FDA supports Medicare rule on anemia drugs
WASHINGTON The Food and Drug Administration is agreeing with Medicare on restrictions for government payments for anemia drugs made by Amgen and Johnson & Johnson, according to Bloomberg.
Payment rules set by Medicare, are “generally consistent’’ with prescribing information for use of the drugs in cancer patients, the Food and Drug Administration said in a letter released today by Representatives Pete Stark and Henry Waxman.
Medicare said back in July that they would not pay for the drugs, Epogen, Aranesp, and Procrit used in cancer patients with hemoglobin levels exceeding 10 grams a deciliter. The companies are trying to convince Medicare that the drugs were safe to use up to 13 grams.
U.S. sales of Amgen’s Aranesp fell 19 percent in the second quarter after the FDA warned doctors to dispense the lowest doses possible to minimize heart risks. Sales of Johnson & Johnson’s Procrit fell 15 percent in the third quarter.