The U.S. Food and Drug Administration (“FDA”) released two new sets of guidance regarding the use of social media to disseminate information about prescription drugs and medical devices.  This guidance supplements years of FDA warning letters and untitled letters sent to manufacturers, packers or distributors in regulated industries (each a “Regulated Entity”).  We have previously discussed the FDA letters on this blog.

In the first prong of its social media guidance, the FDA provided new “Twitter Rules.” For Internet and social media platforms with character space limitations (e.g., Twitter, Google AdWords and the paid search results links on Yahoo! and Bing), the Regulated Entity must present risk and benefit information for prescription drugs or medical devices (U.S. Department of Health and Human Services Food and Drug Administration, Guidance for Industry Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014).  In the guidance, the FDA reminds the Regulated Entities that the “benefit claims in product promotions should be balanced with risk information.”  That is, for every statement of a drug or devices benefit, the benefit description should:

  • be accurate and not misleading;
  • include material facts about the indications and usage of the product; and
  • be accompanied by risk information disclosing, at a minimum, the most serious risks associated with the product (Id., pages 5 and 9).

In addition to balanced drug or device descriptions, the description should provide “direct access” (e.g., a URL) to a more complete discussion of the associated risks (Id., page 8).

The FDA recommends that Regulated Entities “carefully consider the complexity of the indication and risk profiles for each of their products to determine whether a character-space-limited platform is a viable promotional tool for a particular product” (Id., page 4). In other words, the FDA is signaling that the agency believes online interactions having a limited character space may not be suitable for discussing the benefits and risks of drugs and devices, and as such, the FDA may show less flexibility when objecting to behavior on platforms with character space limitations, both in present-day enforcement and in future guidelines.

In the second prong of social media guidance, the FDA addressed the murkier topic of misinformation made public by unrelated third parties (“User-Generated Content” or “UGA”) as part of a conversational media forum (e.g., Facebook, Twitter, Tumblr, etc.) regarding a Regulated Entity’s own prescription drugs and medical devices (U.S. Department of Health and Human Services Food and Drug Administration, Guidance for Industry Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices ( June 2014).  If a Regulated Entity chooses to correct erroneous UGA, any “appropriate corrective action” should “address all misinformation in a clearly defined portion of a forum on the Internet or social media, whether the misinformation is positive or negative.”  To qualify as “appropriate corrective action” the Regulated Entity’s corrections should meet the following criteria (Id., pages 5 and 6):

  • Be relevant and responsive to the misinformation;
  • Be limited and tailored to the misinformation;
  • Be non-promotional in nature, tone, and presentation;
  • Be accurate;
  • Be consistent with the FDA-required labeling for the product;
  • Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
  • Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
  • Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

Appropriate corrective action may be provided directly on the conversational media forum itself, when feasible (Id., page 7); or to the independent author for the author to incorporate (Id., page 8); or request that the author or site administrator modify or remove the misinformation (Id).  It is important to note that this guidance does not mandate that a Regulated Entity actively police all UGA available on the Internet.  Instead, it outlines the process by which a Regulated Entity may go about correcting misinformation in conversational media.

As a reward for staying within the boundaries of this guidance, the FDA “does not intend” to enforce the more stringent standard requirements related to labeling or advertising (Id., page 9). If a Regulated Entity chooses to provide information outside the scope of this guidance, however, it will be subject to the aforementioned labeling and advertising requirements.

Jay Greathouse (jay.greathouse@nortonrosefulbright.com / +1 210 270 7155) is a lawyer in Norton Rose Fulbright’s San Antonio Corporate, M&A and securities practice.