FDA Warning Letters Headed “To The Cloud”

The best part of my job is that I get to associate on a daily basis with outstanding individuals in a broad array of industries.  What is even better is that these people are often willing to share their expertise with me and now with you. 

John English is such an individual and someone who always has his finger on the pulse of Pharmaceutical world and how the FDA regulates what happens in that world.  For those of you who understand this world read on.  For those that don’t,  I hope that you will read this as well and appreciate some of the changes that are taking place in this arena and in light of the newest technology trend:  Cloud Computing.

~Gretchen Gunn

FDA Warning Letters Headed “To The Cloud”

The intensity of FDA enforcement efforts as well as their efforts at transparency have both increased significantly this year.  The number of Warning letters that are dated 2010 and that are currently available on the FDA website has reached a significant milestone.  The number of letters that have already been put on the website to date this year exceed the total number issued by FDA in any single year since 2004.

Just reading the public press will tell you that FDA enforcement activities have been ramped up.  The numbers referenced by the DOJ this week (07 DEC) point out over $4 billion dollars in fines and recoveries related to the healthcare industry during the last 2 years.  http://www.justice.gov/opa/pr/2010/December/10-civ-1398.html

The number of warning letters is also on the increase when compared to recent levels.  When you look at the numbers provided in the last issue of the FDA Enforcement Story, the average number for the total Warning Letters issued by all Centers was 543.  This covers FDA Fiscal Years (FY) 2004 thru 2008.  That average is skewed by the 2004 number which was over 700.)  While there are no official numbers yet for 2009, here is an estimate for 2010 based upon available date.

Thus far, during this calendar year of 2010, the FDA has made over 530 Warning Letters dated 2010 available on their website.  Please note that the word is “available” and not “issued.”  

  1.  The FDA website currently has over 1500 warning letters available, covering the years 1996 thru 2010.  Of these, the letters dated 1996 thru 12/31/2009 totaled 1,000.  Therefore 35% of the letters currently available were issued this year.
  2. During the most recent 5 year period used above, the total number of letters issued by all Centers was over 1700.  The number of those available on the website is slightly over 350 – about 21% of the total or a mean of just over 70 per year.


I do not believe that the number made available so far in 2010 suggests that the number of letters issued will be in the thousands.  What the data does show is that the Agency FOI group is making a huge effort to provide data on a scale we have not seen before.  This may have been enabled by the new website capabilities – it may be in response to increased requests – or the pace of enforcement activities/ discretion may be what is driving it.  In any event, there has been a significant change in the number available.  At the current rate, the site will be making its next full thousand (‘the 2000th’) available around the time Derek Jeter gets his 3,000th hit as a Yankee – apologies for the sports reference – unless there are significant changes in industry compliance levels or Agency Enforcement efforts. 

This is not to pretend all Warning Letters are equal and the Agency is also dealing with numerous ‘internet-only companies’ which will increase the numbers.  It is fair to say that the full 2010 numbers in Enforcement Story will be interesting.  Oh, as for 2009, there were no total numbers available to me as noted already, but there are over 150 letters dated 2009 on the website.  This is more than double the mean number for the prior five years. 

Sources:  These numbers are available on the FDA website or on request from John.T.English@prodigy.net     

 From www.FDA.gov – Enforcement Story Archive

Chart 1: Total Warning Letters Posted For All Centers – Most recent Five Year Period (Mean = 543)








Chart 2:  Total Warning Letters Posted For All Centers – From Year of Oldest Letter Posted to 2006


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