Boxed Warnings and Warning Letters

Last week I reported on some of the activities during the Food and Drug Law Institute meeting on Advertising and Promotion which I attended here in Washington, where many aspects of enforcement were discussed.  I had some data I did not get to present, so thought I would write about it now.

When FDA wants to draw attention to a particular risk with a prescription drug product, the package insert for the product will often contain a boxed warning.  It is just what you would think it is – a box with a warning in it and almost everyone connected with the marketing of these products is aware of the existence of the boxed warning, sometimes also called a “black box warning”.

But are there communications implications to having one in the label? It turns out there may be.  Looking at FDA’s boxed and warning letters from 2006 through the second quarter of 2012 (inclusive), by my count there have been 206 letters sent by the Office of Prescription Drug Promotion (OPDP – formerly known as DDMAC).  Those letters are divided into two types – Warning Letters (WLs) and Notice of Violation (NOVs) letters – also known as “Untitled Letters”.  WLs are regarded with more significance than NOVs. And finally, the thing of note for communicators.

Of the entire group of 206 letters sent in the five and a half year time frame, about 32% of them have been WLs – while 68% have been NOV letters – so for every WL issued, there are two NOVs. But when we look at drugs that have boxed warnings, the picture changes.  Within this time frame, I found only 20 instances where a product with a boxed warning received either a WL or NOV letter.  However, of the 20 WL/NOV instances, a WL was issued 55% (n=11) of the time or WLs are even more common that NOVs. That would seem to indicate what common sense might already be telling you – when you are working with a product that has a boxed warning, efforts to ensure that you are communicating within regulatory parameters – while always paramount – should be given extra attention.  In other words, if you are promoting a drug with a boxed warning, “handle with care.”

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