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The Food and Drug Administration (FDA) today announced plans to make significant changes to its organizational structure to provide for an even stronger and more consistent approach to the review process for drugs and most therapeutic biologics used to diagnose, treat, and prevent cancer.
"Biomedical research in the United States is second to none, and it is our responsibility to see that patients reap the fruits of that research," Health and Human Services Secretary Tommy G. Thompson said. "We are committed to creating the most effective and efficient review process possible to ensure life-saving treatments are made available to cancer patients."
"This new structure highlights FDA's on-going commitment to finding new and better ways to get safe and effective treatments to cancer patients," said Dr. Lester M. Crawford, Acting FDA Commissioner. "FDA has worked closely with the cancer community to plan these changes, which have the support of many stakeholders in the fight against cancer."
"This initiative by the FDA will benefit cancer patients in the future by helping important cancer drugs reach the community," said NCI Director Andrew C. von Eschenbach, M.D. "As NCI promotes research to develop new interventions to prevent, detect, and treat cancer, we look forward to supporting FDA's efforts."
FDA will create a new oncology office, called the Office of Oncology Drug Products (ODP), to be housed in the Center for Drug Evaluation and Research (CDER). This new office will be a consolidation of three existing areas within CDER responsible for the review of drugs and therapeutic biologics used to diagnose, treat, and prevent cancer. This new office will also include drugs and certain therapeutic biologics used in medical imaging, many of which are used to detect, treat, or monitor cancer.
The Office of Oncology Drug Products will contain three review divisions. Decisions on the specific grouping of products and staff within these three divisions are under active consideration and will be finalized later this summer. The therapeutic biologic products that will be included in this new office include recombinant therapeutic proteins and monoclonal antibodies.
The creation of this new office will improve consistency of review and policy toward oncology drugs, and bring together a critical mass of oncologists who will help develop new therapies. This office will also provide technical consultation between CDER and other FDA components including FDA's Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Food Safety and Applied Nutrition (CFSAN).
To support this oncology office, and coordinate work performed throughout the FDA Centers (CDER, CBER, CDRH, and CFSAN) related to the prevention, diagnosis, and treatment of cancer, FDA is also creating a cross-cutting Oncology Program, to be housed within the oncology office, that will facilitate cross agency expert consultation, provide a forum to discuss and develop regulatory policy and standards, and serve as a focal point for agency interaction and collaboration with the Oncology professional societies, National Cancer Institute (NCI) and other important stakeholders. This program will also coordinate cross-cutting training and oncology educational activities.
A national search to recruit a Director for this new office will begin later this summer. The final implementation of this new structure will occur when the new drug review staff from CDER moves to the new FDA White Oak facility, which is scheduled to begin in April 2005.
Today's announcement follows several other important changes FDA has made to cancer review over the last few years, such as the formation of the FDA/NCI Interagency Oncology Task Force to enhance the efficiency of clinical research and the scientific evaluation of new cancer medications.
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