In addition to CMS’ recent payment revision, the U.S. Food and Drug Administration said in the July 20 Federal Register that a joint meeting of its renal and cardiovascular drug safety advisory committees will meet September 11 to “discuss updated information on the risks and benefits of erythropoiesis-stimulating agents when used in the treatment of anemia due to chronic renal failure.”
In particular, the panel will discuss Amgen’s Epogen and Aranesp and Johnson & Johnson’s Procrit.
In March, the FDA issued black box warning that outlined new safety information, which included updated product labeling for ESAs. The FDA pointed to recent studies with ESAs that have shown a higher chance of serious and lifethreatening side effects and a greater number of deaths in patients treated with ESAs.
The FDA held a similar meeting in May to discuss ESA safety issue in treating anemia in cancer patients. That panel said additional restrictions should be placed on the drugs, which Medicare acted on by restricting payment in certain areas. FDA officials, however, said a renal-specific panel should discuss these concerns before a policy decision can be made.
