Warning and NOV Letter Summary – 3rd Quarter 2012

Each quarter Eye on FDA examines what has occurred in enforcement by the Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising, and Communications (DDMAC).  Apart from being instructive for those working in communications and medical products, in the absence of specific guidance documents, these letters are the only means for gaining insight into the agency’s current thinking regarding communications around medical products.

Looking at the broader picture, overall enforcement appears to be on the wane once again at the OPDP.  The past quarter brought the total number of letters issued during 2012 up to 23.  Barring a flurry of letters in the 4th quarter, this pace would have the agency just below last year’s 30 and far below the 52 letters issued in 2010, and of course a far cry from where it was before 2002.

Looking specifically at the third quarter, there were only 5 letters issued citing 9 different violations.  Of the 5 letters, 3 were aimed at traditional media communications vehicles (Oral statements made by a sales rep and two brochures) while 2 were aimed at digital communications (both Websites).  Only 1 of the letters was a Warning Letter (the drug label on that one had a boxed warning) while 4 were Notice of Violation (NOV) letters.

Contrast that for all of 2012 so far, there were 23 letters for the year citing different violations.  Of the 23 letters, 17 were aimed at traditional communications vehicles, while 6 were aimed at digital (none involved social media).  There have been 4 Warning Letters compared to 19 NOVs.  Of those receiving Warning Letters, 2 involved drugs with boxed warnings.

Normally the number one violation cited involves a minimization or omission of risk information, but this quarter there were only 2 of those, along with 2 Superiority Claims, 2 Overstatements of Efficacy and 2 Broadening of Indication.

Next quarter will summarize both the quarter and provide a comparison to the entire year for 2012.  Look for it in early January.


Note:  Post publication an astute reader noted that my math didn’t add up where I stated that of the 23 letters, 18 were traditional communications vehicles while 6 were digital – it should have been 17 traditional and 6 digital, which of course does add up to 23.  Thanks again to the reader for pointing out and apologies for the error.

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