A 10K “Cloud”-burst of FDA Warning Letters
On-line site availability exceeds the 10,000 warning letters mark
At the end of 2010, an analysis was made of the warning letters available on the FDA FOIA website. At the time, my post made an analogy to the pursuit of 3,000 hits by Derek Jeter of the NY Yankees. Would the FDA FOIA site post the 2000th warning letter before Jeter reached hit number 3000?
Since Derek (along with the Yankees) is now out for the season, it seemed a good time to recheck “the statistics.” The result was “No Contest!” While Jeter had 3,304 hits when his post-season ended, the FDA FOIA team has been “pounding them out” with a tally of 10,096 now available by mid-October 2012. Figure 1 below updates the prior post.
Figure 1: Totals reported for all FDA Centers (01 OCT 2003 thru 30 SEP 2011)
The FDA site posted its 10,000th letter within the last two months of this post – probably on 20 AUG 2012. Compare that to less than 1600 in DEC 2010. The number of letters available has increased by more than 550% and represents nearly 90 percent of all warning letters issued from FDA FY 1997 thru FY 2011. The Summary Table below updates the numbers posted versus issued during that 15 year period, which closed 30 SEP 2011. The numbers exclude the letters related to the Center for Tobacco Products (CTP).
The following items are useful to place these numbers in perspective:
- The FDA FOIA website currently provides on-line access to Warning Letters that were dated on or after NOV 1996. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
- The total number of warning letters reported issued for this period is over 12,000.
- The large spike in the chart above (Figure 1) for 2011 reflects the number of letters issued under the new enforcement program for tobacco. Of those 1,720 letters, the CTP program (both Center and State activities) totaled 1040 – therefore the ‘traditional type’ of warning letters issued for 2011 totaled 680.
- An additional 340 CTP letters were subtracted from the total issued to reach the figure of 10669
NOTE 1: The Summary Table above is based on an extract taken on 16 OCT 2012 and represents that point in time only. The extract does not include the CTP letters and adjusts the FDA total letters issued (1997-2011) to control for those numbers.
NOTE 2: The ‘untitled letters’ formerly issued by DDMAC – now the Office of Prescription Drug Products (OPDP) – are no longer included on this site and therefore not in the totals. They are maintained separately by CDER.
NOTE 3: The total for FY 1996 is not included in the totals since there are no letters currently posted. It is included for reference purposes.
THE ‘STATISTICAL SIGNIFICANCE’
Not every warning letter is currently available on line and if there is one you have a special and urgent need for, it may well be one of the ’12 percent’ that are missing. As in sports, some years are better than others for results. Compare 1997 to 2002, for example. Equally important is that the bulk of all letters do not relate to the cGMPs for Drugs, Biologics or Devices. The letters from CFSAN are the most common – not a surprise since this is “The FOOD and Drug Administration.”
As every set of facts raises new questions, this set does as well. There are more letters posted on the FOIA site for FY 2001 and 2003 than FDA enforcement statistics have reported issuing. Those extra letters skew the averages but as Mark Twain once said – “Facts are stubborn things. Statistics are much more pliable.” (Even “an .850 batting average” for the repository would still be worth a trip to Cooperstown, don’t you think?)
These numbers do not include the Closeout Letters which are also available and represent additional effort by the FOIA web resources. In addition, OPDP (formerly DDMAC) ‘untitled letters’ as well as the CBER ‘administrative action’ letters are located elsewhere.
The purpose of this post is to alert you to the resources that are currently available and to acknowledge a significant shift of effort by the FDA to make ‘public records public.’ If you have not searched for these letters recently, be advised that the bulk of them are now available in html rather than the PDF format that was used in the past. (Consider the effort involved in that shift which has made them compliant with theADAaccessibility mandates.) These resources are worth a look if there is an item you need to find or there is a question you need to research.