FDA, CMS in sync on ESAs
CMS's determination that it isn't safe for Medicare cancer patients to receive erythropoiesis-stimulating agents under conditions permitted on their label is the first time the agency has second-guessed an FDA safety determination. It isn't likely to be the last time. And while there is little formal interaction between the two agencies, FDA has made it clear it is willing to give CMS political support for a decision that has stirred up a hornet's nest of opposition.
Indeed, even as CMS officials last week asserted their authority to make independent judgments about safety and efficacy, FDA released a statement unambiguously endorsing its sibling agency's National Coverage Decision (NCD) on ESAs for cancer.
"FDA's evaluation of safe and effective is not always generalizable to the Medicare population, especially to the bulk of that population, which is over 65," CMS