Warning and NOV Letter Summary – 1st Quarter 2012

Another quarter has zoomed by.  And with it, FDA’s Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC), has issued a stream of regulatory action letters known as Notice of Violation (NOV) letters or Warning Letters (WL).  And on a quarterly basis, we take a look to see what regulatory wires were tripped.

In the last quarter of 2011, the pace at OPDM had picked up a bit having issued 9 letters. However, over time, the pace seems to have slowed a bit from year to year.  And during the first quarter of 2012 there were a total of 6 letters issued, 1 WL and 5 NOV letters.

The 6 letters contained 18 violations by my count.  One of the most notable things from this quarter however was in the frequency of some violations and lack of others.  The minimization or omission of risk information has almost invariably been by far the most frequent violation cited in regulatory action letters.  One of the less common violations is the promotion of an unapproved use.

However, this quarter there were only two Minimization or Omission of Risk violations noted, but there were two also for unapproved use promotion.  Here is the complete breakdown:

  • Overstatement of Efficacy – 6
  • Unsubstantiated Claims – 5
  • Promotion of Unapproved Use – 2
  • Omission or Risk Minimization – 2
  • Omission of Material Facts – 2
  • Broadening of Indication – 1

The vehicles that carried the communications involved 3 traditional print items, 2 digital (Websites) and 1 oral statement made by a presenter.

With the frequency of violations this quarter in overstatement of efficacy and unsubstantiated claims, it appeared that a common pitfall was the description of patient experiences that, while they may have been accurate, went beyond what the typical patient experience might be or went beyond what was reflected in the label.

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