Warning Letter Summary – Third Quarter 2008, Part 2

J0386036The third quarter saw some highly unusual activity on the part of FDA’s DDMAC in terms of both content and quantity.  Addressing the latter first, the FDA issued 8 letters for the quarter, which is a substantial increase for the agency’s quarterly output under the Bush Administration.  Is it a sign that as the Administration enters its final days, that enforcement levels will return to previous levels?  Perhaps. 

But looking at content, there is also surprising news.  Six of the letters issued in one week were all about ADHD drugs.  Obviously, the FDA was paying a great deal of attention to the marketing of Attention Deficit Disorder.

The reason?  The takeway lesson is interesting.  Each of the manufacturers had run promotional materials ranging from Web sites to YouTube videos to printed materials such as brochures and slide decks that listed the effects of ADHD on a patient’s life. 

These effects included negative impact on academic performance, behaviors, sex life and other areas of concern, including low self-esteem or high rates of car accidents.  In each of the promotional pieces, the ADHD treatment was then positioned as a drug that could help those with ADHD. 

This might seem harmless, but the FDA interpreted the juxtaposition of the drug treatment with the negative aspects of ADHD as a direct implication that taking the drug in question would necessarily positively impact those effects.  In other words, the drugs were not marketed for how they treat symptoms of ADHD, but the FDA stated that the drugs were being marketed in a way that suggested that these negative impacts could be addressed by successful treatment.  While that is a logical thought progression, it sends the distinct message that FDA’s DDMAC is looking for companies to strictly have claims centered on the label for the drug without embellishment, however, logical it may be.  In the span of each of these letters, a number of vehicles were used for the promotional material. 

It bears repeating that whether you are talking about a YouTube video or traditional media, it is not the medium, it is the message. 

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One Response to Warning Letter Summary – Third Quarter 2008, Part 2

  1. Matthew Harrington says:

    Mark,
    Interesting note. I searched all warning letters over the last 3 years (thanks for the link) and there are no DDMAC warnings until 4th Quarter 2007 (2). Nothing for 3 months, then a huge spike in 2nd Quarter 2008 (25), followed by the 8 you note in 3rd Quarter 2008. It’s hard to discern any sort of pattern here, except to say that was a busy May-June for the folks at DDMAC.