DDMAC Warning / Untitled Letters - Impact on Pharma

As many of us know, the FDA's DDMAC has been increasing its staff and stepping up its issuance of warning and untitled letters (also called notice of violation letters) for violative promotional activities. In fact, according the FDA's website warning and untitled letters have risen from 21 in 2008 to 41 in 2009. Mid-way through 2010, we have already seen the number hit 38.

As the number of these letters continue to rise, I wonder how this is impacting the perspectives of promotional material reviewers. Is the first thought around communicating messages with the patient in mind or regulators? The reality is that regulatory compliance is a part of our everyday lives. But I hope that marketers and reviewers continue to place the safety and concerns of patients first.