Warning and Untitled Letters By Therapeutic Category – Oncology

Ever since developing a data base on the Office of Prescription Drug Promotion (OPDP) Warning and Untitled letters, I have wanted to sort the information along various lines to see differences and similarities given different circumstances.  Last year, I produced a White Paper, for example, comparing violations by traditional communications vehicles versus those carried by digital means.  I also did a posting that looked at a particular violation – promotion of an investigational compound – to see what the characteristics of that particular violation.

The data is tracked along a number of fields and one of them is the therapeutic area for which a drug involved in a violation.  Therefore I thought it might be interesting to look at specific areas to profile them against the aggregate.  Today I chose to look at all violations involved in oncology.

First let’s review the overall violations.  There are 390 letters spanning the years 2004-2014, inclusive and covering over 1000 violations.  Here is a table that compares Oncology to the entire group:

How does Oncology differ? One of the surprising things perhaps is that Oncology products account for over half (62.5 percent) of all violations related to promotion of an investigational drug.  Given the fact that there are numerous disease-specific categories, this was a surprise and perhaps sounds a word of caution about pre-approval communications for oncology products.

Also of note, oncology related letters had a lower proportion of warning letters than the general population of letters.  That too is surprising given the serious nature of the drugs involved

As seen below, oncology was also under-represented in terms of the most common violation – the omission or minimization of risk information, but more represented in the category of overstating efficacy.

Finally, there were many more violations in the “other” category for oncology.  This is a hodge-podge of less common violations, with perhaps the most common being a “failure to submit” materials under 2253.

So there are a few lessons about oncology worth noting.  Over time, I will examine other categories of treatment.

This entry was posted in Warning Letters. Bookmark the permalink.