Abbott Marketing of AIDS Drug Misleading, FDA Says

Abbott Laboratories' marketing its AIDS drug Norvir in certain patient information materials as the lowest-cost protease inhibitor is false and misleading, the Food and Drug Administration (FDA) warned the company Thursday in a letter (PDF). The FDA action escalates the controversy surrounding Abbott's December decision to increase Norvir's price by 400 percent. That hike prompted attorneys general in New York and Illinois to launch investigations and AIDS activists to file lawsuits against Abbott.

In the letter, FDA cited a cost chart Abbott uses to market Norvir that claims the 100-milligram dose costs less per day than similar drugs. But FDA noted Norvir is only effective at doses three to six times greater than that. "Your cost chart raises significant public health and safety concerns because of the violations outlined ... and the potential adverse impact these false and misleading messages may have on the HIV community by promoting a subtherapeutic dose and regimen of Norvir," said FDA.

Two patient brochures, a cost-comparison chart, a wall chart and statements on a promotional Web site included the misleading material. FDA said the drug maker also omitted some drugs from a list of medications that should not be taken with Norvir, and it failed to state that Norvir is not a cure for HIV, does not reduce the risk of transmitting HIV, and has unknown long-term risks.

Responding to the FDA letter, Abbott said it plans to change its marketing materials and has taken down the materials cited from its Web site. "Abbott will modify the materials in accordance with FDA guidance to address these issues," the company said in a statement released Thursday evening.

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