This past month in December, 2012, Amgen pleaded guilty to illegally marketing Aranesp and voluntarily agreed to pay $762 million in criminal penalties as well as settlements of whistle-blower lawsuits. Aranesp was promoted to treat anemia in cancer patients who were not undergoing chemotherapy, even though the drug's approval was only for patients receiving chemotherapy.
Amgen was also cited for promoting dosage use which was not approved. Sales people urged doctors to use larger but less frequent doses, something that helped sales over a competitor's product, Procrit. The FDA denied Amgen's application for the modified dosage, but this was declined as Amgen provided no medical studies supporting efficacy. Notwithstanding this, Amgen continued to promote the off-label prescribing.
A litigation document documented that while sales representatives were not supposed to initiate discussions of off-label uses, they were trained to elicit questions from doctors. Such questions would provide the "necessary cover" for the sales representatives to provide the doctor with studies supporting the off-label use. Roger Burlingame, a federal prosecutor, told the judge Tuesday that "in certain instances, Amgen employees were so thoroughly indoctrinated to sell the drug for off-label uses that they did not, in fact, know that the drug had not been approved for the use for which they were selling it."