Social Media Promotion in a FDA regulated World -- Part 2

This section focuses on the FDA's opinion of social media and promotion via the internet in general and social media in particular. 

FDA’s Opinions

Introduction

The FDA has often hinted that it treats social media the same as every other type of media. Early indications of this “medium neutrality” has been seen in enforcement actions against several pharmaceutical innovators. Specifically, in the case of social media, this message has been communicated in enforcement actions relating to youtube and facebook.

The FDA’s enforcement actions against individual companies and based on specific violative promotions may not necessarily indicate its official position against companies in general. Nevertheless, these enforcement actions provide us with informal indications of how it intends to respond to similar stimuli.

For the most part, a “take away” that has often been seen is: If the consumer/ intended audience can see, hear or have the company message hinted at, the FDA considers to “fair game” to assert that such a message reflects the company’s “official position”. While “seeing” and “hearing” are difficult enough to control, the “hinted at” portion of promotional pieces is particularly worrisome since what constitutes a “hint” has not been objectively well defined.

Impact and Fines

While the FDA, HHS and the DOJ have long had the authority to go after illegal activities by pharmaceutical companies, and have often used this authority, the last two years have demonstrated the FDA’s renewed focus and zeal associated with the enforcement against such activities. While such enforcement activities were often limited to audit reports, untitled letters and warning letters culminating in corporate integrity agreements, the stakes are much higher this time around. Some of the notable enforcement activities have included combining forces with the Federal Trade Commission (FTC), and engaging in enforcement proceedings against “responsible corporate officials” in combination with the Department of Health and Human Services (HHS) [4] and Department of Justice (DOJ)[5].

What is likely to be Regulated?

41% of surveyed individuals said that they use social media as a source of health care information.[6] A significant portion of this information necessarily includes the drugs and devices that these individual may either already be using or are actively considering using. The FDA recognizes these changes in information gathering methods, and seems to understand that there are limitations imposed by this “new media”. It has nevertheless continued to maintain that information provided by pharmaceutical companies is subject to the same rules irrespective of how the information is distributed. While this consistency relating to “medium neutrality” is useful for many, the interactive nature of the Internet causes significant problems particularly resulting from the innate interactivity associated with the internet, and limitations in disclosures that such media necessitate .

The FDA has indicated that it intends to address several of these concerns with multiple guidances it intended to originally release starting in 2010. The release dates of those guidances have, unfortunately, now been pushed into the first quarter of 2011.[7] This write-up intends to address some of the impending guidances and the potential directions it may take.

The next blog posting shall focus on specific themes that the FDA is likely to follow in the regulation of this "new media."