FDA Office of Oncology -- Questions and Answers
Posted on: 07/20/2004
FDA Office of Oncology -- Questions and Answers
July 16, 2004
Q: What is FDA announcing?
A: The FDA is today announcing important changes to the agency’s organization to strengthen the way it reviews products to diagnose treat and prevent cancer. FDA will take bold steps to create a new model that will enhance the efficiency and consistency of product reviews, so cancer patients will have access to the best new treatments.
Q: What caused FDA to announce this?
A: FDA is always looking for ways to carry out its public health mission more effectively. This action grows out of many fruitful discussions the agency has had with numerous cancer advocacy organizations, industry representatives, and the National Cancer Institute over the past two years.
Q: How will new Oncology Office be set up?
A: FDA will form a new Oncology Office that will help forge a more coherent approach to evaluating drugs and therapeutic biologics created to diagnose, treat and prevent cancer. This new Oncology Office will also include drugs and therapeutic biologics for medical imaging procedures, many of which are used to detect, treat, and monitor cancer. The new office will consist of three review divisions. FDA is currently evaluating the most efficient and effective way to organize the products that will be reviewed in this office into the divisions and expect to arrive at a final plan later this summer.
The Office of Oncology Drug Products will be housed in the Center for Drug Evaluation, because the majority of cancer products already are reviewed in various locations throughout this Center. The new Oncology Office Director will report to the Director of the Office of New Drugs, CDER.
Q: What will be the Office’s authority for approving cancer drugs?
A: The Director of the Office of Oncology Drug Products will have the authority to approve NME’s—new molecular entities, or totally new cancer products. Most other drugs (e.g., new dosage forms, new indications) will be approved by the division directors within the Oncology Office.
Q : How will the Oncology Program work within the new Oncology Office?
A: To support this Oncology Office and coordinate work performed throughout the various FDA product Centers (i.e., CDER, CBER, CDRH and CFSAN) related to the prevention, diagnosis and treatment of cancer, FDA is also creating an Oncology Program that will be housed in the Oncology Office.
The Oncology Program will facilitate the consultation of FDA experts across the agency, provide a forum to discuss and develop regulatory policy and standards, and serve as a focal point for Agency interaction and collaboration with the National Cancer Institute and other important stakeholders.
Q: Are you reorganizing just reviewers or are you changing where products will be reviewed?
A: This change will move personnel within the Center for Drugs, and also will consolidate the responsibility for review of cancer drugs within the Oncology Office.
Q: Will current review standards for oncology products be changing?
A: The legal standards for approval of drugs will not change, but the new program is designed to help facilitate the ongoing development of new standards as practice and science evolve.
Q: Is this a first step?
A: The agency believes that this new structure and program for the review of cancer drugs will significantly improve efficiency and consistency of product reviews, so cancer patients will have access to new treatments quickly. FDA will closely monitor the success of this new program in meeting these goals and will consider the need for any further enhancements in the program over time.
Q: Does creating an Office of Oncology and an Oncology Program represent the most appropriate way to reach our public health goal of bringing cancer products to patients more quickly?
A: Yes. Our goal is to strengthen the way FDA reviews products to diagnose, treat and prevent cancer. We believe creating this office and centralizing decision making and creating a cross-cutting program to coordinate activities will enhance the efficiency and consistency of product reviews.
Q: Who will run this new Oncology Office and Oncology Program?
A: FDA plans to conduct an internal and external search to select the Director of this new Office. Strong management skills, an understanding of drug development and regulation, and expertise in oncology will be job prerequisites.
Q: When will this change be initiated?
A: FDA will immediately begin further planning to put this structure in place. A search for Director of the Oncology Office will begin later this summer.
This new structure will be fully implemented when the new drug review staff in CDER move to the new FDA White Oak facility, which is scheduled to begin in less than 9 months (April 2005).
Q: Will this change how or where devices are regulated?
A: No. However, the cross-cutting nature of the planned Oncology Office will ensure that CDRH has access to oncologists in other centers as well as the benefit of learning about any new thinking in oncology.
Q: Is the Medical Imaging Division being turned to cancer imaging only?
A: No. The medical imaging division includes drugs related to diagnosis of cancer, as well as the detection, diagnosis, and monitoring of other diseases and conditions. In addition, it will continue to review drugs that speed the elimination of radioactive contamination. These drugs are very important to our national security. The division also is responsible for therapeutic drugs that use radioactivity as a means to treat diseases are also reviewed in this division.
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