Two Abbott Laboratories promotions for anti-HIV drug Kaletra exaggerated benefits and left out information about life-threatening safety risks, U.S. regulators charged in a letter made public on Tuesday. The Food and Drug Administration ordered the company to stop circulating the advertisements immediately. One ran in Poz, a magazine aimed at HIV-positive people; another was posted in restrooms, the FDA said. "These promotional pieces overstate the effectiveness of Kaletra and omit material information about the risks associated with Kaletra," the FDA wrote in a letter that was dated October 29 and posted on the agency's Web site. The FDA said both promotions implied Kaletra could help HIV patients stay healthy for five years. Officials at Abbott did not immediately return calls seeking comment.
Each ad featured pictures of a man looking healthy and captions indicating the images were taken over a four- or five-year period. Text on the ads asked "Where do you see yourself in five years?" and urged patients to discuss Kaletra with their doctors. The ads were misleading because Kaletra was approved based on studies lasting 48 weeks and 72 weeks, the FDA said. "FDA is not aware of substantial evidence or substantial clinical experience to support claims of survival, good health, undetectable HIV (blood) levels, and disease control for five years," the agency said. The ads also failed to mention potential side effects, which can include life-threatening interactions with other drugs, the FDA said. The promotions were reviewed as part of the FDA's routine monitoring of drugmaker advertisements, the agency said. (Reuters)
Abbott marketing of AIDS drug misleading, FDA says
Chicago Tribune - June 11, 2004
Bruce Japsen, Tribune staff reporter
The U.S. Food and Drug Administration accused Abbott Laboratories Thursday of false and misleading marketing of the health risks and costs of its AIDS drug, Norvir. 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.