The Food and Drug Administration on Thursday warned drugmaker Abbott Laboratories that it should stop touting its protease inhibitor Norvir as the lowest-cost HIV protease drug and accused the company of false and misleading marketing information about the drug's health risks and costs, the Chicago Tribune reports. The misleading marketing and advertising material includes two patient brochures, a cost-comparison chart, a wall chart, and statements made on the company's Web site, according to the letter sent by the FDA.
The cost-comparison chart claims Norvir is the cheapest protease inhibitor when used at a 100-milligram dose, but the FDA says the drug is only effective at doses three to six times greater than that. The 100-milligram doses referred to by the company are used only to boost the effects of other protease inhibitors and are not the dosages used when Norvir is the primary protease inhibitor in an anti-HIV drug cocktail. "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 FDA also says Abbott omitted some drugs from a list of medications that shouldn't be taken with Norvir and that the marketing materials don't state that the drug is not a cure for HIV, that its long-term risks are unknown, and that use of the drug doesn't reduce the risk of transmitting HIV to others. Abbott officials say the company has taken down the incomplete information from its Web site and will change its other promotional and marketing materials to meet the FDA's guidelines.
Abbott has come under fire from AIDS activists and many government officials because of its 400% price hike on Norvir enacted last December. AIDS groups have filed lawsuits against the company claiming the price increase on the eight-year-old drug violates antitrust and anticompetition laws. The company also is under investigation by the attorneys general in Illinois and New York over the price increase, and is facing a request to the federal government from a generic drug manufacturer to be allowed to make cheaper versions of the patented medication.