RECOMMENDS PROMPT APPOINTMENT
Dear Dr. Crawford:
The undersigned organizations have been engaged in discussions with officials of the Food and Drug Administration (FDA) over the course of the past several years in support of a reorganization of the agency to provide better review and regulation of products to prevent, diagnose, and treat cancer. We were pleased when FDA announced in July 2004 that a new Office of Oncology Drug Products would be established within the Center for Drug Evaluation and Research (CDER), and we are now writing about the appointment of the Director of the new Office.
The success of the
new Office and enhancement of cancer product review will depend significantly
on the qualifications and qualities of the new Director. We realize that
FDA has the ability to tailor its search and appointment process to ensure
that the new Director has the skills that are necessary for this important
position. We are pleased that FDA has made commitments to include outside
experts as part of the selection panel for this position and to recruit
a seasoned cancer clinical researcher. As the process for recruiting and
evaluating candidates moves forward, we urge FDA to retain as a basic
qualification that the Director be a board certified medical oncologist
or hematologist with substantial experience in designing and conducting
cancer clinical trials. Beyond these fundamental qualifications, the new
Director should have the administrative and leadership skills necessary
to ensure the smooth functioning of the Office and to attract a critical
mass of oncologists to complete the important work of the Office.
Thank you for your consideration of our views on this important matter.
cc: Janet Woodcock,
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