Socializing Medicine – FDA Enforcement Involving Social Media

Have you ever had a conversation with someone who said pharma needs to stay away from social media because it is too risky? Even today, some hold that opinion. When social media, used primarily by individuals in its nascent stage, began to migrate into use by institutions, highly regulated industries were necessarily wary. In particular, the pharmaceutical and biotech industry had reason to be concerned given all of the oversight over promotional speech in print and broadcast. Add to that the slow and often confusing efforts by FDA’s Office of Prescription Drug Promotion (OPDP) to enunciate regulatory positions and what resulted for many was a genuine reluctance to engage.

Today, however, most companies are involved in social media platforms, some more than others, and do so across a spectrum – from career recruitment on Twitter to corporate communications and even a small amount of product-specific efforts. There are hundreds of industry sponsored Twitter feeds, Facebook pages, YouTube channels, Pintrest pages and on Periscope. However, there are still some who believe that digital communications in general, and social media in particular, is a riskier communications adventure than traditional communications vehicles.

In 2013, I tried to address that somewhat by issuing a white paper that compared OPDP enforcement actions as represented by the issuance of Warning or Untitled Letters. Measuring the period when institutional adoption of social media was in its ascendancy – 2008-2012 – the results demonstrated that not only did traditional communications vehicles such as print ads, brochures and sales aids garner the bulk of violations, there was no increase occurring among digital media when you looked at it on a year by by year basis. That analysis was recently updated in a blog posting that again showed no increase in regulatory actions aimed at digital properties.

But that is digital broadly, where have the pitfalls been when it comes to social media?Looking through my warning letter data base which tracks enforcement through a range of characteristics, I came across only six OPDP letters involving a social media communications vehicle. Here is a brief overview:

  • 3 involved YouTube
  • 2 involved Facebook
  • 1 involved Instagram (with subsequent Facebook posting, also deemed violative)
  • It is perhaps notable that no violations occurred involving Twitter, despite the fact that Twitter is likely more heavily utilized by industry in number of outlets, number of updates and number of followers than any other social media platform
  • All in all, with the Instagram posting to Facebook, there were a total of seven social media encounters in the six letters occurring between the years 2008 and 2016 (this year’s only letter so far did involve a YouTube video)
  • Two of the letters involved situations involving the use of patient testimonials
  • Two of the letters were Warning Letters, the rest were Untitled
  • Of these seven, six of the violations had nothing to do whatever with the fact that the communication occurred via social media. In other words, had the same communication been carried in a written brochure, the material still would have been in violation
  • The single violation that did relate to the social media platform was the situation involving a Facebook Share widget whereby the risk information did not convey when shared;
  • In fact, the common thread through all of the social media-related violations was the minimization or omission of risk information

So while not to suggest that social media is risk-free (any communication carries risk), 6 letters involving social media over 6 years is not bad considering the migration of communication by both industry and patients into social media and health.By contrast, looking at the same time period, there were 22 letters citing brochures for violations. While not definitive, it certainly gives you something to respond with next time someone says that social media is too risky for industry.

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