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Leading House Republicans Decry FDA Move on Breast Cancer Drug as a First Step Towards Rationing Care


Location: Washington, DC

Congressman Fred Upton (R-MI), incoming chairman of the House Energy and Commerce Committee, today joined incoming Committee Vice Chair and breast cancer survivor Rep. Sue Myrick (R-NC), incoming Health Subcommittee Chairman Rep. Joe Pitts (R-PA) and senior Health Subcommittee Member Phil Gingrey, M.D. (R-GA) in releasing the following statement in response to the U.S. Food and Drug Administration's (FDA) decision to commence the process of removing approval of Avastin as a treatment for metastatic breast cancer. Reps. Gingrey, Myrick, Pitts and Upton are gravely concerned that the FDA is putting economics ahead of proper courses of treatment and that today's announcement is the first step towards government rationing of health care. Upton vows strict FDA oversight in the 112th Congress. Reps. Myrick and Gingrey pressed Health and Human Services Secretary Kathleen Sebelius on the FDA's pending action towards Avastin in a July letter.

"Metastatic breast cancer patients often have limited options for treatment due to the aggressive nature of the disease. Patients in Europe will continue to have access to Avastin, one of the only drugs that treat women with stage IV breast cancers. Today, the European Medicines Agency issued a statement that it 'has confirmed that the benefits of Avastin in combination with paclitaxel outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer.'

"However, in this country the Food and Drug Administration (FDA) is withdrawing approval for Avastin to treat late-stage breast cancer. Many in Congress have expressed concerns that the FDA's review of Avastin would be predicated on its price -- not in its effectiveness in treating patients.

"Allowing the FDA to factor in the cost of a drug when determining whether that drug should be approved is the first big step towards government rationing. The FDA should only look at the safety and efficacy of a drug. Allowing the FDA to inject cost into the approval process jeopardizes the care of those nearly 18,000 women who rely on this drug. At a time when Europe is moving away from restricting access to life-saving medications, the FDA appears to be moving in the opposite direction.

"Last year, the United States Preventive Services Task Force recommended that women under 50 forgo routine mammography screenings. Today, the FDA is withdrawing its approval of a drug that helps prolong the lives of thousands of women living with aggressive breast cancer. Unfortunately, this is only just the beginning. 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.

"A doctor making medical decisions with informed patients has been the foundation of our medical system. The Energy and Commerce Committee is committed to repealing the new health care law and we will hold hearings to hold the FDA accountable for its decision and protect access to treatment for the thousands of women who rely on this drug."

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