(Note: On November 15, 2010, a correction was made to this post due to a mistake in the count on the number of DDMAC letters issued. By error, two letters from the fourth quarter had been added in. Apologies for the error in the original post.)
This has been the year of the bounce-back for enforcement from FDA. Periodically here at Eye on FDA, the warning and Notice of Violation (NOV) letters sent out by the Division of Drug Marketing, Advertising and Communications (DDMAC) are reviewed here, trying to look and assess what is going on both quantitatively and qualitatively to better inform communications efforts. Today we look at the quantitative aspects by looking at the letters produced during the third quarter of 2010.
First, there were a total of 9 7 new letters issued during the third quarter. That is a steep drop from the quarter before when DDMAC sent out 19 such letters, and a total of 456 for the combined three quarters of this year. And, if you average that out to 15 letters a quarter, that would put the total number for this year at about 61. Therefore, while the number for this quarter did slow down, this pace still puts the division to be on target to issuing more regulatory action letters than during any time since 2001.
Of the 9 7 letters issued this quarter, one-third nearly one half of them (3) were Warning Letters as opposed to NOV letters (4). For the year so far, DDMAC has issued a total of 10 Warning Letters compared to 346 NOV letters.
I thought that might be an uptick in Warning Letters versus NOV letters, so I went back to look at 2009. That year is a bit of an anomaly due to the 14 letters DDMAC sent out regarding paid search ads, which kind of throws comparisons out of whack. But last year, with a total number of 41 regulatory action letters sent out by DDMAC, 14 of them were Warning Letters, or about one-third, so the proportion does appear to be about the same.
All in all, enforcement is still on the rise, though at a slightly slower clips than during the first half of the year, and certainly when compared to the second quarter.
That's it for the quantitative look. In an upcoming post, a review of the reasons and types of violations that occurred during the third quarter.