Warning and NOV Letter Summary – 1st Quarter 2014

Each quarter, I provide an overview of the most recent Warning and NOV letters from OPDP to gain insight into any lessons learned and to look at overall trends.  But this quarter, it is really slim pickings.  More than slim in fact.  This quarter, OPDP issued only two (2) letters. Still, remaining true to form, let’s take a look at them.

Needless to say this is not the norm, but if OPDP would continue at this rate, it would mean that for the year, there would only be eight letters, which would be the lowest number in a year.

Both of the products involved in the letters had boxed warnings. One involved a non-digital property – the other digital.  Between the two of them there were seven violations:

• Risk Minimization – (2)
• Superiority Claim (1)
• Unsubstantiated Claim (1)
• Broadening of Indication (1)
• Omission of Material Facts (2)

Both letters this quarter were untitled letters and given that there were only two, they were both interesting.    Let’s take them in order.

The first of the letters involved a non-digital means of communication – a sales sheet. One of the more notable aspects of this letter was the number of violations. Five of the total 7 violations from these two letters involved the sales sheet.  That is a lot of violations for an Untitled Letter, though not that uncommon when the letter is a Warning Letter.  The most interesting thing in this letter was perhaps the fact that the sales sheet carried the claim that the product’s shorter dosing “streamlined” recovery.  That was taken to imply that recovery with shorter dosing was quicker and easier than compared to products with a longer dosing period.

The second of the letters, which had only 2 violations, was interesting because the vehicle was not only a digital property, but one involving Facebook – for which many in the pharma industry have an extreme sensitivity.  That was covered in a March 12 posting here, but the bottom line is that the fact that the violation occurred on Facebook was inconsequential and it would have been a violation if on Facebook or in a brochure.  It was not the medium, it was the message.

What accounts for the lull in enforcement that results in only 2 letters in a quarter? Perhaps everyone is keeping in line.  Or perhaps there is about to be another deluge of several letters issued in a day over some common practice such as happened in the Spring of 2009.  Hard to know.  But as it happens, we will continue to cover the developments here.