LETTER
TO REP. ALLEN REGARDING FDA APPROVAL PROCESS
(July 10, 2001)
July 10, 2001
The Honorable Thomas
H. Allen
U.S. House of Representatives
1717 Longworth House Office Bldg.
Washington, D.C. 20515
Dear Representative Allen:
It has come to our attention that you may be considering a proposed amendment to the Appropriations bill for the Food and Drug Administration (FDA) that would bar the agency from approving any new drug application that was not accompanied by prior written disclosure of the cost of the drug's development. According to your amendment, itemization of the drug's development cost must include data with respect to each stage of drug development, as well as specific information related to research funding from federal or state sources.
As a community of organizations advocating for quality cancer care, we are concerned that your amendment constitutes a recipe for stalemate with industry and will cause delays in the approval of new medications for cancer. For people with cancer, stalemate and delay are unacceptable. The Congress has worked very hard to make the FDA approval process more accountable and more efficient. As a result of these changes and the dedication of the FDA's oncology review staff, a new life-extending anti-cancer drug for a rare blood cancer was recently approved in record time. Your amendment could place at risk the improvements in FDA procedures for reviewing new drugs.
Being very familiar
with the processes for funding and carrying out cancer research, we understand
that basic science research funded by the federal government most often
results in generalized information that could potentially make contributions
to many medical advances, including cancer. While we believe reporting
of research funding dollars and how they are spent in pursuit of these
new therapies is desirable, we believe your amendment, as written, would
not achieve that outcome and would have the unintended consequence of
a chilling effect on public/private research collaboration. We strongly
urge you to reconsider your proposed amendment and instead find some alternative
approach to achieving your goals with respect to reporting of research
funding.
Thank you for your attention to our concerns. We look forward to your
response.
Sincerely,
Cancer Leadership Council
Alliance for Lung
Cancer Advocacy, Support, and Education
American Society
of Clinical Oncology
Association of American Cancer Institutes
Cancer Care, Inc.
Cancer Research Foundation of America
The Children's Cause, Inc.
Colorectal Cancer Network
Cure For Lymphoma Foundation
International Myeloma Foundation
Kidney Cancer Association
The Leukemia & Lymphoma Society
National Alliance of Breast Cancer Organizations
National Coalition for Cancer Survivorship
National Patient Advocate Foundation
National Prostate Cancer Coalition
Ovarian Cancer National Alliance
Pancreatic Cancer Action Network
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