Mississippi Lawmakers Knock FDA Decision
Federal Agency Withdraws Best-Selling Cancer Drug
Monday, November 21, 2011
WASHINGTON, DC – U.S. Senator Roger Wicker and Reps. Gregg Harper and Alan Nunnelee, Republicans from Mississippi, today expressed disappointment with the U.S. Food and Drug Administration’s (FDA) decision to revoke approval of the breast cancer indication for Avastin (bevacizumab).
FDA Commissioner Margaret A. Hamburg, M.D., cited safety concerns in the agency’s announcement, noting the difficulty in reaching the conclusion. But the Mississippi lawmakers believe the lack of treatment options for terminally-ill breast cancer patients outweighs the risks linked to the drug.
“While I am disappointed with FDA’s decision, I encourage the Center for Medicare & Medicaid Services to continue covering this therapy,” said Wicker. “For some battling this deadly disease, Avastin is the only option.”
“While drug safety is an important consideration, women taking Avastin have run out of options,” said Harper, a second-term House member who serves on the Energy and Commerce Committee. “Until a cure is developed or a greater number of successful treatment alternatives are available, women with metastatic breast cancer should be allowed the option of taking Avastin.”
“Although I was not in Washington for the health reform debate last year, if there is one thing that I have learned, it is that the American people do not like to be told that the government will limit their access to treatments,” said Nunnelee. “I am greatly disappointed in the FDA’s decision to revoke approval of the metastatic breast cancer indication from Avastin, and I am hopeful that Medicare and private insurance companies do not do the same.”
According to the FDA, risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.
Wicker sent a letter to Commissioner Hamburg in July signed by four of his Senate colleagues asking the FDA to take into consideration those patients who take Avastin as their last option for treatment.
Harper and Nunnelee also sent a letter to the commissioner in July signed by 15 of their House colleagues which called attention to the negative impact the agency’s decision could have on end-stage breast cancer patients. The bipartisan letter said that Avastin has produced significant positive results for some patients battling cancer, increasing their odds of survival or extending their lives.
“While not everyone taking Avastin experiences the same benefits, no perfect treatment exists for terminally-ill cancer patients, and we must continue to allow options for those with nowhere else to turn,” the lawmakers wrote.
Avastin entered the market in 2004 for colon cancer and went on to gain approval for lung, kidney and brain cancers. The FDA approved the medication for the treatment of metastatic cancer in 2008 under its accelerated approval process.
Commissioner Hamburg’s conclusion resulted from a review of clinical trials, input submitted by the public and the record from a two-day hearing held in June.
The treatment will still be available to patients with certain types of colon, lung, kidney and brain cancer.