Fred in the News

THE HILL: Following Avastin decision, Republicans say FDA rationing care

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Washington, DC, December 16, 2010 | Sean C. Bonyun ((202) 225-3761) | comments
By Jason Millman -

Leading House Republicans accused the Food and Drug Administration (FDA) of rationing care after the agency’s decision Thursday to revoke its approval of an expensive drug for late-stage breast cancer treatment

The FDA said it made the recommendation after reviewing clinical studies that showed Avastin does not prolong overall survival in breast cancer patients or sufficiently slow the disease’s progression. The FDA rejected speculation the decision was based on the treatment’s cost, which can run upwards of $90,000 each year.

However, key Republicans brought back allegations that persisted during the healthcare reform debate that the Obama administration wants to ration care. In a statement issued Thursday afternoon, Republicans pointed out that the European Medicines Agency on Thursday approved Avastin for the same treatment.

“Today, the FDA is withdrawing its approval of a drug that helps prolong the lives of thousands of women living with aggressive breast cancer,” said incoming Energy and Commerce Committee Chairman Fred Upton (Mich.), incoming Health subcommittee Chairman Joe Pitts (Pa.) and Reps. Phil Gingrey (Ga.) and Sue Myrick (N.C.), a breast cancer survivor.

“Unfortunately, this is only just the beginning,” they continued. “The new health reform law — the so-called Patient Protection and Affordable Care Act — creates 159 new boards, commissions and agencies that will destroy the doctor-patient relationship and replace it with federal bureaucrats deciding who gets care and what treatments they can receive.”

Sen. David Vitter (R-La.) argued in July that the FDA wants to ration care after an agency advisory panel voted 12-1 in July to revoke approval of Avastin for treating breast cancer.

Breast cancer advocate Susan G. Komen for the Cure said it was concerned that the FDA’s decision would hinder access to treatment.

“We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, that their insurers will continue to pay for it and that the drug’s manufacturer, Genentech/Roche, continues making the drug available to women through its patient support programs and considers an expanded access program,” the organization said in a statement.

Genentech has 15 days to appeal the FDA decision.

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