(July 12, 2001)

July 12, 2001

The Honorable George W. Bush
President of the United States
Washington, D.C. 20500

Dear President Bush:

As a community representing most of the country's leading cancer organizations, we are writing to request your attention regarding an appointment to Commissioner of the Food and Drug Administration (FDA). With jurisdiction over more than a quarter of all consumer products, FDA exerts an influence that is pervasive and powerful in the lives of the American people, and the agency critically requires aggressive, innovative and experienced leadership.

People with cancer have a special concern about leadership at FDA because, as with other serious or life-threatening diseases, they rely on the agency as gatekeeper for access to potentially life-extending new therapies. Delays or other inefficiencies in the review process for these products can literally mean the difference between life and death for patients with cancer, and they seek leadership that is committed to improving the agency's performance in review of drugs, biologicals and devices, particularly those for serious and life-threatening diseases.

FDA faces many challenges as it considers new products that incorporate recent biomedical research discoveries. To meet these challenges, the next FDA Commissioner must be completely conversant with the latest knowledge about the scientific and medical background relevant to disease mechanisms. At a minimum, we believe the new Commissioner should be a physician with sufficient clinical and research experience to enable him or her to engage the FDA staff as they carry out their responsibilities on behalf of the American people. Of course, we also believe that specific experience in cancer or other serious or life-threatening diseases would make an important contribution to the mission of the agency.

Several months ago, we brought to the attention of Secretary Thompson a candidate whom we regard as extremely well qualified to be FDA Commissioner, Dr. Richard Pazdur, currently Director of FDA's Oncology Drugs Division (see enclosed). His work in the review of cancer products has recently attracted public attention when a major new drug for a rare but deadly blood cancer was approved in record time. Dr. Pazdur remains an excellent candidate

deserving of your consideration, and there may be others equally qualified. It is essential, however, that your Administration not risk loss of confidence in FDA by selecting a Commissioner who lacks the training, experience and vision to lead the agency in meeting the challenges of the future.

Thank you for your consideration of Dr. Pazdur. We look forward to your response.


Cancer Leadership Council

Alliance for Lung Cancer Advocacy, Support, and Education
American Society of Clinical Oncology
Association of American Cancer Institutes
Cancer Care, Inc.
The Children's Cause, Inc.
Coalition of National Cancer Cooperative Groups
Colorectal Cancer Network
Cure For Lymphoma Foundation
International Myeloma Foundation
The Leukemia & Lymphoma Society
Multiple Myeloma Research Foundation
National Alliance of Breast Cancer Organizations
National Coalition for Cancer Survivorship
National Patient Advocate Foundation
National Prostate Cancer Coalition
Oncology Nursing Society
Pancreatic Cancer Action Network
Y-ME National Breast Cancer Organization


cc: The Honorable Tommy Thompson
Secretary, Department of Health & Human Services