Since the inception of blogs, Facebook, Twitter, YouTube and other social media platforms, many life sciences companies, mainly big pharma, have been anxiously awaiting regulatory guidance from the US Food and Drug Administration on how to use them. Interestingly, FDA did issue some guidance in 2012 on it use last year but many drugmakers felt that it was insufficient and not detailed enough. Despite the lack of clearly defined regulatory guidance, many companies took the social media plunge anyway. And according to a recent survey of regulatory actions and letters conducted by Mark Senak author of the fabulous EyeonFDA Blog the agency has done very little to thwart the social media strategies implemented by drug companies. In fact, there has been no obvious increase in the number of warning letters or violation letters regarding the use of digital or social media as compared with traditional media violations.
Senak drew this conclusion after analyzing 173 warning and notice of violation letters (advertising and media related) that were issued by the agency from 2008 to 2012. Of the 173 regulatory letters that were issued, 675 violations were cited and only 43% involved digital media. And, for the most part, most of the cited violation had little to do with the digital or social media vehicle used but more to do with the message being delivered. For the full report click here.
What does this all mean? While it is difficult to draw any firm conclusion, I believe that the bottom line is that the importance and significant of the long awaited FDA guidance on the use of social media has been overstated. Put simply, if you follow the existing rules guiding advertising and print media, companies ought to be able to craft a regulatory-compliant social media communication strategy without the fear of running afoul of the agency. Those who violate the existing rules will likely be caught and have to clean up their acts.
The bottom line. Many drug companies have been able to mount very effective social media campaigns without getting into trouble with FDA. The key to success is following the rules and implementing a digital/social media campaign that has passed internal regulatory muster to insure that everything is in order and regulatory compliant. Companies that have made the investment into digital/social media will be successful whereas others that jump into the game without taking the time to understand the rules of engagement will fail.
Until next time…
Good Luck and Good Job Hunting!!!!