Amgen Ends Controversial Aranesp Marketing PracticesAug 29, 2008 | Parker Waichman LLP
The maker of Aranesp is halting marketing practices that critics said encouraged over-use of the anemia drug. Criticism of the policies, in which Amgen paid rebates to doctors for the purchase of Aranesp, had grown along with questions about the drug's safety.
Aranesp is an erythropoiesis-stimulating agent (ESA). Two other ESA's, Epogen and Procrit, are also currently available. All are made by Amgen, but Procrit is sold by Johnson & Johnson subsidiary Ortho Biotech under a licensing agreement. ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells.
In March 2007, the Food & Drug Administration (FDA) added a black box warning to the drugs’ labels cautioning doctors that the medications should be administered at the lowest dose possible in order to bring red blood cell counts to the lowest level necessary to avoid transfusions. This past November, that black box warning was modified to include more specific dosing information.
Then in March 2008, Amgen and Johnson & Johnson announced that they would be including another black box warning on the drug’s labels. The latest black box warned of the medications’ association with increased tumor growth and shortened survival time in some cancer patients.
Amgen has long offered rebates and discount to oncology clinics for their use of Aranesp. Oncology practices typically buy the drugs they use and then are reimbursed for them by patients and insurers. If doctors pay less for the drugs because of discounts and rebates, they can make a higher profit.
Critics say that such marketing programs encourage doctors to overuse ESAs. The criticism has gotten the attention of Congress, where a probe of the practice is ongoing. In April, Reps. John Dingell and Bart Stupak, both Michigan Democrats, sent letters to Amgen and Johnson & Johnson on Monday, suggesting their marketing campaigns for Procrit, Aranesp and Epogen convinced physicians to prescribe the drugs at unsafe dosages. Senator Charles E. Grassley, Republican of Iowa, said in April that Amgen had provided nearly $800 million in rebates to more than 6,000 facilities in 2006.
Amgen once offered discounts and rebates to doctors based on how much Aranesp they bought. But that program was changed in February, and the company started to offer the discounts and rebates based on the share of a clinic’s anemia drug purchases were represented by Aranesp as opposed to Procrit. At the time, the company maintained that the marketing program was to help Aranesp compete with Procrit, not increase its overall use.
But now, the company has decided to end the rebate program all together. It also said it would stop offering discounts on two other drugs, Neulasta and Neupogen, based on a doctor’s purchase of Aranesp.
But the discount aren't being halted completely. In place of the rebate program, Amgen will now offer bigger discounts at the time of purchase to doctors who buy at least 50 percent of their anemia drugs from Amgen rather than Johnson & Johnson.