OPDP Issues Untitled Letter Involving Social Media

Sort of.

There is, of course, a difference between a regulatory action letter that is issued because of a social media use and a regulatory action letter that is issued the communication happens to involve a social media platform.  In the former, there is something about the unique aspect of the social media platform chosen that has caused there to be a violation. That was the case in 2010 when FDA issued a letter regarding the use of a Facebook share widget that did not convey the risk information with it.  The latter, however, involves the use of a social media platform to convey a communication that would have been a violation if it had been via social media or if it had been written on a piece of paper in a brochure.

This week FDA’s OPDP issued only the second violation letter of the year.  It was an untitled letter to a company because of the use of its Facebook page. It was not the fact that Facebook was being used, but rather the fact that there was a statement on the page that advised the reader  – if you had been diagnosed with the condition for which the drug was indicated, you should talk to your doctor about a prescription.  The mention of the indication and the drug, which has a boxed warning on the label, included no risk information about the drug.

In addition, the Facebook page failed to mention some of the limitations of the use of the drug – the boundaries of its indication.  For these reasons – failure to include risk information and omission of material facts, FDA stated that the page was violative.  FDA directed that the company cease the violation.  A response could be amending the page with the edifying information or taking the page down.  Following the link provided in the letter to the Facebook page, apparently the page was taken down.  FDA, however, provided a shot of the Facebook page with the material on it here.

It is worth noting because there is sometimes a hypersensitivity to risk involving social media that leads some to believe that any use of social media is inherently risky.  But in this case, the medium did not provide the risk.   It is not unlike videos that have been cited in violations on YouTube where risk information was not conveyed.  Like them, it was the classic case where – as FDA stated in the podcast here on Eye on FDA in April 2009 – it was the message, not the medium.