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Tuesday, November 20, 2012

FDA Pulls “Plug” on PATANASE Detail Aid

Subtitled: Alcon Caught Illegally "Plugging" PATANASE Nasal Spray to Docs The FDA's Office of Prescription Drug Promotion (OPDP) sent a "untitled" letter to Alcon Research regarding a PATANASE "detail aid", which the FDA claims is "misleading because it implies that Patanase has been shown to be effective in the treatment of the specific symptom of nasal congestion, when this has not been demonstrated by substantial evidence or substantial clinical experience."

Language in FDA's letter regarding graphic images and the product logo appearing in the detail aid caught my attention:
  • Graphics of a woman and child with a cork in each nostril [my emphasis] on the front of the sales aid and the contrasting image of the same woman and child without corks in their nostrils on the back of the sales aid.
  • The tagline “Unplug with” in conjunction with a graphic of two loose corks  [my emphasis] and the Patanase logo
FDA is not known for its humor, so I had to see if these images were actually in the detail aid. Fortunately, FDA linked to a pdf version of the aid here. Below is the first page:


Of course, the "after" image shows the mom and boy without the corks up their noses and smiling:


Usually, FDA's letters often tell pharma marketers who overstate efficacy to "put a cork in it"; i.e., stop making false claims. But, in this case, FDA would rather that Alcon just get rid of the corks altogether!

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