Warning Letter Summary thru Second Quarter 2010, Part 1

J0385349  Looking at things from a strictly quantitative point of view, for sometime now, there has been speculation that the FDA was ramping up enforcement when it came to medical product promotion.  That was first seen in 2009 when there was an uptick in the total number of letters issued, though that year contained an anomaly in the form of 14 letters issued in a single day.  

However, during the first quarter of 2010, there were 17 letters issued, nearly as many as had been issued in an entire year during some of the most recent years of the agency's enforcement activities. That certainly looked like an increase, but more time would shed light on whether or not there was a true increase in enforcement actions.

During the second quarter of 2010, the numbers appear to demonstrate that there is indeed a renewed commitment to enforcement around the communications associated with medical product promotion.  The Division of Drug Marketing, Communications and Advertising (DDMAC) issued another 17 letters in the second quarter.  In April, the agency issued 12 Warning or Notice of Violation (NOV) letters, followed by a more restful May in which only 2 were issued.  Having caught their breath, however, in June, the agency issued a further 5 letters.

Warning and Untitled Letters 2nd QU 2010
 The chart above plots out the enforcement actions of DDMAC since 1997, where one sees that during much of the 00's, enforcement plummeted.  Clearly now, there is a different approach than during that decade.  Note:  The number entered for 2010 is a projected number – i.e., if letters are consistently issued by DDMAC for the second half of the year as during the first half of the year, then the total number for the year would reach 68 actions, the most since the year 2000 and over 3 times what were issued in 2007.  So far, the actual number issued for 2010 is 34, which is still nearly twice as many as were issued in 2007.  

The substance and nature of the actions cited by the agency are for a future posting.  Stay tuned.  

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One Response to Warning Letter Summary thru Second Quarter 2010, Part 1

  1. Matt M says:

    Is that bump in 2005 because of Vioxx?
    Just curious if the Bush FDA felt the need to ramp up for a short time during that. . .