12:00 AM
 | 
Oct 22, 2007
 |  BioCentury  |  Regulation

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 Chief Medical Officer Barry Straube said last week at a conference on comparative efficacy sponsored by the ECRI Institute in Washington.

CMS is increasingly making coverage decisions contingent on outcomes data, particularly data in the Medicare population, he said.

FDA approval is usually supported by short-term evidence that a product is safe and effective, and the agency only reevaluates its approvals in extraordinary circumstances, Straube noted.

CMS has "to deal with long-term effectiveness which FDA does not deal with in its approval decisions," Straube said. This raises the question "if something appears to be safe and effective in the short term but not in the long term, should we continue to pay for it?"

Straube amplified his point in hallway conversations with conference participants.

In cases when FDA reevaluates the risk-benefit ratio of an approved drug,...

Read the full 1370 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >