Warning Letters and Boxed Warnings

My data base on warning and untitled letters now includes the years 2004-today.  It includes 282 letters covering a neat total of 1000 different violations.  When I was working on it earlier, I did a post looking at letters aimed at products with boxed warnings and thought it a good time to revisit the topic now that there is more information in the data base.

Common sense might tell one that if a product has a boxed warning – and therefore there are specific safety issues that FDA wants to highlight, then regulatory action letters from the Office of Prescription Drug Promotion (OPDP) might more often come in the more serious form – Warning Letters – as opposed to Untitled Letters (a/k/a Notice of Violation).  It appeared true in 2012.

What is the ratio of Warning versus Untitled Letters?  Of the 282 letters, 34 percent (96) were Warning Letters between 2004 and the present.  And of the 282 letters, only 14 percent (40) involved a product with with a Boxed Warning while 86 percent (242) did not have Boxed Warnings.  However, of the 40 Boxed Warning Letters, 45 percent of them were Warning Letters while of the 242 regular labels, only 32 percent were Warning Letters.

Therefore it stands to reason that when you are dealing with a product with a Boxed Warning in its label, extra care needs to be taken with regard to communications because if there is a violation, it would appear that there is a greater tendency for it to be in the form of a more serious Warning Letter than Untitled Letter.

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