Reading the Tea Leaves: When Will the FDA Issue Social Media Guidance?

Posted by: in Healthcare Insights, Medical Communications on December 7, 2012

For watchers of the U.S. Food and Drug Administration, the question of whether a new year will bring solid social media guidelines has become as much a part of December as peppermint bark and “Grandma Got Run Over by a Reindeer.” So will the FDA act in 2013?

In November, the answer was “yes”: “The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says.” (Drug Industry Daily)

In August, the answer was also “yes”: “Social media ‘high priority’ for FDA 2012, despite lack of 2012 guidance.” (Scrip)

In June 2011, the agency said it was poised to act: “Tom Abrams, director of FDA’s Division (soon to be Office) of Drug Marketing, Advertising & Communications (DDMAC), said that publishing social media guidelines for industry is the division’s “highest priority.” (PharmaExecBlog)

The FDA said it was ready in March 2011, too: “Policy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities.” (FDA email)

And two years ago, in December 2010, guidance was imminent: “Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011.” (FDA email)

Of course, this was all kicked off in November 2009, when the agency held a two-day meeting on social media that was capped by a firm commitment to come up with rules: Social media guidelines are “important and we will do it.” Tom Abrams, Director, Division of Drug Marketing, Advertising, and Communications (FDA Public Meeting, page 450)

I don’t mention the historical record to suggest that 2013 won’t be the year where some pressing questions are answered (though the agency is working against a summer 2014 congressional deadline). Clearly, whatever the communications concerns that prompted the original FDA meeting in 2009 have only grown more clear, and some sort of action will come, either dramatically or more gradually. But, as the past few years shows, the tea leaves remain hard to read.

So what should companies be doing in the meantime? The advice remains almost unchanged from what we were suggesting two years ago: move quickly — and cautiously — to build up social media chops in corporate and unbranded spaces, improve online monitoring and work to understand and engage with the new leaders in social media. And if you need help with that? Well, we’re standing by. Drop us a line.

By: Brian Reid

Brian Reid is a managing director at W2O Group, where he oversees influencer relations. He is a former journalist who believes content really is king.

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  1. The Op-Ed: FDA Really Will Issue Social Media Rules | Global Regulatory Science linked to this post on January 14, 2013

    […] deadline came and went (see this), though the agency told reporters that the new rules were among its “highest priorities.” But […]

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