Warning and NOV Letter Summary – 2d Quarter 2013

It is so hard to believe the year is half gone, but it is and that means – among other things – that it is time to look at the past quarter of enforcement letters from the Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC).  Each quarter we review what has happened by the numbers and look for any lessons that may be learned.

The first quarter was a slender volume, with only 3 letters issued in February and March. The second quarter was a little more active, but so far the year overall is rather slow compared to almost any previous year.  If we annualize this rate (in the chart below) 2013 will only see a total of 20 or so letters.

What of the 7 letters from this quarter.  There were 7 letters involving 7 communications vehicles. Therapeutically speaking, there were 2 in the CNS category, 3 in oncology, one in cardiovascular and 1 in opththalmology.  While none of the violations in the first quarter involved a digital property, 4 of the 7 for this quarter did – meaning that for the year, 40% of the violations so far were among digital properties.  The digital properties were, with 1 exception, were all Websites.  All of the letters for this quarter (and this year) have been Notice of Violation (NOV) letters – no Warning Letters.  And of note, 4 of the seven products had boxed warnings.

The 7 letters involved 16 violations:

  • Over one-third (n=6) of the letters involved the Omission or Minimization of Risk information;
  • Unsubstantiated Claims constituted 4 of the violations;
  • There was one Superiority Claim;
  • There was one Overstatement of Efficacy;
  • One involved promotion of an Investigational Drug;
  • Three were in the “Other” category – Two were Omission of Material Facts and another involved Misleading Claims.

The minimization or omission of risk was, as is almost always the case, the most common violation.  On this count, one of the more interesting letters from this quarter involved a DTC print ad for a product with a boxed warning which had copy that had many of the benefits listed in bold face for emphasis, but risk information to the side in small, regular copy with out any of the emphasis that was used in talking about the benefits.

All of this year’s letters have been added to the FDA OPDP Warning Letter database that I have put together, meaning that it now includes letters from 2004-mid-2013, containing 276 letters involving nearly 400 different communications vehicles and almost 900 violations.

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