TO REP. ALLEN REGARDING FDA APPROVAL PROCESS
The Honorable Thomas
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
Cancer Leadership Council
Alliance for Lung
Cancer Advocacy, Support, and Education
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