FDA Orders Abbott Laboratories To Revise Marketing Materials for Antiretroviral Medication Norvir
FDA regulators on Thursday ordered Abbott Laboratories to stop including in marketing materials and on its Web site, misleading claims that its antiretroviral drug Norvir is the lowest-priced drug in its class, Reuters reports. In a chart made to explain the company's 400% price increase of the drug it made in December 2003, Abbott compared the $8.57 daily cost of a 100 milligram dose of Norvir to the costs of other antiretroviral drugs, which ranged from $9.84 to $32 per day. However, FDA in a warning letter said that the comparison is "misleading" because the drug is approved only for use in doses between 300 milligrams and 600 milligrams twice a day, according to Reuters (Richwine, Reuters, 6/10). "Your cost chart raises significant public health and safety concerns because of ... 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 letter said. In addition, FDA said that the materials fail to state that the drug does not cure HIV, has unknown risks and does not reduce the risk of transmitting the virus. The agency also said Abbott failed to list the names of some medications from a list of drugs that cannot be taken with Norvir. Misleading material was found on two patient brochures, a wall chart and on the company's promotional Web site (Japsen, Chicago Tribune, 6/11). The letter, signed by FDA Division of Drug Marketing Advertising and Communications Director Thomas Abrams, said that the agency would impose sanctions on the company if it failed to correct its marketing materials (Associated Press, 6/10). FDA called on the company to develop a plan to correct and circulate accurate marketing materials to those who received the misleading information. Abbott spokesperson Melissa Brotz said that the company did not intend to give false impressions about Norvir and that it would modify its marketing materials (Reuters, 6/10).
The FDA letter "escalates the controversy" surrounding the company's 400% price increase on Norvir, according to the Chicago Tribune. Abbott is facing lawsuits from AIDS advocacy and consumer groups and is being investigated by the attorneys general of Illinois and New York over the price increase (Chicago Tribune, 6/11). In addition, NIH is considering a request from the consumer group Essential Inventions for a license to produce a generic version of the drug while it is still under patent (California Healthline, 5/28). The request claims that the drug was developed using federal funding and is being sold at an unreasonably high price (California Healthline, 5/27). Abbott says that the price increase was needed to reflect the true value of the drug and to fund future AIDS research, according to Reuters (Reuters, 6/10).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.