Remember when the calendar was turning to the year 2000 and there was a great hand-wringing going on about whether or not Y2K would bring a digital meltdown? And then the clock ticked, and it didn’t?
One was reminded of that when for many weeks leading up to August 15, the date when Facebook would institute policy changes that would no longer allow blocked comments on corporate pages, there was a lot of buzz in the pharma communications community about what that would mean. Would companies have to pull their pages down? When would FDA finally issue its long-tardy guidance that might answer some questions related to interaction between medical product companies and patients?
But ultimately whether or not a company would stay or go and what the policy would mean to them depended on the regulatory culture of each respective institution. It is worth noting that social media has been around now for several years, and pharmaceutical company participation in it has slowly crept up. There are a number of YouTube channels and while many do not allow commentary, some do. There are, by my last count, 156 pharma sponsored Twitter feeds sending out Tweets daily – any one to which a person could hit reply and make a comment. One company held a Twitter Chat and as the venerable Jonathan Richman noted – the world did not come to an end.
In fact, the policy change does not seem to have resulted in much of a stir at all, per this Spreadsheet put together by Matthew Snodgrass at the CommonSense blog premised on the nice research and tracking by Jonathan Richman at Dose of Digital.
It seemed that prior to the angst over the policy change, two important facts were not being taken into account by all. First and most obvious, there already is a good deal of interchange between the public and medical product manufacturers in digital and social media, and the world has gone on. Second, there are two avenues for FDA’s DDMAC to enunciate policy – one is by guidance – which the agency has failed to do – and the second is through regulatory action letters more commonly known as Notice of Violation (NOV) letters (of which DDMAC also does not issue many). Among those letters over the past four years, there has been no action taken due to any interchange between manufacturer and the public via social media.
In fact, the only regulatory action that has been taken involving a specific social media platform has been the NOV letter issued by DDMAC about sharing via the Facebook share function which when used failed to convey risk information with indication with a specific product. Any other regulatory action letter from DDMAC involving digital media over the past four years regarded a violation that would have been noted had the material been carried by broadcast or print media. In the words of the FDA in the podcast carried here on Eye on FDA from March 2009 – it is not the medium, but the message which has been the issue.
This is not to mimize the risks involved in social media by a highly regulated industry like the pharmaceutical industry but rather assess the risk in perspective. There certainly is risk involved for companies engaging in social media. But it is important to bear in mind that there is also risk for companies involved in traditional media – more risk if one looks at the way the warning and NOV letters have stacked up since social media has become so enmeshed in our communications. There, the most common violation over the past four years has been the failure to convey risk information in print or video when promoting a product. That is the single biggest regulatory risk companies take when communicating. As policies change among digital platforms, and new platforms come on line (such as Google+), it is perhaps important to remind ourselves of the facts.