U.S. Sen. David Vitter today sent a letter sharply criticizing the Food and Drug Administration's Center for Drug Evaluation and Research for the FDA's failure to respond to Vitter's repeated inquiries regarding the agency's pending decision to take the drug Avastin "off-label" for the treatment of metastatic breast cancer.
"From the beginning, I've had serious concerns about the decision by an FDA panel to revoke support for Avastin, which has been a life-saving tool for many women battling advanced forms of cancer," said Vitter. "Although I've attempted to reach out to the FDA to understand their reasoning behind this decision through a conference call and follow-up letters detailing my concerns, FDA officials have flat-out refused to cooperate with any of my requests for information. This, unfortunately, suggests a deeply political agenda at FDA as they refuse to be forthcoming and prepare to take a life-extending drug off the market."
The full text of Vitter's letter is below.
September 10, 2010
Dr. Janet Woodcock
Director, Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Dear Dr. Woodcock:
I'm writing to express my severe disappointment that the FDA has failed to address any of my concerns or questions about the Oncologic Drugs Advisory Commission's decision on Avastin after more than a month of my initial letters.
First, our original phone call in July was as unproductive as possible, with FDA so unprepared that the FDA participants did not even have copies of the FDA Oncologic Drug Advisory Committee's report in front of them to discuss.
Second, I sent a follow-up letter asking twenty-eight specific questions about the Avastin decision, specifically seeking more information about the alleged safety concerns, clinical meaningfulness, and the decision-making process at ODAC. To date, I have not been given a single answer despite the fact that the FDA claims to have thoroughly reviewed Avastin.
This leads me to conclude that this level of unresponsiveness is political so that the Administration can withhold information before a decision is finalized. It seems that the FDA would rather delay and hide behind their decisions than attempt to justify taking a life-extending drug off the market and away from the 17,500 women taking Avastin. This is far too important an issue for you to ignore, and I hope to finally receive the already long overdue response.
United States Senate