Recently FDA’s Office of Prescription Drug Promotion (OPDP) published an untitled letter issued to Institut Biochimique SA for this Facebook post. As can be seen from the screenshot, the claim made in the post omitted safety information as well as statements of material fact (the approved indications). While none of these violations is groundbreaking, the fact that the letter was issued as the result of a Facebook post caused a bit of a flurry in the blogosphere.
Many in industry have long puzzled over the use of social media, perhaps fearing that the larger audience would prompt greater scrutiny from FDA. FDA, for its part, has asserted several times that while the manner in which the medium interacts with the message and the viewer is important, the standards for what is false and misleading remain the same regardless of the medium. While we don’t truly know whether the medium caught FDA’s attention in this case, the letter did not emphasize the fact that the claim was made over social media. After all, a claim that omits all safety information and indication statements could certainly draw FDA’s attention even if the claim was in printed format.
If there is a takeaway here, it’s that industry should not be concerned over this letter. While it’s important to be cognizant of inherent differences in mediums, and the effect these differences have in how claims should be presented, the fundamental concepts of false and misleading remain the same. This letter does nothing to change that narrative. We will, of course, continue to monitor the attention given to social media by FDA, but for now, stay the course. Nothing to see here.