Warning Letter Summary – Second Quarter 2008

Warning letters from the FDA’s DDMAC have only been at the pace of a trickle under the Bush Administration, and the second quarter was no exception, though there was at least one interesting lesson to be learned.

• In April, DDMAC issued a Warning Letter to Pfizer for a video it made available on the CNN Web site to promote Viagra.  While the label has risk information in it, the video did not.  It is interesting to note that the company had submitted the video to the FDA for review.   Also of interest, the video apparently began with a notation to see important risk information on the Web page where the video was housed, but the FDA did not see such information.  Hence a Warning Letter.  And the lesson is that submission for review to the FDA does not mean that something cannot go wrong in the execution of a marketing effort, i.e., the omission of risk information that was to accompany the video.  I think the best lesson is that all vids should contain risk information in it exactly the way one does in a broadcast commercial, especially in a day when vids can be taken and posted almost anywhere. 
• A similar lesson involving a professional mailer was the subject of a warning letter to Zila Pharmaceuticals and is the object of our next lesson.  In April, 2008, Zila received a warning letter from DDMAC for promotional activity around Peridex, an oral rinse.  Now this professional mailer included a brochure about the product, used to treat gingivitis between visits to the dental authorities, and also included the package insert (PI).  The brochure and materials were cited by CDER for failing to contain ANY risk information and for making unsubstantiated claims by saying the product was the "gold standard".  How can a mailing containing a PI not have risk information?  You would think that if you included a PI in the mailing, you would be covered for risk information.  Not so apparently.  Said the FDA – We note that the PI is included in the envelope along with the letter and the brochure, but the inclusion of the PI is not sufficient to provide the appropriate qualification or pertinent information for the claims made in the letter and brochure."  You avid readers of Eye on FDA will take note, I have said many, many times, if the risk information is detachable from the promotional material, it will not suffice.  Take note please and listen to me, I don’t kid around about this stuff!   
• Our next letter involves, get this, a magnet.  Yes, like the kind that goes on your fridge.  The subject company was Novartis and the product Trileptal and the cite was not including full indication information and risk information.  That would have to be a pretty big magnet!    The drug is indicated for treatment of partial seizures and CDER felt that it could be construed to be used for all kinds of seizures.  But, more  importantly, the risk information was on the back of the magnet where it would not be displayed if affixed to say, a fridge or file cabinet.  The lesson is, in sight, it must be right.
• Lastly in May, Shire also received a letter for a reminder ad which would exempt the material from regulations regarding risk information, but CDER decided wasn’t a reminder ad after all.  Reminder ads, you may recall, may mention the name of a product, but not its indications or dosage or any other language that would suggest the use of the product.  Pretty much, just the name.  The lesson, calling something a reminder promotional piece doesn’t always make it so.  The FDA noted that the promotional pieces "took the form" of a reminder ad, but the content didn’t follow suit.   Form must follow substance, or in this case, the lack of substance.  The promotional pieces in this case, included language that could be associated with the drug’s use, such as "First line".  That was enough to disqualify it from non-regulatory status.    

The next quarterly summary may be very easy to put together.  So far, no one has gotten a Warning Letter.  FDA – regulatory lights on, no one appears to be home and I’m sure someone like Congressman Waxman is taking notice.