In 2009 FDA set up the framework outlining its approach to regulating promotional speech by pharmaceutical companies by posing five questions for discussion during a two-day public meeting the agency held in Washington, D.C. Rather than issue a single guidance document that outlined responses to those questions, what followed many years later were a few guidance documents specific to digital platforms – one on correcting third party misinformation and one on use of platforms with character space limitations. And in the course of addressing broader topics, there were other guidance documents that encompassed digital as well. An overview of FDA social media actions can be found on a tab set up on the blog site here.
With respect to character space limitations, the guidance document provided examples of branded communications where space would be limited – one for ostensibly for a platform like twitter and one for an online advertisement. There was no mention of creating a web site for mobile viewing on a small screen.
One of the few areas that provides any insight into the advance-regulatory thinking of FDA’s Office of Prescription Drug Promotion (OPDP) is looking at the research it conducts. In 2017 FDA completed a research project that analyzed promotional content regarding prescription drugs on mobile devices – i.e., tablets and phones, which was published in the Journal of Medical Internet Research (JMIR) in April of 2017. That effort examined 51 mobile communications that were DTC. The study had a particular emphasis on looking at the presentation of benefit and risks with regard to presence, place and prominence. Of these 51 advertisements, 35 of them linked to branded web sites. Of those sites, the researchers found multiple approaches to presenting risk and benefit information.
While fully trusting the research I engaged in a bit of my own that differed from the methodology used in the OPDP research and simplifying it greatly with perhaps a related, but different objective. I merely wanted to examine the approaches with respect to the landing pages of branded sites (not the advertisement that leads people there). I took a list of 20 top-selling drugs and visited their branded websites using my phone and my iPad. I looked to see if indication was mentioned on the landing page and how the risk information was positioned.
What I found indeed confirms the conclusions of the OPDP research – the approach is not uniform, though it does cover the bases. Unlike the last time I did a check on top-selling pharma branded sites, this time all of the ones I looked at were mobile sites, readable in the small screen. But the approach in design was often different. Many, for example, did not mention an indication on the landing page – leaving you to either click on prescribing information or scroll to find it. Likewise, risk information is often either click or scroll. And it happens in different combinations. Some with indication on landing and risk on scroll, others with risk on landing and indication on scroll or click. In other words, any lack of stated FDA preference or guidance has meant that different approaches are being taken. It is a little mystifying why OPDP would conduct research to discover what common sense would bear out.
For many, access to the Internet is actually reliant on online access via smart phones, and in particular, this is true for younger Americans, non-whites and lower income individuals, according to a Pew Research Center Fact Sheet dated February 2018.
It is not entirely clear how interested FDA is in this topic. While they have put some effort at research on the issue, a regulatory approach to this does not merit a decade of thought. Perhaps they are just taking the “risk-based approach” and assessing that any risk here is negligible, which would be hard to argue with. But if that is not the case, lacking any standards from the agency, companies will do the best they can. That is likely sufficient from a patient safety point of view, but at some point the agency could decide that a single approach is necessary. When that happens, everyone else will be wrong.