FDA To Establish New Cancer Office
The Food and Drug Administration (FDA) announced on July 16 that it will create the Office of Oncology Drug Products (ODP) to help foster a strong and 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," said Health and Human Services Secretary Tommy G. Thompson. "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 initiative by FDA will benefit cancer patients in the future by helping new cancer drugs reach the community," said National Cancer Institute Director Dr. Andrew C. von Eschenbach. "As NCI promotes research to develop new interventions to prevent, detect, and treat cancer, we look forward to supporting FDA's efforts.
"We have been working with FDA and other agencies and organizations to bridge the gap between the promise of research and its application to people with cancer," Dr. von Eschenbach continued. "It is critically important that we seamlessly integrate discovery and development of new drugs with the approval process so we can deliver these vital therapies to the American people."
This announcement follows other changes to the FDA cancer review processes, including formation of the FDA/NCI Interagency Oncology Task Force to enhance the efficiency of clinical research and scientific evaluation of new cancer medications. Announced in May 2003, this joint agreement allows FDA and NCI researchers to share knowledge and resources to optimize the development and delivery of new cancer drugs to patients.
In addition to improving consistency of review and policy for oncology drugs, ODP will bring together a critical mass of oncologists to help in development of new therapies and provide technical consultation between FDA's Center for Drug Evaluation and Research (CDER) and other FDA components. ODP also will be responsible for reviewing drugs and certain therapeutic biologicals used in medical imaging to detect, treat, or monitor cancer.
To support this new oncology office and coordinate cancer prevention, diagnosis, and treatment work performed throughout its centers, FDA is also creating a cross-cutting oncology program to be housed within ODP. This oncology program 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 oncology professional societies, NCI, and other stakeholders. This program will also coordinate educational activities.
A national search to recruit a director for this office will begin later this summer. Final implementation of this new structure will occur when new CDER drug review staff move to a new FDA facility in April 2005.