In a bid to streamline the review of new treatments for cancer, the FDA has reorganized and renamed the Office of Hematology and Oncology Products (OHOP) in the Center for Drug Evaluation and Research (CDER). Richard Pazdur, M.D., who led the former OHOP, will continue as acting director of the revamped office, now called the Office of Oncologic Disease (OOD).
The move is the second step in plans the agency laid out in September to modernize its Office of New Drugs (OND). In four phases between this October and March next year, the FDA will increase the number of clinical offices and divisions and group them by therapeutic area. The plan calls for OND to bring the number of clinical offices from six to eight; the eight offices will each cover a different therapeutic area such as infectious diseases, neuroscience and oncological diseases.
The OOD will go from four divisions to six. Two of them, called the Division of Oncology Products 1 and 2, will drop the “products” from their name and become three Divisions of Oncology: DO1, DO2 and DO3, the FDA said in a statement Wednesday. DO1 will review treatments for breast, gynecologic and genitourinary cancers and DO2 will review those for thoracic and head and neck cancers, central nervous system cancers, pediatric solid tumors and rare cancers. DO3 will be responsible for gastrointestinal cancers, melanoma and other advanced skin cancers and sarcomas.
The Division of Hematology Products will split into two Divisions of Hematologic Malignancies to review treatments for blood cancers. These divisions will no longer review non-malignant blood conditions, such as anemia, hemophilia and other bleeding disorders. That responsibility will move to a new division in the CDER’s Office of Cardiology, Hematology, Endocrinology and Nephrology. The Division of Hematology Oncology Toxicology will not change.
“As the practice of oncology and the treatments for these life-threatening diseases have become more complex, we recognized the need to flatten the organization with additional but smaller review divisions to enable more efficient drug review,” Pazdur said in the statement. “Reorganizing the office in this manner will allow for greater stakeholder engagement in the various disease programs.”
The OOD has created a new safety team that will work with the different divisions “to provide for consistent review, management, and communication of safety information across development programs and throughout the pre- and post-market life-cycle of oncology drugs,” the FDA said.
This is part of the second phase of OND’s revamp. The Office of Antimicrobial Products is slated to become the Office of Infectious Diseases and a new Office of Neuroscience will be created from “select Divisions” in the Office of Drug Evaluation.
In the first phase of its reorganization, which kicked off last month, the OND created a handful of new offices, including the Office of New Drug Policy, the Office of Drug Evaluation Sciences and the Office of Regulatory Operations.