Warning and NOV Letter Summary – First Quarter 2011

For a while it seemed that FDA’s DDMAC was raising the enforcement bar.  During the Bush years, enforcement plummeted from previous years dramatically.  In 2008, the numbers seemed to rise, though in 2009, the numbers were actually a bit thrown off by the anomaly presented by the issuance of 14 letters in a single day aimed at a single medium – paid search advertising by pharma companies.  That may have created a case of “enforcement inflation”.

Last year, while the first half of the year saw a flurry of activity out of DDMAC, the last half of the year was more like a slow summer day, with a total of 8 Warning or NOV letters issued by the agency.  This year, they are on track with that same pace.  During the first quarter of 2011 there were only four NOV letters issued by DDMAC.  If enforcement kept up at this pace for the year, DDMAC would only be issuing about 16 letters this year – certainly the fewest in over a decade.

The Triggers for Regulatory Action

Of the 4 letters issued this quarter, one was a Warning Letter and three were Notice of Violation Letters (NOV).   It is usual for an NOV letter to contain more than one violation, however, this quarter the three NOV letters issued by DDMAC only contained one violation each.  The combined violations of the NOVs and the Warning Letter for the quarter numbered seven and included

  • Overstatement of Efficacy – 3 violations cited
  • Omission of Risk Information – 2 violations cited
  • Unsubstantiated Superiority Claim – 1 violation cited
  • Broadening of Indication – 1 violation cited

The vehicles that carried the communications deemed violative included direct mail pieces, advertisements and a book.

It is noteworthy that DDMAC has scheduled a Webinar to review the violative content and reasoning behind the letters that were issued for the quarter.  The event is to be held on May 3, 2011, from 2:00 to 2:30 p.m EST.  DDMAC has stated that this is a pilot program in which the agency will give key stakeholders a chance to directly communicate with the Agency on clarifications or questions about the Warning Letters and Untitled Letters issued by DDMAC in a given quarter. This particular webinar will cover Warning Letters and Untitled Letters issued from January 2011 to April 2011.  The Webinar sign in is linked here.

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