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Letter to The Honorable Margaret Hamburg, Commissioner, U.S. Food and Drug Administration

Letter

By:
Date:
Location: Washington, DC

Sent letter this week urging agency to allow continued use of drug

U.S. Sen. David Vitter today responded to the FDA's announcement that it will take Avastin "off-label" for the treatment of metastatic breast cancer.

"With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug," said Vitter. "We can't allow this government takeover of health care to continue any further. I urge the FDA to consider any forthcoming appeals of this decision and immediately reverse course."

For months, Vitter pressured the FDA to be transparent in its decision-making regarding Avastin, which has shown benefits for some women battling advanced breast cancer. Earlier this week, Vitter and U.S. Sen. Roger Wicker sent a letter to FDA Commissioner Margaret Hamburg urging the FDA to allow the continued use of Avastin to treat metastatic breast cancer, along with a petition signed by more than 9,000 Americans, including many cancer survivors. The full text of the letter is below.

December 14, 2010

The Honorable Margaret Hamburg
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue, Room 2217
Silver Spring, MD 20993

Dear Commissioner Hamburg:

As you know, thousands of breast cancer patients take Avastin to extend their treasured time with their family and friends. Many are concerned that ODAC's recommendation will result in fewer treatment options for breast cancer patients. Three major insurers already have taken steps to drop Avastin coverage pending the FDA's final disposition on the matter.

Patient safety must be carefully balanced with the medical benefits of any drug, and while not all women respond to Avastin, some do in very significant ways. We believe doctors should have the ability to prescribe treatments they feel will work best for their patient's individual situation.

Thousands of Americans -- breast cancer patients and their family and friends -- have signed a petition urging the FDA to reconsider its position. We have included this petition to assure that their voices can be heard by the FDA before a final decision is concluded.

Thank you for your attention to this important issue, and we look forward to a hearing from you.

Sincerely,
David Vitter Roger Wicker
United States Senate United States Senate

CC: Richard Pazdur, Director, Office of Oncology Drug Products, FDA
Patricia Keegan, Director, Division of Biologic Oncology Products, FDA


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