Warning and NOV Summary – 4th Quarter 2012

To gain insight into the most recent thinking at FDA’s Office of Prescription Drug Promotion (OPDP), Eye on FDA regularly reviews the number of letters and types of violations that were cited by the agency each quarter in Warning Letters and Notice of Violation (NOV) – also known as Untitled Letters.  I usually aim to get these out about 4 weeks after the end of the quarter, but here it is – a bit late.

This quarter there were a total of six letters issued, for a  grand total for 2012 of 28 letters, two fewer than last year.

For this quarter, the 6 letters carried a total of 15 different violations involving 9 different communications vehicles.  There were NO warning letters issued, 6 letters were Notice of Violation (NOV) or Untitled letters.   Of the 9 communications vehicles, 5 were digital while the balance were non-digital.  These included 2 visual aids, 1 sales aid, 4 involving Website copy, 1 video and 1 pitch letter.  Here is a breakdown of the violations incurred:

As usual the most common violation was the omission or minimization of risk.  It is also, however, noteworthy that there were two violations for the relatively less common promotion of an unapproved drug.

Every so often, OPDP carves out “new territory” with its regulatory action letters.  It is, after all, one of the few means by which FDA/OPDP enunciates policy – the other being through the painstakingly slow and laborious process of developing draft guidances.  For example, in 2009, the agency issued a slew of letters that cited a common and long-standing practice to use sponsored links in the context of product promotion.

The last quarter of 2012 involved an instance where another common practice – using a pitch letter to transmit a press release – was defined as part of material that is considered promotional. Therefore the fact that the pitch letter contained information about the product that included the indication and efficacy claims but did not include risk information within the letter (only within the press release) was deemed a risk violation.  That means one of two things for communicators.  Either do not mention information about a drug’s in a the text of the transmittal letter for a press release, or if you do, include risk information and run it through MedReg.

As for the first quarter of 2013, sequester at FDA may have kicked in a little early. So far there have been only two letters issued (none in January).

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