Warning and NOV Letters Plummet in 2014

There are two types of letters issued by FDA’s Office of Prescription Drug Promotion (OPDP) related to its role in regulating the commercial speech of medical product manufacturers – Warning Letters (WLs) and Notice of Violation (NOV) letters. One can see here that in 1998, the OPDP’s predecessor – the Division of Drug, Marketing, and Advertising Communications (DDMAC) issued a total of 156 letters.  However, beginning in 2000, the number of letters issued began to drop precipitously to just 75.  By 2002, the office was generating less than 30 a year – with a slight increase experienced 2009-2011. However, 2014 is a banner year – producing the least number of letters by far – 10. Depending on your point of view you could say that OPDP has either stopped looking for violations or industry has gotten really proficient at communicating within regulatory parameters.

But is it as simple as all that?  There are two primary means by which FDA enunciates policy.  One is through the laborious and lengthy process of Guidance production. Guidances are drafted and published as drafts – a docket gets opened and the public has opportunity to comment.  The development of a guidance may take place after a public meeting on the topic to allow input.  All of this takes a great deal of time.  The other means by which FDA lets those outside know what it is thinking is through the issuance of Warning and NOV letters which clarify policy and sets parameters – or guideposts – for the guidance documents.  When you don’t have much in the way of guidance, and you don’t have much in the way of letters, you don’t have much insight into FDA’s thinking.

For example, let’s consider the guidance development process for social media.  The agency first held a public meeting in November 2009 and opened a docket for written commentary. Preliminary estimation was that draft guidance would emerge by the end of 2010.  Many expected an individual guidance that covered all of the various aspects of social media. But that did not happen and it was not until 2011 that a guidance even mentioned a very particular aspect of social media and not until 2014 that some substantive guidance was finally delivered – and even with that, there are still many open questions.  FDA opened a docket to get input into the social media guidances from 2014 and even extended the comment period until late in the year – all in all – five years.

But during all of that time, very little insight was provided through the production of letters that would shed light on the agency’s take on social media – and their enforcement of these guidances.  In fact since 2009, there have been only a handful of enforcement actions relating to a social media function – two having to do with Facebook.  In addition, there was one letter related to a banner advertisement.

In spite of this, there has been a true ascendance of the use of social media by patients, patient organizations, pharmaceutical, biotech and device manufacturers, healthcare reporters, and even FDA itself, though not OPDP.

In years past, Eye on FDA has provided a quarterly summary of the Warning and NOV letters, but this year with so few, there was no point in doing it quarterly.  An overview of all 10 letters will be the subject of an upcoming Warning Letter Summary for 2014. However we are giving it a few more days to ensure that FDA does not post any further letters for 2014.

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