FDA Seeking Even More Input on Character Space Limitation

This week FDA published a notice in the Federal Register seeking comment on the proposed collection of information regarding research entitled “Character-Space-Limited Online Prescription Drug Communications“. The notice states that the objective of the research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about that drug are made within the character-space-limited communications used in prescription drug promotion.

In other words, if a tweet or small online ad mentions that Drug X Cures Toenail Fungus will a person run out and get their doctor to give them that drug without clicking on the link to warning information? Is this development a good one or one to be concerned about?It sort of depends on the agency’s motivation.

On the one hand, FDA’s curiosity regarding the matter of balancing risk information with benefit information in a character-space-limitation setting is to be commended. It demonstrates a healthy interest in exploring the realm of social and digital media – something the agency has been grappling with since 1996 when it held its first meeting on dealing with the newly emergent Internet. Understanding the implications of social and digital media has not come easy to FDA and the menu of guidance documents promised in 2009 at a two-day public hearing on the topic has produced only a partial response on the part of the agency. In fact, patients, physicians and pharma companies have moved far ahead, and FDA has been struggling to catch up for many years.

The issue of character-space-limitation is one of the areas in which FDA has actually shed some light by producing a guidance document on the topic in June 2014. Is the agency trying to crystallize its thinking in that regard? Are they looking for evidentiary support to go back on the position they took in April 2009 regarding the “one-click rule” – the notion that risk information could be included a click away – when they issued 14 untitled letters in a single day about the use of links to third party information? If so, that would be a good thing.

But on the other hand, one might question whether so much attention to this particular aspect of social media use by pharma is actually warranted.

In the first place, between the patient and the prescription there is a learned intermediary – the doctor. The real world is made up of many variables that will impact whether or not risk information is picked up. And the real world is made up of many attempts to alert patients to risk information, which may or may not be particularly useful. Right now many prescriptions are delivered with pages and pages of information about a drug, but how many people actually read and absorb that information? Are those inclusions really impactful? (I personally doubt it). Do people read them once? Do they read them every time they get a re-fill?  How people get risk information, how they perceive it and act on it and how other factors figure in is complex. In short, a study to discover the use of a single link to risk information is going to tell you a small part of the picture, but it is not going to tell you the whole picture, or anything looking like it.

In the second place, FDA might better spend its time addressing the gaps in guidance around social media – for example the Use of Links to Third Party Sites guidance that was on the guidance agenda not only this year, but last year as well. Or what about adverse event reporting, listed as one of the original five questions posed during the 2009 public meeting on social media?

Finally, in fact, while pharmaceutical companies have many Twitter feeds (I have a database that contains all of the feeds of which I am aware and there are over 300), the overwhelming majority of them are not product specific, but are oriented to corporate news, recruitment and advocacy. You can see the Twitter list here.

The decision to delve further into the question of a link to risk information is important, but the question has been around for a long time. Let’s get it answered and move on.

If so inclined, you can submit comments to the docket on this matter here. And for an overview of FDA activity around social media, there is a tab on the blog devoted to resources located here.