FDA Orders Abbott to Stop Circulating Two Ads for Antiretroviral Drug Kaletra, Charging Ads Are Misleading

on Tuesday made public a letter ordering Abbott Laboratories to stop circulating two advertisements for its antiretroviral drug Kaletra because the agency said the ads "exaggerat[e]" the drug's benefits and omit information about possible "life-threatening safety risks," Reuters reports (Reuters, 11/2). Both ads, one of which ran in the May 2004 issue of POZ magazine and the other which is meant for posting in restrooms, feature photographs taken over a four- or five-year period of a "healthy-looking" man, the Wall Street Journal reports. The caption beneath the photographs says, "Where do you see yourself in five years? Talk to your doctor about Kaletra." FDA's Division of Drug Marketing, Advertising and Communications in a letter to Greg Murawski, Abbott's manager of regulator affairs, said, "The ad thus implies that the man shown in the photographs has been healthy over the past several years and that this positive outcome is a direct result of taking Kaletra. Accordingly, the ad implies that patients taking Kaletra can expect to survive and be healthy for at least five years." The bathroom ad also has a tagline that says, "Still undetectable. Still in control." The letter said that "FDA is not aware of substantial evidence or substantial clinical experience to support claims of survival, good health, undetectable HIV RNA levels and disease control for five years" (Hovey, Wall Street Journal, 11/3). FDA also said that the ads are "misleading" because they fail to mention potential side effects of Kaletra, which include potentially life-threatening interactions with other drugs, Reuters reports (Reuters, 11/2). The letter asks that Abbott "immediately cease the dissemination" of the two ads in question and any other similar promotional materials for the drug, the Journal reports. Abbott has until Nov. 15 to respond to the FDA letter, according to the Journal (Wall Street Journal, 11/3). Kaletra has been a "blockbuster" for Abbott since it gained FDA approval four years ago and is projected to generate more than $800 million in worldwide sales this year, the Chicago Tribune reports (Japsen, Chicago Tribune, 11/2).

Reaction
Abbott spokesperson Laureen Cassidy said that the company has received and is reviewing an "untitled letter" from FDA and expects to respond to it within the "requested time frame," the Journal reports (Wall Street Journal, 11/3). Lynda Dee, a Maryland attorney and member of the drug development committee of the AIDS Treatment Activists Coalition, said, "It is unbelievable that, when the FDA just wrote Abbott a letter about Norvir, that they would try to pull something with Kaletra. Do they think no one is watching?" (Chicago Tribune, 11/2). FDA regulators in June ordered Abbott to stop using in marketing materials and on its Web site misleading claims that its antiretroviral drug Norvir is the lowest-priced drug in its class. In a chart intended to explain Norvir's 400% price increase in December 2003, Abbott compared the $8.57 per day 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. 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 (Kaiser Daily HIV/AIDS Report, 6/14).

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