Warning Letter Summary thru Second Quarter 2009, Part 1

As mentioned last week, there may be a pattern of greater enforcement emerging at FDA and there are a number of vectors by which one can try to ascertain the level of regulatory action, or lack thereof, on the part of the agency.  One such area is the issuance of Warning and Untitled letters by the Division of Drug Marketing, Advertising and Communications (DDMAC).  In this first installment, we examine solely the numbers of letters issued, followed in a future posting by looking at the substance of the enforcement.

And by looking at the numbers, after only two quarters, DDMAC as already issued as many letters with the year only half way done as it did in 4 of the last 5 years.  Of course, a note of caution – 2009 letters include the absurdity of the 14 letters issued on April 2 to companies regarding search engine advertising (See New York Times – "FDA Rules on Drug Ads Sow Confusion as Applied to the Web") which inflate the numbers considerably and artificially.  

Warning and Untitled Letters

As noted in previous postings, during the Bush Administration, enforcement at DDMAC dropped extensively – a happenstance not limited to DDMAC or the FDA, but to many federal agencies.  In this case, however, with more PDUFA dollars flowing into the agency, less regulatory action flowed out, which would be grist for many naysayers on the utility of having an industry pay for its own regulation.  

At this pace, DDMAC could end up producing about 50 enforcement actions, which would be the most since 2001 saw 64 letters issued, but still far below the 108 of 1999.   And if we substract the anomoly of the infamous 14 "confusion" letters, then the annual number of actions would actually plummet to 22 letters, which would be consistent with the production rate since 2003.  

Is enforcement ratcheting up?  Only more time will tell.   In the meantime, we'll continue to look by other means for new signs that the agency is departing its regulatory slumber.  
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