FOR IMMEDIATE RELEASE, Thursday, November 8, 2007
CONTACT: Yoni Cohen, Stark (202) 225-3202

WASHINGTON, D.C. – Representative Pete Stark (D-CA), Chairman of the Ways and Means Health Subcommittee, today issued the following comments in support of the Food and Drug Administration’s revised warning and label changes for erythropoiesis-stimulating agents (ESAs).

“The Food and Drug Administration’s second warning in less than a year should give pause to every patient and doctor using or prescribing Epogen or Procrit,” said Stark. “According to the FDA, when administered above certain levels, these drugs pose clear health risks for patients.”

“Incessant lobbying by industry lobbyists who care more about profits than they do about patients has ginned up a controversy over Medicare’s recent national coverage determination (NCD) on the use of ESAs for cancer patients,” continued Stark. “Today’s label change makes it clear that doctors and cancer patients can’t be too careful when using Epogen or Procrit. The FDA points out that even at lower levels, cancer patients may be at risk of adverse effects. That’s why doctors should always dose ESAs for cancer patients at the lowest level necessary to avoid transfusion.”

“As for renal failure patients, I have long been an advocate for improving quality of care for those suffering from kidney disease. I welcome further guidance from FDA on appropriate treatment, particularly for those who fail to respond to ESAs. As Congress moves forward with improvements to the Medicare benefit for End Stage Renal Disease patients, I intend to make sure that any changes we make encourage practice patterns that reflect FDA’s recommendations, respond to beneficiaries’ needs, and protect patients’ health,” concluded Stark.

In March of 2007, the FDA issued a black box warning recommending the “use of the lowest dose necessary to avoid the need for blood transfusions” and cautioning against the administration of ESAs to raise patients’ hemoglobin levels above 12 grams per deciliter (g/dL). The March label specifically warned of risks of tumor progression, shortened survival and increased risk of death for certain cancer patients when ESAs are used to raise hemoglobin above 12 g/dL.

Today, FDA revised its warning for cancer patients to include a list of cancers where ESA dosing at high levels resulted in more rapid cancer progression or shortened survival, a statement that health risks have not been excluded below a hemoglobin of 12 g/dL, a warning that ESAs should only be used to treat anemia in cancer patients while they are undergoing chemotherapy, and advice to stop using ESAs when chemotherapy treatment ends.

For patients with chronic kidney failure, the label now warns of greater risk of heart attack, stroke, and heart failure when ESAs are used to achieve higher hemoglobin levels and advises that dosing be individualized to achieve and maintain hemoglobin levels between 10 and 12 g/dL.

The new label also includes specific instructions for adjusting or discontinuing ESA use for kidney failure patients who do not respond to ESA treatment.