On Tuesday, the FDA issued proposed guidance for the pharmaceutical and medical device industries for advertising on social media platforms with character space limitations and for correcting misinformation posted to social media platforms by third parties.
The proposed guidance with respect to character space limitations effectively limits the amount of product advertising a company can do on platforms where character space is limited, such as Twitter. The proposal would require companies to post both the benefits and the main risks associated with a product, potentially with a hyperlink taking the reader directly to a more detailed list of risks. For instance, the FDA said that an acceptable Tweet could read: "NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk."
The FDA made clear that even in Tweets, a company must spell out the exact indication for a product. For instance, if a drug’s indication was for "mild to moderate memory loss," it would not be sufficient to Tweet that the drug is for "memory loss.” The Guidance was clear that a company cannot use the platform as an excuse for not providing accurate, balanced product promotion. “[R]egardless of the platform, truthful, accurate, non-misleading, and balanced product promotion best serves the public health. For some products, particularly those with complex indications or extensive serious risks, character space limitations imposed by platform providers may not enable meaningful presentations of both benefit and risk. ... If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message.” The FDA did say, however, that simple "reminder" promotions in which only the name of the product is displayed would be allowed.
The FDA also outlined proposed guidance for companies seeking to correct misinformation posted by independent third parties and in chat rooms. A company is not required to correct third-party misinformation posted on media not affiliated with the firm, but if it does, the FDA said it would give leniency and would not require a full balancing of risks and benefits that are normally needed as long as the corrections are clearly defined, accurate, and not misleading. Further, if a firm corrects one or more occurrences of misinformation, it is not expected to correct each piece of misinformation in an entire forum or go back to the forum to check if there is more misinformation. “[A] firm should clearly identify the misinformation it is correcting, define the portion of the forum it is correcting, and should correct all the misinformation that appears in that clearly defined portion.” For example, the FDA said that if an interactive website consists of three consecutive sentences of misinformation about the firm’s product, the “firm should correct all three sentences. It should provide a statement that the firm is responding only to the specified information on that one page and provide the date the change was made. The firm is not expected to correct misinformation that appears on other webpages of the website.”
The FDA was clear that this guidance did not relate to postings by a firm’s employees or another company affiliated with the firm. “This draft guidance does not apply when a firm is responsible for the product communication that contains misinformation. ... A firm is thus responsible for communications on the Internet and Internet-based platforms, such as social media, made by its employees or any agents acting on behalf of the firm to promote the firm’s product, and these communications must comply with any applicable regulatory requirements.” For example, the FDA said that a company would be responsible for incorrect statements about a product’s safety made by an employee on a discussion board hosted by an independent third party.
Tip: While the FDA’s proposed guidance would only be applicable to the pharmaceutical and medical device industries, this guidance is consistent with the FTC’s position that character limitations imposed by social media platforms do not excuse the requirement to include material disclosures that are necessary to avoid conveying a false or misleading advertising message.