Over the past few years, regulatory action letters from FDA’s Office of Prescription Drug Promotion (OPDP), while once plentiful, has been something of a rare occurrence. In response to questions on the matter, FDA was often vague. This week however, OPDP was on the move in ways worth noting, issuing not one, but two regulatory action letters and announcing plans for some study of direct-to-consumer advertising. Together with recently reported comments from FDA, the letters bring into sharper focus the picture of of the current enforcement approach by the agency than there has been for a while.
First, the letters. These were only the fifth and sixth letters of the year. The first was a Warning Letter (as opposed to Untitled Letters).
In the first letter posted this week, the communications vehicle involved was a Facebook page, making it the third letter in the long history of OPDP to involve that particular social media platform. The product, inhaled insulin for the treatment of diabetes, comes with a boxed warning. The violation was the most common violation of any – the presentation of risk information. The fact that the violation occurred via Facebook communications is actually not relevant, but that it was digital is. When FDA set up a framework for considering how it would regulate social media in November 2009, the framework involved specific questions for which the agency was looking for input and one of them was the appropriate use of links. However, no specific guidance has been forthcoming on that topic. That said, for a long time, it has been clear through enforcement actions that risk information cannot be incorporated by reference (or link) and must be present when viewing the benefit information. In this case, the Facebook posting in question talked about taking insulin with “no drama” and referred the viewer to a page for full prescribing information on the one hand, and had a pop-up when the cursor hovered over the logo on the posting, but the agency stated that is not adequate.
The second letter was an Untitled Letter and was unusual in that the communications vehicle involved the words spoken by a sales representative. Of the 329 letters in my data base of warning/untitled letters, this is only the 14th involving an oral statement. FDA was citing language made by the sales representative during a presentation that it said promoted a product for a use for which it was not approved and in addition, minimized the risks associated with the use of the product, which also came with a boxed warning.
Recently Dr. Janet Woodcock, head of FDA’s Center for Drug Evaluation and Research, was quoted as saying that the agency was taking a more cautious approach to enforcement in light of First Amendment issues and was focusing on situations where there might be an important safety concern.
That said, low enforcement obviously does not mean no enforcement. While different circumstances, both of the letters involved products with boxed warnings. In fact, of the six letters issued this year all but one involved a product with a boxed warning. It is notable also that both involved reports of violations made to FDA through the Bad Ads program, whereby healthcare professionals are encouraged to report violations.
And aside from letters, OPDP also published intent to conduct some specific studies related to promotional aspects of medicines and direct-to-consumer advertising. One of the studies aims to examine the presence, wording and prominence of disclosure information related to products granted accelerated approval. In the second announcement, OPDP signaled it will be studying disease awareness and prescription drug promotion on television. The agency says that it is interested in seeing “whether and to what extent” the practice of engaging in disease awareness in relation to a product results “in consumers confusing or otherwise misinterpreting the different information and claims presented”.
Those in healthcare communications around medical products should sit up and take note this week. While OPDP has been less active on the enforcement front, the letters this week demonstrate that when the agency receives complaints via the Bad Ad program, it will act on them, particularly where, as Dr. Woodcock indicated, it believes there is a safety issue – which may be more pronounced when a product has a boxed warning.