In June 2014, the FDA issued two draft social media guidance documents that may not clearly answer all of the questions that the drug and device industries have about how to use social media to promote their products. Any remaining ambiguity affords both the agency and industry the opportunity to further define the parameters of social media promotion of drugs and devices through ongoing trial and error whereby industry acts and FDA reacts - through enforcement letters - to reign in industry actions that the agency thinks push the social media envelope too far.
This "regulation through enforcement" is not an unfamiliar concept to the drug and device industries. It is a technique employed by the Office of Inspector General (OIG) through its Corporate Integrity Agreements (CIAs). OIG enforcement actions help to prescribe the boundaries of appropriate marketing and sales practices for drugs and devices and its CIAs enumerate the types of prophylactic activities that companies should (or must in the case of the signatories) put in place to prevent running afoul of those boundaries. There is perhaps no more prominent example of such a prophylactic activity than the proliferation of CIA monitoring and auditing requirements over the past few years.
So what implications might the two draft social media guidance documents have on the OIG's monitoring posture? Before considering the answer to that question, we need to have a basic understanding of what the social media guidance documents say.
Internet/Social Media Platforms with Character Space Limitations - Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
This guidance document sets out the FDA's thoughts on how a company should use platforms such as Twitter and search engine sponsored links as vehicles for the company's marketing messages. The agency makes clear that the limitations of these platforms do not relax traditional FDA promotional requirements. For example, the guidance specifically states:
Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.
The guidance demonstrates that the fair balance requirement survives in the Twitterverse and continues the agency's previous enforcement stance quashing the one-click rule. It also may effectively remove character-space-limited messaging from the tool kits of most drug and device company marketing teams. Query whether the tweets of company sales forces are as easily managed.
Internet/Social Media Platforms: Correcting Independent Third Party Misinformation About Prescription Drugs and Medical Devices
As the title suggests, this guidance explains how companies should go about correcting misinformation posted by independent third parties on the Internet and social media platforms. The guidance does not require that a company correct such misinformation but, if it chooses to do so, the document explains how to do so in a manner that will not lead to an FDA enforcement action. In particular, FDA states that, when correcting misinformation about a product, the communication should "be limited and tailored to the misinformation." FDA provides the following example to clarify this point:
A firm discovers a chat room where participants are discussing the firm's product for one of its approved indications - diabetes. The firm finds misinformation posted by an independent third party about the diabetes indication that the firm would like to correct according to this draft guidance. Although the product has multiple approved indications, the firm should limit its corrective information to the relevant diabetes indication being discussed.
Put another way, a company should not use a communication intended to correct misinformation about a product as a vehicle to promote the product. This harkens to FDA's expectation that responses to unsolicited off-label questions be narrowly tailored to the question asked and not be an opportunity to elaborate upon off-label information that is beyond the specific scope of the question.
The two social media guidance documents are meant to do just that, provide guidance on how companies should communicate - whether proactively or reactively - on social media platforms. The implications for companies venturing into social media communication go beyond the guidance provided by FDA. From a compliance program perspective, the two documents beg the question - what should a company's Compliance Department be doing to monitor social media communications to ensure that those communications do not violate company policies and procedures or the FDCA? I will explore this question later.
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