The Regulation of Search

Where are we when it comes to the regulation of search and digital media by FDA? After issuing some guidance documents, we know a little more about FDA’s approach to digital and social media, but there are still many outstanding questions. One of those may reasonably be related to search – the means by which users of the Internet find their way to your digital properties.

When FDA chose to begin addressing the regulation of digital and social media in November 2009, the framework in which the discussion occurred was set up to answer five basic question areas:

  • Responsibility – for what communications are companies responsible and accountable for in digital and social media?
  • Limited Character Spaces – how can this be negotiated while meeting regulatory requirements?
  • Misinformation – how can companies correct misinformation?
  • Links – how are they best used?
  • Adverse Events – how to handle?

It is these five topical buckets that have formed the conversation around the regulation of digital and social media. Many thought there would be a single guidance document to address social media, but FDA instead has handed out spoonfuls of regulatory insight through a penumbra of guidance documents and warning/untitled letters over a great span of time. In some ways, this paradigm for the conversation has been frustrating and in some respects, it is useful.

FDA wanted to avoid discussing platform-specific regulation – so, for example, there is not a Facebook focus. Rather, various areas of responsibility are spelled out so that using any platform (one here today or emergent tomorrow), one would have an idea of regulatory parameters in which to operate.

So what is the question on search? Specifically, how should stakeholders approach the optimization of a digital property for search?  That is a topic that would seem to fall in the responsibility bucket.

Responsibility, in turn, is a broad topic and is not addressed in a single document, but there is certainly a good deal to say on the matter.  For example, in the Draft Guidance Document on Correcting Misinformation, the agency states parameters when companies are responsible for content generated by third parties and when they are not. But responsibility is discerned not through a single guidance, but through the range of discussion by the agency regarding digital communications.

While not in guidance form, the answer regarding the question of responsibility and search may have been at least partially provided in a recent Warning Letter sent not by OPDP, but elsewhere from within FDA. This letter was directed to a company that the agency said was promoting an non-prescription product as a drug. The majority of the letter is directed at claims made with respect to the products. But one portion of the letter addresses the use of specific meta tags used to direct search to the sites – tags that related to disease specific conditions that helped support the agency point of view with relation to the promotion of products that were in fact being promoted to address specific diseases and conditions.

In short, while not from OPDP, FDA seems to make clear here that responsibility includes communication that a company generates to direct web searchers to a particular site. Specifically methods of search enhancement that drive traffic from Internet users seeking information on topics that may be off label could be problematic. That may seem obvious, but the issuance of a letter mentioning the meta tag use specifically informs stakeholders that the agency is looking at this.

This is one of many examples of how insight into understanding that the regulation of the use of social and digital for industry is a an on-going process represented through the evolution of thought as expressed not just in guidance documents, but in enforcement patterns requiring the many stakeholders in this area to look at and understand the whole picture.

Just a reminder that on the Eye on FDA blog site, there is a special page reserved for a comprehensive look at developments in the regulation of digital and social media. You can check it out here.

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