have character space limitations such as Twitter. Heavy emphasis was placed on the requirement that when presenting drug benefit information, manufacturers generally should disclose all boxed warnings, including fatal and life-threatening conditions, and all contraindications. Linking to the information is insufficient. For more details, the Agency has posted its presentation slides and Q&A from the July webinar online.
Around the same time the new draft guidance documents were released, FDA issued warning letters providing further insight on the Agency's social media and internet policies. In one letter, FDA warned a dietary supplement manufacturer that "liking" a post on Facebook equates to an endorsement of any express or implied claims made in the post. In this context, FDA found that the manufacturer was promoting supplements for unapproved drug uses by "liking" comments that made express or implied therapeutic claims. Though the letter was issued to a dietary supplement company, drug and medical device companies can expect FDA to apply this policy across all categories of FDA-regulated products. In another letter, FDA warned a drug company that its sponsored Google link provided evidence the drug is intended for a new use for which it lacks approval. Specifically, the sponsored link appeared when a user searched for a therapeutic use for which the drug was not approved.
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