FDA to Consolidate Oncology Approvals
Pharmaceuticals to prevent, diagnose, and treat cancer will have a new home and single boss at the Food and Drug Administration (FDA) when the staff that reviews new drug applications moves from Rockville, Md., to nearby Silver Spring in 2005.
The agency announced today that reviews of oncology-related drugs, recombinant therapeutic proteins, monoclonal antibodies, and imaging agents by the Center for Drug Evaluation and Research (CDER) will fall under the purview of the soon-to-be-created Office of Oncology Drug Products and yet-to-be-recruited director.
Under CDER's current structure, new drug applications and related paperwork for brand-name oncology-related pharmaceuticals are handled by personnel in at least three divisionsOncology Drug Products; Therapeutic Biological Oncology Products; and Monoclonal Antibodiesthat report to directors of different offices. This reporting arrangement is a consequence of the 2003 transfer to CDER of oversight for the therapeutic monoclonal antibodies, proteins, immunomodulators, growth factors, and cytokines formerly handled by the Center for Biologics Evaluation and Research (CBER).
Each office director, said John Jenkins, director of the Office of New Drugs, which will oversee the new oncology drug office, has the authority to approve the marketing of totally new pharmaceuticals. The division directors can approve the marketing of pharmaceuticals for new indications and in new dosage forms.
Launch of the Office of Oncology Drug Products will mean that decisions on whether to approve new oncology-related drugs, recombinant therapeutic proteins, monoclonal antibodies, and imaging agents will be made by the same person, who will also set the course for the approval of new indications, dosage forms, and safety information.
"This will allow us to have greater efficiency and consistency in how we approach the regulation and the advice we give to sponsors about the development of these drugs to treat and diagnose and prevent cancer," Jenkins said during a teleconference.
He explained that having one office oversee the work of divisions regulating pharmaceuticals having the same general purpose is similar to how the agency reviews applications related to antiinfective agents. The divisions of Anti-Infective Drug Products and Anti-Viral Drug Products report to the same Office of Drug Evaluation.
In addition to oncology-related drug evaluations, FDA announced that the new office will be home to the Oncology Program, which is being created to coordinate the work at CDER, CBER, the Center for Devices and Radiological Health, and the Center for Food Safety and Applied Nutrition on the prevention, diagnosis, and treatment of cancer. This new program will also serve as the agency's base for collaborating with oncology professional societies, the National Cancer Institute, and other stakeholders in the cancer field.