FDA Backs CMS on ESAs

A lot of initials, I know, but Rep. Pete Stark (D-CA) and Henry Waxman (D-CA) just released a letter from the Food and Drug Administration that firmly endorses the Center for Medicare and Medicaid Services' restrictions on the use of Aranesp (Amgen) and Procrit (J&J) in cancer chemotherapy patients. The two companies have financed a massive lobbying blitz to role back CMS' July coverage decision, which limited use of the drugs because they have been shown to spur tumor growth and increase mortality.

The lobbying blitz is paying off on Capitol Hill. A House joint resolution sponsored by Rep. Anna Eshoo (D-CA), whose district includes Amgen's headquarters, that would rescind the July decision has garnered at least 26 co-sponsors. It has also won backing from the American Society of Clinical Oncologists, which had claimed that the FDA label and CMS policy were at odds.

Who put Congress in charge of medical decision making? If ASCO has a complaint about CMS payment policy, it should provide evidence to the physicians at that agency who made the decision (which, we have confirmed today, is in line with the FDA label).