FDA Warns Abbott on Magic Johnson DVD for HIV Drug
July 23, 2009
The Food and Drug Administration has asked Abbott Laboratories to immediately cease dissemination of a promotional DVD about its AIDS drug Kaletra, citing what FDA calls serious violations.
In a letter, FDA said the DVD featuring HIV-positive basketball great Earvin "Magic" Johnson suggests "that Kaletra is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience," and encourages "use in circumstances other than those for which the drug has been shown to be safe and effective." The DVD also appears to be accompanied by an outdated product label, FDA said.
FDA wants Abbott to draft a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages to audiences that received the promotional materials.
Much of the DVD focuses on an interview with Johnson about his use of Kaletra and its impact on his life. Johnson has been a public face of HIV since his diagnosis in 1991. "FDA is not aware of substantial evidence or substantial clinical experience to support effectiveness for five or more years of treatment with Kaletra in treatment-experienced adults. The personal experience of a Kaletra patient, such as Magic Johnson, does not constitute such evidence," the agency noted.
"The promotional material referenced in the FDA letter is no longer in use and was discontinued earlier this year," said Abbott spokesperson Michelle Johnson. "Abbott will fully address the agency comments and the guidance provided within the letter within the timeline addressed in the letter," which requested a written response by July 28.
07.22.2009; Bill Berkrot
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