FDA Draft Guidance for Social Media Platforms

By | 2016-11-04T16:57:29+00:00 September 15, 2014|Viewpoints|

The FDA’s draft guidance regarding the pharmaceutical industry’s use of social media platforms that have character space limitations—Twitter being the most obvious platform—is a credible effort to encourage the creative use of such platforms while adhering to long-established FDA guidelines regarding fair balance. While branded promotional use of such platforms offers some serious challenges, the door is open for creative unbranded efforts such as disease awareness, disease education, patient advocacy, patient support, and customer service. It’s important to consider that social media is most powerful when communications are not directly related to a brand, so perhaps the medium’s limitations regarding branded communications is in some respects an opportunity to most effectively think of it as a marketing tool.

Branded communications immediately run into regulatory hurdles that most other channels simply don’t face. While the FDA draft guidance provides examples of how a few hypothetical drugs could possibly promote themselves within 140 characters, these examples aren’t exactly cause for celebration. The lead characters need to spell out the “material facts” about indications and limitations of use (e.g., “mild to moderate”); the remaining characters must spell out the risk information and “certain other required information.” The other required information includes the brand’s generic name; a ten-letter generic name is on the short end of the scale, yet it would consume ten percent of the allotted characters. Under these guidelines, the word “promotion” becomes irrelevant.

There may be, of course, some imaginative solutions to the branded promotion dilemma, such as embedded video, click-to-call, and sponsored link promotions. Risk information could be elaborated upon by providing a URL that links to the brand’s Important Safety Information—not an ideal solution in itself, since the guidance suggests that “/risk” be appended to the URL, making the example they provide consume 20 of the 140 characters. And that doesn’t let the brand off the hook regarding the disclosure of the most prevalent risks within the 140-character limit; it simply provides a vehicle for disclosing the full ISI. Since most medical regulatory bodies will err on the side of caution, in most cases we’ll run out of letters before we run out of risks.

So that leaves unbranded communications, and the possibility of creating communications that are much more likely to appeal to real people. Twitter could be very effective for nonpromotional usage that is designed to reflect well on a brand by engendering trust, providing highly relevant information, and promoting community. Hyperlinks that lead to sponsored (as opposed to product-branded) landing pages, videos, and other non-branded assets can offer great value to patients, caregivers, healthcare providers, and, by extension, brands. The recent Digital Health Coalition survey of its DHC Health Scholars found that fewer than 20% of those surveyed think that the guidelines would stifle or limit unbranded communications, while almost 60% think it will stifle or limit branded communications. If the FDA has further opened the door to creative thinking about social media communications that our most important constituents are actually open to receiving, then the FDA has accomplished what our industry has previously failed to address.

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About the Author:

Robert Palmer
EVP, Digital Innovation Officer

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