Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Chicago Triune - June 11, 2004
Bruce Japsen, Tribune staff reporter
Abbott was warned in an agency letter that it should stop touting Norvir, in certain patient information materials, as the lowest-cost protease inhibitor, a key ingredient in so-called "cocktails" used to fight the HIV virus.
The FDA action escalates the controversy surrounding December's 400 percent price increase for Norvir, which pushed the daily 100-milligram dose price to $8.57 from $1.71.
Attorneys general in Illinois and New York have launched investigations, and lawsuits have been filed against Abbott by AIDS activists.
Activists had claimed that Abbott's depiction of Norvir as a bargain is disingenuous because the 100-milligram dose is used as a booster in conjunction with other HIV medicines made by other companies.
A cost chart that the FDA described as part of materials that Abbott uses to tout Norvir claims the 100-milligram dose costs less per day than similar HIV drugs. But the FDA says 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," the FDA said in its letter.
The misleading material involved two patient brochures, a cost-comparison chart, a wall chart, and statements on a promotional Web site.
The FDA said Abbott also omitted some drugs from the list of those that should not be taken with Norvir, and failed to state that the drug is not an HIV cure, has unknown long-term risks, and does not reduce the risk of transmitting the virus.
In response to the FDA letter, Abbott confirmed it has taken down the materials in question from its Web site and plans other changes to marketing materials.
"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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