Resources for Food and Drug Administration (FDA)

A Moral Test for the FDA

online.wsj.com

Some 40,000 women died from breast cancer in 2007. Almost unbelievably, the federal government may block one of the disease's more promising therapies for no other reason than the Food and Drug Administration's obsolete, even antimodern, regulations and approval models. Since the lives of terminally ill patients are in the balance, this is fundamentally a moral test -- and one, true to type, that the FDA may well flunk.

At issue is the biologic medicine Avastin, which interferes with the growth and spread of tumors through the body by choking off their blood supply. Manufactured by Genentech, Avastin was approved for colorectal cancer in 2004 and lung cancer in 2006, and it's been shown effective for treating recurrent or metastatic breast cancer. But in December, the FDA's Oncologic Drugs Advisory Committee voted 5-4 against approval. The FDA is not bound by such decisions but usually follows them, and a final ruling is expected by Saturday.

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