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FDA Releases Long-Awaited Guidances on Character Limitations and Misinformation on Internet/Social Media

In two separate guidances, the Food and Drug Administration (FDA) advises prescription drug and device manufacturers on its "current thinking" on advertising through space-constrained social media (e.g., Twitter) and on the monitoring of third-party online posts. Although the guidances, issued June 17, 2014, remain open to comment and are not binding, they express a general warning to drug and device manufacturers to provide accurate information concerning product risks-in essence, to adhere to the FDA's advertising rules, even within the space constraints and "static" of the online environment.

The first guidance advises prescription drug and device manufacturers on how to accurately and effectively convey risk information when making product benefit claims on Internet and social media platforms that contain character-space restrictions. Importantly, the guidance does not address or apply in situations when benefit, indication, dosage or other information-such as reminder promotions-is not present. The guidance is oriented primarily toward platforms such as Twitter and Google's Sitelinks. Providing a number of examples of permissible messaging, the guidance generally warns manufacturers to provide risk information clearly in their promotional materials, despite the space restrictions. If a manufacturer tweets about a product's benefit (even just the indication), it should provide risk information comparable to any claims about the product's benefits. The FDA identifies two factors to determine whether the risk information is comparable: the risk information qualifies any representation about the product, and the risk information is presented as prominently and clearly as the benefit information. "At a minimum," the guidance instructs, "a firm should communicate the most serious risks associated with the product together with the benefit information within the individual character-space-limited communication." The guidance recommends that space-constrained messages such as tweets include direct hyperlinks to the product's risk information page on the manufacturer's website. While manufacturers should consult the guidance's specific recommendations concerning the use of punctuation and wording, the message of the proposed guidance is clear: even if characters are severely limited, a drug or device manufacturer should ensure that messages are balanced-in terms of a drug's risks and benefits-and that messages direct the online audience to more comprehensive information concerning a drug's potential risks.

The second proposed guidance addresses how firms might monitor and correct misleading information posted by third parties-individuals not employed by or associated with the firm-in online forums, including chat rooms, blogs and tweets. The FDA recognizes that online commentary is profuse and that it would not be feasible to monitor all third-party comments about a product. Instead, the guidance addresses efforts firms voluntarily take to correct misinformation disseminated by third parties. The guidance warns companies that they may correct misleading information-such as blog posts providing inaccurate information about a drug's side effects-as long as they do so in a "truthful and non-misleading manner." The guidance sets forth eight factors to qualify as "appropriate corrective action": the information must be (1) relevant and responsive; (2) limited and tailored; (3) non-promotional in nature, tone and presentation; (4) accurate; (5) consistent with FDA-required labeling; (6) supported by sufficient or substantial evidence, if necessary; (7) in the same area or forum; and (8) a disclosure that the corrective information is affiliated with the company.

Midway through 2014, the FDA seems to be on track to publish the advertising guidances identified in its annual agenda. At least one more guidance regarding use of links will deal with the Internet and social media.

This client alert is a publication of Loeb & Loeb LLP and is intended to provide information on recent legal developments. This client alert does not create or continue an attorney client relationship nor should it be construed as legal advice or an opinion on specific situations.