The Food and Drug Administration said Friday that it will form a panel to address safety concerns surrounding anemia drugs made by Amgen Inc. and Johnson & Johnson. The panel is set to meet September 11.
The FDA said the panel will examine "updated information on the risks and benefits" of Aranesp and Epogen, which are made by Thousand Oaks-based Amgen, and Procrit, made by Johnson & Johnson, when used in the treatment of anemia in patients with kidney failure.
Aside from the safety issues of the drugs, lawmakers have also argued that Medicare's current payment system creates an incentive for doctors to over-prescribe the drug in order to collect more money from the government. Medicare's No. 1 expense for seniors is anemia treatment. Epogen and Aranesp account for 47 percent of Amgen's annual sales.
Concerns arose after studies released earlier this year indicated that higher doses of anemia drugs can put patients at an increased risk of stroke, heart attack or death.
A new analysis of U.S. dialysis data by the company shows that physicians have been using Epogen even more conservatively since the Centers for Medicare & Medicaid Services revised its policy in November 2005, and the FDA made changes to the product labeling last March.
Shares in Amgen closed up 61 cents to $56.18 in afternoon trading Friday on the Nasdaq.
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