 
July 24, 2009
FDA Warns Abbott Over Kaletra Ad Featuring Magic Johnson
The U.S. Food and Drug Administration (FDA) has issued a warning letter to Abbott Laboratories regarding a promotional DVD in which HIV-positive basketball Hall of Famer Earvin “Magic” Johnson discusses his experiences with HIV medication Kaletra, Bloomberg reports.
According to the letter, which was posted on the agency’s website, the video “minimizes the serious risks” and “overstates the efficacy” of the treatment. According to company spokeswoman Michelle Johnson, Abbott stopped using the consumer-targeted DVD earlier this year and will cooperate with the FDA to address these concerns.
In 2004, the FDA issued Abbott a separate warning over a print advertisement for Kaletra that did not include risk information and made unverified implications that patients taking the drug can expect to be healthy for at least five years. The FDA affirms that such promotions are misleading and in violation of federal law.
“The violations described [in the letter] are serious,” wrote Thomas Abrams, director of the FDA’s division of drug marketing. In the warning, the agency ordered Abbott to submit a plan to “disseminate truthful, non-misleading and complete corrective messages about the issues discussed in this letter.”
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