FDA warning letter calls Lilly ads, articles for dog drug misleading
Pharma Compliance Alert, July 11, 2007
Eli Lilly's ad and other materials promoting Prozac for dogs are misleading, says an FDA warning letter. According to the letter, the dog-version of Prozac is touted as a treatment for separation anxiety. However, the materials failed to mention that the dogs studied also received behavior training.
In the letter, the FDA pointed to claims made on the product Web site, Reconcile.com, in an article, and in a print ad in the May issue of Veterinary Forum Magazine. According to the FDA, the pieces and the product Web site "suggest that the product is more effective than has been demonstrated" because the company failed to reveal certain information, including the fact that "the dogs in the comparison group were treated with behavior modification and did not just receive a placebo."
The FDA requests that the Lilly division Elanco Animal Health stop disseminating these pieces immediately and respond in writing within 15 working days of receiving the letter, detailing how it will fix the offending pieces.
The letter is dated June 26 and was posted on the FDA Web site this week. Click here to read the letter.
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