December 14th, 2009

Philadelphia Inq report:

WASHINGTON – The advertisement for an athlete’s foot drug depicted attacks on a giant fungus alongside the words Crush, Kill and Destroy in bold type.

But after looking at clinical studies related to the drug, the Food and Drug Administration in August sent a letter to the distributor, Johnson & Johnson, warning that the ads “greatly overstate” claims that the prescription drug, Ertaczo, wipes out infections.

The FDA was similarly troubled by a testimonial video featuring former professional basketball star Earvin “Magic” Johnson describing his “normal life” while taking the HIV drug Kaletra. The FDA wrote to Illinois-based Abbott Laboratories, Kaletra’s manufacturer, in July warning about unsubstantiated claims of long-term effectiveness.

“The personal experience of a Kaletra patient such as Magic Johnson does not constitute such evidence,” the letter read.

The letters were among about 36 sent to pharmaceutical manufacturers so far this year warning of violations and ordering the ads to stop, correspondence shows. In all of 2008, the federal agency sent out just 22 warning letters, similar to the FDA’s regulatory pace during much of this decade.

Stung by the recent scrutiny, major drugmakers are pushing for online advertising flexibility in hopes of launching a new wave of Internet marketing.

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