Warning and NOV Letter Summary – 4th Quarter 2013

I usually wait a little bit longer after the end of the quarter to write up a summary of letters issued by the Office of Prescription Drug Promotion (OPDP) because there can sometimes be a healthy lag time between the issuance of a letter and the posting of a letter on the site, but here goes.

For starters, this quarter comes on the heels of a quarter notable for its utter lack of enforcement activity. The third quarter of 2013 – July, August and September, OPDP had only 3 letters issued during July and none for the entire August – September time period (note – the government shutdown was only October 1-16).  During the 4th quarter, OPDP seemed to try to make up for lost time and issued a total of 10 letters during the quarter, but that still resulted in the fewest number of letters issued since 2008 and only about half the number issued during 2010.

The 10 letters issued this quarter cited 27 different violations with the category garnering the most violations being the minimization or omission of risk information – as is the usual case.  There were

  • 4 violations of Superiority Claims and
  • 3 of Unsubstantiated Claims with
  • 2 broadening of indication and only
  • 1 overstatement of efficacy
  • the balance in a catchall “other” category are less common violations

Warning versus NOV – Interestingly, of the 10 letters issued this quarter, only one was a Warning Letter and the balance were NOV or Untitled Letters.

Digital versus Traditional Properties - Also of note, of the communications vehicles involved which carried the material OPDP found in violation, only 2 were digital properties (both Webpages) and the balance were non-digital forms of communication including

  • one brochure
  • one direct mail piece
  • three letters or direct mail pieces
  • one sales aid
  • one invitation, and
  • oral statements made by a company representative (the CEO)

Numbers aside, there were some valuable lessons learned from this quarter.  One is that when it comes to oral statements – it is very important that a speaker be prepped to understand the parameters of what may be permissible in characterizing the impact of a medical intervention.  See Warning Letters and the Spoken Word from Eye on FDA, November 25, 2013.  Other lessons will be covered in the upcoming annual look back at letters where the entire year will be profiled.

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