Warning Letter Quarterly Update, Last Quarter 2008, First Quarter 2009, Part 1
It is always a good idea to review the content of Warning and untitled letters to learn from the lessons being taught be DDMAC with respect to communications that promote the marketing of pharmaceutical, biotech and device products. However, I have been behind on reporting on the Warning and Untitled Letter updates from DDMAC and my last report was for the third quarter of 2008. But today is catch up day. Here is a report that covers the last quarter of 2008 and the first quarter of 2009, which does not include the infamous day after April Fool's Day issuance of the 14 Warning Letters on search engine ads.
Before delving into the letters themselves and the lessons learned however, let's turn first to the volume. It has always been my contention that under the Bush Administration, domestic government and the enforcement of law and regulation was drastically hobbled. Here is the pattern of Warning letters since 1997 out of DDMAC. This chart includes the 2009 letters issued so far. It is notable that by the end of April 2009, DDMAC had already issued as many Warning and Untitled letters as in nearly all of the past 3 years.
Is this new uptick ominous and portending the possibility of a greater volume of enforcement? It is hard to say. This uptick does include the infamous 14 letters, which skew the statistics considerably (not to mention the policy). And it takes some time to generate the letters. After all, the practice of search engine marketing had been in place for some time and the Warning Letter issued to General Mills for Cheerios
focused on the product "label" (the box) which had carried the claim for two years. They are not exactly speedy. So it may be too early to tell whether there is an uptick or not.
The lesson learned here? It would be prudent for companies to consider whether or not the regulatory environment is shifting based on the evidence of the infamous 14 letters and the Cheerios warning. It may be time to strategically review and take stock all current promotional materials to assess with a new and highly critical eye to question again whether or not there is a potential violation. Because the message so far out of FDA is that just because you have been engaged in a promotional practice for some time, doesn't mean that it won't be the subject of future regulatory actions. There is no statute of limitations on promotional practices and their eventual regulation by the FDA.
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