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Athlete’s Foot Drug Ads

The FDA just issued a warning letter to Johnson & Johnson over their athlete’s foot drug Ertaczo. The letter, located here, alleges that Johnson & Johnson’s advertisement features a broadening of the indication (misleadingly suggests that Ertaczo is approved for all patients, regardless of age or immune status, with any form of tinea pedis caused by any organism); unsubstantiated efficacy claims (ad says that the drug will “Crush. Kill. Destroy” when studies show it to be 13.1% to 27.2% effective); that the ad does not include significant drug risks, and that Johnson & Johnson failed to submit the ad for review prior to publication.
Let’s take a step back—this is for an anti-fungal cream. For athlete’s foot. If Johnson & Johnson is willing to go to such extreme measures for something like this, what are they willing to do for a blockbuster drug? And, after the drug company responds, is it too late—the ads have already hit the streets. No corrective action can be corrective enough to undue whatever damage was done. And, I bet the drug companies know that.
Of course, it may be that the efficacy issues (“Crush. Kill. Destroy”) qualifies as puffery. Most of us are jaded with regard to advertisements, and we know they overstate their products a fair bit.
Here’s a link to the advertisement. Puffery or false claims? You be the judge.

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