Pfizer and the Feds

WASHINGTON — Federal regulators ordered Pfizer Inc. to stop running a print advertisement for cholesterol-lowering drug Lipitor, saying the ad’s claim that Lipitor can cut the risk of heart disease is misleading.

The Food and Drug Administration told Pfizer (PFE) that an eight-page ad for Lipitor that recently ran in a medical journal creates “an overwhelming impression” that Lipitor can reduce the risk of developing coronary heart disease.

Although Lipitor can be promoted as a cholesterol-lowering drug, it hasn’t received FDA approval as a treatment for coronary heart disease.

The letter, sent to the company last month, also called the ad “misleading” because it doesn’t clearly and prominently state the risks of taking the drug.
The agency told Pfizer to pull the ad and any other ads making similar claims. The company said the ad ran only in medical journals.

A Pfizer spokeswoman said the ad already has been pulled. “We certainly comply with every FDA request and work with them to remedy the situation as soon as possible,” said Mariann Caprino, a Pfizer spokeswoman.

An FDA spokeswoman said only that the agency and Pfizer were discussing issues raised in the letter.

The agency objected to a series of pictures of people wearing name tags in the ad.

The tags identify individuals not by name, but by factors that pose a higher risk for coronary heart disease, like smoking or diabetes, when people already have high levels of fats such as cholesterol in their blood.

Text that elaborates on the name tags accompanies the pictures.

The FDA letter warned that “the effect of Lipitor on cardiovascular morbidity and mortality has not been established, and Lipitor is not indicated to reduce the risk of developing” coronary heart disease.

This is the third time the agency has criticized Lipitor advertising. In 1999, the agency raised concerns with Warner-Lambert Co.’s Parke-Davis unit, which was then producing Lipitor, about misleading claims in promotional materials; it also rejected a television ad in 1998 for similar reasons. Pfizer co-marketed Lipitor with Parke-Davis before buying Warner-Lambert last year.

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