In my data base of Office of Prescription Drug Promotion (OPDP) Warning and Untitled Letters issued during the years 2004-2013, one of the many fields I track is, of course, the type of violations that were incurred.
There are many, many kinds of violations, but the primary categories that were tracked include:
- Risk omission or minimization
- Superiority claims
- Overstatement of efficacy
- Unsubstantiated claim
- Broadening of indication
- Promotion of an unapproved use
- Promotion of an unapproved compound
There is an “other” category which is a catch-all for many other types of violations such as a failure to submit form 2253, omission of a material fact, inadequate communication of an indication and others.
The data base now contains 286 letters and over 1000 violations. The breakdown of the primary violations (n=746) seen in the bullets outlined above is as follows:
As one can readily see represented in blue, the omission or minimization of risk information is by far and away taking the lion’s share when it comes to FDA citation for violations. And yet, ironically, it would seem to be one of the easiest with which to comply.
Where have there been hangups? Well, a considerable number of the violations for risk are where the communication names the product, the indication and perhaps some benefits and does not list any risk information at all. None. Zip. How can that be? Well, some of them were clearly intended as reminder ads, but in fact did not qualify as such. And some may not have included the information because the vehicle was perhaps not considered promotional. For example, two very recent letters from OPDP involved promotional communications contained in a letter – a communications vehicle that OPDP has indicated in the past is, in fact, promotional.
Others have gotten into trouble where there has been a presentation of the benefits of a product in a way so as to obviously garner attention – large font, color settings, graphics, etc, while the risk information is presented via a more austere means – black and white, small font, no graphics – or is positioned not in close proximity to the benefits. And, as we all know by know, the risk information cannot be incorporated by reference or be “one click” away when the communications vehicle is digital.
The presentation of risk information is always an important factor, but if a product has a boxed warning, it may be especially so. As mentioned a few weeks ago, products with boxed warnings may be more likely to be of greater concern and greater concern may translate into the issuance of a Warning versus Untitled letter.
Once you go beyond reminder ad status, you are in. Once in, better to be safe than sorry.