FDA Chides Celgene, Novartis AG on Drug Promotion
Published: Jan 26, 2012
Health regulators said drugmakers Celgene Corp and Novartis AG misrepresented their cancer drugs to doctors, overstating how well the medicines targeted tumors without having evidence to support it. The complaints concern Celgene's breast cancer drug Abraxane and Novartis's cancer drug Gleevec. The Food and Drug Administration posted separate letters to each company on its website on Wednesday, asking them to stop using advertising that violates FDA guidelines. The FDA inspects companies' marketing materials to make sure they do not illegally promote drugs for uses other than those approved by the agency, or make false claims that are not backed by clinical data.