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Erythropoiesis-stimulating agents (ESAs) are widely used to treat patients with kidney disease and chemotherapy-induced anemia. Amgen's Aranesp and Epogen, along with Johnson & Johnson's Procrit, recorded combined sales of $9.7 billion in 2006. However, these firms have been under fire from Capitol Hill in recent months and have suffered through a round of negative publicity regarding the products. Late last year, representatives from the House Ways and Means Committee called for immediate changes to reimbursement policies for ESAs as witnesses testified that the Centers for Medicare & Medicaid Services' (CMS) current reimbursement policies promote dangerous overdosing of the drugs. In March, the FDA added a black box warning to labeling for ESAs that warns physicians to curb use of the products in patients with end-stage renal disease and chemotherapy-induced anemia. The safety issues will be discussed at the Oncologic Drug Products Advisory Committee meeting May 10, where the committee could weigh in on whether ESAs actually promote tumor growth and shorten the time to disease progression. Following the FDA announcement of the black box warning, the CMS said that it was reevaluating reimbursement policies for ESAs, in oncology and kidney dialysis settings. Because of their high cost, ESAs are in one of the classes of drugs cited by proponents of follow-on biologics. This issue of The Food & Drug Letter examines the challenges manufacturers face with these products.