More Warning and NOV Letters to Come?

Everyone has noticed the uptick in Warning Letters and NOV letters coming out of DDMAC these days and written about several times over the past year on this blog. In case you haven't, here is an updated chart where I have projected an issuance of letters for the balance of this year based on the rate of issuance for the first half of the year.   

Warning and Untitled Letters 2nd QU 2010(2)

One of the reasons that many have offered for the dramatic drop-off in action letters that you see a decade ago was the institution of a new policy that such letters have a review by legal counsel before they are issued.  This extra layer of review reportedly caused a serious drop in the rate at which DDMAC was issuing letters.

According to Forbes, which editorialized the policy as "sound", the FDA has recently reversed the policy.  That, in turn, could easily signal not only an increase in warning and Notice of Violation letters, but even a return to the levels of the 1990s.   

There are other indications as well.  Last week, the FDA issued a Notice of Violation letter regarding the "Share" function on Facebook, which was the first real action taken regarding a social media vehicle.  As Wendy Blackburn pointed out in an excellent post on the topic on the ePharma RX blog (also added this week to my blogroll), the FDA has indicated that in anticipation of the expected upcoming guidance or set of guidances regarding social media, there would likely be a number of  "letters that address some of the issues and questions surrounding pharma's use of social media."

Toss in the recent "Bad Ads" program, of which I am still highly dubious, and there is another potential to open up the throttle on action letters.  

Lastly, rumor has it that DDMAC has staffed up.  

In the end, it appears that changes in policy, growing attention to social media and an enunciation of guidelines, and greater staffing will mean that those of us who write about these things will have far more to write about in the future than we have in the near past.  Be careful out there everyone.   

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2 Responses to More Warning and NOV Letters to Come?

  1. Thanks for the mention, Mark. Always appreciate your insights on whats going on at FDA!

  2. Pingback: Pharma’s 2010 Christmas Wish List for Santa | Pharma Marketer