(March 5, 2004)


March 5, 2004

Dear Senator:

As you know, the President has nominated Dr. Mark McClellan to be Administrator of the Centers for Medicare & Medicaid Services (CMS). While the cancer community regrets the loss of his vital leadership at the Food & Drug Administration (FDA), we welcome his nomination to CMS and believe that he will bring to the Medicare and Medicaid programs the vision and energy that made him a success at FDA.

We are writing to urge that the Senate act promptly to confirm Dr. McClellan, in recognition of the pressing need for reform of policies and practices at CMS, a need that we believe Dr. McClellan can admirably satisfy.

During Dr. McClellan's tenure at FDA, the agency made very real progress in review and approval of new drugs for the treatment of cancer, as is strongly suggested by the approval of two new anti-cancer drugs just within the past several weeks. There is a widespread perception in the cancer community and beyond that Dr. McClellan fostered an environment within FDA that valued good science as well as patient access to life-extending new therapies.

In contrast, CMS has embarked on a variety of initiatives that are regarded as threatening to evidence-based medicine and to appropriate patient access. Notable among these has been an effort to restrict Medicare coverage for certain new cancer drugs in clear contravention of both the Medicare law and sound medical practice. We hope that Dr. McClellan, with his unique qualifications in medicine and economics, will view these issues with a perspective that appreciates the value of medically appropriate off-label uses of cancer drugs.

If Senators disagree with some elements of Dr. McClellan's policies at FDA, they will have an opportunity to raise those issues afresh with his successor at FDA. However, we urge that those disagreements not be used as a justification for delay in the appointment of a capable Administrator to the CMS post, which is in urgent need of new leadership.


Cancer Leadership Council

American Psychosocial Oncology Society
American Society of Clinical Oncology
Cancer Care, Inc.
Cancer Research and Prevention Foundation
The Children's Cause, Inc.
Coalition of National Cancer Cooperative Groups
International Myeloma Foundation
Kidney Cancer Association
The Leukemia & Lymphoma Society
Multiple Myeloma Research Foundation
National Coalition for Cancer Survivorship
National Patient Advocate Foundation
North American Brain Tumor Coalition
Ovarian Cancer National Alliance
Us Too International Prostate Cancer Education and Support Network
The Wellness Community
Y-ME National Breast Cancer Organization