HIV Digest	HIV Digest Archive

The US Food and Drug Administration has ordered Abbott Laboratories to immediately suspend print ads for its AIDS drug Kaletra, accusing the company of exaggerating the medication's benefits. "These promotional pieces overstate the effectiveness of Kaletra, and omit the indication and material information about the risks associated with Kaletra in the treatment of HIV infection," FDA wrote. "Therefore, the promotional materials misbrand the drug [under federal rules]." FDA said the ads imply "that patients taking Kaletra can expect to survive and be healthy for at least five years."

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The ads show a multiyear sequence of photos of a seemingly healthy man and ask, "Where do you see yourself in five years?" A caption refers to HIV that is "still undetectable."

FDA said the ads are misleading because regulators approved Kaletra based on patient data from 48- and 72-week periods. FDA said it is unaware of substantial evidence or clinical experience to support claims of survival, good health and disease control over five years.

Kaletra is expected to generate more than $800 million in global sales this year. Company spokesperson Laureen Cassidy had no comment except to say Abbott has agreed to pull the ads and "respond to the FDA in the requested time frame, which is Nov. 15."

Abbott had already drawn criticism from AIDS patients, advocates and state prosecutors for the 400 percent price hike it instituted in December on its AIDS drug Norvir.

In June, FDA accused Abbott of falsely marketing Norvir's health risks and promoting it as the lowest-priced protease inhibitor. Abbott denied wrongdoing and said the price increase was justified.

Editor's Note: from the Chicago Tribune