Social Media Not Attacked By FDA As Much as Thought

Social Media Not Attacked By FDA As Much as Thought

April 2nd, 2013 // 5:35 pm @

For the past few years, one obsession in the pharmaceutical industry is the proliferation of social media tools and the lack of regulatory guidance from the FDA on how to use them without getting into trouble (a back story here). The uncertainty, however, has not prevented drugmakers from tiptoeing into this marketing realm, but the activity also begs a question – to what extent has the use of digital communications prompted the agency to issue warnings?

A new survey finds the answer is, simply put, not very often. Social media properties – such as web sites, Facebook pages, blog and YouTube channels, have actually not increased the number of regulatory action letters involving digital communications, according to Mark Senak, a senior vp at Fleishman-Hillard, a communications consulting firm, who writes the EyeonFDA blog.

After dissecting 173 regulatory letters –both warning letters and notice of violation letters – from 2008 through 2012, he also found there was no increased proportion in the number of violations versus traditional media properties; no increase in warning letters directed to companies concerning digital communications, and only property was the subject of more than one letter regarding the use of a social media platform.

“FDA expresses policy through only two means, guidance and these letters. Lacking guidance, this is the only window into what they are thinking. And looking at the numbers, particularly the fact that traditional media platforms get more warning letters than digital and the fact that digital does not appear to be increasing in proportion, it is an indication that digital may not be the regulatory bogeyman that many think it is, though there are obvious limitations to the data,” he writes us. For instance, he acknowledges that the proportion of digital versus non-digital platforms used in communications is unclear, which means it is hard to say which type incurs more risk.

But as the report states: “In short, there is nothing in the regulatory enforcement patterns of the (FDA Office of Prescription Drug Promotion) to suggest that digital and social media carry a higher risk of regulatory action by the agency. In fact, traditional communications vehicles —print, advertising, and video — not only continue to take the lion’s share of enforcement, but also bear the brunt of more serious types of enforcement from the agency by receiving more warning letters than do digital communications efforts.”

Here are some nuggets: Of the 173 regulatory letters issued, 675 violations were cited and 43 percent involved digital media vehicles.  And of these violations, 19 percent minimized or omitted risk. And just what was the regulatory enforcement pattern?

Frequency: Of 236 violations cited, 56 percent concerned traditional communications – brochures , exhibit booths, sales aids. Most of the digital violations involved web sites or sponsored links.

Comparison of violations: In all, there were 173 letters involving 236 communications vehicles with 675 violations. Each letter usually contained more than one violation and often more than one form of communication. Again, a majority – 57 percent – involved non-digital communications.

Frequency of more serious violations: Of the 173 letters, 26 percent, or 45, were warning letters and only 12 involved digital communications. Meanwhile, the total number of communications vehicles cited were 61, but only 16 were a digital form of communication. The remaining 74 percent were notice of violation letters.  In short, warning letters were issued three times more often for non-digital communications.

Year-By-Year Comparison: Between 2008 and 2012, letters issued for digital communications exceeded traditional communications only once – in 2009, 52 such letters were issued compared with 24 for traditional communications. And during 2011 and 2012, the overall number of letters were 35 and 33, respectively, down from 66 in 2010 and 76 in 2009.

Only one of the 173 letters involved a so-called social media asset, specifically, such as a Facebook page, blog or YouTube channel. This one letter involved a Facebook page widget. “The influx of social media assets by pharmaceutical companies has not resulted in an increase in FDA regulatory actions regarding social media.”

There were other violations involving videos, but these represented violations that would have been cited whether a video was on a social media site or note. In other words, the message, not the medium, is the issue (HERE IS THE COMPLETE WHITE PAPER).

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