The FDA Issues More Pieces of the Social Media Puzzle

By | 2016-11-04T16:57:55+00:00 January 22, 2014|Viewpoints|

The FDA has chiseled more guidelines into the social media tablet that is coming down from the mountaintop on July 9, 2014. These newest guidelines have created some excitement around several important areas:

  • A brand will not be held responsible for content it did not create

  • There is no requirement for prior submission of content produced inside a “real-time channel,” although monthly submissions of activity must be made
  • Brands can provide third-party bloggers or managed communities with educational or promotional materials as long as they have no control or influence over how those materials are used

The first two bullets are somewhat liberating for content marketers and social media advocates—and somewhat Zen-like.  Not being responsible for something one has nothing to do with is a safe assumption in most of life’s circumstances, but in pharma’s regulatory world it’s nice to see it in writing. However, the question of responsibility for unapproved information that is simply incorrect is left open. Does the brand have an obligation to safeguard the public by correcting inaccurate information? And in doing so, has a brand joined the conversation in a promotional manner that puts it in less-defined territory? And responsibility for reporting AEs as they come up in third-party conversations presumably remains the same. Unless more explicit guidance is issued, those questions will be left to individual company regulatory groups—and we know what that can mean.

ob Palmer, EVP, Digital Practice

ob Palmer, EVP, Digital Practice

Equally Zen-like is the ruling that prior submission is not required for content produced in real-time channels, which amounts to the FDA granting permission to engage in basic social media. Metaphysical issues aside—obtaining prior consent for spontaneously created content would be quite a trick—it is a very significant ruling; social media is relatively ineffective if conversations are perceived to be contrived and promotional. But again, there are significant unresolved issues, such as how and when to provide fair balance in a 140-character missive. And should off-label information be immediately deleted if it appears in a blog string, a Twitter discussion, or on a Facebook wall? Such deletions would negatively impact a brand’s social media credibility, amounting to censorship in what is usually an uncensored environment—which may be worse than not participating in the first place.

It is a very significant ruling that brands can now feel free to provide third-party bloggers and managed communities with educational or promotional materials. To simply hand these materials over to key influencers and then step back can be a powerful tool in the battle to promote trust. Trust is the most basic building block of effective social media and content marketing. If we believe in our products and their benefits, then we have nothing to fear. Of course, some important restrictions are implied; once information is provided, can there be subsequent one-to-one conversations if the third party has questions regarding the information? Does that enter the restricted zone of brand influence, or is it the responsible way to respond to legitimate questions? What if a pharmaceutical company’s medical director fields the response, instead of someone from marketing – should that be standard best practice, and does that make a difference?

The FDA’s objective has never been to lay down specific guidelines on how to use Twitter, Facebook, Pinterest, or any of the many social media platforms that spring up with dizzying speed. Their objective is to warn us away from areas within those channels that violate rules regarding off-label communications that would be enforced with or without social media. If we accept that there will never be a comprehensive “User’s Guide to Social Media” for pharmaceutical marketers, we can concentrate on the pressing issue of streamlining internal regulatory processes so marketers can do their job. In a world where “lead, follow, or get out of the way” is a fundamental business mantra, we marketers have to find a way to lead so that regulators can safely get out of the way.

There are other nuances to these most recent FDA guidelines, many regarding how to respond to off-label, unapproved questions, information, or postings. Big issues remain unresolved, such as establishing how many clicks away from a promotional Tweet should a product’s disclosures be. But the broader, more fundamental questions surrounding social media and content marketing are slowly being addressed, and it’s obvious that the FDA expects pharmaceutical marketers to actively participate in social media. If pharma marketers can resist the urge to merely use social media for promotional purposes, seeing it as a great way to educate and answer legitimate questions about their products, we could be on the brink of a great leap forward in building trust and understanding with our customers. While there’s no reason to expect a perfect solution in July, we should at least be in a better position to join the communications revolution that has been going on without us.

Let me know your thoughts on the new guidelines.  How do you think they’ll change the way we use social media?

About the Author:

Robert Palmer
EVP, Digital Innovation Officer

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