July 23, 2009
FDA Warns Abbott Over Misleading Content In Kaletra DVD
The U.S. Food and Administration (FDA) has sent a letter to Abbott Laboratories warning the pharmaceutical company against serious violations in a promotional DVD of the HIV drug Kaletra.
The letter cited violations in Abbott's DVD featuring basketball icon and HIV sufferer Earvin "Magic" Johnson, which it said contains misleading information about Kaletra.The DVD is of public health concern "because they suggest that Kaletra is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstances other than those for which the drug has been shown to be safe and effective," the agency said.
The DVD also seemed to be accompanied by an outdated version of the FDA-approved product label, the FDA said.
In its letter, the agency asked Abbott to immediately halt distribution of the promotional material in question, and to submit a written response by July 28 stating whether the company intends to comply with the request.
The FDA also asked Abbott to create a broad plan of action to disseminate truthful, non-deceptive, and thorough corrective messages about the issues addressed in the letter to those who received the misleading promotional materials.
Abbott has said it will respond to the FDA on or before the July 28 deadline.
"The promotional material referenced in the FDA letter is no longer in use and was discontinued earlier this year," a Reuters report quoted Abbott spokeswoman Michelle Johnson as saying.
"Abbott will fully address the agency comments and the guidance provided within the letter within the timeline addressed in the letter," she said.
Much of the DVD referenced in the FDA's letter is in the form of an interview and discussion with Magic Johnson about his use of Kaletra, and about its impact on his life. The basketball legend has an appealing personality, and has been a public face of HIV for many years.
However, the FDA said the DVD does not disclose any of the significant and serious risks of Kaletra during the interview, and that Johnson's personal experience is not necessarily applicable to the wider HIV patient population.
"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 patients, such as Magic Johnson, does not constitute such evidence," the agency said.
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