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In recent years, guidance by the U.S. Food and Drug Administration (“FDA” or “Agency”) for industry on the use of social media has continued to evolve in incremental steps, but the pharmaceutical and medical device industries continue to await more comprehensive guidance regarding the use of social media for drug, biologic, and medical device product communications. Beginning with the “sponsored link” warning letters to 14 pharmaceutical manufacturers in April 2009 and through the most recent untitled letter involving social media promotion sent to Swiss drug manufacturer Institut Biochimique SA (“IBSA”) in February 2014, much of FDA’s guidance on the use of social media for product communications has come in the form of untitled and warning letters to manufacturers. These letters demonstrate, in particular, that FDA has been independently scrutinizing social media outlets, including Facebook,1 Twitter,2 and YouTube,3 and offer a window into FDA’s nascent social media policies.

While it is clear that FDA has held social media promotions to the same standards as traditional prescription drug promotional media (e.g., balance of therapeutic benefits and potential risks, and stating only FDA-approved indications), drug and medical device manufacturers are still uncertain about the boundaries on using social media to promote products  and  interact  in  real  time  with  customers  and  about  how  to  submit  such materials to FDA for approval. Though recently issued guidance documents shed some light on the manner in which companies may utilize social media platforms to communicate regarding their products, FDA has not yet provided the more extensive guidance anticipated by industry in advance of the July 2014 deadline for FDA to issue social media guidance established by Section 1121 of the Food and Drug Administration Safety and Innovation Act (“FDASIA”). In the absence of comprehensive guidance, an increasing number of manufacturers are forging ahead to promote their products through social media.

FDA’s Latest Facebook Enforcement Action

FDA’s Office of Prescription Drug Promotion (“OPDP”) recently sent an untitled letter to IBSA and its U.S. agent, Akrimax Pharmaceuticals, LLC, warning IBSA that its Facebook site for a prescription drug, Tirosint, violates FDA’s promotional labeling requirements.4 The letter stated that IBSA had failed to disclose any risks associated with Tirosint, whose label contains a Boxed Warning and other specific Warnings and Precautions, and did not include material information about the drug’s FDA-approved indications that limit its therapeutic uses. OPDP stated that the Facebook post was misleading because it “suggests that Tirosint is safer than has been demonstrated” and failed to convey the limited extent of the FDA-approved indications.

As with some previous enforcement actions involving social media,5  FDA  became aware of the violation through its internal monitoring and surveillance program, meaning that FDA continues to monitor manufacturers’ social media sites, as well as traditional static websites, for statements that violate promotional labeling rules. This enforcement action highlights why manufacturers must pay close attention to information about their products posted on social media outlets, and should carefully consider the recently released Draft Guidance (discussed below) on submitting social media promotional materials for FDA review.

Draft Social Media Guidance

On January 13, 2014, FDA released a significant piece of the social media guidance that manufacturers have been seeking. The document, “Draft Guidance: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” (“Draft Guidance”),6 sets out the Agency’s expectations for submitting prescription drug promotional materials to be posted on social media sites. The Draft Guidance states that FDA intends to exercise its enforcement discretion regarding regulatory requirements for postmarketing submissions of interactive promotional media under “certain circumstances.” In its determination of whether a drug or medical device manufacturer is responsible for submitting specimens of interactive promotional media, FDA will consider the following criteria:

The Draft Guidance recommends that manufacturers submit interactive promotional media using the following possible approaches:

FDA specifies that the Draft Guidance applies only to interactive promotional media rather than traditional static webpages (e.g., a product webpage without interactive elements).

Broader Implications

While the Draft Guidance answers some basic questions about how companies may submit interactive promotional media to FDA, the guidance does not address all aspects of social media use for product communications. FDA is expected to provide additional guidance covering other aspects of social media promotion in the near future.

One particularly notable example of the Draft Guidance’s incompleteness is the absence of any mention of the “like” function on Facebook or any similar function on other social media sites allowing one to “endorse” another’s post. FDA warning letters have addressed the use of the “like” function,7 indicating that the Agency considers such use a promotional activity; however, the Draft Guidance does not clarify whether “liking” or “re-tweeting” someone else’s post gives a manufacturer “control or influence” over a third-party site.

FDA’s recommended approaches for submitting interactive promotional media clarify that manufacturers need not report all real-time communications in separate submissions. Instead, a manufacturer must initially submit (1) its own entire interactive or social media website, or (2) the home page of a third-party site on which the manufacturer posts along with the first communication on that site. Otherwise, a manufacturer must submit monthly reports listing sites on which the manufacturer is an active participant. This implies that FDA will independently monitor manufacturers’ real- time promotional communications by periodically reviewing the listed sites. We expect that the interactive media submission requirements will continue to evolve as FDA begins regular surveillance of reported websites. Given the greater visibility resulting from required submissions, the industry will likely continue to see FDA enforcement in this area.

Compliance Considerations

Although the Draft Guidance is not yet final, it represents FDA’s current thinking on enforcing manufacturer compliance regarding interactive, real-time promotion of prescription drug products on social media outlets. Manufacturers should review current policies and procedures on product promotion and submitting marketing materials to FDA in light of the Draft Guidance and determine whether to take advantage of the comment period to provide comments and suggestions to FDA before the April 14, 2014, deadline. FDA has stated that it will provide clarification on the Draft Guidance in July 2014.

In light of the recommendations offered by FDA in the Draft Guidance, manufacturers should consider the following questions: