FDA issues warning over ads for Abbott’s Kaletra
Abbott Laboratories received a warning letter from the FDA's
Division of Drug Marketing, Advertising and Communications
(DDMAC) regarding DTC ads for its HIV drug, Kaletra. The ads
appeared in the May 2004 issue of POZ magazine, and in a "restroom poster" for the drug.Abbott said that it is reviewing the letter and will respond to DDMAC by the given deadline, Nov. 15th.
"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," wrote Jennifer Murphy, a consumer promotion analyst with DDMAC in the letter. In June, Abbott received a warning concerning marketing materials for its AIDS drug Norvir, accusing the
company of making false claims about health risks and drug costs.