Dendreon (NASDAQ: DNDN) is in hot water with the FDA's marketing watchdogs already. The company's sales materials for the brand-new prostate cancer vaccine Provenge don't pass muster, the agency says, because they exaggerate the novel treatment's benefits and soft-pedal its risks.
"These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of Provenge," the FDA says in a letter to the company, Reuters reports. The agency also tells Dendreon to stop using the offending materials immediately, and to also pull any other sales aids that make similar claims.
Granted, it's not easy to explain the subtleties of Dendreon's data on Provenge. The FDA appears to acknowledge that in its letter, saying that one piece lacked "sufficient contextual information" that would "convey the limitations" of Dendreon's main study of the drug.