Review of Warning and Untitled Letters for 2014

Earlier this month, I had posted about the steep decline in FDA’s OPDP enforcement rates as the number of Warning and Untitled letters for 2014 hit a new low of only ten for the year. In the posting, I had mentioned that while I usually do a quarterly overview of the letters, this year there were insufficient numbers to do that – so here is an annual review of the types of violations and also a comparison to those issued in 2013.

As regular readers know, the data comes from a data base of warning and untitled letters I maintain that includes all letters going back through 2004. It now profiles over 300 letters, characterizing them along a number of fields including treatment area, communications vehicle type, digital or non-digital, whether the product had a boxed warning, and of course types of violations.

In 2013 there were over twice as many letters (24) compared to 2014 (only 10). The letters in 2013 included 63 violations (2.7 violations per letter) compared to 2014 when there were a total of 25 violations (2.5 violations per letter).  Do fewer letters and fewer violations in 2014 connotate a better ability of industry to devise communications within regulatory guidelines?

Not only are there fewer letters (for both years) but it would appear that there are fewer Warning Letters, the more serious missive from OPDP.  And despite the fact that digital communications are on the rise, the proportion of digital versus non-digital communications vehicles has not increased.

Finally – what types of violations occurred?  As usual, risk minimization was the most frequent violation, followed by claims of superiority and unsubstantiated claims.  The following is profile by proportion by year:

One of the striking things about both years is that nearly all of the letters were directed to smaller-sized companies – not the ones that are generally considered household names, particularly when looking at 2014.

So in sum, fewer letters, fewer violations per letter, fewer expressions of serious violations, fewer large companies involved. If the volume picks up, Eye on FDA will go back to quarterly reviews.

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