NEW YORK (Reuters) - The U.S. Food and Drug Administration sent a warning letter to Abbott Laboratories, citing what it called serious violations in a promotional DVD about its HIV drug Kaletra that the agency said includes misleading information about the medicine.
The letter says the violations, seen in a DVD featuring basketball legend and HIV sufferer Earvin “Magic” Johnson, are 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.”
It also said the DVD appeared to be accompanied by an outdated version of the FDA-approved product label.
The FDA, in the letter, asks Abbott to immediately cease dissemination of violative promotional material for Kaletra and to submit a written response by July 28 stating whether it intends to comply with the request.
In addition, the agency asked Abbott to come up with a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audiences that received the violative promotional materials.
Abbott said it would respond to the FDA by the July 28 deadline.
“The promotional material referenced in the FDA letter is no longer in use and was discontinued earlier this year,” Abbott spokeswoman Michelle Johnson said.
“Abbott will fully address the agency comments and the guidance provided within the letter within the timeline addressed in the letter,” she added.
Much of the DVD is in the form of an interview and discussion with Magic Johnson, an engaging personality who has been a public face of HIV for many years, about his use of Kaletra and its impact on his life.
But the FDA said the DVD fails to convey any of the serious risks of Kaletra during the interview, and that Johnson’s personal experience is not necessarily applicable to the general 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.”
Reporting by Bill Berkrot; editing by Gunna Dickson