Sorry, Amgen and Johnson & Johnson. So says the FDA, which is backing up Medicare's new limits on using the companies' anemia drugs Aranesp, Epogen, and Procrit. You'll recall that the FDA told doctors a few months ago to use the lowest doses possible of the drugs, to avoid cardiac complications. In July, Medicare said it would only pay for the lower doses. J&J and Amgen, along with the American Society of Clinical Oncology, have been lobbying Medicare to reconsider.
The FDA's opinion is a blow to that effort. In a letter to Rep. Pete Stark, who had asked for FDA's assessment of the Medicare limits, the agency not only said it considered Medicare's decision consistent with the latest data, but also said there was "no evidence" that the drugs improved quality of life in chemo patients.
Late last month, Amgen released a meta-analysis that attempted to show just that--that Aranesp reduced the need for blood transfusions and so forth. Apparently that data didn't sway anyone at FDA.
- see the release from Rep. Pete Stark
Medicare cap on anemia drugs could hammer Amgen. Report
Top 5 layoffs of 2007: Amgen
Amgen, J&J win a round in anemia controversy. Report
New rules limit use of anemia drugs. Report
Read more on: Amgen | Anemia drugs