Warning Letter Summary 4th Quarter 2010 – Part 1

Warning letters and NOV letters from DDMAC have a rather irregular cycle of posting to the FDA/DDMAC Web site.  Some of the letters are posted the very day they are sent, others are not posted for days, sometimes weeks afterwards.  I have been holding off on the 4th Quarter survey of letters to see if any new letters were posted and while one was posted on January 4, it was not a DDMAC letter.  Last year, the last DDMAC letter for 2009 was not posted until January 12, but I am throwing caution to the wind here.  Today we are going to look at both the quantitative aspects of the 4th quarter 2010.

While DDMAC had a lot of steam at the beginning of the year, the agency lost momentum and did not keep going at the same pace with which it started the year. During the first quarter there were 18 letters issued, followed by 20 in the second quarter, and then only 7 for each of the last two quarters of the year.

In all for 2011, there were a total of 52 letters which certainly was nevertheless an increase over past years, including last year when there were 41 issued, meaning that there was an increase of almost 27% and an increase of 173% over 2007.

By my count, during the 4th quarter, there were 30 violations cited in the the 7 letters that were issued during the fourth quarter and 3 of the 7 letters were Warning Letters while 4 were Notice of Violation (NOV) letters.  The Warning Letters were all issued to companies where the vehicles were multiple (web pages) and where there were multiple violations being cited.

Looking at the categories of violation – Minimization or Omission of Risk; Unsubstantiated Superiority Claims; Overstatement of Efficacy; Unsubstantiated Claims; Broadening of Indication: and finally Other, by far, the most common violation 9 involved the lack and/or minimization of risk information, followed by unsubstantiated superiority claims (4) and overstatement of efficacy (3).

Of the seven violations noted in the “Other” category, two were for a failure to provide directions for use for the product, while two were for failure to provide adequate communication of the indication.  In addition, one of the violations was the comparatively rare promotion of an unapproved use.

Later we’ll look at the qualitative aspects and at a look back for the year.