Warning and NOV Summary – 1st Quarter 2013

Each quarter I regularly try to provide a little insight into OPDP’s current thinking as expressed through the issuance of Warning and NOV letters.  What we saw last year is that the number of such letters after rising a bit in 2009 and 2010 in number, slumped again in 2012.

But that is nothing compared to the first quarter of 2013, where we saw a total of 3, count ’em 3, letters issued from OPDP to industry.  Despite the fact that this quarter provides slim pickings, we persevere.

From this quarter, the three letters involved only three communications vehicles, none of which were digital properties (two were brochures) and none of which were Warning Letters and none of which involved drugs with boxed warnings.

The category for most common violation is usually Risk Minimization and while that did get the most this quarter, it tied with Superiority Claims at 3 and 3.  Also included in this quarter was one instance of Overstatement of Efficacy, one Unsubstantiated Claim and one Inadequate Communication of Indication, making a total of 9 violations for the quarter, or 3 per letter.

Will keep you posted on next quarter some time in July.

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