U.S. House committee targets anemia drug marketing

Last Updated: 2007-03-22 13:07:29 -0400 (Reuters Health)

LOS ANGELES (Reuters) - The U.S. House Energy and Commerce Committee has asked Amgen Inc. and Johnson & Johnson for information on their anemia drug marketing practices following recent safety concerns.

Both companies said on Wednesday that they will comply with the request from committee.

The committee, which oversees the U.S. Food and Drug Administration, made its request on Wednesday in letters, which also called for the companies to pull advertisements and end financial incentives to physicians.

Amgen sells anemia drugs Epogen, for kidney disease patients, and Aranesp as a treatment for both kidney disease and cancer patients undergoing chemotherapy. Johnson & Johnson's anemia drug Procrit is marketed for cancer patients and patients with chronic renal failure.

The drugs have come under scrutiny after recent medical studies linked them, when used at high doses, to a higher risk of stroke, heart attack, blood clots and even death in certain patient groups.

All three are a genetically engineered form of a natural protein that boosts the levels of oxygen-carrying hemoglobin in red blood cells.

At the request of the FDA both companies have added strong safety warnings to labels for the drugs, which will be the subject of an FDA advisory committee review on May 10.

Amgen spokesman David Polk said the company will fully cooperate with the committee inquiry, and continues to strongly believe that Aranesp and Epogen are safe and effective medicines when used in approved patient populations in accordance with labeled dosing recommendations.

He said the company has never run direct-to-consumer ads for either drug and does not offer sales incentives to physicians.

J&J spokeswoman Stephanie Fagen said the company, which is continuing to review the committee letter, has not run any direct-to-consumer television ads for Procrit since 2005 and has no plans to resume them.

She said J&J does offer discounts for physicians to prescribe the drug, but said the incentives fall within federal guidelines.