US FDA, Medicare anemia drug policy consistent-FDA

WASHINGTON, Oct 16 (Reuters) - Medicare's limits on U.S. payments for Amgen Inc (AMGN.O: Quote, Profile, Research, Stock Buzz) and Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz) anemia drugs are "generally consistent" with Food and Drug Administration recommendations, the FDA said in a letter released on Tuesday.

Medicare announced earlier this year that it would restrict payments for the drugs, which include Amgen's Aranesp and J&J's Procrit, when given to cancer patients. The move followed concerns that the drugs were overused and may be linked to a higher risk of heart attack, stroke and death.

The drugs are erythropoietin-stimulating agents, also known as ESAs or Epo drugs. Aranesp is Amgen's best-selling drug, with sales of about $4.1 billion in 2006. Last year's sales of Procrit were $3.18 billion. Use has fallen sharply this year amid safety concerns.

The Centers for Medicare & Medicaid Services decided it would only pay for the drugs in cancer patients undergoing chemotherapy when hemoglobin levels fell below 10 grams per deciliter of a patient's blood.

In a letter to California Democratic Rep. Pete Stark, the FDA said it "believes that the approved labeling and the (CMS) national coverage determination (NCD) are generally consistent in their recommendations regarding the use of ESAs in patients with cancer undergoing chemotherapy."

Amgen and the American Society of Clinical Oncology have asked the CMS to reconsider, saying the limits interfere with the practice of medicine and jeopardize care. "Amgen continues to urge CMS to quickly respond to the oncology community's collective concerns by allowing patients access to the medicines their doctors believe are a critical part of their cancer care," Amgen spokeswoman Kelley Davenport said on Tuesday.

Ortho Biotech, the Johnson & Johnson unit that makes Procrit, "disagrees with the FDA's conclusion" that the CMS ruling is consistent with the approved label for the drugs, the company said in a statement.

The Medicare policy requires doctors to stop treatment when hemoglobin reaches 10 grams per deciliter, while the FDA-approved labeling allows physicians to treat patients up to 12 grams per deciliter if they think it is appropriate, Ortho Biotech said.

(Reporting by Lisa Richwine; Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691)) Keywords: AMGEN ANEMIA/

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