Warning and NOV Letter Summary – 2nd Quarter 2012

In addition to it being a very hot summer, it has been an extraordinarily busy one and I am a bit tardy in bringing the quarterly summary of Warning and NOV letters put out by the Office of Prescription Drug Promotion (OPDP), formerly known as DDMAC – the Division of Drug Marketing, Advertising and Communications.  Late, but nevertheless here at last.

One of the first things we look at is the overall pattern of enforcement over several years to see how this year is faring.  So far for the year there have been 17 letters issued in the first half of the year and if it keeps up at this rate, this would be a more active year than in recent memory.

For this quarter there were 11 letters issued, 2 of which were Warning Letters and 9 were NOV.  Only 2 of the letters involved digital properties vehicles while the balance were aimed at traditional communications vehicles.  (Note that digital includes Web pages, social media, but video are counted as traditional.)

Last quarter, there were only 6 letters issued carrying 18 violations.  This quarter’s 11 letters carried notice of 30 violations – so almost the same 1-3 ratio.  As usual the most often cited reason for a violation was due to the minimization or omission of risk information, but this quarter there were an equal number regarding overstatement of efficacy which were seen in two DTC ads and two videos as well as a written script.

One of the overstatement of efficacy violations involved a circumstance that is common where there are patient testimonials or patient examples.  This involves a patient who has taken a course of treatment and then makes references to quality of life changes that ensued. In one instance, this involved saying that the patient is able to enjoy nice vacations and was able to retire and start a successful business.  To this, FDA stated that such claims overstated the efficacy of the product “by suggesting that the usual outcome of treatment… is a positive effect on a patient’s interpersonal relationships, physical functioning, work productivity and overall quality of life.”

Already in the third quarter, there have been two letters issued.  We’ll be back next quarter with a summary.

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One Response to Warning and NOV Letter Summary – 2nd Quarter 2012

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