A U.S. Food and Drug Administration advisory panel on Sept. 11th rejected the idea of setting a hemoglobin target of 11 grams for kidney patients being treated for anemia with biologic drugs, and instead seemed supportive of the idea of doctors targeting a range of 10-to-12 grams to achieve best outcomes.

The members of the FDA's Cardiovascular and Renal Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee on 14-to-5 votes rejected a target of 11 for use of biologics Procrit, Aranesp and Epogen with kidney patients on dialysis, and those with chronic kidney disease not on dialysis.

Panel members suggested they were more comfortable with targeting a range of 10-to-12 grams or eliminating the words "not to exceed" 11 grams in the FDA's proposal, giving doctors more flexibility to keep the hemoglobin level at about 11, which many agree appears to be optimal.

The recommendations of the independent advisory panels, which are not binding but are usually followed by the FDA, also are expected to heavily influence decisions by Medicare, which earlier this summer adopted a policy restricting use of anemia drugs for cancer patients undergoing chemotherapy

Medicare, which has said it would not pay for the anemia biologics when a cancer patient's hemoglobin count exceeded 10, was awaiting the results of today's FDA advisory panel meeting before issuing a similar policy on use of anemia biologic drugs for kidney patients.

The increasingly contentious public debate over the use of the anemia biologics followed reports in late winter that studies showed using the drugs to raise hemoglobin levels excessively could lead to increased risk of heart problems and even death.

The FDA subsequently recommended that the biologics be used at the lowest dose possible to boost red blood-cell levels in order to avoid the need for a blood transfusion.

But what those target red blood-cell levels should be has never been defined by the FDA, and there was no consensus among the experts today though most appeared to believe doctors should aim to achieve a hemoglobin of around 11, but that number should not trigger a cut-off.

Ortho Biotech, a Johnson & Johnson company which markets Procrit, and Amgen, which produces Aranesp and Epogen, both have urged the FDA to recommend that doctors target a hemoglobin range of 10-to-12 grams in kidney patients.

Paul Eisenberg, Amgen vice president of global regulatory affairs and safety, said "we believe the data do demonstrate there is risk when you target a hemoglobin above 13 (grams), but achieving a target of greater than 11 grams per deciliter is associated with better outcomes."

"The weight of clinical evidence suggests that patients experience the greatest benefit from a hemoglobin of between 10-12, and that patients who fall below a hemoglobin of 10 experience greater morbidity and mortality, and are more likely to require a blood transfusion," Ortho said in a statement.