>> FDA to Cancer Patients: We're in Your Corner July 20, 2005
In response to your July 6 editorial "Pazdur's Cancer Rules," addressing the Food and Drug Administration's approach to cancer drug approvals:
We are extremely disappointed in this one-sided opinion and know that the American public and cancer patients and survivors throughout our country are well aware of the strides we are taking in approving safe and effective treatments for this horrible disease. The FDA has a consistent and competent approach to cancer therapeutics and has been able to utilize an accelerated approval process allowing potentially life-saving drugs into the marketplace more quickly for those who need it the most.
While your editorial criticizes the agency for removing Iressa, a treatment for lung cancer, it fails to point out that this is a great example of how well the accelerated approval process works -- the drug does help about 10% of the population, and for those patients the treatment will still be available. However, a new drug, Tarceva, which also was approved through accelerated approval, is now available and showing even more progress in the fight against lung cancer.
Finally, your focus on Dr. Richard Pazdur, of our oncology drug division, is wholly unfair. He heads a team of scientists who work tirelessly to ensure that the balance of benefit and risk to cancer patients is in their favor. We hope that patients and their families continue to understand that Dr. Pazdur and the entire FDA are in their corner.
Dr. Janet Woodcock Acting Deputy Commissioner for Operations Food and Drug Administration Washington <<
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